Cortex- ( COR )-- Ampakine, neue Behandlungsmöglichkeit bei Schizophrenie u. v. a. - 500 Beiträge pro Seite

[Erbse1]

Cortex Pharmaceuticals COR
Ich möchte heute eine Aktie vorstellen, die bei meinen Recherchen zu neuen Behandlungsmöglichkeiten bei Schizophrenie wohl bald in den Mittelpunkt der Diskussionen rücken dürfte. Gehandelt wird Cortex an der Amex unter dem Kürzel COR. In Berlin kann man sie unter der WKN 879005 ordern. Leider ist es in Berlin selten möglich einige Stücke zu einem halbwegs vernünftigen Preis zu bekommen, da der Makler einfach nur hochtaxt und die Order nicht bedient. Deshalb möchte ich raten nur in den USA zu ordern.

Kurz zu Schizophrenie (Psychosen)
Betroffen sind ca 1% der Bevölkerung. Maßgeblich für diese Krankheit ist eine überhöhte Ausschüttung des Neurotransmitters Dopamin. Zwischen den Nervenzellen im Gehirn werden ständig Neurotransmitter ausgeschüttet. An den Nervenenden befinden sich Synapsen, an denen die einzelnen Botenstoffe (Neurotransmitter) ausgeschüttet oder wieder aufgenommen werden. Bei Schizophrenie ist es nun so, daß ein Überangebot des Botenstoffes Dopamin besteht. Es kommt zum Ausbruch der Krankheit mit folgenden typischen Merkmalen. Kurz erwähnt werden sollte wohl noch das bei ca 20% der betroffenen Patienten eine vollständige Heilung nach ein oder zwei Psychosen eintritt. Der weitaus größte Teil muß lebenslang mit Psychosemedikamenten behandelt werden. Leider ist es so, daß einige Patienten ihr ganzes Leben in psychiatrischen Einrichtungen verbringen müssen.
Jetzt kurz zu den Merkmalen.
Die Positivsymptomatik---Während der Akutphase kommt es zu Wahnideen mit verschiedensten Ausprägungen. Denkstörungen Feindseligkeit und Mißtrauen sind oft zu beobachten.
Die Negativsymptomatik--- Im weiteren Verlauf entwickeln viele Patienten eine Affektverarmung, emotionale und soziale Isolation, Sprachverarmung, Depressionen, Schuld und Angstgefühle.
kognitive Leistungsminderung---Bei einem Teil der Patienten tritt eine Minderung der Leistungsfähigkeit des Gehirns ein. Noch vor kurzer Zeit wurde in den alten Lehrbüchern von einer "Verblödung" fast aller Psychotiker ausgegangen. Dies stimmt so nicht. Dennoch kann bei vielen Erkrankten eine Minderung beobachtet werden, die bei einigen Patienten auch sehr ausgeprägt sein kann.

Bisher wurde folgender Behandlungsansatz gewählt. Durch Medikamentengabe wurden nun die Synapsen im Gehirn blockiert, die für die Dopaminaufnahme zuständig waren. Leider ist es so, daß bei dieser Methode sehr viele unerwünschte Nebenwirkungen auftraten und viele Patienten die Behandlung wieder abbrachen und so bald wieder eine Einweisung in die Psychatrie notwendig war.
Neuere Medikamente, die immer weiter verfeinert werden, versprechen gute Erfolge bei der Positiv und Negativsymptomatik. Dies geschieht hauptsächlich dadurch daß die Synapsen für Dopamin (Positivsymptomatik) und Serotonin (Negativsymptomatik) blockiert werden. Das größte Manko sind halt bei diesem Ansatz bei vielen Patienten die enormen Nebenwirkungen. Außerdem wirken diese Medikamente nicht gegen die kognitiven Leistungseinbußen.

Hier rückt jetzt auch Cortex mit seinen Ampakinen in den Mittelpunkt. Ampakine beeinflussen den Glutamattransmitter, den meistvorkommenden Transmitter im Gehirn. Zwischen den einzelnen Transmitter und Glutamat besteht eine Wechselwirkung. Gelingt es nun das Glutamat nun so zu beeinflussen, daß nur noch die richtige Menge an Dopamin ausgeschüttet wird, wäre eine Blockierung der Synapsen gar nicht mehr notwendig. Außerdem hat die Substanz CX516 noch folgende Eigenschaft. Es verbessert die Leistunsfähigkeit des Gehirns ganz enorm. So wurde in bisherigen Versuchen nachgewiesen, daß diese Substanz die Leistungsfähigkeit eines alten Menschen fast auf den Level eines jungen Menschen bringt. Das sind Eigenschaften, die einen fast an eine Wunderdroge glauben lassen. Nun, Cortex ist eine kleine Firma mit 28 Mitarbeitern und sie suchen sich Partner für die einelnen Testphasen und Anwendungsgebiete. Im Bereich der Schizophrenie und Depressionen arbeitet Cortex mit Organon zusammen. Erst vor einigen Tagen zahlte Organon Milestones in Höhe von 2Mill.$ an Cortex und plant in die Testphase 2 zu gehen.

Ich habe versucht die Ampakine kurz im Zusammenhang mit Schizophrenie zu erläutern. Doch dies ist nur ein Anwendungsgebiet. Mittlerweile wurden ca 100 Substanzen isoliert, die auch bei anderen Erkrankungen des Gehirns in Frage kommen.
Folgend kurz die Gebiete in denen die Ampakine zur Anwendung kommen können. Weitere Anwendungsgebiet werden laufend erforscht.
- Schizophrenie
- Alzheimer
- Parkinson
- ADHD Attention Deficit Hyperactivity Disorder
- Sexuelle Dysfunktion
- Depression
- MCI Mild Cognitiv Impairment
- Multiple Sklerose
- Lou Gehrigs Disease

Partnerschaften bestehen mit folgenden Firmen, die die einzelnen Testphasen durchführen.

- Organon
- Les Laboratoires Servier
- Shire Pharmaceuticals Group

Weitere größere Partner werden gesucht, da Cortex nicht in der Lage ist, mit seinen bescheidenen Geldmittel selber Testphasen durchzuführen.

Dies soll hier keine vollständige Analyse werden, dazu hab ich auch keine Lust, sondern als Einstieg dazu dienen sich in der kommenden Zeit mit Cortex zu beschäftigen. Sehr gute Analysen gibt es auf der Homepage von Cortex. Eine Recherche, die sich wirklich lohnen sollte. Allerdings solltet Ihr ein wenig Zeit mitbringen, denn die Recherchen sind doch etwas umfangreicher . Folgend kurz die Adresse.
www.cortexpharm.com
Auf dem Yahooboard wird Cortex unter dem Kürzel COR diskutiert. Bei RagingBull noch unter der alten Bezeicnung CORX.
Das Sahnehäubchen nun zum Schluß. Cortex ist bei einem Kurs von ca 2$ mit ca 35 Mill.$ bewertet. Auch wenn sich die Ampakine noch in frühen Testphasen befinden, eine geradezu einladende Bewertung.
Ich möchte Euch noch darauf hinweisen, daß dies hier als Diskusionsforum gedacht ist und jeder selbst dafür verantwortlich ist, welche Aktien er kauft. Selbstverständlich halte ich Aktien von Cortex und bin an steigenden Kursen interessiert. Ich hoffe, daß sich demnächst einige Mitstreiter finden und wir hier über Cortex streiten können. Ihr seid alle herzlich eingeladen.
Mit lieben Grüßen
Erbse1

[puhvogel]

Hallo Erbse: Das ist eine feine Einführung in die Biotechfirma Cortex. Auch diese Firma gehört zu den kleinen, noch unbeobachteten Juwelen der Biotech Branche. Firmen, die natürlich ein erhebliches Risiko in sich tragen, aber auch ein potenziell riesiges Wachstumspotenzial inne haben. So könnte man hier leicht mit 40 Milliarden US-Dollar Umsatzpotenzial um sich werfen, aber der Weg dorthin ist natürlich riesig riesig weit und in dieser Höhe wahrscheinlich auch unrealistisch.
Einige Aspekte von Cortex möchte ich aber dennoch besonders herausstellen: Zum einen war Cortex früher einmal ein Freihandelswert OTCBB, der sich zu einem regulären NYSE- Wert entwickelt hat. Man kann also auch bei den ganz kleinen Firmen manchmal ein exzellentes Unternehmen heraus sieben, ein Verdammen im Bausch und Bogen der OTCBB-Werte ist also nicht angebracht. Cortex ist jetzt bei weitem aber immer noch nicht groß. Zum anderen besitzt Cortex eine Reihe von Patenten, die die Anwendungsgebiete der Ampakanine umfassend abdecken.

Schließlich sollte noch angefügt werden, dass die Ampakanine unter Umständen wie das Neotrofin die Fähigkeit besitzen könnten, bestimmte Gene der Hirnzellen zu aktivieren, die für das Wachstum und die Proliferation der Nervenzellen zuständig sind. Bewiesen ist aber natürlich noch nichts. Überhaupt muss man mit dem Begriff "Beweis" bei Medikamenten der klinischen Experimentalphase noch sehr vorsichtig sein, solange noch keine Phase 3 Daten vorliegen.

[Erbse1]

Hallo Puhvogel, liebe Cortex Fans, falls es schon welche gibt.
Kurz noch zur Einführung. Genaugenommen gibt es zwei Anwendungsgebiete im Zusammenhang mit der Schizophrenie. Mit der Substanz CX 516 wurden bisher sehr gute Ergebnisse erziehlt, was die kognitive Leistungsminderung betrifft. Also hätten wir hier ein Anwendungsgebiet, daß alle Psychotiker betrifft. Die ersten Versuche wurden ja auch bei zusätzlicher Gabe von Leponex durchgeführt.
Das zweite Anwendungsgebiet betritt nun Organon mit der Substanz ORG 24448, nämlich über den Glutamattransmitter das Problem anzugehen und so die Psychose zu behandeln. Dies ist vollkommen neu. Leider sind wir hier noch in einer frühen Phase und wir müßen abwarten, ob die Tierversuchen auch am Menschen bestätigt werden. Sollte dies gelingen, entsteht hier ein ganz neuer Behandlungsansatz. Meine Hoffnung besteht darin ohne die bisher bekannten Nebenwirkungen eine Behandlung gegen Schizophrenie durchführen zu können.
Kurz noch zum Potential von Cortex. Hätte ich von 10000% in der Eröffnung geschrieben so wäre hier bestimmt keine sinnvolle Diskussion zustande gekommen. Doch es ist so. Sollten die Ampakine ein Erfolg werden, schlummert hier ein enormes Potential. Puhvogel ich muß Dir Recht geben, der Weg kann sehr lang werden und ein Scheitern ist auch nicht ausgeschloßen. Ich rechne eher damit, daß Cortex bei einem sich abzeichnendem Erfolg bei dieser Bewertung ein Übernahmekandidat für einen Pharmariesen werden könnte.
Die Geschichte wird so oder so spannend. Ich denke mal, daß es sich lohnt sie zu verfolgen.
Liebe Grüße
Erbse1

[Erbse1]

Hier eine Meldung von heute. Bei solchen Tierversuchen muß man immer sehr vorsichtig sein. Dennoch bestätigen sie erste Ergebnisse. Bisher habe ich Ampakine nur im Zusammenhang mit Schizophrenie erläutert. Dies betrifft nun das Anwendungsgebiet ADHD. Das ist das Gute an den Ampakinen, daß sie nicht auf ein Anwendungsgebiet beschränkt sind.
Liebe Grüße
Erbse1
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Duke University Investigators Publish Positive Effects Of Cortex`s AMPAKINE(R) Molecules in Mouse Model of ADHD
October 02, 2001 08:31:00 AM ET

IRVINE, Calif., Oct. 2 /PRNewswire/ -- Cortex Pharmaceuticals, Inc. COR today reported that Drs. R.R. Gainetdinov, A.R. Mohn, L.M. Bohn and M.G. Caron have published their results that include the use of Cortex`s AMPAKINE compounds in genetically engineered mice. Dr. Marc G. Caron is an investigator at the Howard Hughes Medical Institute, Duke University Medical Center in Durham, North Carolina. His team developed a transgenic mouse model for ADHD. The model involves "knocking out" the dopamine transporter gene, which causes abnormal dopaminergic function in the mouse. As a result, the mice are hyperactive when placed in new environments, which closely mimics one of the characteristics of ADHD in children. Furthermore, genetic alterations in the dopamine transporter gene may contribute to ADHD in humans.

In Dr. Caron`s studies, four AMPAKINE compounds were tested, and all four gave statistically significant reductions in hyperactivity. The results, under the title "Glutamatergic modulation of hyperactivity in mice lacking the dopamine transporter" were published in the September 25 issue of the Proceedings of the National Academy of Science (USA) (Vol. 98, pp 11047- 11054). In previous publications, Dr. Caron`s group demonstrated that drugs commonly prescribed for treating Attention Deficit Hyperactivity Disorder ("ADHD") also gave positive results in their mouse model.

"These results are very encouraging," said Vincent F. Simmon, Ph.D., President and CEO of Cortex. "CX516 was one of the molecules tested that proved effective. This is the molecule that our partner, Shire is evaluating in a Phase II study in patients with ADHD. One of the exciting results was that our new and more potent molecules were 30 to 100 times more effective than CX516. This presents a clear second generation opportunity of improved molecules for Shire and Cortex."

The authors noted that "these findings support the concept of reciprocal functional interaction between dopamine and glutamate in the basal ganglia and point to agents enhancing glutamatergic transmission as a potential approach to treat conditions associated with hyperdopaminergic function." In addition to the "hyperdopaminergic" activity in ADHD, the authors point out that schizophrenia is a hyperdopaminergic condition that may benefit from treatment with AMPAKINE compounds.

"The results clearly support our hypothesis that AMPAKINE drugs may be useful for treating a number of disorders, including ADHD and schizophrenia," concluded Dr. Simmon.

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The strengthening of these connections is thought to be important in the treatment of memory difficulties in patients suffering from Alzheimer`s disease or schizophrenia. The symptoms of schizophrenia are believed to be caused by hyperactivity of dopamine pathways and a reduced activity of the glutamate pathways. Cortex has an alliance with Organon for the potential treatment of schizophrenia and depression; with Servier for the potential treatment of declines in cognitive function related to aging and neurodegenerative diseases; and with Shire Pharmaceuticals Group for the evaluation and potential licensing of the AMPAKINE technology as a treatment for ADHD.

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[Erbse1]

Habe hier einen Ausschnitt aus einem Interview gefunden. Ist leider nicht komplett. Ich suche noch nach der vollständigen Version und stell sie dann, wenn es mir gelingt hier rein.
Liebe Grüße
Erbse1
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(COMTEX) B: CEO of Cortex talks about the difficulties of drug developme
B: CEO of Cortex talks about the difficulties of drug development in Wall
Street Transcript Interview VINCENT F. SIMMON is President and Chief Executive
Officer and a Director of Cortex Pharmaceuticals, Inc.
New York City, New York, Oct 05, 2001 (The Wall Street Transcript via COMTEX)
-- Four analysts, two experts and top management from thirty-seven sector firms
examine the Biotechnology sector in this special 179-page issue from The Wall
Street Transcript, available at (212/952-7433) or http://www.twst.com/info/info423.htm
TWST: You`ve mentioned a number of enterprises, a number of applications. Does
all that suggest that even if you fail in certain areas, the company could still
be a financial success because the application would still be broad, even if you
succeeded in two out of 10, let`s say?
Dr. Simmon: Very good point. If we take a look at the currently-marketed drugs
in the fields I`ve talked about, the total market is somewhere around $30
billion in annual sales of drugs in those fields. And as I indicated, there are
not any drugs being sold in some of the fields, such as recovery from traumatic
brain injury or stroke and to treat mild cognitive impairment. Those would be a
whole new growth area. If Cortex were to succeed in any one of those, or our
pharmaceutical partners were to succeed in any one of those resulting in
royalties to Cortex (AMEX:COR), the company would be a tremendous financial
success.
TWST: Could you talk more about the risks, difficulties, obstacles, etc.?
Dr. Simmon: Drug development is fraught with difficulties, and we`re at the
early stages of development. Drugs to treat the central nervous system have been
on the high side in terms of drug failures. However, we believe that this new
technology does have a strong possibility of success. We have safely exposed
more than 100 people to date, using drugs based on this technology. We are
encouraged in this, and we have many different chemical forms, or molecules,
that have the capabilities I`ve described. We select those molecules that seem
to work best in different indications. Therefore, we are not reliant on a single
chemical, or a single type of chemical. We have many different prospects, we and
our partners have different prospects - and we`re developing more of those all
the time. We think we have a good chance, but there is a risk longer-term that
there would be something about these molecules that we`re not currently aware of
that could hinder their development.
TWST: Speaking of things that you`re not currently aware of, is there a
likelihood that you could exceed your own expectations in part of what you do?
Dr. Simmon: Historically we`ve set fairly aggressive development goals for the
company for the upcoming years. And we`ve been pretty successful at achieving
those goals. Our partners have done a very good job in working on the
development of our compounds. But we also try not to claim too much about what
can occur or will occur. We think there`s a big upside in this technology,
assuming that the drugs can be shown to be effective and safe, and your question
previously brought that out. If our technology works, there is a huge upside.
Cortex`s market cap today is around $40 million, well below most people`s radar
screens. If we succeed in clinical trials in any of these indications, it could
easily go up tenfold to a hundredfold.
TWST: Are there areas you`d like to work on? Any things you need to strengthen
or beef up, shall we say?
Dr. Simmon: We will be adding a key person on the clinical side during our
current fiscal year, which started July 1. I mentioned that we will be looking
opportunistically at acquiring other technologies that fit in with ours. If


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[Erbse1]

Ich poste hier mal einen kleinen Artikel von Cortex. Ist leider nur in Englisch. Hieran kann man sehr schön sehen, auf welchen Gebieten Cortex arbeitet und welches Potential hier schlummert. Hier wird das Anwendungsgebiet MCI sehr schön beschrieben.
Kurz noch zum Makler in Berlin. Der Kurs wird morgens gegen 8.45 Uhr und Abends gegen 19.30 gestellt. Tagsüber wird meistens überhaupt nicht getaxt. Ich würde die Order sehr zeitnah plazieren, da der Makler nur rumtaxt und selten eine Order bedient. Ist eigentlich eine Frechheit, einen Kurs zu stellen und dann die Order nicht auszuführen
Liebe Grüße
Erbse1
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Potential Therapeutics for Mild Cognitive Impairment

Vincent F. Simmon, Ph.D.

On March 13, 2001, the FDA convened an advisory committee to consider MCI as a new clinical indication. Individuals with MCI are not demented, but clearly are not normal in terms of memory, considering their age and education. Generally, they may score more than 1 standard deviation below the norm compared with their peers. In some cases, patients score nearer to the norm, but have additional deficits in other cognitive domains.

Individuals with significant memory impairment (amnestic MCI) have a high probability of progressing to Alzheimer’s disease, with 12%-15% converting to dementia each year. Over a 5 year period, 70% to 80% of these patients will progress to AD. Patients with less memory impairment have a somewhat lower probability of progressing to AD.

Post-mortem analysis of patients with MCI frequently reveals both plaques and tangles, although the patients were not demented at the time of their death. The results suggest that for AD and other dementias, there is likely to be a continuum, with individuals at varying stages of development. While the Clinical Dementia Rating scale suggests a sharp cutoff between normal aged and MCI individuals, and between MCI and AD patients, the reality is an overlap with some degree of gray zone.

Dr. Steve DeKosky, University of Pittsburgh pointed out at the FDA Advisory Committee meeting that post-mortem measurements of enzymes in the cholinergic pathway indicated normal to somewhat elevated ranges for MCI patients compared with very deficient levels for patients with AD. In interviews of several CROs, we learned that in on-going “progression trials” with MCI patients, the acetylcholinesterase drugs have little or no effect on tests of delayed recall and short term memory. It is also widely recognized that currently approved acetylcholinesterase drugs provide at most a modest and temporary benefit to patients with AD.

Taken together, these results indicate that a new pharmacology, independent of the cholinergic neurotransmission pathway, is needed to improve memory in MCI and to provide a greater benefit to patients with AD.

Glutamate is the major neurotransmitter in the brain, and serial connections of glutamate neurons are prevalent in the cortex, hippocampus and other regions of the brain implicated in psychiatric and neurodegenerative diseases. Gary Lynch and Gary Rogers invented a new pharmacology based on positive modulation of the AMPA-type glutamate receptor. The AMPAKINE® technology which has been licensed to Cortex is based on small (mw ~ 250) synthetic molecules that have good to excellent bioavailability and rapidly cross the blood brain barrier. The potential for this class of compounds to exacerbate stroke has been evaluated with several compounds in models of stroke and excitotoxicity. No exacerbation of the penumbra was observed in the middle cerebral artery occlusion test and some neuroprotection was observed when the AMPAKINE CX516 was administered to animals injected with the glutamate agonist AMPA.

Cortex has an extremely strong patent position based on standard composition of matter patents, as well as method of use patents that cover any molecule for AMPA receptor modulation to improve memory and cognition, to treat schizophrenia as a monotherapy or in combination with anti-psychotic medications, to increase libido and to upregulate neurotrophin expression.

AMPAKINE administration in vitro or in vivo results in regionally specific up-regulation of the immediate early gene, c-fos. This gene is a transcription factor that participates in the up-regulation of a number of other genes including the neurotrophic factors brain derived neurotrophic factor (BDNF) and nerve growth factor (NGF). Messenger RNA transcripts for c-fos and BDNF are increased in animals performing various behavioral tasks, resulting in enhanced protein production. Protein synthesis, and the persistence of various protein products may account for some of the prolonged effects of AMPAKINE drugs.

Novascreen tests have shown that the AMPAKINE drugs do not directly interact with other neuroreceptors systems. Nevertheless, these compounds can reduce the dopamine induced hyperactivity in rats treated with methamphetamine. The drugs have also been shown to reduce amphetamine induced rotation in the Ungerstedt model.

Double-blind clinical studies in 18 schizophrenic patients receiving clozapine and adding CX516 (n = 12) or placebo (n = 6) for 4 weeks resulted in statistically significant improvement in a number of clinical and neuropsychiatric tests. Improvements were noted on the last day of treatment as well as in a follow-up evaluation conducted 2-4 weeks after the last treatment day.

Results of a pilot study in 14 Alzheimer’s patients were encouraging. Mild to moderate AD patients received CX516 (n = 8) or placebo (n = 6) during a 4 week double blind treatment period. Treatment was preceded by a placebo run-in and placebo washout period. Within subject analysis showed a statistically significant improvement in the CIBIC in treated subjects evaluated at the end of washout compared with their baseline immediately prior to treatment. Within subject analysis of the ADAS-Cog gave a statistically significant improvement over baseline both on the last day of treatment and at the end of washout.

Cortex and Servier are planning a cross-national, double-blind, placebo controlled trial in 200 patients with MCI that is scheduled to begin this winter. Patients will be treated for 29 days and evaluated for memory improvement using Word List Delayed Recall as the primary endpoint. Additional memory and cognition tests will also be conducted.

Cortex is currently seeking partners for its AMPAKINE drug technology in the Americas for MCI, AD and other neurodegenerative dementias, and age-related decline in libido. Worldwide licensing opportunities are available for a number of psychiatric disorders, including anxiety, panic and OCD, as well as for recovery from stroke and traumatic brain injury.
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[Erbse1]

Hallo hier eine Meldung von Heute. Bei den Zahlungen handelt es sich um die Versuche in Zusammenhang mit Leponex. So weit ich weiß sollen die Zahlungen bei einem Eintritt in Phase3 wieder zurückfließen, falls sich ein Partner dafür findet. Also hier gehts um die Versuche mit den oben angesprochenen kognitiven Leistungsdefiziten. Das Betätigungsfeld von Organon zielt auf die Schizophrenie allgemein.
Liebe Grüße
Erbse1
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Cortex Receives $770,000 Grant From NIMH for Schizophrenia Research
- Preliminary Clinical Results Published in Journal of Clinical Psychopharmacology -
IRVINE, Calif., Oct. 17 /PRNewswire/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - news) today announced it has been notified that the National Institutes of Mental Health (NIMH) will fund the Company`s grant application, ``Therapeutic Potential of AMPAKINEs in Schizophrenia.`` It is anticipated that the grant will cover a period of two years and provide total funding of $769,818. The Principal Investigator for the grant is Steven A. Johnson, Ph.D., Director of Clinical Research at Cortex. This grant represents a Phase II Small Business Innovative Research (SBIR) follow-on to research previously funded by the SBIR Research Program.

``This award will allow us to follow-up on previously reported clinical tests of our AMPAKINE® CX516 as a potential combination therapy for schizophrenia,`` said Vincent F. Simmon, Ph.D., President and Chief Executive Officer of Cortex. ``Earlier tests were encouraging, with AMPAKINE-treated patients showing improvement in a number of clinical and neurocognitive scores.``

``Schizophrenia involves several categories of symptoms,`` stated Dr. Johnson. ``Currently available antipsychotics effectively control positive symptoms (hallucinations and delusions), but do not always alleviate persistent negative symptoms (withdrawal and apathy) or cognitive deficits.``

This award will support a Phase IIb study of CX516 as a combination therapy in schizophrenia patients concomitantly treated with olanzapine. The trial will employ a randomized, double blind, placebo controlled design in which the placebo group receives olanzapine plus placebo and the active group receives olanzapine plus CX516. A total of eighty patients will be enrolled in the trial, to be performed by Dr. Donald Goff, M.D. of Massachusetts General Hospital and Harvard University in Boston, MA.

Separately, Cortex announced the publication of an article entitled ``A Placebo-Controlled Pilot Study of the AMPAKINE CX516 Added to Clozapine in Schizophrenia`` in the October 2001 issue of the Journal of Clinical Psychopharmacology. The authors include Donald Goff, M.D., the Principal Investigator of the study, Gary Lynch, Ph.D., Professor of Psychiatry and Human Behavior at University of California, Irvine and Steven A. Johnson, Ph.D. The authors reported that ``CX516 was tolerated well and was associated with moderate to large between-group effect sizes compared with placebo, representing improvement in measures of attention and memory. These preliminary results suggest that CX516 and other AMPAKINE compounds hold promise for the treatment of schizophrenia.``

In 1999, Cortex licensed exclusive rights to its AMPAKINE technology as a potential treatment for schizophrenia to Organon. As recently reported, Organon is currently entering a Phase II study of an AMPAKINE as a therapy for the disorder. ``We believe that this grant-funded study of an AMPAKINE compound as a combination therapy may be useful in progressing the drug development of Organon,`` added Dr. Simmon.

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[Erbse1]

Hallo liebe Cortex Freunde. Kurz noch zur Meldung von gestern. Bisher liegen sehr gute Ergebnisse aus einer Studie mit Leponex (Clozapine) vor.
Die neuen Studien sollen jetzt mit Zyprexa (Olanzapine) durchgeführt werden. Damit zielt Cortex auf die größte Gruppe der Psychosemedikamente. Leider ist es so, daß die bisherigen Medikamente nicht oder nur bedingt gegen die kognitiven Leistungseinbußen wirken.
Der Kurs ist die letzten Tage ja auch ganz schön angezogen.
Liebe Grüße
Erbse1

[puhvogel]

Ich denke mir, dass sich die meisten potentiellen Investoren vor einer Nicht-Weiterinanzierung fürchten. Obwohl Cortex in der Vergangenheit dort recht erfolgreich war. Neurocrine ist übrigens eine Firma, die Cortex als Vorbild dienen könnte, wie man Pharmafirmen gegeneinander ausspielt. Die besitzen ja auch die Patente an einer bestimmten Rezeptorart.

[Hollawind]

@puhvogel u. Erbse1

1. Bei dem im ersten Posting angeführten Erklärungsmodell von Schiziphrenie handelt es sich selbsterklärend um ein biologisches. Ich sage das nur, wie ihr sicherlich selbst wisst, weil es auch andere Erklärungsmodelle von Schizophrenie gibt, aus deren Behandlungsableitung der Einsatz von Medikamenten eine weniger wichtige Rolle spielt. Fakt ist, daß das biologische Modell das derzeit akzeptierteste ist, was sicher auch daran liegt, daß biologische Erklärungen derzeit Hochkonjunktur haben. Für mich, der seit 8 Jahren mit schizophrenen Patienten arbeitet, ist aber auch klar, daß Medikamente auch weiterhin massiv im psychiatrischen Bereich eingesetzt werden (auch wenn mir das nicht so recht ist).

2. Seit Jahren werden immer wieder neue Supermedikamente gegen Schizophrenie kolportiert. Seit Jahren höre ich immer wieder, daß jetzt der Stein des Weisen gefunden sei und das Schizophrenie-Gen identifiziert sei. Fakt ist, daß nichts dergleichen der Realität entspricht. Das Schizophrenie-Gen wird sich meines Erachtens nicht finden lassen.

3. Die Dopamin-Hypothese ist uralt. Die Frage ist nur, ist der Dopaminüberschuss die Ursache der Krankheit oder nur eine Folge davon. Für die Behandlung der Krankheit eine entscheidende Frage, die weiterhin unbeantwortet ist. Das heißt eben: behandle ich die Ursache oder nur ein Symptom. Aus meiner Sicht wird das Symtom behandelt, was für den Absatz von Medikamenten natürlich vorteilhaft ist.

4. Die Verbesserung von Medikamenten im Bereich der Schizophrenie beziehen sich zu einem wesentlichen Teil auf die Verminderung ihrer Nebenwirkungen, die gerade bei Neuroleptika teilweise katastrophal sind. Insofern ist die Entwicklung zu begrüßen. Die Wirkung der Neuroleptika ziehlt hauptsächlich auf die positiv-Symtomatik, die Negativ-Symtomatik wird kaum tangiert.

Grüße Hollawind

[Erbse1]

Hallo Hollawind, freut mich, daß sich einer hier für das Thema ineressiert.
Kurz noch zu Deinem Einwand mit der Medikation mit Psychopharmaka. Es ist wohl eine Tatsache, daß bei einem Abbruch der Medikation ca. 80% der Patienten wieder einen Rückfall erleiden. Also besteht hier keine Alternative.

Zu Deinem zweiten Punkt. Bisher wurden nach meinen Informationen zwei Gene identifiziert, die für die Psychose zuständig sein sollen. Erstmal von Decode Genetics in Zusammenarbeit mit Roche. Weiterhin ein Gen für die Katatone Form der Schizophrenie. Inwieweit dies letztendlich auch die tatsächlichen Gensequenzen sind, weiß ich allerdings auch nicht.
Cortex arbeitet an einer ganz neuen Technologie, die auf die Glutamat Hypothese beruht. Natürlich bleibt abzuwarten, ob hier bei einer Medikation nicht auch Nebenwirkungen auftreten. Es liegen ja auch erst Daten von etwas über 100 Personen vor. Bisher sind aber keine gravierenden Nebenwirkungen bekannt. Nur noch kurz zur Information. Erst vor einigen Tagen wurde eine neue Theorie vom Karolinska Institut veröffentlicht.Es handelt sich hierbei um die Kynurenic acid Theorie. Meine Hoffnung besteht bei dem Glutamat Ansatz, da hier keine Synapsen mehr blockiert werden, daß hier die Nebenwirkungen nicht mehr auftreten und so die Zusammenarbeit mit den Patienten enorm erleichtert werden.
Zu deinem letzten Punkt. Bisher ist mir nur Solian bekannt, daß auch stimmungsaufhellend ist. Die neueren Medikamente sind in Deutschland noch gar nicht zugelassen, die auch gegen die Negativsymptomatik wirken. In den USA ist vor kurzem Geodon zugelassen. Abilitat ist zur Zulassung eingereicht. Zomaril ist wohl bis auf weiteres verschoben, da hier noch zusätzliche Tests durchgeführt werden.
Mir geht es in diesem Thread aber hauptsächlich darum, die Chancen und Risiken von Cortex einzuschätzen.
Wir können uns aber auch gerne in einem neuen Thread über die Schizophrenie im Allgemeinen unterhalten.
Falls Dich Cortex auch interessiert, solltest Du mal auf die Homepage von denen gehen und das neueste Interview vom Vorsitzenden lesen. Hier noch mal die Adresse.
www.cortexpharm.com
Liebe Grüße
Erbse1

[Hollawind]

@Erbse1

Nicht nur bei einem Abbruch der Medikation erleiden Patienten einen Rückfall (zu 80%), auch bei regelmäßiger Einnahme der Medikamente kommt es immer wieder zu Rückfällen. Auch wenn ich den Einsatz von Medikamenten in der Psychiatrie durchwegs kritisch sehe, gebe ich dir Recht, daß derzeit keine Alternative in Sicht ist, die derart allgemein akzeptiert ist. Natürlich würde ich ein Medikament begrüßen, das nebenwirkungsfrei eine wirkliche Verbesserung der Situation der Betroffenen wäre. Ich zweifle ein wenig daran. Danke für den Hinweis mit der Homepage von Cortex.

Ich traue mich noch nicht an ein solches Investment, beobachte aber interessiert das Geschehen.

Grüße und alles Gute für ein zufünftiges Investment
Hollawind

[puhvogel]

@Hollawind: Vielen Dank für Deine Einschätzung. Solche Kommentare machen erst für mich dies Board erst interessant!
Du überschätzt dabei auch meine Kenntnisse der Psychosen bei weitem, aber irgendwann und irgendwie muss man auch mal anfangen.
Vielleicht hast du mit deiner kritischen Einschätzung recht, aber Psychosen sind für Pharmafirmen offenbar ein wichtiges Forschungsfeld. Eli Lillys Gewinn hängt nach dem Wegfall von Prozac jetzt scheinbar völlig von Zyprexa ab, und das ist ein 87 Mrd $ Unternehmen!
Auch wenn Cortexs Aussichten sehr, sehr unsicher sind, so ist doch deren Marktkapitalisierung, also deren Preis, mit 0,045 Mrd $ 2000 mal kleiner als der von LLY. Selbst, wenn die Chance nur 1% beträgt, dass die Ampakine die Rolle von Zyprexa übernehmen werden, und sie sonst pleite gehen würden, würde sich rein rechnerisch das Investment lohnen, wenn eine hinreichende Diversifikation stattfindet (als Zielmarktkapitalisierung für einen doppelten Blockbuster nehme ich 10 Mrd $; ich nehme IMNX mit Enbrel als Vergleichsmassstab). Und Diversifikation bedeutet aber eben nicht die üblichen 3-6 Werte Depots (aus Sicht eines Finanzmathematikers eine Katastrophe!), sondern 30 Titel, sonst fällt man leicht auf die Schnauze!
Bei einer hypothetischen Gewinnwahrscheinlichkeit von nur 1% muss man noch viel mehr diversifizieren.
Das ist in kurzen Worten meine Investmentphilosphie, auch wenn die Realität natürlich differenzierter und nicht so schwarz-weiss ist. So funktionieren auch Venture-Capital-Fonds, die investieren ja aber oft noch viel früher.

[rjenzi]

@puhvogel

Interessante Philosophie... habe aber Bedenken, ob sie auch in Wirklichkeit funktioniert. Darum moechte ich Dich fragen, wie lange Du schon diese Strategie verfolgst und mit welchen Erfahrungen.
Meine Bedenken sind zum einen, dass man bei 30 Depotwerten doch schon eine ganz schoene Investitionssumme beisammen haben muss, damit es sich "lohnt". Zum Anderen, wie ist es einem normalen Berufstaetigen moeglich, 30 Depotwerte zu ueberblicken, zu kontrollieren und auch immer wieder nach neuen aussichtsreichen Unternehmen Ausschau zu halten? Ein anderer Punkt ist, dass mit Diversifizierung eine Aufsplittung in verschiedene Unternehmungen, Branchen (auch "unattraktive" Branchen - z.B. wie willst Du in der Nahrungsmittelbranche eine Aktie finden mit einem hypothetischen Potential von 1000%?), Laender und Waehrungen, Wertpapiergattungen (Obligationen / Aktien) usw. gemeint... Meiner Meinung nach ist es unmoeglich als Einzelperson, all diese Maerkte zu ueberblicken und dann auch noch in all diesen Branchen so risikoreiche und chancenreiche Werte zu finden. Noch ein anderer Punkt ist, dass wenn man das "Glueck" hat, ein Wert zu finden der z.B. 1000 % steigt, dann besitzen doch die Wenigsten die Geduld diese Gewinne auch vollstaendig auszusitzen. So verkauft man vielleicht nach den ersten 100 % mal die Haelfte seiner Position usw.
Warum ich so skeptisch bin? Habe auch verschiedene Strategien ausprobiert... Mit der Strategie "aus 30 hochspekulativen Werten muss ein Wert zu riesigen Kursgewinnen fuehren" bin ich persoenlich auf die Schnauze gefallen. Klar, ich hab zwar ca. 20 - 30 Werte gehabt, aber ich hab den Ueberblick verloren (zumal ich auch einem "normalen" Job nachgehe)... und ich hab den Fehler gemacht praktisch nur in Technologiewerte zu investieren (=keine Diversifikation). Obwohl ich mit 2 bis 3 Werten sehr gut verdient habe (an die 1000%), so hat`s sich im Gesamten nicht gelohnt. Meine Devise ist darum nun, dass ich ca. 3 - 4 Werte als Kerninvestment (langfristig) habe und nochmals ungefaehr gleichviele als Ergaenzung (kurz- und mittelfristig). Dies ist auch noch ueberblickbar... und kontrollierbar.

[Hollawind]

@puhvogel

Ich habe keinen Überblick welche Verbreitung Zyprexa hat. Was ich beobachte ist, daß viele verschiedene Medikamente mit antipsychotischer Wirkung auf dem Markt sind und auch eingesetzt werden. Es fallen weniger weg als neue Medikamente auf den Markt kommen. Es ist ja auch so, daß ein Patient auf ein Medikament anspricht, das beim nächsten nichts bewirkt ausser lästigen Nebenwirkungen. Das heißt für mich, daß die Auswahl immer größer wird und theoretisch der Markt für ein einzelnes Medikament kleiner. (Vielleicht nur eine Milchmädchenrechnung). Meines Erachtens liegen die Chancen von neuen Medikamenten vor allem in der möglichsten Nebenwirkungsfreiheit. Sollte es gelingen hier wieder Verbesserungen zu erzielen, denke ich, daß die Chancen (auch oder vor allem in Bezug auf die Compliance mit den Patienten) eines verbreiteteren Absatzes nicht gering sind. Bei diesem Investment sind die Chancen den Risiken entsprechend, nach dem Motto alles oder nichts. Ich würde eine solche Investition nur mit Spielgeld eingehen. Bin ein gebranntes Kind, scheue das Feuer. Solche Investitionen hängen meines Erachtens auch vom Anlageziel ab.


Viele Grüße aus Tirol

Hollawind

[Erbse1]

Hallo Hollawind, liebe Cortex Fans.
Den Löwenanteil an den neuen Verkaufszahlen macht Zyprexa mit einem Marktanteil von ca 28% aus. Mit ca 20% folgt dann Risperdal. An dritter Stelle liegt mit ca 10% Seroquel. Etwa auf den gleichen Anteil kommt Leponex.
Diese Anteile wurden im Laufe der letzten zehn Jahren erreicht. Oft ist es aber so, daß in einigen Ländern aus Kostengründen nur zögerlich auf die teueren atypischen Medikamente umgestellt wird.
Hier noch kurz eine Adresse für Leute, die sich auf den neuesten Stand bei Schizophrenie halten wollen. Man kann die schwedische Seite auf Englisch umschalten.
www.hubin.org
Liebe Grüße
Erbse2

[puhvogel]

In diesem alten Link sind alte Verkaufszahlen der anderen Medikamente zusammengefasst.

http://www.schizophrenia.com/newletter/newsl13p3.html
Man sieht also, die Summen, um die sich hier handelt, sind alles andere als klein.

Nun zur Strategie. Ich habe in der Tat in der Vergangenheit vor allen Dingen dann mit meinem Depot dazu gewonnen, wenn sich ein Wert davon besonders stark entwickelt hat. Das liegt unter anderem vielleicht daran, dass ich auch ein gewisses Auge für solche Werte habe, die bei einer völlig anderen Ausgangslage einen wesentlich höheren Wert besitzen würden. Ein klassisches Beispiel dafür ist die Tatneft: Diese habe ich gekauft, als der Ölpreis bei seinem absoluten Tiefstand war, und als diese Firma durch ihre Schulden erdrückt zu werden drohte. Danach schoss der Ölpreis in die Höhe, die Firma konnte ihre Schulden auf einmal zurückzahlen, und auf einmal rückte der Buchwert und das eigentliche Ertragspotenzial der Firma in den Vordergrund. Ich hätte mir noch weitaus höhere Kurse vorstellen können, aber Russland hat immer noch einen sehr großen Risikoabschlag. Ich allerdings nie versucht, schon nach 100% zu verkaufen, weil das Ertragspotenzial im voraus berechnet hatte. Cortex würde ich auch niemals bei $ 100,- Millionen Marktkapitalisierung verkaufen, wenn deren klinischen Produkte Erfolg haben. Dazu sind die möglichen Erträge - siehe oben - zu groß.

Sich nur auf vier oder fünf Werte zu beschränken, dass wär mir zu riskant (Hauptgrund siehe unten): Werte, mit denen ich mich besonders stark beschäftigt habe, haben oft dennoch gefloppt, zum Teil weil man nicht alles überschauen kann, z.T. weil Insider im Vorfeld verkauft haben. Ob diese Strategie über alle Börsenphasen funktioniert, weiß ich nicht, denn ich führe sie erst seit 4 Jahren durch. In der Tat fehlt mehr in den vergangenen 18 Monaten ein Wert im Depot, der sich wirklich vervielfacht hat. Meine Kernwerte dümpeln vor sich hin oder fallen, oft muss man auch noch zu allem Überfluss traden. Meine Gewinner seit Anfang des Jahres sind eher Werte, die ich nicht so stark beachte, wie zum Beispiel KDE , National finance oder CNCT. Ich möchte aber betonen, dass meine Werte, die solche Vervielfacher wurden, niemals klassische Technologie oder Neuer Markt Werte waren. Diese waren mir immer hoch suspekt, daher ist dieser Kelch sowohl in guten als auch in schlechten Zeiten an mir vorbei gegangen.

Wenn du jemanden suchst, der mit dieser Strategie über mehrere Jahrzehnte erfolgreich gefahren ist, dann schaue mal hier nach dem User "E Joe". Der sucht sich Katastrophenwerte aus, da klappen sich sogar mir die Fußnägel hoch! Dennoch hat seine Strategie funktioniert mit der Einschränkung, dass er auch im vergangenen Jahr erhebliche Schwierigkeiten gehabt hatte. Dreh - und Angelpunkt seiner Strategie ist aber immer die extreme konsequente Diversifizierung. Und glaube mir, er hat bestimmt nicht alle Werte immer genau im Auge. Man muss aber natürlich Zeit investieren, wenn man den Wert kauft, damit man es vermeidet, einen chancenlosen Wert zu kaufen.

Das alles Entscheidende ist aber, dass hinter dem Prinzip der Diversifizierung ein knallhartes mathematisches Prinzip steckt, dass Du nur aushebeln kannst, wenn Deine Analyse Dir eine 90-100% Erfolgswahrscheinlichkeit beschert, sonst gehst du auf lange Sicht baden! Das folgende Experiment soll das verdeutlichen:
http://www.tradingexplorer.de/content/money/
Ist das Stockpicking an für sich schlecht, dann hilft allerdings auch das beste money management nichts.

Ich hoffe dass hilft dir weiter.

[rjenzi]

Das ist ein guter Link! Ist fast ein bisschen schockierend, wenn man das Beispiel mit den 40 Studenten liest...
Allerdings hat die Seite mit Money Management zu tun und weniger mit Diversifizierung. Money Management ist aber auch eine Art der Risikominimierung. Gerade das Money Management (das man z.B. nur 25 % Risikoanteil im Depot hat) legt aber einem Nahe, dass man nach einem 100 prozentigem Gewinnanstieg, einen Teil verkauft, da ansonsten der urspruenglich 25 prozentige Anteil dann vielleicht ploetzlich 35% des gesamten Kapitals ausmacht.

Ich will nicht sagen, dass Diversifizierung schlecht ist, im Gegenteil... Aber vielfach wird der Begriff Diversifizierung auch falsch gedeutet. So bedeutet es z.B. nicht automatisch, dass ein Depot diversifiziert ist, nur weil es 30 verschiedene Aktie zaehlt. So koennten die 30 Aktien alles Biotech Aktien sein und so hat jemand mit 4 verschiedenen Werten in 4 verschiedenen Branchen (z.B. ein Biotechwert, ein Nahrungsmittelwert, ein Bankenwert und ein Technologiewert) eine bessere Diversifizierung als der mit den 30 Aktien.

[puhvogel]

Das ist teilweise richtig. Die Diversifizierung ist aber die Kernaussage des Money Managements nach Markowitz und Konsorten. Bei fester Gewinn-/Verlustwahrscheinlichkeit gibt es einen optimalen Bruchteil, optimal-f genannt, bei dem ein maximaler Ertrag wahrscheinlich ist.
Da in der Realität sich die Wahrscheinlichkeiten ändern (der Ölpreis zB anstieg) ändert sich auch u.U. das optimale f , so dass ein Verkauf nicht zwingend ist.
Übrigens verdienen die Spielbanken nicht an der grünen Null sondern am schlechten Money Management der Spieler.

[puhvogel]

Deine letzte Aussage ist übrigens ohne Wissen der Ertragswahrscheinlichkeiten und wohl auch in der Realität mathematisch falsch.
Im übrigen setzt Du implizit voraus, dass die Ertragswahrscheinlichkeiten von Biotechfirmen per se geringer sind als die anderer konservativen Branchen.
Würde das für Dich auch gelten, wenn man 30 verschiedene US-Anleihen wählen würde?

[rjenzi]

Zu 19#: Ich kenn die Aussagen von Markowitz und Konsorten nicht. Hier jedoch ein Zitat aus Deinem Link: "Money Management ist die Größe, die besagt, welcher Teil des gegebenen Kapitals in der nächsten Position riskiert werden soll." Die logische Schlussfolgerung ist also, dass dadurch, dass nicht das ganze Kapital in einen Wert investiert werden kann, automatisch diversifiziert wird. Aber ist gibt keinen Aufschluss ueber die Qualitaet der Diversifikation (ob man die Diversifikation nach Branchen, Maerkten und Waehrungen beruecksichtigt).

Zu 20#: Definition von Diversifikation (gem. http://www.aalto-online.de/glossar.htm): "auch Risikostreuung oder Risikomischung. Im Bereich der Kapitalanlage wird das Risiko durch die Streuung des Kapitals auf eine Vielzahl verschiedener Anlageformen, Unternehmen, Branchen, Länder oder Währungen vermindert. Das Ergebnis dieses Vorgangs ist das Portfolio." Auf gut Deutsch = nicht alle Eier in den gleichen Korb legen.

Derjenige mit den 30 Biotechfirmen hat zwar innerhalb der Branche diversifiziert - nicht mehr. Bei einer Milchbuchrechnung wuerde die Gegenueberstellund der Strategie 1 (30 Biotechfirmen) und Strategie 2 (4 verschiedene Werte aus verschiedenen Branchen) so aussehen:

Ich nehme an, dass alle Werte bei beiden Depots gleich gewichtet sind und dass bei jedem schlechten Ereigniss ein Totalverlust erfolgt:

Negatives Ereignis auf Unternehmensstufe (1 Unternehmen ist betroffen):

Biotech-Depot: - 3.33 %
4-Werte-Depot: - 25 %

Negatives Ereignis auf Branchenebene:

Biotech-Depot: - 100 %
4-Werte-Depot: - 25 %

Meistens ist es ja so, dass eine ganze Branche in die Mitleidenschaft gezogen wird... Darum ist meines Erachtens gerade die Branchen Diversifizierung wichtig. Dies ist nur eine Veranschaulichung und ist in Wirklichkeit natuerlich viel komplexer...

Hier habe ich noch einen Link ueber Diversifizierung gefunden: http://www.fool.de/depots/rulebreaker/2000/rb001221.htm

Meine Aussage ist nicht im gleichen Sinne auf Anleihen uebertragbar, da bei Anleihen Branchen-News weniger ins Gewicht fallen, wie bei Aktien. Ich stehe aber auch immer noch hinter meiner Meinung, wenn wir statt von 30 Biotechfirmen von 30 Nahrungsmittelhersteller ausgehen.

[puhvogel]

Du redest von Erfahrungen, ich rede von Mathematik.
Andere haben die Erfahrung gemacht, dass Stop-loss das non-plus-ultra ist, ich nicht, jemand anderes hat hier in einer retrospektiven Analyse sogar nachgewiesen , dass es schädlich für die Gesamtperformance ist.
Erfahrungen sind durch menschliche Gefühle beeinflusst und kaum objektivierbar.
Dagegen ist die Spieltheorie reine Mathematik und damit nicht beugbar. Allenfalls ist fraglich inwieweit das mathematische Modell, dass für Roulette exakt ist, sich auf den Aktienmarkt übertragen lässt. Die Voraussetzung zum Beispiel, dass es nur zwei oder endliche viele Ausgänge gibt ist sicherlich falsch. Die Bestimmung der Wahrscheinlichkeiten ist nicht möglich, allenfalls abschätzbar und sehr subjektiv.
Man kann dennoch Grenzfallüberlegungen machen. Setzt man nichts, so wird man bei einem Spiel mit positivem Erwartungswert niemals was gewinnen (oder verlieren). Setzt man immer alles auf eine Karte, so wird man irgendwann mal vom Pech erwischt werden. Irgendwo zwischen 0% und 100 % muss also eine optimale Investitionsrate existieren, die vermutlich auch nicht bei 0.1 und zwischen 99.99% gleich sein wird. Die Gesetzmässigkeiten werden vermutlich ähnlich sein wie denen im exakt berechenbaren Fällen.

Das Experiment an den Doktoranden, das sich auch beliebig wiederholen lässt, zeigt, dass es Methoden gibt, wie man garantiert scheitert, selbst wenn man an einem Spiel teilnimmt, in dem man im Schnitt gewinnt. So etwas kann auch einfach am Computer simuliert werden. Und mit vier Werten fährt man so oder so gegen die Wand, es sei denn, man hat ein Buffett Gespür. Bei meinen Biotechwerten steht das hingegen nicht im vornhinein fest!

Als erstes möchte ich wiederholen: Wenn man ein schlechtes Stockpicking betreibt, dann kann man das ganz sein lassen, man verliert immer! Und wenn jemand meinte, dass Internetwerte im Jahre 2000 eine gute Idee gewesen wären, dann betreibt er in meine Augen ein schlechtes Stockpicking.

Nun zu den Anleihen: Angenommen, die Inflation steigt auf 70er Jahre Niveau, so werden sowohl die Anleihen (sofern keine Kurzläufer) als auch Deine 4 Werte in einem enormen Maße verlieren, die Aktien vielleicht dritteln. Die Werte korrelieren in diesem Fall durchaus!

Dein Beispiel mit dem negativen Ereignis aus der Biotechbranche ist ziemlich unrealistisch: Niemals fällt die gesamte Branche auf Grund einer Meldung derart in die Grütze. Als Lipobay zurückgezogen wurde, profitieren Pfizer und BMS davon, weil sie Marktanteile dazugewinnen konnten. als MATX um 93 % fiel, stieg der BTK. Genauso geht das auch mit Nahrungsmittelproduzenten oder Utilitys. Wie heisst es so schön: Gegessen und gestorben wird immer werden.
Obwohl wir einen Jahrhundertcrash hatten, liegt der BTK genau 1/3 unter dem 2000er Höchststand, das ist weniger als der wesentlich besser diversifizierte DAX.
Aber das sind alles Nebenkriegsschauplätze: Entscheidend ist die Mathematik dort oben.
Was fool da schreibt ist IMHO falsch und irreführend, obwohl ich auch für eine inhaltliche Diversifizierung eintrete! Die volumenmässige Diversifizierung ist aber wichtiger!

[rjenzi]

Ich glaube wir kommen zu keinem Ende mit der Diskussion und schlussendlich muss jeder selbst wissen, was die beste Anlagestrategie fuer ihn ist.

Ich habe soeben einen Arbeitskollegen gefragt, der dieses Jahr das MBA abschliesst. Dort lernen sie zur Genuege Theorien (wie Markowitz usw.) und mathematische Berechnungen. Nun, er sagte mir, dass Sie in der Schule die Diversifikation auch so lernen, dass man auch Branchenuebergreifend investiert. Nun, klar das Beispiel mit nur 4 Werten ist ein bisschen extrem, aber gemaess der Theorie, waere dieses Modell vorzuziehen, gemaess seiner Aussage.

Ich mache noch ein Beispiel warum ich denke, dass die inhaltliche Diversifikation wichtiger ist. Gehen wir von einem gegebenen Kapital von 100`000.-- aus. Hat nun jemand, der mit diesem Geld 30 verschiedene Biotechaktien kauft besser diversifiziert als jemand, der von diesem Kapital nur gerade 3`333.-- in eine Biotechaktie investiert?

(Immerhin hat derjenige im zweiten Fall noch 29 Versuche (falls der erste floppt) die ultimative Aktie zu finden...) Redest Du aber im 2. Fall trotzdem von Diversifikation, obwohl er nur eine Biotechaktie hat?

Deiner Aussage, dass man mit 4 Werten so oder so an die Wand faehrt, muss ich wiedersprechen. Wenn wir von 4 Biotechwerten reden, kann ich Dir grundsaetzlich Recht geben (wegen dem relativ hohem inherenten Risiko). Da in meinem Modell aber in verschiedene Branchen investiert wird und auch konservativere Aktien im Depot vorhanden sind, ist diese Behauptung aus der Luft gegriffen. Ausserdem vergisst Du das Gesamtbild, welches gemaess dem Money Management wichtig ist. Ich mag vielleicht 4 Werte haben, bin aber nur mit 30% meines Gesamtkapitals in diese Werte investiert. Falls nun ein Wert floppt, habe ich immer noch genuegend Cashreserven um wieder zu investieren (das habe ich mit dem Vergleich 1 Biotechaktie zu 30 Biotechaktien zu illustrieren versucht)... Einer der hingegen alles Geld gleichzeitig in 30 Biotechaktien investiert, der hat diesen Spielraum nicht.

Nun ich geb Dir recht, dass mein Beispiel sehr unrealistisch ist, sollte auch nur ein bisschen verdeutlichen... Du sprichst hingegen nur von Unternehmens spezifischen News. Mit Branchennews meine ich z.B. im Biotechbereich, wenn sich etwas grundlegendes aendert in der gesetzlichen Grundlage (Patente usw.) oder wenn die Krankenkassen ihre Bestimmungen aendern. Nach dem 11. September dieses Jahres hats "Branchennews" im Bereich der Airlines und der Versicherungswerte gegeben usw.

Dieses Argument ist nicht haltbar: "Obwohl wir einen Jahrhundertcrash hatten, liegt der BTK genau 1/3 unter dem 2000er Höchststand, das ist weniger als der wesentlich besser diversifizierte DAX." Es stand nie zur Frage, ob man mit einem schlechter diversifiziertem Depot ein besser diversifiziertes Depot ueberperformen kann. Der Sinn der Diversifikation ist hingegen die Risikostreuung und die ist im DAX ohne Zweifel besser, als die vom BTK.

Klar ist es unattraktiv einfach nur ein Index abgebildet zu haben (und damit auch wenig chancenreiche Branchen - was wieder subjektiv ist - einzuschliessen). Und darum ist selbstverstaendlich das Stock Picking essentiell. Gerade in diesem Bereich ist aber Erfahrung sehr wertvoll und kann mit Mathematik nicht wettgemacht werden.

[puhvogel]

Schade, ich habe gehofft, die mathematischen Zusammenhänge verdeutlichen zu können. Erfahrung ist immer subjektiv und auf die Vergangenheit gerichtet, Mathematik immer wertneutral.
Die 30 Werte oder der 1 Wert plus Rest Cash wären gleichwertig, wenn es keine Inflation gäbe. Im letzteren Fall finden die Einzelspiele hintereinander statt statt gleichzeitig, ansonsten ist das Szenario in der Spieltheorie gleich. Es ist auch egal, ob ich an 30 Roullettetischen gleichzeitig spiele oder an einem 30 mal. Das Endergebnis wird im Schnitt das gleiche sein, und das hängt im wesentlichen von dem eingesetzten Betrag ab!
Bargeld ist übrigens auch ein Anlageform, und DER Outperformer in Japan in den letzten 10 Jahren (leider).
Zum Thema konservativ und "sicher" fallen mir spontan folgende Werte ein:

[rjenzi]

O.k. ich glaube wir schreiben ein bisschen aneinander vorbei. Das mit Erfahrung und Mathematik ist mir natuerlich auch klar... Auch lehne ich Mathematik nicht ab, im Gegenteil ist es sehr hilfreich und bildet die Grundlage fuer eine Investmententscheidung. Nur allein auf Mathematik zu hoeren, ist auch verwegen, denn mit Mathematik bekommt man eine Zahl und die Auslegung der Zahl ist wieder subjektiv.

Uebrigens bin ich nicht ganz so dumm und ich versteh, das Beispiel mit den 40 Doktoranden und auch dass es ein optimales f gibt. Nur wie berechnet man das optimale f? Da muss man entweder auf vergangene Daten zurueckgreifen oder Schaetzungen machen (und ist somit nicht mehr soweit entfernt von der Erfahrung, welche Vergangheitsgerichtet ist). Ich will damit sagen, dass Mathematik ein aeusserst hilfreiches Hilfsmittel ist, aber leider beim Investieren auch nicht "DER Stein des Weisen".

Zudem ist Diversifikation eine Risikostreuung und nicht eine Risikoausschliessung - d.h. auch mit einem konservativen Wert wie z.B. dazumal die Swissair kann man alles verlieren. Aber dadurch, dass man nicht alle Eier im gleichen Korb hat resp. nicht 30 verschiedene Airlines im Depot (welche mehr oder weniger alle von der Krise betroffen sind), ist es nicht gar so schlimm.

Mit einem Punkt stimme ich mit Dir aber ueberein: "Das Endergebnis... ...hängt im wesentlichen von dem eingesetzten Betrag ab!"

[puhvogel]

Stimmt wir reden auch ein wenig aneienander vorbei. Wenn ich meine, dass man mit vier Werten gegen die Wand fährt, impliziere ich damit, dass man 25 % seines Gesamtvermögens in einen einzelnen Wert investiert und nicht das irgendwo noch Geld in bar oder Immobilien hat! Und ich wollte auch nur betonen, das es so etwas wie einen optimalen Anlagebetrag gibt, der abhängig von der Ertragswahrscheinlichkeitsverteilung der Anlage ist.
Diese Verteilungsfunktion verschiebt sich erfahrungsgemäss gegen Null, wenn man wenig Zeit zur Recherche hat, ansonsten wäre eine maximale Diversifikation anzustreben (zB für den schlechten Stockpicker oder den dartwerfenden Affen sind Indexzertifikate Pflicht!). Irgendwo dort gibt es dann einen optimalen Teilbetrag für dasundas Risikoverhältnis. Bei 25% ist man in Regel aber zu weit weg vom optimal-f, es sei denn, man erhält in der Regel auf eine Mark 1,5 DM wieder raus (Pimaldaumenabschätzung).

Als Anhaltspunkt kann man seine historische Rendite verwenden,wie das auch prof. Trader meines Wissens auch machen.
Hier kannst du Dir einige optimal f Kurven anschauen, bei einem Handelssystem, dass wahre Wunder verspricht (im Rückblick natürlich ). Ein realitätsnäheres Szenario finde ich leider nicht im Netz.
http://www.neurotrading.com/Results/body_results.html

[rjenzi]

Habe mir mal den Link angeschaut... Kennst Du dieses System persoenlich? Arbeitest Du ueberhaupt mit einem System?

Ansonsten ist doch recht schwierig Theorien wie die Optimal f in die Tat umzusetzen... Oder wie machst Du es?

[Erbse1]

Hab hier eine kleine Veröffentlichung zum Thema Schizophrenie und Ampakine gefunden.
Eine kleine Bitte noch an Puhvogel und rjenzi. So interessant Eure Diskussion auch ist, so möchte ich Euch bitten in diesem Thread hauptsächlich zu Cortex zu posten.
Es gibt Leute, die wollen Cortex recherchieren und müßen sich dann durch lange Diskussionen über optimale Anlageformen quälen. Nehmts mir bitte nicht übel.
Liebe Grüße
Erbse1
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Am J Psychiatry 2001 Sep;158(9):1367-77

The emerging role of glutamate in the pathophysiology and treatment of schizophrenia.

Goff DC, Coyle JT
Schizophrenia Program, Massachusetts General Hospital, Boston, USA.

OBJECTIVE: Research has implicated dysfunction of glutamatergic neurotransmission in the pathophysiology of schizophrenia. This review evaluates evidence from preclinical and clinical studies that brain glutamatergic neurotransmission is altered in schizophrenia, may affect symptom expression, and is modulated by antipsychotic drugs. METHOD: A comprehensive review of scientific articles published over the last decade that address the role of glutamate in the pathophysiology of schizophrenia was carried out. RESULTS: Glutamatergic neurons are the major excitatory pathways linking the cortex, limbic system, and thalamus, regions that have been implicated in schizophrenia. Postmortem studies have revealed alterations in pre- and postsynaptic markers for glutamatergic neurons in several brain regions in schizophrenia. The N-methyl-D-aspartic acid (NMDA) subtype of glutamate receptor may be particularly important as blockade of this receptor by the dissociative anesthetics reproduces in normal subjects the symptomatic manifestations of schizophrenia, including negative symptoms and cognitive impairments, and increases dopamine release in the mesolimbic system. Agents that indirectly enhance NMDA receptor function via the glycine modulatory site reduce negative symptoms and variably improve cognitive functioning in schizophrenic subjects receiving typical antipsychotics.

CONCLUSIONS: Dysfunction of glutamatergic neurotransmission may play an important role in the pathophysiology of schizophrenia, especially of the negative symptoms and cognitive impairments associated with the disorder, and is a promising target for drug development.

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[puhvogel]

Läuft ja nicht schlecht, deine Aktie.
Der Widerstand bei 3,25 sieht aber ziemlich massiv aus.

[Erbse1]

Hallo Hollawind, liebe Cortex Fans. Hab hier einen interessante Artikel zu dem Ansatz zur Viruseinfektion bei Schizophrenie gefunden. Ich denke mal, daß es sich lohnt auch diese Geschichte weiter zu verfolgen. Gerade in letzter Zeit werden einige neue Lösungsansätze zur Bekämpfung der Schizophrenie veröffentlicht. Der Artikel hat zwar nichts mit Cortex zu tun, aber so hat man interessante Informationen schnell zur Hand.
Liebe Grüße
Erbse1
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Thu Nov 8 17:22:06 2001 Pacific Time

Stanford-trained Gene Researcher Says Schizophrenia Is Caused By Brain`s Inability to Produce Enough Proteins
ATTENTION: Medical editors

KIEL, Germany, Nov. 8 (AScribe News) -- A gene researcher announced today that the brain`s inability to produce enough proteins, the building blocks of nerve cells, is the most likely cause of schizophrenia, a severe psychiatric disorder that afflicts 60 million people worldwide, including three million in the United States. He said the protein deficiency, which may be caused by virus infections in the brain, could be prevented or treated by a new kind of drugs. The scientist, Dr. Hans Moises, is a Stanford-trained gene researcher at the University of Kiel in Germany. He presented his findings on Oct. 24 at the 8th International Meeting of the Human Genome Project in Valencia, Spain.

If borne out by further research, Moises says "schizophrenia might be easily preventable and treatable, partly by immunization against viruses that attack nerve tissue and partly by new drugs which improve the rate at which the brain makes proteins." Moises`s research is now being reviewed at BMC, a new Internet-based journal (http://www.biomedcentral.com ).

Moises` findings, which must still be confirmed by independent groups emerged from the application of an unusual method to data from of the Human Genome Project, which provides information on nearly all human genes.

Frustrated by the slow progress in using conventional gene mapping methods, Moises says he employed a new method to narrow the number of genes responsible for the susceptibility to schizophrenia from among the large population of genes provided by the Human Genome Project. The identified genes play a role in the production of proteins which leads to the conclusion that schizophrenia must be caused by the deficient production of proteins.

Moises says his genetic results support recent findings by Robert Yolken and Fuller Torrey in the November issue of the Archives of General Psychiatry showing evidence for a role of virus infections in schizophrenia.

About Hans Moises

Moises studied medicine in Heidelberg, Germany and molecular genetics at Stanford University. In 1989, he organized together with Tomas Helgason in Iceland an international genome scan in schizophrenia which employed for the first time informative genetic markers. The results were published in NATURE Genetics (volume 11, pp. 321 ff). A copy of Moises`s recent paper is available at http://arxiv.org/abs/cond-mat/0110189 . Moises can be contacted at [e-mail].

-30-


AScribe - The Public Interest Newswire / 510-653-9400
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[Erbse1]

Hallo liebe Cortex Fans. Ich stell mal die Quartalszahlen rein. Ich denke mal mit diesem Konzept dürften wir uns um die Finanzen keine Sorgen machen.
Liebe Grüße
Erbse1
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Cortex Announces First Quarter Fiscal 2002 Results
- Cortex`s MCI Trial Discussed in Fortune Magazine -
IRVINE, Calif., Nov. 13 /PRNewswire/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - news) today reported net income of $1,196,000 ($0.07 per share) for the quarter ended September 30, 2001. This compares with a net loss of $1,591,000 ($0.10 per share) for the corresponding prior year period.

For the quarter ended September 30, 2001, revenues include $2,000,000 from the second milestone under the Company`s agreement with Organon. As reported earlier, Cortex achieved the milestone when Organon elected to continue development of an AMPAKINE® compound by entering Phase II clinical studies.

``We are very pleased with the progress that our partners are making in further developing our AMPAKINE technology,`` stated Vincent F. Simmon, Ph.D., President and Chief Executive Officer of Cortex. ``We soon will have AMPAKINE compounds in Phase II studies for three important indications. Organon is entering Phase II studies of an AMPAKINE compound as a potential treatment for schizophrenia. Shire Pharmaceuticals Group is conducting a Phase IIb study of an AMPAKINE compound as a treatment for Attention Deficit Hyperactivity Disorder. And beginning in early 2002, together with Servier we plan to begin a cross-national study of an AMPAKINE compound as a treatment for Mild Cognitive Impairment (MCI), a disorder believed by many researchers to be a ``transitional state`` to Alzheimer`s disease.``

``We expect to release preliminary results from these trials in the next 12 to 24 months,`` added Dr. Simmon. ``All of the clinical costs for these studies will be paid by our partners. This will allow us to maintain the relatively low burn rate that has characterized our operations for the last few years. These truly are exciting times for Cortex.``

Cash and cash equivalents totaled $3,152,000 at September 30, 2001, which does not include the $2,000,000 milestone payment from Organon (because it was received shortly after the reporting period ended). In comparison, at June 30, 2001 cash and cash equivalents totaled $4,557,000.

For the quarter ended September 30, 2000, the Company recorded a charge of $530,000 related to the adoption of the Securities and Exchange Commission`s Staff Accounting Bulletin No. 101 (``SAB 101``). The new principle required the Company to change its accounting method for the nonrefundable up-front payment received from Organon.

Under SAB 101, for the quarter ended September 30, 2000 Cortex restated revenues to include $250,000 originally recognized when it received the up-front payment in fiscal year 1999. The net impact of SAB 101 was an increase in the net loss for the quarter ended September 30, 2000 of $280,000, or $0.02 per share.

The net loss for the quarter ended September 30, 2000 also included $585,000 of non-cash, stock-based compensation charges. Excluding these charges, total operating expenses for the quarter ended September 30, 2001 were $1,861,000, compared to $1,489,000 for the corresponding prior year period. The increase for the current year quarter primarily represented expenses related to the Company`s license of the AMPAKINE technology from the University of California.

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[Erbse1]

Hallo liebe Cortex Fans. Hier eine Zusammenfassung zum Stand der Ampakine. Ist leider nur in Englisch.
Der Kurs ist in den letzten zwei Wochen wieder etwas zurück gekommen, so daß sich für Interessierete noch gute Einstiegschancen bieten.
Liebe Grüße
Erbse1
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Fiscal 2001 was a very good year for Cortex, with some very important events. One of the most important events was the formation of a new partnership with Les Laboratoires Servier in October 2000. Servier is the largest privately-owned pharmaceutical company in France with almost $2 billion in annual sales worldwide. Before our partnership, Servier had been working in the field of AMPA-receptor modulation compounds, making them a natural partner for us.

The second important event was our listing on the American Stock Exchange in May 2001 under our new symbol “COR.” This action served to significantly improve our visibility among potential investors. As evidence of the effect of the listing, our press releases are now routinely reported by Dow Jones News Service, something that did not occur at all when we were traded over the counter.

During fiscal 2001, we operated with financial prudence, broadened our patent portfolio and strengthened our scientific and clinical programs.

Cortex now benefits from alliances with three major pharmaceutical companies: NV Organon, a division of AKZO Nobel in the Netherlands, Shire Pharmaceuticals Group, Plc, in England, and Servier in France. Below is a summary of our partnerships and their exclusively licensed rights and territories:


Partner (fiscal year) Indication Rights
NV Organon (1999) Schizophrenia
Depression Worldwide
Shire (2000) ADHD (option) Worldwide
Servier (2001) Alzheimer’s disease
MCI
Sexual Dysfunction
Dementia associated with
Multiple Sclerosis,
Amyotrophic Lateral
Sclerosis Europe
Asia
Middle East
Several South American
countries


In fiscal 2000, we were pleased to announce near break-even results of operations, demonstrating our fiscal conservatism as we seek to expand the AMPAKINE® drug platform. Cortex would have reported an increase in both revenue and income in fiscal year 2001 except for the implementation of new accounting guidelines. These guidelines required us to delay recognition of most of the upfront payment that we received from Servier. This new accounting approach produces revenue recognition across several quarters, rather than making fiscal periods appear volatile due to the timing of lump-sum payments. As a result of implementing this new standard, we realized decreased revenues and a loss of $0.16 per share for fiscal 2001. It is important to remember, however, that most of the revenues from the $5 million nonrefundable upfront payment from Servier will be recognized over the next few years.

With the resources in hand and scheduled payments from our partners, Cortex is in a sound financial position to continue its development program.

The following programs have provided significant funding to Cortex:

Servier: Our alliance with Servier includes three agreements. An exclusive licensing agreement will enable Servier to develop and commercialize Cortex’s AMPAKINE technology for the treatment of declines in cognitive performance associated with aging and neurodegenerative diseases. Specific indications will include, but are not limited to Alzheimer’s disease (AD), Mild Cognitive Impairment (MCI), sexual dysfunction and dementias associated with other neurodegenerative diseases such as multiple sclerosis and Lou Gehrig’s disease. Servier’s territory includes Europe, Asia, the Middle East and several South American countries. In connection with the licensing agreement, as already mentioned, Servier paid us an upfront fee of $5 million. The second agreement with Servier provides for a collaborative research and development arrangement under which Cortex and Servier will jointly research and clinically develop new AMPAKINE molecules for licensed indications. Under the agreement, Cortex will receive slightly more than $6 million for three years of research funding. Furthermore, Cortex has rights to all compounds and data to use outside of Servier’s territory. The third agreement involves a cross-national collaborative MCI study to enroll patients in North America and Europe to determine the efficacy of the AMPAKINE CX516 compared to placebo in improving memory and cognition in patients with MCI.

Servier has agreed to pay nearly all of the costs associated with the MCI cross-national study. Separately, Cortex previously received funding from the Institute for the Study of Aging to offset part of its clinical cost. Under the agreements with Servier, Cortex also may receive milestone payments based on successful AMPAKINE clinical and commercial development, plus royalties from product sales.

Organon: NV Organon, which had licensed the AMPAKINE technology for treatment of schizophrenia, exercised its option to develop AMPAKINE molecules for use in the field of depression. By this action, Organon is subject to annual R&D spending requirements using our technology in the depression field. The terms of the depression agreement also include milestone payments based upon clinical development and royalties on worldwide sales. We are very pleased with Organon’s clinical progress with the AMPAKINE technology for treating schizophrenia. In September, after the end of fiscal 2001, Organon announced it had decided to move its AMPAKINE candidate, Org 24448, into Phase II clinical studies. Org 24448 is the first Phase II candidate from a new generation of AMPAKINE molecules that are substantially more potent than CX516. In addition, this decision triggered a $2 million milestone payment that will be recognized in fiscal 2002. With its expertise in anti-depressants, we believe that Organon will be an excellent partner in the area of depression. We believe that Organon’s decision to expand its rights adds validity to the potential of Cortex’s technology in this field.

Shire: Shire, which has an option to license the AMPAKINE technology for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), initiated enrollment in a Phase II Study with CX516 in patients with ADHD. Preclinical (animal) and human studies have shown that this compound appears to improve a number of cognitive functions including attention, distractibility, problem solving, memory and verbal learning. If the current clinical study proves effective, Shire has the right to convert its option for CX516, and/or newer AMPAKINE compounds, into an exclusive worldwide license under a previously negotiated research, development and licensing agreement. Should Shire elect to execute this agreement, Cortex would receive an upfront fee, research support for additional AMPAKINE compounds, milestone payments based on successful clinical and commercial development, and royalties on sales.

Stroke Research: The National Institutes of Health (NIH) funded our grant application to study the use of the AMPAKINE technology as a potential treatment for stroke victims. The grant, which covers three years, will provide total funding of up to $1.1 million. Treatment of stroke victims is a critical clinical need unmet by current medications. Stroke and traumatic brain injury patients suffer from disrupted communication among brain cells and must try to recover function by engaging new pathways of nerve cell communication. We believe that the AMPAKINE compounds, which improve memory by enhancing the communication between nerve cells, may be ideal for this. Furthermore, if AMPAKINE drugs are effective in treating stroke, there is good scientific reason to believe that they also may be effective in the treatment of traumatic brain injury.

Cortex Patent Portfolio: We continue to develop patent protection for the AMPAKINE technology. A total of four patents were issued in fiscal year 2001 and three more were allowed. This brings our total to 25 issued patents with another five patents allowed, including 15 issued patents and three allowed in the United States, respectively. These patents are critical to the future value of Cortex as clinical development and potential commercialization of our technology progresses.

Many of our patents, as well as those of our competitors, cover specific chemical structures (compositions of matter). Cortex has received a number of patents covering structures of molecules that modulate the AMPA receptor. We believe that our portfolio is unique in that it recognizes and protects a totally new pharmacology based on the mechanism of action by which the AMPAKINE molecules exert their effect, resulting in a number of broad clinical method-of-use patents. These uses include improvement of memory and cognition; increase of neurotrophic factor production; and treatment of schizophrenia, depression and sexual dysfunction.

Our broad method-of-use patent is currently under review in the European Patent Office. This patent application covers all AMPA receptor modulating compounds that enhance the effect of glutamate and may be useful for the treatment of memory or cognition. While this application was under review, one of our potential competitors filed an observation in which they pointed out the possible existence of certain prior art. Through our European patent counsel, we have responded to the issues that were raised and provided additional information in support of our case. We do not anticipate any action on this important item before the end of November 2001. We believe that we have a valid case and intend to vigorously pursue it on behalf of Cortex and its partners. If Cortex prevails, we may still be challenged, but our position will be strengthened. Even if this patent does not issue, we will still have the benefit of our composition of matter patents.

Mild Cognitive Impairment: On March 13, 2001, the FDA held an Advisory Committee Meeting on the topic of MCI. Patients with MCI experience memory impairment beyond that expected for normal individuals of the same age and education.

Overall, the scientists who presented at the meeting were in agreement that a condition, MCI, exists and that it can be readily distinguished from Alzheimer’s disease. Furthermore, it was stated that there is an emerging body of evidence that the underlying pathology of Alzheimer’s disease exists in most (>60%) patients with MCI.

Although there was not unanimity of agreement on the precise entry point into MCI from “normal” aging, or the precise exit point from MCI to AD, the involvement of short-term memory was almost always a component of the diagnosis of MCI.

From Cortex’s perspective, the comments of the Advisory Committee and FDA leadership could not have been more positive. Cortex believes its AMPAKINE drugs will directly affect short-term memory. Thus, tests of efficacy can focus on the nearer-term measurements of memory improvement versus the longer-term effects of possible prolongation of the conversion of MCI to AD. Key leaders of the FDA were very comfortable with treating MCI patients for the symptoms of memory impairment. Several times they stated that they would have no difficulty approving a drug that was safe if it was shown to have efficacy in memory improvement in patients with MCI.

Most trials in patients with MCI have or are focused on trying to slow progression to AD. To achieve this, relatively large numbers of patients are enrolled in trials that typically last three years. A trial to show efficacy by improving symptomatic memory problems would be much shorter. Nevertheless, a drug to treat this relatively benign condition would necessarily have to be shown to be extremely safe. This will take large numbers of people and safety trials in people that last six months or more.

As stated above, Cortex and Servier plan a cross-national trial in MCI patients that will begin early next year. An article in the June 11, 2001, issue of Business Week highlighted this planned trial and included several paragraphs of information mentioning Cortex.

With three substantial corporate partners at work on various AMPAKINE programs, the clinical development of Cortex’s AMPAKINE technology is well underway. We are operating the company in a sound manner, consistent with available funding, and believe more than ever that both Cortex and the AMPAKINE family of drugs have a bright future.

Many thanks go to our hardworking employees and professional colleagues for their achievements last year. I also thank our Directors for their continued wise counsel and our shareholders for your support. It continues to be a pleasure and a privilege working for you.

[rjenzi]

Danke Erbse, dass Du uns auf dem Laufenden haeltst. Ich meinerseits sehe jetzt den Zeitpunkt gekommen, wo ich ein kleiner Teil meines Kapitals in Cortex investiere. Sieht Charttechnisch gesehen gut aus und ich denke mal, dass man in dieser Bewegung wieder ueber 3 USD kommt...

[Erbse1]

Hallo liebe Cortex Fans. Folgend ein Artikel von bio21cent zu dem Thema ADHD, bei denen Cortex mit Shire zusammenarbeitet. Dieser Artikel ist kopiert von
www.biotech-world.de
im Nasdaq Board. Dort wird Cortex auch diskutiert. Falls interesse besteht, schaut dort bitte auch mal vorbei.
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Was ist ADS und wie wirkt sich die Erkrankung aus?

Das Aufmerksamkeitsdefizit-Syndrom wird auch als Hyperkinetisches Syndrom bezeichnet. Diese Aufmerksamkeitsstörung tritt mit und ohne Hyperaktivität auf. Je nachdem kommen einem die Kinder wie „Zappelphilipps“ oder „Tagträumer“ vor. Ich möchte mich auf den Bereich mit Hyperaktivität konzentrieren.
Typische Anzeichen sind motorische Unruhe, Störungen der Aufmerksamkeit und Störungen der Impulskontrolle
Generell ist die Aufmerksamkeit stark eingeschränkt. Nicht nur das Lernverhalten ist dadurch stark negativ beeinflußt, sondern durch ihr Störverhalten werden die betroffenen Kinder häufig zu Außenseitern und der Sozialkontakt wird durch die Impulsivität behindert.

Was sind die Ursachen für die Erkrankung:

Hier gibt es verschiedene Theorien, die ich mal in drei Modelle einteilen will. Neurologische und/oder biochemische Störungen, Bioumwelt (Interaktion zwischen Biologie und Umweltauslöser) und dysfunktionale soziale Ursachen im Umfeld von Familie und Schule
Inzwischen unbestritten, daß ADS eine neurobiologischee Störung ist, die mit einer andersartigen Informationsverarbeitung einhergeht. und verantwortlich für die beeinträchtigungen im Alltag und beim Lernen ist
Wesentlich sind hier die beiden Botenstoffe Dopamin und Noradrenalin. Diese beiden Stoffe wirken als Überträgerstoffe in verschiedenen Zentren, die die Informationsaufnahme und –modulation steuern. Aufnahme, Sortierung und Speicherung laufen generell gesagt nicht optimal, weil eben u.a. der Dopamin-Stoffwechsel nicht optimal verläuft

Wie erfolgt die Diagnosestellung?

Hierzu ist es zunächst wichtig, daß Pädagogen und Eltern ausreichend über dieses Karnkheitsbild aufgeklärt sind und die mögliche Symptome kennen, um überhaupt einen Anfangsverdacht zu haben.
Der übliche und richtige Weg ist, daß bei Verdacht auf die Erkrankung das Kind an einen Kinderarzt überwiesen wird.
Dieser wird dann eine gründliche körperliche, neurologische und psychatrische Untersuchung vornehmen um mögliche andere Erkrankungen auszuschließen.

Wie geht es weiter bei bestätigtem Verdacht auf ADS?

Die Therapie fußt auf den drei Säulen.Psychotherapie, Beratung der Kinder, Eltern und Bezugspersonen und der medikamentösen Therapie.

Wie sieht die medikamentöse Therapie aus?

Die medikamentöse Therapie besteht überwiegend aus dem Einsatz von Stimulantien, für die ein Betäubungsmittelrezept benötigt wird. Dies erscheint vielleicht absurd, bereits unruhige und rastlose Kinder auch noch mit Stimulantien zu behandeln. Das Gegenteil ist jedoch der Fall, da diese Kinder unruhig sind, weil sie nicht wach genug sind. Die Stimulantien verändern den fehlerhaften Stoffwechsel der Neurotransmitter Dopmanin und Noradrenalin (siehe oben Ursachen)
Großer Erfolg und weite Verbreitung finden Substanzen wie Methylphenidat (Medikinet, Ritalin) oder Pemoloin.
Methylphenidat wird in 95% aller Fälle verschrieben und 75% der Kinder.
Das Ritalin wirkt ca. 3-4 Stunden, Ritalin SR 5 Stunden und das neue Ritalin LA sogar 8 Stunden. Hier kam es kürzlich zur Zulassung des Entwicklers Celgene.
Leider ist jedoch auch durch diese Medikamente ein Heilung von ADS nicht möglich und bei Absetzen der Medikamente treten die Symptome wieder rasch auf.
Ganz wichtig ist es, daß Kind entsprechend auf eine richtige Dosis einzustellen, weshalb die Einnahme permanent ärztlich begleitet werden sollte und diesem genau die eigenen Beobachtungen mitgeteilt werden sollten. Auch sollte Gewicht, Puls und Blutdruck überwacht werden und es empfiehlt sich auch ein vollständiges Blutbild mindestens einmal pro Jahr.

Wie wirken die Medikamte?

Methylphenidat wirkt als Stimulanz, das zur vermehrten Produktion des fehlenden Neurotransmittersubstanzen anregt.
Dadurch können Botschaften schneller übermittelt werden

Welche Nebenwirkungen gibt es?

Die Stimulantien sind bereits seit über 60 Jahren in der kontrollierten Anwendung und es ist bisher kein Fall von Abhängigkeit aufgetreten. Teilweise kommt es zu Appetitmangel und in der Folge zu Gewichtsverlust. gelegentlich Müdigkeit, Kopfschmerz und zuweilen Schwindelgefühl und Schlaflosigkeit.
Meist reduzieren sich die Nebenwirkungen oder verschwinden ganz, wenn das Kind sich an das Medikament gewöhnt hat.

(von bio21 cent am 9.12.2001 erstellt)

Wenngleich die Nebenwirkungen nicht so dramatisch wie bei Schizophrenie sind und ich aus diesem Grunde Cortex bei der Indikation Schizophrenie für aussichtsreicher erachte, stellt der Ansatz von Cotex eine interessante Alternative zur bisherigen Behandlung dar. Ich werde hier
"am Ball bleiben"

Beste Grüße bio21 cent

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[Erbse1]

Hallo liebe Cortex Fans. Habe einen interessanten Artikel zum plötzlichen Herztod bei Einnahme von Psychopharmaka gefunden. Je nach Medikamenten und Dosierung ist das Risiko eines Psychotikers zwei bis drei mal so hoch, wie bei einem, der keine Medikamente nimmt.
Bei Cortex und den Ampakinen liegen leider erst sehr wenig Daten vor. Sollte sich ORG 24448 als genauso wirksam in der Symptomatikunterdrückung erweisen und von den Nebenwirkungen ein besseres Profil haben, so tun sich für Cortex riesige Chancen auf. Bisherige Veröffentlichungen zu Nebenwirkungen sind sehr positiv für die Ampakine. Folgend noch der Artikel.
Liebe Grüße
Erbse1
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Thursday December 13 5:46 PM ET

Older Antipsychotic Drugs Pose Heart Death Risk
By Emma Hitt, PhD

NEW YORK (Reuters Health) - Antipsychotic medications may dramatically increase the risk of sudden cardiac death, although newer forms of these drugs introduced after 1994 may not be as harmful as older forms, according to researchers.

Antipsychotics, the primary treatment for schizophrenia and certain other mental disorders, are thought to increase what is known as the ``QT`` interval, which heart specialists can determine from the peaks and valleys of an electrocardiogram printout. A prolonged QT interval is believed to increase the risk of developing abnormal heart rhythms.

``We had anecdotal evidence that these medications caused cardiac deaths, but this has not been investigated on a such large scale before,`` Dr. Purushottam Thapa, of the University of Arkansas in Little Rock, told Reuters Health.

Thapa and colleagues studied nearly 500,000 Medicaid patients, including many who were taking antipsychotics. They report their findings in the December issue of the Archives of General Psychiatry.

The researchers categorized the patients into four groups: those currently taking a moderate dose of antipsychotics, those taking a low dose, those who took them in the past year only, and those who did not take them at all.

After following the patients for an average of about 2.5 years per patient, the investigators found that 1,487 patients died suddenly from heart problems.

Patients in the moderate dose category, meaning they were taking more than 100 milligrams of thioridazine or the equivalent amount of another drug, were more than twice as likely to suffer sudden cardiac death as patients not taking antipsychotics.

Furthermore, patients taking a moderate dose who already had heart problems had more than triple the risk of sudden cardiac death compared to patients with heart problems who were not on the drugs, the report indicates.

The investigators also found that patients taking low doses of antipsychotics or who had stopped taking them had only a slightly increased risk compared with nonusers.

According to Thapa, the newer antipsychotics, such as risperidone, olanzapine and quetiapine, are less likely than the antipsychotics evaluated in this study to cause these side effects.

``The older generation antipsychotics are prescribed only rarely these days,`` Thapa said. ``The newer antipsychotics may cause these side effects also, but so far, their effects appear to be milder,`` he added.

``Clinicians should be careful to monitor the heart activity of patients taking these drugs and could consider prescribing a lower dose of antipsychotic wherever possible,`` Thapa suggested.

Dr. Carlos A. Zarate, Jr., of the National Institute of Mental Health, who wrote an editorial accompanying the study, noted that the reason antipsychotics have this effect is unclear. ``It`s probably multifactorial,`` he told Reuters Health.

``Just because of these findings, patients should not stop taking these types of antipsychotics. However, heart monitoring of these patients should increase,`` Zarate said.

SOURCE: Archives of General Psychiatry 2001;58:1161-1167, 1168-1171.

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[stefan1799]

@Eröffner dieses Threads:

Wie kann man nur so einen Scheiss schreiben:
1. Von Schizophrenie ist nicht 1% sondern 1 promille der Bevölkerung betroffen

2. Schizophrenie ist nicht gleich Psychose sondern eine mögliche Form von Psychose

3. Schizophrene sind eine absolute Randgruppe innerhalb der Randgruppe der psychisch Kranken. D.h. weder die Bevölkerung noch die Politiker noch die Versicherungen sind bereit, dafür viel Geld auszugeben. Sollte tatsächlich eines dieser angeblichen Wundermedikamente mal wirken (was sie bisher trotz grossen Ankündigungen jeweils nur mangelhaft taten), so wird dennoch kein hoher Verkaufspreis dafür verlangt werden können.

Fazit: Finger weg!

[Erbse1]

Hallo stefan. Normalerweise freue ich mich über jeden Beitrag. Zum Recherchieren gebe ich Dir nur eine Adresse
www.hubin.org
Ich möchte Dich bitten solch einen Mist nicht mehr zu posten.
Liebe Grüße
Erbse1

[Erbse1]

Hallo stefan, hier noch ein kleiner Beitrag, der Dir bei Deinen Recherchen hilft. Da Du angeblich Psychologe bist, möchte ich doch mal wissen, woher Du Deine Daten hast. Für eine Quellenangabe wäre ich recht dankbar.
Liebe Grüße
Erbse1
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1. Begriffserklärung:

Das Wort Schizophrenie kommt aus dem Griechischen und wird aus den Teilen schizo- [zu griech. schízein = spalten] und phrenie [zu griech. phrenós = Zwerchfell; Geist, Gemüt] gebildet. Also bedeutet Schizophrenie wörtlich übersetzt eine Spaltung des Geistes- oder Gemütszustandes. Die Schizophrenie wurde 1896 erstmals von Emil Kraepelin als Dementia praecox (frühzeitiger Schwachsinn) beschrieben [Anmerkung: die geistige Leistungsfähigkeit ist nicht unbedingt gemindert, auch wenn dieser Begriff diesen Irrtum zu bekräftigen scheint.] und von Eugen Bleuler 1911 mit ihrem seit dem verwendeten Namen belegt.

Es handelt sich dabei nicht um eine einzige Krankheit, sondern eine "Gruppe von Schizophrenien", weshalb die klinischen Erscheinungsbilder, die Krankheitsverläufe und - endstadien der schizophrenen Störungen sehr unterschiedlich sein können. Manchmal ist es schwierig, aufgrund der Symptome eine Schizophrenie von einer bipolaren Störung zu unterscheiden.(siehe unten)

2. Auftreten:

Die Verteilung der an Schizophrenie erkrankten auf die Gesamtbevölkerung wird auf 1% geschätzt, was für den deutschsprachigen Raum ungefähr eine Million und weltweit in etwa 60 Millionen sind. Angeblich bleibt die Zahl stabil, nimmt also nicht zu wie z.B. bei Depressionen und/oder Angstzuständen. Die Dunkelziffer unerkannter Erkrankungen ist jedoch vermutlich nicht gering. Dabei handelt es sich um Personen, die nicht oder nur kurzfristig auffällig sind, nicht als schizophren diagnostiziert und entsprechend behandelt und damit auch nicht statistisch erfasst werden. Ungefähr nur ein Drittel der Erkrankten soll sich in ärztlicher Behandlung befinden.

Frauen und Männer sind annähernd gleich von der Schizophrenie betroffen. Aber es gibt im psychosozialen Bereich geschlechtsspezifische Unterschiede. Bei Männern zeigt sich ein steiler Anstieg des Krankheitsausbruchs zwischen 15 und 24 Jahren, anschließend kommt es zu einem gleichbleibenden Abfall; erste Symptome konnten rückblickend bei nicht wenigen Patienten schon um das 10. Lebensjahr registriert werden. Bei Frauen findet sich ein erster flacher Anstieg zwischen 20 und 29, und ein zweiter, noch niedrigerer zwischen 45 und 50 Jahren.

Dabei ist zu beachten, dass abgesehen von diesen Eigentümlichkeiten der Leidensausbruch theoretisch in jedem Lebensalter möglich ist.

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[Erbse1]

Hier gleich noch ein Beitrag, der Dir weiterhilft.
An Psychosemedikamente ist nichts zu verdienen?
Die Behandlung eines Psychotikers mit den neuen atypische Medikamenten kostet pro Patient je nach Dosierung zwischen 500 und 1000 DM pro Monat. Natürlich kommt jetzt noch ein Beitrag.
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Was ist eine Psychose?

Eine Psychose ist ein krankhafter Geisteszustand, der geprägt ist durch Wahnerleben und veränderte Wahrnehmung bzw. Interpretation der Realität. Dieser Zustand tritt am häufigsten bei der bipolaren Störung (manische Depression) und bei der Schizophrenie auf. Auslöser ist in beiden Fällen eine Fehlreaktion des Gehirns, basierend auf biochemischen Vorgängen. Das ist allerdings eine Vermutung im logischen Umkehrschluss, weil sich beide Erkrankungen gut mit Medikamenten in den Griff bekommen lassen.

Die Medikamente sind aber nur die eine Seite. Im psychotischen Zustand erkennt der Erkrankte meistens nicht, daß er krank ist. Bei der schizophrenen Psychose kommt oft ein Beeinträchtigungs- und Verfolgungserleben dazu. Deshalb ist es in vielen Fällen notwendig, zum Schutz des Erkrankten vor Selbstmord oder zum Schutze der Umwelt vor evtl. zerstörerischen Aktivitäten, den Erkrankten (oder die Erkrankte) zwangsweise in eine psychiatrische Einrichtung zu bringen. Dort wird der Erkrankte mit entsprechenden Psychopharmaka behandelt, wenn notwendig auch gegen seinen Willen. Das Problem bei der Genesung ist, daß nach erfolgter Entlassung aus dem Krankenhaus bei dem Patienten die Einsicht für die Medikation vorhanden sein muß. Ohne Medizin tritt die Krankheit meistens wieder auf. Es gibt aber auch Leute, die wieder gesund werden, ohne fortdauernd Medikamente zu nehmen.

Der Ausbruch einer Psychose bringt für den Betroffenen meistens auch einen herben Einschnitt in das bisherige Leben. Beim Auftreten in jungen Jahren be- oder verhindert sie die Ausbildung des jungen Erwachsenen. Die oft bleibende Behinderung bzw. Beeinträchtigung des Leistungsvermögens verringert die Chancen auf dem Arbeitsmarkt. Oft wird der Erkrankte dann zum Sozialfall oder, wenn er "Glück" hat, bekommt er Leistungen aus seiner Rentenversicherung. Er kommt, wenn sich nicht andere um ihn kümmern, in eine soziale Isolation. Das Bild eines psychisch Kranken in der Öffentlichkeit ist auch nicht gerade vertrauenserweckend. Der Begriff "verrückt" oder schizophren wird meistens abwertend gebraucht. Und wenn man mal etwas von Schizophrenie hört, dann meist in den Nachrichten in Zusammenhang mit Mord und Totschlag. Die bizarren Motive, die man da hört, ziehen die Reporter magisch an. Dabei sind schizophren erkrankte Menschen im Durchschnitt auch nicht gewalttätiger als der "normale" Teil der Bevölkerung.

Was ist Schizophrenie?

Der Begriff Schizophrenie wurde Anfang dieses Jahrhunderts von einem Schweizer Psychiater eingeführt und ist eigentlich ein wissenschaftliches Konstrukt. Denn die Krankheit zeigt kein einheitliches Bild und kann sogar bei demselben Patienten zu unterschiedlichen Zeiten unterschiedlich verlaufen. Man spricht deshalb auch von den Psychosen aus dem schizophrenen Formenkreis. Schizophrenie bedeutet Bewußtseinsspaltung und soll damit meinen, daß das Erleben des Erkrankten geteilt ist in die Wahrnehmung der Realität so wie sie ist und in die Wahrnehmung einer "virtuellen" Realität, nämlich der eingebildeten.

Der Verlauf der Krankheit gibt oft Rätsel auf. So hören manche Patienten innere Stimmen, die sie beeinträchtigen, haben optische Halluzinationen, fühlen sich von Strahlen bedroht und von magnetischen Einflüssen. Insbesondere letztere Phänomene erleben die Erkrankten als Gedankenentzug. In der akuten Phase der Psychose, insbesondere bei Ersterkrankung, wenn man noch nicht weiß, daß man krank ist, versucht man sich verständlicherweise eine Erklärung für all diese, zum Teil körperlich erfahrbaren Dinge, zurechtzulegen. Die Erklärung findet sich leicht in vermeindlicher Überwachung und Verfolgung der eigenen Person. Von CIA und Stasi hat man ja genug schlimme Dinge gehört. Hinzu kommt, daß bei akuter Überforderung des Gehirns, verursacht durch den Wahrnehmungsstreß, alle Dinge um einen herum als auf die eigene Person bezogen fehlinterpretiert werden können. So bildet sich schnell ein Wahn, in dem sich alles um die eigene Person dreht. Das Charakteristische an der ganzen Geschichte ist aber, daß der Verstand dem Kranken bleibt, er ist nur in eine Falle geraten und wandelt auf den Spuren des Wahns. Selbst im von außen betrachtet desolaten Zustand der Gedankenverwirrung und der Katatonie arbeitet der Verstand des Kranken normal, er sieht sich jedoch auf Grund der Wahneinbildungen zu diesem Verhalten gezwungen, was immer auch das konkrete Wahnmotiv sein möge.

Durch medikamentöse Behandlung der Erkrankten mit speziellen Neuroleptika können die Symptome gemildert werden und dadurch der Wahn oft beseitigt werden. In schweren Fällen, insbesondere bei Katatonien, ist oft die Elektroheilkrampfbehandlung die einzige Rettung. Sie hat unverdientermaßen einen etwas schlechten Ruf als Elektroschocktherapie, weil sie früher ohne Narkose durchgeführt wurde und nicht selten zur Disziplinierung störender Patienten diente.

Schizophrenie ist gar nicht so selten. Zirka 1% der Bevölkerung ist davon betroffen. Das heißt aber nun nicht, daß jeder 100., dem wir begegnen, vom Wahn befallen ist. Die akute Krankheitssymptomatik tritt bei einem Drittel der Betroffenen einmal auf im Leben und dann nie wieder. Bei einem weiteren Drittel kann es in größeren Abständen zu Rückfällen kommen. In der Zwischenzeit sind sie aber völlig gesund, was ihren Geisteszustand anbelangt. Nur beim letzten Drittel überwiegen die Rückfälle und die Krankheitssymptomatik. Für fast alle Betroffenen gilt: Eine bestimmte, regelmäßig eingenommene, Erhaltungsdosis von Neuroleptika verhindert in der Regel den Rückfall. Oft bleibt nach Rückfällen eine Behinderung in Form von verminderter Streßverträglichkeit und Defiziten bei der sozialen Kommunikation. Somit ist die Schizophrenie eine der Hauptursachen für die Invalidisierung junger Menschen. Bei Männern tritt die Ersterkrankung angefangen vom Teenageralter bis in die 20er hinein auf, bei Frauen ein paar Jahre später.

Obwohl es oft fälschlicherweise angenommen wird, ist die Schizophrenie keine Persönlichkeitsspaltung. Störungen der Persönlichkeit sind eine völlig andere Form psychischer Erkrankung.

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[puhvogel]

Hier ein Artikel über Risperdal in einem sehr wichtigen Medizinjournal,da sStudiendaten schon sehr genau prüft:
Study Published in New England Journal of Medicine Suggests That the Drug Risperdal Can Decrease Risk of Relapse in Long-Term Treatment of Schizophrenia

TITUSVILLE, N.J., Jan. 3 /PRNewswire/ -- A study published today in the New England Journal of Medicine found that stable patients with schizophrenia or schizoaffective disorder have less risk of symptoms returning when they are treated with the atypical antipsychotic medication, Risperdal(R) (risperidone), than when they are treated with the older, conventional treatment, haloperidol. Haloperidol was long considered the "gold standard" for treatment of psychosis, and continues to be widely used throughout the world.
"For a long time, physicians operated under the assumption that patients taking atypical medications might relapse less because they were able to tolerate the newer drugs better," says John Csernansky, MD, lead investigator and Gregory B. Couch professor of psychiatry at Washington University in St. Louis. "This study is the first to demonstrate that even when patients stay on treatment, the atypical drug risperidone can do a better job keeping patients free of symptoms long term than the most commonly used conventional drug, haloperidol."
In the study, which followed more than 300 patients for at least a year, Risperdal* reduced the relative risk of relapse by 48 percent compared to haloperidol. Some patients were followed for more than two years. This is the first published, long-term study to examine the ability of an atypical antipsychotic medication to prevent relapse, compared to another drug in the class.
More than 2 million Americans suffer from schizophrenia, a brain disorderthat impairs a person`s ability to think clearly, relate to others, and distinguish between reality and imagination. Signs of the disease include so-called "positive" symptoms (such as delusions, hallucinations, disorganized thinking and paranoia) and "negative" symptoms (lack of drive or initiative, social withdrawal, apathy and emotional unresponsiveness). According to the American Psychiatric Association, between 20 and 50 percent of people with schizophrenia who are treated with medication are re-hospitalized every year.

Study Design and Results
In this multicenter, randomized, double-blind study**, U.S. investigators monitored stable outpatients with schizophrenia or schizoaffective disorder to compare the overall rate and time to relapse in individuals followed for at least one year. Relapse was defined as the need for psychiatric hospitalization; an increase in the level of psychiatric care accompanied by a marked return of positive or negative symptoms; significant suicidal thoughts, violent behavior or other deliberately self-injurious acts; or a substantial overall deterioration (as measured by the "Clinical Global Impression of Change" ).
Of the 365 patients included in the final analysis, 177 were randomly assigned to receive Risperdal (average daily dose of 4.9 mg), and 188 received haloperidol (average dose: 11.7 mg per day). Assessments were conducted weekly for the first four weeks and at four-week intervals until the last patient had been enrolled for one year.
By the end of the study, the estimated risk of relapse (adjusted to account for patients who stopped treatment or dropped out of the study for other reasons) was 34 percent for patients taking Risperdal, compared to 60 percent for persons in the haloperidol group (p<0.001). In addition, individuals on Risperdal took a significantly longer time to relapse than those who received haloperidol (p=0.001). Another measure of efficacy was the scores on the Positive and Negative Syndrome Scale (PANSS). This commonly used scale measures the combined severity of patients` positive and negative symptoms. Participants who took Risperdal experienced a significantly greater improvement in their total PANSS score by the time they completed the study than did those on haloperidol (p<0.001).

Safety and Tolerability
Patients taking Risperdal experienced fewer serious side effects during the study than those taking haloperidol. At endpoint, individuals in the Risperdal group reported a lower incidence of extrapyramidal symptoms (uncontrolled tremors and muscle stiffness -- common side effects of antipsychotics) than those on haloperidol (8% vs. 15%, respectively).
Individuals taking Risperdal also reported a lower incidence of other frequent adverse events: somnolence (drowsiness) [14% vs. 25%], agitation [10% vs. 18%] and hyperkinesia (excessive involuntary movements) [5% vs. 20%]. There was a mean increase in mean body weight of 5 lbs in Risperdal patients and a mean decrease of 1.6 lbs in the haloperidol patients.

Grüsse

[Erbse1]

Hallo Puhvogel, liebe Cortex Fans. Ehrlich gesagt überrascht mich diese Studie nicht. Ich denke mal, daß fast alle neuen atypische Medikamente so ähnlich abschneiden würden. Bei den Nebenwirkungen von Haldol ist ein Absetzen der Patienten des Medikamentes nicht verwunderlich. Deswegen ist die Rückfallquote hier extrem hoch. Außerdem wurde eine doch etwas sehr hohe Dosierung gewählt.
Dennoch wird der Trend zu den ganz neuen Medikamenten, nämlich Geodon, Abilitat und demnächst noch Zomaril gehen, die den Vorteil haben auch die Negativsymptomatik maßgeblich zu beeinflußen.
Umso interessanter scheint es hier die Ampakine von Cortex genau zu verfolgen, da sie anscheinend gegen alle drei Aspekte bei Schizophrenie wirken sollen. Für Neueinsteiger bitte ich den ersten Beitrag noch mal zu lesen, da ich hier alles beschrieben habe.
Außerdem steht Mitte des Jahres die Entscheidung von Shire an, ob sie die Ampakine von Cortex bei dem Krankheitsbild ADHD weiter verfolgen werden. Bisher konnte ich recherchieren, daß der Vorteil der Ampakine wäre, daß sie weniger Nebenwirkungen haben und so die Compliance erhöhen sollen. Leider kenn ich mich bei den Nebenwirkungen bei ADHD Medikamenten nicht aus. Vielleicht gibt es ja einen, der sich mit diesem Thema beschäftigt und etwas über dieses Thema postet.
Liebe Grüße und schönes neues Jahr
Erbse1

[puhvogel]

Ich wollte damit ausdrücken, was die Chefärzte demnächst als Goldstandard ansehen werden, denn das NEJM ist ein ganz, ganz wichtiges Journal. Die Vertreter von neuen Medikamenten haben erfahrungsgemäss ganz, ganz dicke Bretter zu bohren, bis sie in den Praxen als Standard ankommen.

[Erbse1]

Hallo Puhvogel. Ich muß Dir Recht geben. In der Psychiatrie dauert alles sehr lange. Leider auch manchmal bei den Ärzten. Dennoch werden sich auf lange Sicht die besten Medikamente durchsetzen. Bei Risperdal hat es bis jetzt zehn Jahre gedauert, um einen Marktanteil von 20% zu erreichen. Risperdal wird die Studie sicherlich nicht schaden.
Wie teuer letzendlich eine Behandlung mit Haldol ist kann man erst errechnen wenn man alle Kostenfaktoren berücksichtigt. Die immer wiederkehrende Krankenhauseinweisung mit den alten Medikamenten ist mit Sicherheit teurer, als eine Behandlung mit den neueren atypischen Medikamenten.
Letztendlich beweist die Studie nur, daß ein Abbruch wegen der Nebenwirkungen mit den neuen Medikamenten nur etwa halb so hoch ist. Der Name Risperdal wäre meiner Meinung nach beliebig gegen Zyprexa, Serdolect, Solian und wie sie noch alle heißen mögen, austauschbar.
Meines Erachtens kommt es hier auch auf einen mündigen Patienten an, der bei seinem Arzt auf die beste Behandlungsmöglichkeit pocht. Der Patient muß die Nebenwirkungen ertragen und nicht der Arzt. Dennoch verschreiben einige ältere Semester aus Kostengründen die angeblich preiswerteren alten Medikamente. Dabei haben sie meist nur ihr eigenes Budget im Auge. Die Gesamtkosten bei einer erneuten Einweisung verlieren sie dabei aus dem Auge, da sie ja über das Krankenhaus abgerechnet werden.
Wenn es noch bessere Alternativen zu den bisherigen Medikamenten gibt, werden sie auf lange Sicht mit Sicherheit auch verschrieben. Allerdings in der Psychatrie dauert manchmal alles sehr lange.
Liebe Grüße
Erbse1

[Erbse1]

Hallo liebe Cortex Fans, auch wenns nur wenige sind. Hab ein interessantes Interview im Yahoo Board gefunden. Trotz der Biotech Schwäche der letzten Tage kann Cortex ein wenig zulegen. Folgend noch der Beitrag.
Liebe Grüße
Erbse1
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Q: for years, you have been working, here in Irvine, on a medecine that can improve the memory, and slow down the aging of the brain: Ampakine.
A: As I said: we have about 120 billion braincells, neurones, and every neurone can connect with up to 50000 other ceurones. When the brain ages, those connections - die. In the spring of one’s live, in the autumn, the leaves fall. That’s a tradegy.
Well, my product, Ampakine, makes sure those connections better; they keep the leaves green. As simple as that.
When I was a young brainscientist I investigated the ways of communication between the neurones, how the signals between ‘m would travel. A
There are hundreds of neurotransmitters, but relative to memory, glutamate is important: it’s the transmitters in over 90% of all cellcommunication. The other neurotransmitters, I leave in the hands of my estemed collegues.
For years we studied the molecular structure of the glutamate-receptor, but we reached a break-through when some Japanese collegues mailed me their suggestions: In less than six hours, I build, in my own lab, a new model. We did the first tests, and everything worked.
De next step was: to develop a product that could increase both the speed and the precision of the flow of information in the glutamate-receptor.It was a pure example of drug-design: we didn’t build a medecine on the basis of an illness, no, we build a molecule, we knew exactly how it had to look, to improve the glutamate-receptor
Q What are the effects of ampakine?
A Very simple: the informationflow goes faster through the neurones, and storage in the memory is better. It works in 10 minutes, as fast as alcohol.
Q Do you notice it’s impact?
A No, you don’t feel euforic, or exited. It’s just the brain that works better. We did a study in Germany on 70 year olds. Their score on the memory tests almost doubled. They did almost as well as 20 year olds – but only in the first two hours after they took it. When you administer Ampakine to young people, the effect is less dramatic: the memory capacity increases with about 20%.
Q Have you took it yourself.
A No (laughs mysteriously). Or better: no comment. I can’t answer that question.
Q I would like to do the test right now. Can I have one?
A No. The FDA would have me locked up. De FDA laws are very strict. We are now in phase II B of it’s development – only in phase III, would you be allowed to take the test.

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[Erbse1]

Hier noch der zweite Teil des Interviews.
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Q I can hardly wait. But do continue.
A It doesn`t just improve the flow of information, it also creates new links. the brain is like a muscle: you have to train it, or else it loses its strenght and possibilities. Links that aren`t used, die. But the opposite is also true: when the brain is under pressure, and has to do a lot of work, it forces itself to create new links. Ampakine helps with this.
The harder, and more complex the brain is, the more neurone are in play, and the bigger the effect of ampakine is. It works like a multiplicator: a stupid person won`t become a genious, but a bright person will be given the possibilities to work faster, more thorough - and forget less. This is no tale, we have extensive publications, to support our claims.
The first test we did on rats: under influence, they started to show new, more sensible behaviour.
Q their brain became a superbrain
A No, their brain stayed the same, but they made better use of it`s possibilities. Say a rat manages to transport a signal over 3 neurones; with Ampakine the signal travel over 4 or 5 neurones.
Q This sounds like SF
A No, it`s the naked truth. All over the world, do people work on these kind of drugs: princeton, NC, Columbia, Harvard, Stockholm. I`m not alone here, I`m no wizard, of magician. The governement supports our research.
Q Within five years will Ampakine hit the market?
A Probably faster. We are approaching a new step in the history on humanity.
Q If you`re right, the world will change dramatically.
A I would agree. Sometimes the consequences scare me. take Sex: a very complex proces, in which the visual cortex works overtime, and in which all the other centers do their bit.
Q (laughs)
A don`t giggle. This is a serious matter (bursts out into laughter) Look, I believe a better functioning brain will provide better sex. And I believe it`s perfectly possible ampakine can jack up a dead libido.
Q Give it to me, mister professor.
A Laugh away, in the lab we saw how older male rats started to show interest for the females. We have developped about 200 different kind of variants of Ampakine. The ampakine that stimulates the brain, has other mechanisme in place than this kind of ampakine.
Q Ampakine plus! I can hardly wait. But let`s talk side effects. Cafëine and Amfetamines are well known stimulators for the brain, but they are addictive and you can`t get to sleep.
A Very simple: ampakine has no side effects. Caf and Amfet are non-specific stimulators: they don`t just poke up the brain, but also the heart rythm, blood pressure... Speed meanly works on the dopamine receptors - another neurotransmitter: you become euforic, you think you can handle more, but that`s an illusion. ampakine is stimulates specific centers, it works there where it we want it to work.
If you feed amfetamines to a rat, you start to notice immediate differences in its behaviour: it becomes restless and stress out. If you feed it ampakine, nothing differentiates it from other rats, apart from the ability to take on complex tasks.
Q There are no side effects?
A In normal, therapeutic dosage, no. we did double-blind tests. There was no difference in bloodpressure, heartbeat. If we overdose 30 to 100 times, epilepsy appears.
Three big farmaceutical firms are interested in the commercialisation of ampakine. The university is involved, money is flying around.

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[puhvogel]

Dann mal los
Die Info-Politik von Cortex ist wirklich vorbildlich
MCI ist die "Vorstufe" von Alzheimer

Cortex Pharmaceuticals, Inc. and Les Laboratoires Servier Kick Off Investigators` Meeting to Train for Mild Cognitive Impairment Trial

Trial Objectives, Research Parameters and Timeline Announced

LONDON, Jan. 18 /PRNewswire-FirstCall/ -- Cortex Pharmaceuticals, Inc. (Amex: COR) and Les Laboratoires Servier, of Paris, France, today began a two-day training meeting for clinical investigators involved in an upcoming international clinical trial for patients with Mild Cognitive Impairment (MCI). Over 120 clinicians and researchers are attending the meeting, representing six countries including the United States, France, Belgium, Great Britain, Sweden, and The Netherlands.
This trial will be the first cross-national study of AMPAKINE(R) compounds -- a class of compounds that are positive modulators of the AMPA-type glutamate receptor, as well as the first international study designed to show acute memory enhancement in patients with MCI.
In March of 2001, the US Food and Drug Administration (FDA) recognized MCI as an indication that could be defined and that was separate from Alzheimer`s disease (AD). Many patients (60-80%) with MCI may progress to AD over a five year period. Patients with MCI have more difficulty with recent memory tasks than their peers who are of the same age and educational background. However, they are quite capable of conducting routine tasks of daily living. It has been estimated that there are 2.5 to 4 million people in the US with MCI and probably an equivalent number in Western Europe.

About the Trial:
This seminal trial will evaluate the safety and efficacy of AMPAKINE CX516 in approximately 160 patients with MCI who are between the ages of 55 and 85.
Patients will be randomized to receive placebo or the AMPAKINE CX516 for a period of four weeks. The trial is double-blind. Cortex has overall responsibility for the conduct of the trial, which is being co-managed by Cortex and Servier. Separately, Cortex previously received funding from the Institute for the Study of Aging (the "Institute" ) to offset part of its clinical cost. The Institute is a non-profit foundation based in New York City dedicated to the improvement in quality of life for the elderly.
Enrollment in the study will commence in various countries during the first quarter of 2002 as regulatory approvals are obtained. The diagnostic procedures, as well as the primary and secondary outcome measures, were agreed upon by an International Scientific Advisory Committee last May in conjunction with the American Association of Neurology meeting in Philadelphia. This Advisory Committee was composed of neurological experts from the United States and Europe and was supported by a grant-in aid from Cortex and Servier.
"The response by clinicians invited to participate in the trial has exceeded our expectations, resulting in more centers than we initially anticipated," said Vincent Simmon, Ph.D., President and CEO of Cortex. "This could lead to more rapid enrollment. Assuming we complete enrollment during January 2002, we anticipate completing a preliminary evaluation during the second quarter of 2003."
This cross-national 28-day trial will evaluate the ability of patients to recall a list of 15 words 30 minutes after they have practiced learning the list. Other endpoints will include evaluation by their clinician for improvement, evaluation on a clinical rating scale for dementia, and a small battery of neuropsychiatric tests, in addition to an assessment of safety.
The primary end point will be on the last day of treatment. However, patients will also return for a final evaluation approximately two weeks after their last treatment. "We have previously observed that this class of compounds has the ability to promote improvements that may last for several weeks," commented Dr. Simmon. "Needless to say, we are interested to see if those earlier observations can be repeated in patients with MCI."

[Coluche]

... ein schönes Dankeschön an Erbse und auch an die anderen Boardteilnehmer hier.

Durch die fundierten Beiträge hat mich diese Aktie interessiert und habe mirnun auch ein kleines package davon zugelegt. Wenn der CEO und der Senior Vice President laufend zukaufen, ggf. mal ein paar shares verschenken und kein einziger Insiderverkauf in 2001 ersichtlich war, ist das ein gutes Zeichen.

Leider fährt Cortex noch unterm Radarschirm der Analysten und Fondsmanager ( hat wohl eher mit der zu kleinen Marktkapitalisierung und der schwachen Cash-Position zu tun ). Aber das ist die Chance des Kleinanlegers ( vergl. auch `Guerilla Investing` von Peter Siris, 2. Auflage 2000 S. 127: "...wenn Analysten eine Aktie unbeachtet lassen, dann sind Einzelinvestoren begünstigt, weil sie diese Unternehmen studieren können, ohne daß sie befürchten müssen, daß irgendwelche Analysten plötzlich Bewertungen verändern..." und S. 128:" ...verwechseln Sie nie die Frustrationen derAnalysten, die keine Informationen erhalten, mit Aussagen über die Gesundheit eines Unternehmens, insbesondere dann nicht, wenn das Management selbst weiterhin die Aktien kauft...".


@ Puhvogel z. Thema viele Aktien im Depot: ich habe diesen Thread hier ganz durchgelesen und bin auf Deine Ausführungen z. Thema Portfoliomanagement mit vielen Aktien gestossen. Hierzu nur eine Bemerkung von W. Buffett: "...wenn du 20 Aktien im Depot hast, ist das wie wenn du 20 Frauen hast, du kennst dann keine mehr so genau..." Ist vielleicht finanzmathematisch falsch, aber von der Sache her richtig und IMHO auch auf die Investitionsstrategie eines Privatanlegers anwendbar.

Gruß Coluche

[Erbse1]

Hallo liebe Cortex Fans. Hier eine Meldung von heute. Leider kenn ich mich bei Übernahmen und deren Abwehr nicht aus und kann hier keinen Kommentar abgeben. Vielleicht finden sich ja ein paar auf dem Gebiet erfahrene Leute, die hier ein kurzes Statement abgeben.
Liebe Grüße
Erbse1
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Cortex Adopts Stockholder Rights Plan
IRVINE, Calif., Feb. 7 /PRNewswire-FirstCall/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - news) today announced that its Board of Directors has approved the adoption of a Stockholder Rights Plan (the ``Plan``). Under the Plan, all stockholders of record as of the close of business on February 15, 2002 will receive a distribution of rights to purchase shares of a newly authorized series of preferred stock. The rights become exercisable in the event that a tender offer for the Company is announced, or an acquirer purchases at least 15 percent of Cortex`s Common Stock.

``We did not adopt the Stockholder Rights Plan in response to any current offer to acquire control of Cortex,`` stated Vincent F. Simmon, Ph.D., President and Chief Executive Officer. ``Our Board of Directors has adopted the Plan to help protect the long-term interests of the Company`s stockholders. While the Stockholder Rights Plan will not prohibit the acquisition of the Company, it is designed to ensure that stockholders are given fair and equitable treatment should an unsolicited acquisition occur.``

The rights, which expire ten years from the record date, will be distributed to stockholders as of the close of business on February 15, 2002, the record date, as a non-taxable distribution. There will be no rights certificates issued unless certain conditions are met. The rights are not currently exercisable and possess no current value. Additional details of the plan will be distributed in a mailing to stockholders as of the record date.

Financial advisory services related to the adoption of the Plan were provided by Roth Capital Partners, LLC.

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[Coluche]

Bzgl. der aktuell veröffentlichten Quartalszahlen gabs wohl keine Überraschung.

Was den Stock-Plan betrifft bin ich auch etwas ratlos, da ich ein derartiges Konstrukt den letzten 20 Jahren noch nicht gesehen habe.

Ausgehend von der Tatsache, daß Simmon 25 % der Aktien hält und im vergangenen Jahr ca. 1/3 seines Gehaltes wieder in die Aktien seines Unternehmens gesteckt hat ( über den regulären Kauf an der Börse ), hat der wohl gezielt ein Interesse, seine quasi Sperrminorität sich nicht verwässern zu lasssen. Gibt es nämlich eine feindliche Übernahme, so könnte er über eine Kapitalerhöhung, wenn er dann nicht genügend Cash beisammen hätte, auf unter 10 % gedrückt werden und hätte dann nichts mehr zu sagen. Mit diesem Stock-Plan ist das geblockt, wobei ich mir nicht ganz im Klaren bin, wie sich das dann mit den "preferred"-Stocks bzgl. der Stimmrechte verhält. Kurzum, der Simmons ist daran interressiert, das Sagen zu behalten und investiert immer noch kräftig in sein eigenes Unternehmen. Ansich kein schlechtes Zeichen, wobei ich ihm im Sinne einer Portfoliostruktur/Altersvorsorge eher zur Diversifizierung in ein paar andere Aktien/Branchen raten würde ( Puhvogel wird mir da ansatzweise zustimmen ). Aber der Simmons ist ja auch schon in einem Alter, wo andere schon an den Vorruhestand denken und die Ernte der Vorsorge schon eingefahren sein müßte.

Ansonsten hoffe ich auf gute Ergebnisse der verschiedenen Testreihen. Die Franzosen zahlen ja angeblich laufend ihren Forschungsanteil, so daß der Cash zunächst mal gesichert sein sollte.

Gruß Coluche

[Erbse1]

Hallo Coluche, erst mal willkommen hier im Thread. Ich bin froh über jeden Mitstreiter hier im Board, der sich ernsthaft mit Cortex beschäftigt. Bei den Quartalszahlen keine Überraschung. Dennoch möchte ich einen kleinen Absatz kopieren, der Raum für Spekulation läßt. Um welche Aqisition handelt es sich?
Liebe Grüße
Erbse1
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For the quarter ended December 31, 2001, operating results included an increase in non-cash, stock-based compensation charges compared to the prior year period. Results for the current year quarter also included fees related to exploring a strategic acquisition of technology. Increased expenses for the six months ended December 31, 2001 primarily represented charges related to the Company`s license of the AMPAKINE technology from the University of California.

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[puhvogel]

Die Grundlagenforschung an den Ampakaninen fand offensichtlich in der Univerversität von Californien statt. Cortex hat diese Forschungsergebnisse einlizensiert. Dafür hat sich Cortex vertraglich festgelgt, bei bestimmten Fortschritten bei der Produktentwicklung (zB Eintritt in die klinische Überprüfung), auch Meilensteine genannt, einmalige Lizenszahlungen zu leisten, und das sind diese Mehraufwendungen.

[puhvogel]

@An Erbse wegen ADHD;

Folgender Übersichtsartikel über die medikamentöse Behandlung von ADHD ist heute veröffentlicht worden:

Long-Acting Psychostimulant Formulations and Novel Antidepressants Will Boost the Drug-Treated Population for Attention-Deficit/Hyperactivity Disorder, According to a Decision Resources Study

Attention-Deficit/Hyperactivity Disorder, a new Decision Resources study, evaluates the future market potential of one of the most common childhood psychiatric disorders. Although awareness of attention-deficit/hyperactivity disorder (ADHD) has increased over the past decade, many physicians remain reluctant to diagnose the disorder because of the associated stigma and the fact that methylphenidate, the current mainstay of ADHD treatment, is a controlled substance with a negative connotation among the public and some physicians.

The Decision Resources study finds that growing public awareness of ADHD and more refined strategies for treatment are fueling an interest in the development of new pharmacological agents. Several promising areas of development are under exploration, including new formulations of existing psychostimulants, novel classes, and agents normally used in other indications that are under investigation for ADHD.

Reformulations of Existing Drugs Promise to Produce a Surge in Compliance
In August 2000, Alza and McNeil Consumer Healthcare launched Concerta, a 12-hour formulation of methylphenidate, in the U.S. market; within five months, sales of Concerta exceeded $60 million. The drug`s market share continues to grow. Concerta`s key benefit is its extended duration, which negates the need for repeat dosing and improves overall compliance. Other new launches that quickly followed Concerta include Celltech Group`s Metadate CD, an eight-hour methylphenidate formulation, and Shire Pharmaceuticals` Adderall XR, a 12-hour formulation of mixed amphetamine salts.

A Promising Nonstimulant Alternative
Atomoxetine, a highly selective norepinephrine reuptake inhibitor for which Eli Lilly recently filed a new drug application (NDA) in the United
States, holds considerable promise in filling the need for a nonstimulant alternative for ADHD patients. Most experts believe that atomoxetine will be less effective for reducing ADHD symptoms than are psychostimulants but will be more effective than current nonstimulant therapies. Its clear advantage will be its status as a noncontrolled substance-a factor that will help propel it into the forefront of second-line therapies. For those patients who are unwilling or unable to take stimulants, atomoxetine will be used as a first-line therapy.

Attention-Deficit/Hyperactivity Disorder offers invaluable strategic intelligence for pharmaceutical companies competing in this market. This study
is part of Mosaic, one of six Pharmacor services from Decision Resources that evaluate the commercial potential of drugs in research and development.


von http://www.dresources.com

[Coluche]

Hier noch was z. Thema Stock-Plan Handelsblatt v.19.02.2002:

"Imclone wehrt sich gegen drohende Übernahme"

Das US-Biotechunternehmen imclone wehrt sich gegen einen Übernahmeversuch durch den US-Finanzier Carl Icahn....

... Imclone teilt mit, den Versuch mit einer "Giftpille" zu bekämpfen: Der Plan sieht vor, dass Imclone eine größere Zahl neuer Aktien ausgeben und sie bestehenden Anteilseignern zum reduzierten Preis anbieten kann, sobald ein Investor mehr als 15 % der Anteile erwirbt. Dies würde die Kosten für eine feindliche Übernahme in die Höhe treiben..."

Das soweit zu Imclone, was IMHO auch auf den Stock-Plan von Cortex anwendbar ist.

Ob das für uns Aktionäre nun gut oder schlecht ist ? Wohl strittig. Der Kurs von Imclone ist nach dieser Ankündigung wieder deutlich gesunken. Dies zeigt, es erschwert tatsächlich eine "feindliche Übernahme" und unterbindet die Kursphantasie von dieser Seite. Für Langfristanleger ist es jedoch nicht unbedingt von Nachteil, wenn allein im Unternehmen selbst und seiner Produktpipeline genug Phantasie steckt, was bei COR gegeben ist. Wie bereits gepostet, hat der CEO wohl den größten Vorteil davon. Er kann solche Situationen nun bis Februar 2012 steuern.

Gruß Coluche

[Erbse1]

Hallo liebe Cortex Fans. Hab hier von der Titan Pharmaceuticals Seite eine interessante Präsentation zu Schizophrenie gefunden.
http://www.titanpharm.com/Presentation/Iloperidone_slides_fi…
Es ist deshalb so interessant, da hier schön die ganzen Nebenwirkungen aufgeführt werden. So können wir dann vergleichen wie ORG 24448 im Vergleich zu den herkömmlichen Medikamenten abschneidet.
Als Termin für den Abschluß der Phase 2 wird etwa Mitte 2003 genannt.
Für Juni dieses Jahres wird dann die Zusage von Shire zu den Ampakinen bei ADHD erwartet.
Im Neuroinvestor, ein Biobrief speziell für das Themengebiet Neuroanlage wird die Vermutung geäussert, dass
Servier seine Ergebnisse auslizensieren könnten. Dies ermöglicht es Cortex mit einem großen Partner eine weltweite Lösung zu finden.
Liebe Grüße
Erbse1

[Erbse1]

Hallo liebe Cortex Fans. Hab hier eine kleine Zusammenfassung vom Neuroinvestor zum Stande der Ampakine gefunden.
Liebe Grüße
Erbse1
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Cortex (AMEX:COR): The miracle of the AMEX listing did not prove to be magical for Cortex`s stock price, but it sets the stage for credibility and access by institutions when news from trials and deals unfolds. During mid-2001, Organon began an 18 month schizophrenia trial for a later-generation Ampakine, and Don Goff is starting two 80 pt schizophrenia trials for CX516, as an adjunct to Clozaril and to Zyprexa, data two years away. Shire will wrap up its Phase II for CX516 in ADHD during 2Q, and will then have to decide whether to exercise its Ampakine option. Since there is animal data showing that later-generation Ampakines are far more potent than CX516, we would not be surprised to see Shire option one of those, to protect an ADHD franchise which is not sufficiently stabilized by extended release Adderall. During 1Q:02, the Servier-partnered Phase II in MCI will begin in the US and Europe, taking eighteen months to complete. Cortex was one of the biggest beneficiaries of the FDA decision to flex on the definition of MCI and suitable related endpoints. All they have to do is show that CX516 improves memory and attention, something which has been shown in a number of human trials. While Cortex does not have to outlicense the North American rights for Alzheimer`s and MCI, they are likely to be responsive to reasonable offers, since their low-burn, lean corporate stance is safe and stable, but it does not allow aggressive development of Ampakines for other indications, like stroke or TBI. While there is no certainty regarding a deal, we are somewhat optimistic that one will be reached 2H:02. The licensing will be aided and abetted if European patent authorities rule against Lilly in their challenge to a Cortex patent. That ruling is anticipated (but not guaranteed) during 1H:02. Lilly has done a lot of work with their own AMPA modulating program, especially in depression, and they will likely have to negotiate with Cortex if they want their molecules to be more than a vehicle for generating publications. Cortex continues to be well-run, and is more financially stable than ever.

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[Erbse1]

Hier eine Meldung von Cortex. Ich stell sie schon mal rein. Muß ich mir selber noch übersetzen. Oh wei, mein Englisch.
Liebe Grüße
Erbse1
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Cortex Announces BioSTAR Co-Funding of Neurotrophin Research
- Collaboration With University of California, Irvine Renewed -
IRVINE, Calif., March 26 /PRNewswire-FirstCall/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - news) today reported that it has been notified that the Cortex-funded project, ``AMPAKINE® modulation of brain neurotrophin expression: a novel therapeutic strategy,`` has been selected and recommended for extended funding under the University of California BioSTAR Project.

``We announced the initial BioSTAR co-funding of this project roughly two years ago,`` stated Vincent F. Simmon, Ph.D., President and Chief Executive Officer of Cortex. We expect the extension to provide roughly $193,000 over an additional two years, allowing us to expand our research objectives for this project.``

As part of Alzheimer`s disease, there is a decline in the production of the neurotrophin BDNF (brain derived neurotrophic factor), which results in less healthy neurons. Neurotrophins are naturally occurring proteins that support the health and functional capacities of brain cells.

Earlier research under the direction of Professor Christine Gall at the University of California, Irvine, demonstrated that Cortex`s proprietary AMPAKINE compounds can increase the production of the neurotrophin BDNF and NGF (nerve growth factor) in critical areas of the brain involved in memory and cognition. A number of researchers have demonstrated that increasing the availability of neurotrophins may restore the viability and function of aged neurons and reduce vulnerability of brain cells to naturally occurring insults such as oxygen deprivation. The ongoing project will test the approach of using AMPAKINE compounds to increase brain neurotrophin content, and the utility of this approach for the treatment of neurodegenerative disorders.

``The initial funding for neurotrophin research under the BioSTAR grant increased our ability to evaluate different AMPAKINE compounds and the results to date have been very exciting,`` added Professor Gall. ``The additional support from the University of California will allow us to extend our collaboration and explore additional research objectives. We are very pleased to be recipients of matching BioSTAR funding to the University of California, Irvine campus.``

As reported earlier, U.S. patent number 6,030,968, ``Positive AMPA Receptor Modulation to Enhance Brain Neurotrophic Factor Expression,`` is assigned to the University of California and licensed exclusively to Cortex. ``The neurotrophin patent -- like our other use patents for improving memory, cognition, treating sexual dysfunction and schizophrenia -- is very broad,`` added Dr. Simmon. ``The patent covers not only compounds invented by Cortex, but any molecule that works by the same mechanism of action. The patent is part of our portfolio of proprietary protection for molecules that positively modulate the AMPA receptor.``

The Biotechnology STAR Project (BioSTAR) is a matching grants program, designed to accelerate the University`s contribution to the California economy by linking business to basic research conducted in the UC system. Proposals are peer reviewed on a competitive basis by expert scientists and engineers from the University of California system. BioSTAR funding of research began in 1997.

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[Erbse1]

Hab hier noch eine kleine Übersetzung vom Aktionär zur gestrigen Meldung gefunden
Liebe Grüße
Erbse1
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Cortex: Ampakine Projekt wird unter BioSTAR gefördert

Das Ampakine Projekt des in der Neurobiologie tätigen Unternehmens Cortex Pharmaceuticals, Inc. (Amex: COR) wurde erneut für die Förderung unter dem BioSTAR Projekt der Universität von Kalifornien vorgeschlagen und erhielt letztendlich auch den Zuschlag. Das Ampakine Projekt verfolgt einen neuen Therapieansatz zur Modulierung der Expression von Neurotrophin im Gehirn. Bereits vor zwei Jahren erhielt Cortex die erste Förderung unter dem BioSTAR Projekt, das nun erneut über die nächsten zwei Jahre $193.000 Forschungsförderung zur Verfügung stellen wird. Neurotrophin, das für die Gesundheit und das Funktionieren der Nervenzellen mitverantwortlich ist, wird vor allem bei der Alzheimer Erkrankung in geringerer Menge im Gehirn gebildet.

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[Erbse1]

Nett, daß der Aktionär die wichtigsten Nachrichten von Cortex übersetzt. Also hier die Meldung von Gestern.
Liebe Grüße
Erbse1
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Heute - Cortex initiiert 1. länderübergreifende Ampakine Studie

Cortex Pharmaceuticals, Inc. (Amex: COR) und sein französischer Kooperationspartner Les Laboratoires Servier, mit Sitz in Paris, haben eine erste länderübergreifende AMPAKINE Studie an 31 medizinischen Zentren in sechs Ländern initiiert. Bereits am Mittwoch begann das erste der sechs Länder mit dem Patienten-Einschlussverfahren. Einschlusskriterium ist die Diagnose "Milde Form der Gedächtnisstörung" (MCI). Dies ist die erste nationenübergreifende Studie, welche die Wirksamkeit und das Sicherheitsprofil des von Cortex entwickelten Produktes AMPAKINE CX516 in durchschnittlich 160 Patienten im Alter von 55 bis 85 Jahren und dem Krankheitsbild MCI evaluieren wird. Die anderen medizinischen Zentren, wovon sich acht in den USA und 22 weitere in Frankreich, Belgien, Großbritannien, Schweden und den Niederlanden befinden, werden mit dem Einschluss der Patienten bereits in den nächsten Wochen beginnen. Mit der Beendigung der Studie rechnet man bereits innerhalb der nächsten 12 Monate. Aus der Literatur ist bekannt, dass bei etwa 60 bis 80% der Patienten die MCI innerhalb von fünf Jahren weiter fortschreitet, Endstadium ist die Alzheimer Krankheit. In den USA leiden etwa 2,5 bis 4 Mio. Menschen an MCI und in Westeuropa ist eine ähnliche Zahl von Menschen von dieser stets mit dem Tod endenden Krankheit betroffen.
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[Erbse1]

Hab auf einem anderen Board einen interessanten Artikel zu den Ampakinen gefunden. Ist leider nur in Englisch. Ich stell ihn trotzdem mal rein.
Liebe Grüße
Erbse1
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Alzheimer`s test planned for new drug
By Paul Recer, Associated Press writer
WASHINGTON – A new drug, which in some tests of healthy elderly men restores memory almost to that of young people, soon will be tested on patients with Alzheimer`s, the fatal brain disorder that destroys the mind.
Dr. Gary Lynch of the University of California at Irvine said yesterday the drug called ampakine CX-516 accelerates signals between brain cells and appears to significantly sharpen the memory.
The drug, used in only mild doses, was tested on students in their early 20s and on men aged 65 to 70 and the results were "particularly striking" among the older people, Dr. Lynch said. He delivered a report on the drug yesterday at a national meeting of the Society for Neuroscience.
Dr. Lynch said clinical trials of the drug consisted of memory tests conducted with and without CX-516.
Before taking the drugs, the subjects were read a series of nonsense syllables, then asked five minutes later to recall as many of them as possible.
The elderly could recall, on average, only one of the syllables. The score for the young men averaged four out of 10.
The subjects later were given mild doses of ampakine CX-516, then retested.
"The results for the 65- to 70-year-old men was particularly striking," said Dr. Lynch. "They scored near the range of young people."
In some tests even the young experienced improvement in memory by about 20 percent, he said.
Dr. Lynch said the hope is that the drug will improve the memory of patients with Alzheimer`s disease, a progressive disorder that destroys memory and other functions of the brain and eventually kills. About 5 million Americans, mostly elderly, have Alzheimer`s, and it is estimated that the number will climb to 15 million over the next quarter-century as the nation`s population ages.
Ampakine CX-516 has been tested only on small groups in clinical experiments to detect any toxic effects. A more definitive test will start next year at the National Institutes of Health, when 16 patients with mild to moderate Alzheimer`s disease will be given the drug.
Dr. Donald Price, a neuroscience researcher at Johns Hopkins University in Baltimore, said the new drug is "intriguing and innovative" and that it will influence "a very important synapse" in the brain.
However, he said, "I have reservations about its use in Alzheimer`s, because it does not directly address the disease mechanism. It is a palliative."
"I would suspend my enthusiasm until I see the results of the clinical trials. It is quite early" in the drug development process, Dr. Price said.
Dr. Lynch and co-workers at the University of California, Irvine, discovered the drug in 1991 while searching for compounds to improve communications between neurons in the brain.
Dr. Lynch said the improvement in memory may be even better with higher doses of the drug. This will be done only after early tests prove the drug has no harmful side effects. Human trials starting next year will be under the control of National Institutes of Health scientists.
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[Coluche]

hi Erbse,

diese Aussage "its a palliative" würde ich nicht so negativ bewerten, wie man es interpretieren könnte.

Viele Schmerzmittel sind "palliative", d.h. i. weiteren Sinne, sie bekämpfen die Symptome und nicht die Ursachen, und dennoch gehören sie zu den meist verkauften Pharmazeutika.

Auch in der Krebsbekämpfung hat man in den Pipelines fast nur "palliative", die die Auswirkungen der Tumorbildung bekämpfen, aber nicht prophylaktisch bzw. ursachenbedingt wirken.

Insofern ist mein persönlicher Standpunkt als Investor, daß bei einem Alzheimermedikament zunächst die Wirkung auf das Krankheitsbild für die Vermarktung wichtig ist, und die scheint sich in den bisherigen Testphasen zu realisieren.

Im übrigen finde ich, daß der stabile Kurs von Cortex und die guten Umsätze von über 20.000 p. Tag eine beruhigende Basis ist, um die zukünftigen Dinge abwarten zu können.

Gruß Coluche

[QuiGon]

Hi Erbse,

klasse, dieser Thread über Cortex!

Weisst du warum Cortex Anfang 2001 von 57$ auf 2$ abgestürzt ist? (Chart Comdirekt)

Gruß
QuiGon

[puhvogel]

@Colouche: Stimmt! Die Forscher können sich ja im Fall Alzhiemer noch nicht mal auf den genauen Mechanismus einigen. Ob das ß-Amyloid oder die Tau-Proteinketten die Ursache oder die Wirkung sind, dass wird erst die Zukunft zeigen. Mittlerweile jagen die Pharmas ihre Statine durch Alzheimer-Studien in der Hoffnung, noch mehr an ihren Statinen zu verdienen.

Die vergebliche Fokussierung der Anleger auf Elans Amyloid-Vakzine macht auch deutlich, dass upstream-Wirkstoffentwicklung keinesfalls ein Nobrainer-Spiel ist.

[Erbse1]

Hallo liebe Cortex Fans. Personell scheint sich bei Cortex einiges zu tun. Mit Carlsson holt Cortex sich einen absoluten Spitzenmann, der hauptsächlich auf dem Gebiet der Schizophrenie forscht. Ich bin begeistert.
Hallo Quigon
Der Chart bei Comdirect wird falsch dargestellt. Nimm den vom Yahoo Board, der ist korrekt.
Liebe Grüße
Erbse1
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Nobel Laureate Neuroscientist, Dr. Arvid Carlsson Named Scientific Advisor to Cortex Pharmaceuticals` Board of Directors
IRVINE, Calif., April 24 /PRNewswire-FirstCall/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - news), today announced that Arvid Carlsson, M.D., Ph.D., co-recipient of the 2000 Nobel Prize for Medicine, has become a consultant to the Company`s board of directors. Dr. Carlsson is currently CEO of Carlsson Research, a development stage neuroscience company that grew out of his research in the Department of Pharmacology at the University of Goteborg, Sweden. Dr. Carlsson is Professor Emeritus at the University of Goteborg and is a member of the Swedish Academy of Sciences and a foreign affiliate of the U.S. National Academy of Sciences.

``Dr. Carlsson`s research has revolutionized our understanding of a number of psychiatric and neurological disorders, including Parkinson`s disease and schizophrenia, and led to the development of new pharmaceutical treatments,`` said Vincent F. Simmon, Ph.D., President and CEO of Cortex Pharmaceuticals. Dr. Carlsson`s research achievements include the discovery of dopamine as a major neurotransmitter in the brain, as well as dopamine`s importance in Parkinson`s disease and schizophrenia. His research with L-dopa, a precursor to dopamine, led to subsequent clinical development of L-dopa as a treatment for Parkinson`s disease. His observation that chemical modification of tricyclic antidepressants resulted in greater blockade of serotonin reuptake, ultimately led to the development of selective serotonin reuptake inhibitors such as Prozac® for the treatment of depression.

In the 1980`s, Dr. Carlsson recognized the importance of restoring a balance between the neurotransmitters dopamine and glutamate in the treatment of schizophrenia, which ultimately led Cortex to evaluate the use of its AMPAKINE® technology for the treatment of schizophrenia.

In 2001, Donald Goff, M.D., Massachusetts General Hospital and Harvard Medical School, and his colleagues published the first clinical study using an AMPAKINE, CX516, in patients with schizophrenia. The drug treatment resulted in improvement in measures of attention, memory and cognition, as well as other clinical symptoms.

``Dr. Carlsson is imminently qualified to advise Cortex`s board of directors of opportunities in the development of new therapies for the treatment of neurodegenerative diseases as well as psychiatric diseases. We are most fortunate that he is willing to devote some of his time to Cortex,`` added Dr. Simmon.

Cortex recently announced the strengthening of its board of directors by recruiting Drs. M. Ross Johnson and Roger G. Stoll, who are both proven senior executives with extensive pharmaceutical industry experience. The additional scientific input provided by Dr. Carlsson adds to the critical scientific mass that already exists from two University of California at Irvine (UCI) Professors and Founders of Cortex, Dr. Carl Cotman, a Cortex Board member and Head of UCI`s Brain Research Center and Dr. Gary Lynch, Executive Scientific consultant to the Company and Professor of Neurobiology at UCI. Dr. Lynch is the co-inventor of the AMPAKINE technology with Dr. Gary Rogers, Senior Vice President of Pharmaceutical Research at Cortex.

About Arvid Carlsson, M.D., Ph.D.

Dr. Carlsson received his M.D. and Ph.D. in Pharmacology from the University of Lund, Sweden in 1951 and was immediately appointed Assistant Professor of Pharmacology. He was promoted to Associate Professor in 1956, and was an early pioneer in the pharmacology of calcium regulation, an area of research that later led others to the development of calcium channel blockers commonly used today to regulate cardiac function. In 1955, Dr. Carlsson was selected to be a trainee at the National Institutes of Health in Bethesda, MD, where he studied the biochemical role of reserpine in the brain in relationship to the neurotransmitter serotonin. In 1956, he returned to the University of Lund, where in collaboration with Dr. Nils-Ake Hillarp, he demonstrated reserpine caused a major depletion of norepinephrine in the brain and in sympathetic nerve fibers, explaining the heretofore unknown mechanism of action of reserpine`s antihypertensive effect. In 1959, Dr. Carlsson became Professor and Chairman of the Department of Pharmacology, University of Goteborg, Sweden, where he stayed for the remainder of his very productive academic career and the formation of Carlsson Research ( http://www.carlssonresearch.com /). Dr. Carlsson has authored several hundred articles, which have helped to form the basis of modern neuropsychopharmacology. In 1975, he was elected as a Foreign Corresponding Fellow of The American College of Neuropsychopharmacology. In addition to the Nobel Prize, he has been the recipient of many other awards, including The Japan Prize in Psychology and Psychiatry, The Research Prize of the Lundbeck Foundation (Denmark) and the Lieber Prize (USA) for research in schizophrenia.

Dr. Carlsson`s memberships include Member of the Academia Europaea, Member of the Royal Swedish Academy of Sciences, Honorary fellow of the World Federation of Societies of Biological Psychiatry, Honorary Foreign Associate of the Institute of Medicine, National Academy of Sciences, U.S.A. and Honorary Member of the German Society of Biological Psychiatry.

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[Erbse1]

Hallo liebe Cortex Fans. Ich möchte mich noch einmal zu Carlsson zu Wort melden. Warum ich so begeistert bin liegt daran, daß das Carlsson Institut selber an den selben Themengebieten arbeitet wie Cortex. Eine Zusammenarbeit in Zukunft bietet sich da an gemeinsam neue Wirkstoffe zur Marktreife zu bringen. Schade eigentlich, daß Cortex nur geringe finanziellen Spielraum besitzt.
Das könnte sich aber nach Veröffentlichung der ADHD Ergebnisse ändern. Hoffen wir mal das Beste, daß Shire die Option einlöst.
Folgend noch die Meldung vom Carlsson Institut zu der Testsubstanz ACR 16. Allerdings ist mir hier der Wirkmechanismus noch nicht ganz klar. Doch handelt es sich hier um eine neue Alternative, die von der bisherigen Blokademedikamenten der Dopaminrezeptoren abweicht.Somit steht neben ORG 24448 eine weitere Alternative bei Schizophrenie zur Verfügung
Liebe Grüße
Erbse1
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Carlsson Research AB Has Completed Phase I Studies And Files For Clinical Trials In Schizophrenia



GOTHENBURG, Sweden, April 19 /PRNewswire/ -- Carlsson Research ( http://www.carlssonresearch.com ) obtained permission from the Swedish Medical Products Agency to conduct Phase I clinical studies with ACR16 in November 2001. The study is completed and Carlsson Research will now file an application for clinical studies in schizophrenia.

``The Phase I study satisfied our expectations in all respects. ACR16 represents a novel principle for the treatment of CNS disorders. This is the principle of dopaminergic stabilisation``, says Arvid Carlsson, 2000 Nobel Laureate in Physiology or Medicine and CEO at Carlsson Research. The biological effects of ACR16 suggest the compound can be used to treat the full range of symptoms associated with schizophrenia, including positive and negative symptoms and symptoms not reached by current therapies, such as the impairment of cognitive and social functions.

``Stabilisation of dopaminergic transmission in CNS diseases holds great promise for treatment efficacy with low side effects``, says Carol Tamminga, Professor at Maryland Psychiatric Research Center, University of Maryland.

``The dopamine stabilisation properties of ACR16 also makes it a candidate for treatment of other neuropsychiatric disorders, such as ADHD, Huntington`s disease, late stage Parkinson`s disease, and dementia, since defects in dopaminergic functions are strongly linked to the symptomatologies of these disorders``, says Arvid Carlsson.

Nobel Laureate Arvid Carlsson and his co-workers formed Carlsson Research in 1998. The company is devoted to the discovery and clinical development of new pharmacological treatment principles for psychiatric and neurological disorders. Carlsson Research identifies new drug candidates using an Integrative Screening Process (ISP). This unique drug discovery platform synthesises knowledge in the fields of chemistry, computational biology, pharmacology and clinical medicine. The process secures beneficial effects at the level of the whole biological system. Carlsson Research has 35 employees working at laboratories in Gothenburg, Sweden.

SOURCE: Carlsson Research

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[Erbse1]

Hallo liebe Cortex Fans. Es geht voran. Langsam stürzt man sich auch auf die kleineren Anwendungsgebiete. Personell hat man sich in den letzten Tagen enorm Verstärkt. Neue Anwendungsgebiete werden in Angriff genommen.
Liebe Grüße
Erbse1
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SOURCE: Cortex Pharmaceuticals, Inc.
Cortex Drug to Be Evaluated as Treatment for Fragile X Syndrome and Autism
IRVINE, Calif., April 30 /PRNewswire-FirstCall/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - news), today announced that the company is collaborating with several research organizations to carry out a phase II clinical study to evaluate one of the company`s AMPAKINE® compounds as a potential treatment for fragile X syndrome and autism. Organizations participating in the study include the FRAXA Research Foundation, Rush-Presbyterian-St. Luke`s Medical Center in Chicago, and the Child and Adolescent Psychiatry Department at the University of Chicago.

The FRAXA Foundation will provide funding for the trial at Rush- Presbyterian-St. Luke`s Medical Center, and Cortex will provide study medication (CX516 or placebo capsules). The principal investigator at Rush- Presbyterian-St. Luke`s is Elizabeth Berry-Kravis, M.D., Ph.D. Edwin Cook, M.D., a renowned expert in autism at the University of Chicago contributed to the development of the clinical protocol. Patients are expected to begin being enrolled during May.

"We`re very excited about this important collaboration," said Vincent F. Simmon, Ph.D., President and CEO of Cortex. "Currently there are no therapies on the market to treat fragile X syndrome or autism. However, in the past five years, basic research has led to an improved understanding of these diseases and a number of scientists have suggested that the use of a drug to enhance glutamate transmission could be beneficial. Our AMPAKINE compounds have been proven to enhance glutamate transmission and therefore are obvious candidates as potential new therapeutics. Cortex has not licensed these indications and retains full rights in the U.S. and abroad."

About Fragile X Syndrome

Fragile X is an inherited disorder and is the most common cause of inherited mental retardation, affecting 1 in 2,000 males and 1 in 4,000 females. Symptoms of fragile X syndrome include mental impairment ranging from learning disabilities to mental retardation, attention deficit and hyperactivity, anxiety and unstable mood, autistic-like behaviors, long face, large ears, flat feet, and hyperextensible joints, especially fingers.

Males are typically more severely affected than females. Although most males have mental retardation, only one-third to one-half of females have significant intellectual impairment; the rest have either normal IQ or learning disabilities. Emotional and behavioral problems are common in both sexes. Currently there are no therapeutic treatments for the disease, although medications are used to treat some symptoms.

About Autism

Autism is a complex developmental disability that typically appears during the first three years of life. The result of a neurological disorder that affects the functioning of the brain, autism and its associated behaviors have been estimated to occur in as many as 2 to 6 in 1,000 individuals. Autism is four times more prevalent in males than in females.

Autism impacts the normal development of the brain in the areas of social interaction and communication skills. Children and adults with autism typically have difficulties in verbal and nonverbal communication, social interactions, and leisure or play activities. Persons with autism may exhibit repeated body movements (e.g., hand flapping or rocking), unusual responses to people or attachments to objects, and resistance to changes in routines. Individuals may also experience sensitivities in the five senses of sight, hearing, touch, smell and taste. There are currently no therapeutic treatments for autism, although early behavioral intervention dramatically improves outcome.

Rationale for the Study

A variety of scientific evidence suggests that increasing glutamate neuronal transmission may be beneficial in autism and fragile X syndrome. Imaging studies demonstrate that areas of the brain that are extremely rich in glutamate transmission are less active in autistic patients. Molecular studies suggest that although genes involved in the AMPA-type glutamate receptor are more active in autistic patients, the density of AMPA-type glutamate receptors is decreased. Drugs that reduce glutamatergic transmission induce symptoms similar to those seen in autistic patients. Taken together, these facts suggest that enhancing AMPA receptor activity may be beneficial in autistic patients.

The scientific logic for using a positive modulator in fragile X is more complex but equally compelling. The genetic defect results in the reduction or absence of an important protein, FMRP. FMRP is believed to play an important role in allowing normal levels of AMPA receptor proteins to be made. Thus increasing the activity of AMPA receptors with an AMPAKINE may to some degree overcome the reduced number of AMPA receptors. FRAXA has previously funded a study of AMPAKINE molecules in fragile X mice.

The design of the Phase II clinical study is a randomized double-blind, placebo controlled trial lasting four weeks after a one-week placebo run-in and ending with a two-week washout period. 50 patients from the Chicago area will be recruited for the study. It is anticipated that enrollment will occur over a two-year period. Outcome measures will include testing in four domains:


-- Attention and executive function
-- Spatial and verbal/auditory memory
-- Language domain
-- Behavior domain


About FRAXA

FRAXA was founded in 1994 by three parents of children with fragile X syndrome, Katie Clapp, Michael Tranfaglia, M.D., and Kathy May, to support scientific research aimed at finding a treatment and a cure for fragile X syndrome.

FRAXA funds grants and fellowships at universities all over the world. The organization has funded more than $3 million in top-notch science. Since FRAXA was founded, the fragile X field has grown tremendously, due in large part to grass-roots efforts. More information on FRAXA can be found at http://www.fraxa.org/ .

About Rush-Presbyterian-St. Luke`s Medical Center

Rush-Presbyterian-St. Luke`s Medical Center is an academic medical center that encompasses the 824-bed Presbyterian-St. Luke`s Hospital (including Rush Children`s Hospital), the 110-bed Johnson R. Bowman Health Center and Rush University. Rush University, with more than 1,200 students, is home to one of the first medical schools in the Midwest, one of the nation`s top-ranked nursing colleges, as well as graduate programs in allied health and the basic sciences. Rush is noted for bringing together clinical care and research to address major health problems, including arthritis and orthopedic disorders, cancer, heart disease, mental illness, neurological disorders and diseases associated with aging. Rush has been the site of a large Fragile X Clinic since 1992, the only such clinic in the Midwest, and is directed by Dr. Berry- Kravis. Rush-Presbyterian-St. Luke`s Medical Center can be found at http://www.rush.edu/index.html/ .

The Child and Adolescent Psychiatry Department at the University of Chicago

The Child and Adolescent Psychiatry Department at the University of Chicago is a specialty department within the departments of Psychiatry and Pediatrics of the University of Chicago`s Division of Biological Sciences and the Pritzker School of Medicine. The department is multidisciplinary and is involved in clinical services, as well as training and research in infant, child and adolescent mental health. The Child and Adolescent Psychiatry residency training program has been recognized since 1963 by the American Board of Psychiatry and Neurology and the Committee on Certification in Child Psychiatry and is fully accredited by the Accreditation Council for Graduate Medical Education. Training in the section is provided for advanced trainees in child and adolescent psychiatry as well as for trainees in general psychiatry, pediatrics, psychology, social work and medicine. More information on The Child and Adolescent Psychiatry Department at the University of Chicago can be found at http://www.psychiatry.uchicago.edu/ .

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[Erbse1]

Hallo liebe Cortex Fans. Gestern fand eine Konferenz zu den Quartalszahlen und zur Entwicklung von Cortex statt. Ich habe mal einen Beitrag vom Yahoo Board kopiert. Hier steht stichwortartig das Wichtigste drin.
Liebe Grüße
Erbse1
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Summary...

1. Shire milestone payment - 2Q02
2. ADHD study results - 1Q03
3. MCI results - 2Q03
4. Schizophrenia results/milestone - 4Q03/1Q04 (?)
5. Discussions continue with a number of other Big Pharma companies
6. Looking to extend partnership with a large pharmaceutical company within the next 12 months
7. Patent litigation status - "action is imminent"
8. Autism/Fragile X not Orphan status
9. Autism = 0.5-1 mill /annually
10.Fragile X = 850K / annually

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[Erbse1]

Hallo liebe Cortex Fans!
Ich möchte mich mal kurz zu der jetzt anstehenden Patenentscheidungen in Europa melden. Es handelt sich um einige Substanzen die Eli Lilly in Europa zur Patenterteilung eingereicht hat.
Cortex hat die Patenterteilung für Amerika und für Europa steht noch eine Entscheidung an. Es sind Substanzen, die auf dem Gebiet der Depressionen zum Einsatz kommen sollen.

Laut einem Gerücht des Neuroinvestors, ein Börsenbrief für Neuro-Bios, soll sich Eli Lilly allerdings in einer Sackgasse befinden. Die Substanzen mit denen Eli Lilly arbeitet sollen zu toxisch sein. Wenn das so ist, wäre es eine Super Nachricht für Cortex. Allerdings hüllt sich Eli Lilly in tiefes Schweigen.
Für Cortex würde das bedeuten, daß sie einen Entwicklungsvorsprung von mehreren Jahren hätten.
Organon hat das Gebiet Depression von Cortex lizensiert und plant mit der Substanz ORG 24448, mit der selben Substanz die auch bei Schizophrenie getestet wird, in die Testphasen zu gehen.
Selbst eine Patenterteilung für Eli Lilly in Europa hätte somit keine Auswirkung. Ich bitte Euch diese Nachricht mit aller Vorsicht zu geniessen bis letztendlich eine Bestätigung vorliegt. Dennoch halte ich diese Nachricht für sehr wichtig, um sie nur für mich zu behalten.

Liebe Grüße
Erbse1

[Erbse1]

Hallo liebe Cortex Fans. Für heute eine schlechte Nachricht.
Shire übt die Option bei ADHD nicht aus. Mal abwarten wie groß der Abschlag heute sein wird, nachdem der Kurs in den letzten fünf Monaten kontunuirlich abgebaut hat. Nach dem Kursverlauf wußten da ja schon einige Leute vorher bescheid.
Ich hätte mich auch lieber mit einer besseren Nachricht gemeldet.
Liebe Grüße
Erbse1
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Cortex Seeks New Partner to Pursue ADHD Treatment Opportunity; Shire Elects Not to Exercise Its Option for ADHD
- Conference Call Scheduled for 1:30 PM PDT -
IRVINE, Calif., July 1 /PRNewswire-FirstCall/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - News), today announced that Shire Pharmaceuticals Group plc has decided not to exercise its option to develop Cortex`s AMPAKINE® technology and compounds for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The decision frees Cortex to pursue new partners that have expressed interest in applying Cortex`s technology platform toward ADHD.

Shire undertook a Phase II clinical trial using the AMPAKINE CX516 in 72 adult patients with ADHD. The trial was terminated prior to expiration of the option period and prior to the recruitment of additional patients into the trial. Based on the results of this study, Shire has decided not to continue development of CX516 or any other AMPAKINE. Under terms of the previously negotiated option agreement, all rights to CX516 and the AMPAKINE technology will be returned to Cortex. Cortex plans to execute its right to get the data from the clinical trial.

"Unfortunately, Shire has decided not to pursue our AMPAKINE technology for the ADHD indication," said Vincent F. Simmon, Ph.D., President and CEO of Cortex. "However, this does not invalidate the use of AMPAKINE compounds or technology for this indication."

"Several major pharmaceutical companies have approached Cortex with a strong interest in our AMPAKINE technology as a nonscheduled (not regulated by the Drug Enforcement Agency) alternative to amphetamines for the treatment of ADHD," Simmon continued. "Now that Shire has made its decision, Cortex will vigorously pursue another partner for this opportunity."

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[Coluche]

Was mir an der Meldung auffällt, ist die Aussage, daß Cortex nun seine Rechte geltend machen wird, um die Versuchsdaten von Shire zu bekommen.

Das bedeutet, sie haben die Daten bis jetzt noch nicht.

Nun versetze ich mich in die Situation des CEO von Cortex, der somit bis heute noch keine genaue Daten zur Versuchsreihe mit ADHD hat ( schlecht verhandelt, falscher Vertrag mit Shire ...??? was auch immer dahinter stecken mag).

Ich würde auf dem schnellsten Wege schaun, diese Modalität zu ändern um jederzeit Transparenz zu haben. D.h. ich würde entweder auf eine Vertragsänderung pochen oder schaun, daß das Engagement mit diesem Partner zügig beendet wird ( was ja nun mit Shire der Fall ist ).

Und mal ehrlich: wenn man die Diskussionen im Yahoo-Board in den letzten Tagen verfolgt hat, lag sowas bereits in der Luft. Und auch eine Vertragsverlängerung wäre nicht erst am Ultimo bekannt gegeben worden.

Will heißen: Ruhe bewahren, ggf. den günstigen niedrigen Kurs zum Einstieg nutzen und schaun was Cortex nun strategisch unternimmt. Die einzige Schwachstelle bei Cortex sehe ich momentan nur in der geringen Cash-Position, und da gibt sich der CEO von Cortex recht zuversichtlich ( während er zur Vertragsverlängerung von Cortex eher zugeknöpft war ).

Gruß Coluche

[Erbse1]

Hallo coluche. Ehrlich gesagt, bin ich überrascht über die konsequente Absage von Shire. Shire hätte die Möglichkeit eine Substanz der zweiten Generation zu übernehmen. Dies wurde rundweg abgelehnt. Die Motivation zur totalen Ablehnung ist mir leider nicht bekannt.

Es scheint nicht gerade das beste Verhältnis zwischen Shire und Cortex zu existieren, da Shire sich weigert die Testergebnisse rauszurücken. Sollte dies nur mit Gerichten geschehen, so kann dies Jahre dauern. Die Motivation zur Ablehnung könnten auch ganz anderer Natur sein und nicht mit den Testergebnissen zusammenhängen. CX 516 diente ohnehin nur dazu eine Tendenz zu erkennen. Zur Anwendung kommen sollte ja wohl eine Substanz der zweiten Generation. Wenn dies so ist, wird wohl schnell ein neuer Partner für Shire in die Breche springen. Nach dem Kursverlauf war wohl einigen Insidern von Shire die Entscheidung schon vorher bekannt.
Für Cortex wird jetzt gegen Ende des Jahres die Kapitaldecke ziemlich dünn und sie müssen sich mindestens für ein halbes Jahr Kapital besorgen. Ich denke mal wir haben für die nächsten 18 Monate eine lange Durststrecke vor uns bis die Ergebnisse aus MCI mit Servier und bei ORG24448 mit Organon bei Schizophrenie vorliegen.

Sollten jedoch gravierende Nebenwirkungen der Grund für die Absage von Shire gewesen sein, so könnte ein vollständiges Scheitern der Ampakine die Folge sein. Dies widerspricht allerdings vorherigen Daten, die bisher von keinen nennenswerten Nebenwirkungen berichteten.
Liebe Grüße
Erbse1

[Coluche]

Hallo Erbse, überrascht über diese Absage war ich auch, und vor allem über den starken Kursrückgang.

Ich hoffe, daß Cortex bald mit positiven Neuigkeiten nachlegen kann. Es wurde ja angedeutet, daß in Nordamerika einige größere Pharmafirmen Interesse an einer Zusammenarbeit bekundet haben.

Die Sache mit Shire sehe ich allerdings auch unter dem Gesichtspunkt, das sie bereits ein ADHD-Medikament zugelassen haben (Adderall) und die Ampakine von Cortex laut Shire lediglich als Ergänzung zum Portfolio ( 23 Projekte ) geführt wurden.

Shire sagt zum Thema Ampakine ( und das war nicht erst gestern oder heute ) "non expected to be classified as a sheduled product". Zu deutsch: sie sind das Produkt mit angezogener Handbremse gefahren (als Anmerkung Zitat von dem Reformator Dr. Martin Luther: "...aus einem verzagten Arsch kommt nie ein fröhlicher Furz..." ... sorry aber so deftig lautet eben das Originalzitat ). Da braucht man sich nicht wundern, wenn es zwischen Cortex Misstimmung gibt/gegeben hat bzw. Shire das Projekt mal eben so aufgibt.

Hoffe, daß sich der ganze Spuk bald wieder beruhigt und vor allem kein Delisting an der AMEX erfolgt. Eine Kapitalerhöhung dürfte bei dem Kurs wohl auch hinfällig werden, glaube da eher an neue Milestone-Payments mit neuen Partnern.

Gruß Coluche

[Erbse1]

Hallo Coluche, natürlich hoffe ich auch, daß für Shire schnell einer in die Breche springt. Doch man müßte wieder ganz von vorne anfangen, da Shire die vorliegenden Daten nicht rausrückt. Ich kenn leider die Firmenpolitik von Shire nicht, doch es könnte sein, daß sie in anderen Substanzen eine bessere Alternative sehen. Außerdem besitzen sie mit Adderall und Adderall XR in Amerika den weitaus größten Marktanteil. Doch gibt es potentere Substanzen als CX 516. Dies ist aus vorliegenden Tierversuchen bekannt.
Gemessen an den verbleibenden Testphasen bei MCI und Schizophrenie ist ADHD nun wirklich nicht ein großes Anwendungsgebiet und ich halte den Kursabschlag wirklich für übertrieben. Als Börsianer allerdings würde ich auch nicht für eine Aktie 1,50$ bezahlen wenn ich sie für 1$ oder weniger bekomme.
Aus Diskussionen aus anderen Boards mit Vince Simmon ist mir bekannt, daß zwar Interessen von anderen Pharmafirmen besteht. Doch wollen sie erstmal Phase 2 Studien abwarten, bevor sie einsteigen. Bis dahin hat Cortex kein Geld mehr.
Ich bin erstmal nicht so optimistisch, was neue Milestones oder neue Partnerschaften angeht. Dennoch ist Vince Simmon sehr optimistisch was die Kapitalmaßnahmen betrifft.
Ich selber laß mich mal überraschen, wie es weitergeht. Selbst ein Delisting ist nur eine Verzögerung, wenn sich ein Erfolg bei MCI oder Schizophrenie einstellt. Doch dauert dies noch einige Zeit.
Liebe Grüße
Erbse1

[Erbse1]

Hallo coluche, liebe Cortex Fans. Folgend noch der Kurzkommentar des Neuroinvestors zur Ablehnung von Shire.
Ich selber spiel in nächster Zeit mal die Vogel Strauss Politik. Kopf in den Sand und im Frühjahr nächsten Jahres schau ich noch mal nach. Nach dem Kursverlauf scheint ja nun keiner mehr an den Erfolg der Ampakine zu glauben. Ich wünsche noch allen Investierten viel Glück.
Erbse1
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Shire did not pick up the ADHD option, and now Cortex is free to seek another partner. We are aware of a couple of large companies with interest in the Ampakine/ADHD project, but nothing will happen until Cortex has fully analyzed the Shire data prior to showing it. We suspect that the process will take to the end of the year before another partner is found. There are potency issues, if one looks at the Caron preclinical data, very high concentrations per kg were used, and one may wonder if CX516 is the best Ampakine for ADHD, since far more potent ones have been synthesized and looked at preclinically. It was frankly surprising to us that Shire did not choose to explore the second and third generation molecules, they may have decided they did not want to develop a drug not already with human exposure. But this seems unwise to us, there are other companies which would be happy to challenge Shire`s ADHD franchise, one they cannot afford to lose. ADHD was always a `bonus` Ampakine target to us, MCI and schizophrenia are much more heavily weighted in our projections.

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[Erbse1]

Hallo liebe Cortex Fans. Stühlerücken bei Cortex. Ich kann die Lage jetzt noch nicht richtig einschätzen. Es könnte allerdings mit der neuen Finanzierung zusammenhängen. Ich werde die Diskussion auf dem Yahoo Board weiter verfolgen.

Wünschen wir dem neuen CEO eine glückliche Hand. Hier noch die Meldung. Ich möchte Euch bitten weitere Informationen selber zu besorgen, da ich im Augenblick aus beruflichen Gründen nicht mehr ständig an Board bin.
Liebe Grüße
Erbse1
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IRVINE, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - News), announced today that Roger G. Stoll, Ph.D., a member of the Cortex board, has been appointed Chairman, President and Chief Executive Officer, effective immediately. Robert F. Allnutt, who has chaired the board since early 1998, is stepping down as Chairman but will remain on the board. Vincent F. Simmon, Ph.D., has resigned as a Director and as President and Chief Executive Officer to pursue other opportunities.

Dr. Stoll has over 30 years of experience in the pharmaceutical, medical devices and diagnostic industries. Most recently, he was the Executive Vice President of Fresenius Medical Care - N. America, in charge of both the dialysis products and laboratory services. Dr. Stoll oversaw the company`s manufacturing, sales, service, research and development, and business development functions, and was responsible for combined sales of approximately $900 million as well as more than 3,000 employees.

From 1991 to 1998, Dr. Stoll was CEO of Ohmeda, Inc., a worldwide leader in anesthesia and critical care products with sales of approximately $1 billion and more than 5,000 employees. From 1986 to 1991, Dr. Stoll held several positions within Bayer, AG. Initially at Bayer, he had responsibilities that included being President of the Consumer Health Care Group of Miles. He then became the Executive Vice President and General Manager of the Diagnostics Business Group of Bayer, during which time the business expanded from $400 million to approximately $1 billion in sales. Before 1986 Stoll held positions of increasing responsibility including President of the American Critical Care Division of American Hospital Supply Corporation (now Baxter International) and in clinical research at The Upjohn Company.

Dr. Stoll received his bachelor`s degree in pharmacy from Ferris State University and a Ph.D. in Biopharmaceutics from the University of Connecticut, and performed postdoctoral studies in pharmacokinetics at the University of Michigan. In addition to the Cortex board, Dr. Stoll currently serves as a member of the boards of directors of Agensys, Inc., Questcor Pharmaceuticals, Inc., and LifePoint, Inc.

Commenting on Dr. Stoll`s appointment, Allnutt said, "Roger Stoll brings seasoned scientific, management and business strengths to his new role. Cortex is fortunate indeed that he is able to take on this leadership role."

"When Vince Simmon joined the company six years ago, there had been little progress in developing our key technologies, the AMPA modulators known as AMPAKINE® compounds. There were no solid prospects for partnering development of these compounds and our intellectual property portfolio was only partially in place," Allnutt added. "The picture today is quite different, thanks in large measure to Vince. Our AMPAKINE drugs are in Phase II clinical trials in Europe and the United States. Solid, effective partnerships are in place with two leading European companies, and there are sound prospects being explored for additional partnerships. Our worldwide intellectual property position has been substantially enhanced. Vince has worked hard to bring the company to this point, and we wish him well in his future endeavors."

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer`s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain`s neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including MCI and Alzheimer`s disease. ( http://www.cortexpharm.com /)

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[Erbse1]

Ich kopier mal einen interessanten Artikel zu den Wechselwirkungen von Dopamin Glutamat und DARPP-32
hier rein. Auf die Ergebnisse mit ORG 24448 Ende nächsten Jahres bin ich wirklich mal gespannt. Den Chefwechsel scheint Cortex nun einigermaßen gut überstanden zu haben, so daß man sich wirklich mal auf die Ergebnisse bei MCI und Schizophrenie konzentrieren sollte.
Liebe Grüße
Erbse1
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Clues to brain changes behind schizophrenia

Last Updated: 2002-08-16 14:40:06 -0400 (Reuters Health)

By Alison McCook

NEW YORK (Reuters Health) - The brains of many schizophrenic patients may be characterized by relatively low levels of an important chemical in a region of the brain implicated in the condition, US researchers report.

This finding may provide needed clues in the genesis of schizophrenia, a condition whose cause remains unknown.

However, these results do not indicate whether lower levels of the chemical, known as DARPP-32, causes schizophrenia, or if DARPP-32 decreases in response to whatever else is causing the condition, study author Dr. Hugh C. Hemmings of Cornell University told Reuters Health.

"We don`t know if the low levels of DARPP-32 are causative, or some sort of compensatory mechanism," Hemmings said.

"It`s an observation without a mechanism," he added.

Schizophrenia is a severe brain disorder that alters a person`s emotions, thought processes and perceptions of reality. Symptoms can include withdrawal from social interaction, blunted expression of emotions, hallucinations and delusions.

DARPP-32 has long been considered to play an important role in schizophrenia, because it interacts with two other chemicals implicated in the condition, dopamine and glutamate. Briefly, when dopamine interacts with its receptors at the surface of cells, a chain of chemical reactions is triggered. This chain includes the activation of DARPP-32, which then carries out functions within the cell. Alternatively, when glutamate interacts with its receptors, this event ends up disabling DARPP-32.

Both dopamine and glutamate likely play key roles in the development of schizophrenia, Hemmings noted, because treatments that block the action of dopamine receptors help treat the condition, while those that block glutamate can make schizophrenia symptoms worse, or cause psychosis in those without the condition.

In the current study, Hemmings, along with Dr. Katherine A. Albert of Rockefeller University and Cornell University in New York and her colleagues, conducted autopsies of the brains of 14 schizophrenic patients, and compared the organs to those from people without the condition. The researchers report their findings in the August issue of the Archives of General Psychiatry.

The investigators found that more people with schizophrenia than without exhibited relatively low levels of DARPP-32 in a region of the brain known as the dorsolateral prefrontal cortex.

Based on the findings, Hemmings said that he suspects lower DARPP-32 levels may, in fact, be a result of the actual cause of schizophrenia. Given that reducing the activity of dopamine reduces symptoms of schizophrenia, the researcher said that hyperactivity of the dopamine system may play a role in producing symptoms of the condition. If so, it makes sense that the brain might try to protect itself from this hyperactivity by reducing levels of DARPP-32, a chemical that does dopamine`s job in the cell, Hemmings noted.

However, he emphasized that this remains pure speculation, for the reason why some schizophrenics have low levels of DARPP-32 remains unclear.

If low levels of DARPP-32 are indeed the cause of schizophrenia, Hemmings suggested that therapies that increase DARPP-32 might help alleviate the condition.

Alternatively, if the brain reduces DARPP-32 to protect itself from the cause of schizophrenia, Hemmings said that reducing the chemical even further might also help people with the condition.

Regardless, he noted that this research might help open up a new area for investigators to target when searching for new therapies, by highlighting the importance of chemicals affected by the primary cause of schizophrenia.

"It just suggests a new sort of area to explore in the disease," Hemmings said.

SOURCE: Archives of General Psychiatry 2002;59:705-712.

Copyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

[Simonswald]

Bin nur interessierter Laie in Arzneimittelbranche. Hat das Cortex-Mittel einen anderen Wirkmechanismus als ZYPREXA von Lilly oder GEDEON von Pfizer?

Wird es sich gegen die "Vertriebsmacht" Pfizer und dessen Neueinführung GEDEON/ZELDOX behaupten können?

[Simonswald]

@puhvogel

Was genau kritisierst du an der Gruppe der Statine?

[Erbse1]

Hallo simonswald. Ich möchte Dich nur bitten die ersten Beiträge von diesem Thread noch einmal zu lesen. Da steht drin, wonach Du fragst.Leider müßen wir erst mal die Ergebnisse der einzelnen Testphasen abwarten, um die Frage zu beantworten, ob die Ampakine eine Chance gegen die herkömmlichen Psychopharmaka haben. Sollten sie sich als wirkungsvoll erweisen, so könnte sich für viele Schizophreniepatienten eine neue Alternative eröffnen, ohne den Nachteil der doch sehr unangenehmen Nebenwirkungen der herkömmlichen Medikamente.
Allerdings wird gegen Ende des Jahres bei Cortex das Geld knapp und ich bin mal gespannt wie der neue CEO an neues Geld kommen will. Es lohnt sich wirklich Cortex auf der watchlist zu haben und bei entsprechender Nachricht dann zu kaufen. Allerdings solltest Du Dich auch ins Thema einarbeiten, um die Nachrichten auch richtig zu interpretieren.
Cortex wird auf dem YAHOO Board meist sehr sachlich diskutiert und weitere Recherchen bieten sich hier an.

Liebe Grüße
Erbse1

[Erbse1]

Das könnte heute ein guter Tag werden für Cortex. Die weitere Finanzierung scheint hiermit erst mal gesichert.
Kurz schnell die Meldung, bevor der Chef wieder reinkommt.
Auf diese Meldung haben wir lange gewartet.
Machts mal gut und liebe Grüße
Erbse1
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IRVINE, Calif., Oct. 9 /PRNewswire-FirstCall/ -- Cortex Pharmaceuticals, Inc. (Amex: COR - News) today announced the expansion of its research collaboration with Les Laboratoires Servier ("Servier") to include the identification and development of AMPAKINE compounds that may be used to treat Anxiety Disorders -- a category that includes Panic Disorder, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Social Phobia and Post-Traumatic Stress -- and collectively represents more than $3 billion in worldwide sales. The decision to be the first company to license AMPAKINE technology for the indication of Anxiety Disorders and to further invest in Cortex comes just three months after Servier selected CX516 as its Phase II lead AMPAKINE compound to treat Mild Cognitive Impairment ("MCI"), Alzheimer`s Disease ("AD") and other neurodegenerative diseases in its territory, primarily Europe, Africa and Asia.
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Under the expanded licensing agreement, Cortex will receive $4 million of research funding in eight payments of $500,000 each. The first payment will be made in October 2002. In addition to the scheduled payments, Cortex will be eligible to receive milestone payments based on successful AMPAKINE clinical and commercial development, plus royalties from product sales. In exchange for research funding, Cortex will provide Servier with an exclusive license for Anxiety Disorders in its territory. Cortex will retain the AMPAKINE rights for Anxiety Disorders, MCI, AD and other neurodegenerative disorders in North America, and Latin and South America, with the exception of Argentina, Brazil and Venezuela. The agreement provides Cortex with the opportunity to develop and market some of these indications for its own use or to license the remainder to other corporate partners. In addition, Cortex retains the worldwide rights for ADHD, Autism, Post Stroke, Traumatic Brain Injury and Spinal Cord Injury.

"This is a further investment in Cortex by a company that has a great deal of knowledge about AMPAKINE technology. With the additional two years of payments, we have solved the immediate financial issues referred to in our previous public statements," said Dr. Roger G. Stoll, the new chairman, president and CEO of Cortex. "We see this agreement as a vote of confidence based on the progress we have made together in developing longer-acting and more-potent AMPAKINE compounds to treat Alzheimer`s Disease and other neurodegenerative diseases."

Productive Partnership

Cortex and Servier began their collaboration in October 2000 with several research and licensing agreements that focused on joint research, clinical development and commercialization of Cortex`s AMPAKINE technology for the treatment of MCI, AD and other neurodegenerative diseases. Cortex and Servier most recently collaborated in designing and implementing the first AMPAKINE CX516 Cross-National Mild Cognitive Impairment Study.

Conference Call

Cortex will host a conference call on Oct. 9, at 1:00 p.m. PDT, to discuss today`s announcement. Following the conference call, the company will open the phone lines to answer questions from investors and members of the media. Those who wish to participate may do so using the following dial-in information: In the United States/Canada, call [phone], passcode: 6070273. Internationally, interested parties should call [phone], passcode: 6070273. An audio replay of the conference call will be available two hours after the completion of the conference call until Oct. 18, 2002. In the United States/Canada, the replay may be accessed by calling [phone] and providing the following passcode: 6070273. The replay may be accessed internationally by calling [phone], passcode: 6070273.
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[Erbse1]

Gute Nachricht für Cortex. Anscheinend haben sie die Patentauseinandersetzung in Europa gegen Eli Lilly gewonnen. Damit wäre eine jahrelanger Vorsprung gesichert und wenn Eli Lilly weiter an der Ampakine Technologie interessiert ist, müßten sie mit Cortex in Verhandlung treten.
In allernächster Zeit stehen noch die Ergebnisse der Testphase 2 zu MCI an. Hoffen wir mal das Beste.
Folgend noch die Meldung zur Patententscheidung.
Liebe Grüße
Erbse1
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Cortex Receives Allowance for Its Broad Use Patent for Drugs that Enhance `Memory and Cognition` in Europe

IRVINE, Calif., Apr 1, 2003 /PRNewswire-FirstCall via COMTEX/ -- Cortex Pharmaceuticals, Inc. (Amex: COR) has received a notice of allowance for European Patent Application No. 01111268.7 from the European Patent Office (EPO). The patent titled, "Drugs that Enhance Synaptic Responses Mediated by AMPA Receptors," when issued, will provide Cortex the same type of broad protection as similar patents that have already issued in the United States, Mexico, Australia and New Zealand. Specifically, Cortex will have rights to claim the use of any drug that works via the mechanism of AMPA type glutamate receptor up-modulation (AMPA-R) for enhancing memory encoding and cognition in humans.

"Thus, any compound that works via the AMPA-R up-modulation or potentiation mechanism, developed by any company, would require a license from Cortex before it could be commercialized as a product in one of the countries covered by this patent portfolio," stated Roger G. Stoll, Ph.D., President and CEO of Cortex. The scientific work that underlies the concept of AMPA-R up-modulation for glutamate-type receptors to treat psychiatric and neurological diseases originated in 1992 with Dr. Gary Lynch, now Professor of Psychiatry at the University of California at Irvine and Dr. Gary Rogers, now Senior Vice President of Pharmaceutical Research at Cortex. Each of the patents described above is exclusively licensed by the University of California to Cortex.

"The importance of this allowed patent is that when it issues in the next few months, it will provide Cortex with a wide ranging territorial franchise for our AMPAKINE(R) compounds and our other AMPA type glutamate receptor up-modulators. Many of the indications for these compounds are literally of the `block-buster` size in our industry -- and we believe we hold the key patent rights," added Dr. Stoll. "As with all patents, this patent could be invalidated sometime in the future and in Europe there is a formal nine-month period for filing oppositions once the patents issues." Some of the diseases that involve memory and cognition functions in the brain include Alzheimer`s disease, dementia, Huntington`s Chorea, Down`s Syndrome, stroke, Parkinson`s Disease, depression, Attention Deficit Hyperactivity Disorder, anxiety, autism, and fragile X syndrome.

Cortex has exclusive rights to approximately 44 issued or allowed patents for AMPA type glutamate receptor modulators, of which 32 are composition of matter patents. The Company has a business strategy to develop licenses for the large indications, which require substantial Phase III clinical trials and huge sales organizations to reach the prescriber. At the same time, Cortex plans to develop internally a selected set of indications, many of which will allow it to address "Orphan Drug" status. These indications typically require more modest investment in the development stages and the sales reach required is usually concentrated to a few, selected medical centers in the United States. In this manner, the Company believes it can achieve growth via a two-pronged approach and provide for somewhat less risk in achieving success for its business.

Several published pilot clinical studies already indicate that the AMPAKINE compounds can successfully treat patients with age associated memory impairment, Alzheimer`s disease, and schizophrenia. Cortex presently is seeking additional financial support to allow it to accelerate some of the programs in its development portfolio.

"I believe that over the last several years my research, and that of other investigators, has demonstrated that enhanced modulation of the AMPA type glutamate receptors can be directly linked to improved memory and cognitive function in animals and humans. The data also show that this can be done safely without creating excitotoxicity. The vast majority of the connections (synapses) between neurons in the brain respond to glutamate as the chemical messenger. There are reasons to believe that reduced activity at these connections may be associated with a large number of neurological and psychiatric diseases. AMPAKINE compounds may well alleviate many of these disorders," said Dr. Gary Lynch.

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[Erbse1]

Ich wollte mich noch mal zu den Veröffentlichungsdatum der MCI Ergebnisse melden. So wie es aussieht tritt hier eine Verzögerung um ca. ein halbes Jahr ein. Also ist hier wieder einmal Warten angesagt. Die Gewinne nach der Patenterteilung haben sich leider wieder abgebaut. Ehrlich gesagt habe ich hier ein wenig mehr erhofft.
Also können wir die wirklich wichtigen Meldungenzu MCI im vierten Quartal diesen Jahres und zu den Schizophrenie Ergebnissen Anfang nächsten Jahres erwarten.
Folgend noch die Meldung zu MCI von der geänderten Cortex Homepage
Liebe Grüße
Erbse1
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Cortex and partner Les Laboratoires Servier are collaborating on an international clinical trial for patients with Mild Cognitive Impairment (MCI). This collaboration marks the first cross-national study of AMPAKINE® compounds as well as the first international study designed to show acute memory enhancement in patients with MCI. The seminal trial is intended to evaluate the safety and efficacy of AMPAKINE CX516 in approximately 160 patients with MCI who are between the ages of 55 and 85. In the double-blind trial, patients will be randomized to receive placebo or the AMPAKINE CX516 for a period of four weeks. Enrollment in the study commenced during the first quarter of 2002. We anticipate completing the study during early third quarter 2003, and reporting a preliminary evaluation during the fourth quarter of 2003.
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[Erbse1]

Hallo liebe Cortex Fans, ich werde von der Homepage mal den Stand zu den einzelnen Testsubstanzen und der zukünftigen Entwicklung kopieren.

Der Kurs hat sich in den letzten Tagen prächtig entwickelt. Ich wäre nicht überrascht wenn in den nächsten Tagen eine neue Partnerschaft veröffentlicht wird.

Mittlerweile ist dieser Thread fast zwei Jahre alt. Damit Ihr nicht mehr den ganzen Thread durchlesen müßt, kopiere ich mal das Wesentliche zum derzeigen Stand hier rein. Ist leider nur in Englisch.

Allerdings würde mich mal interessieren, ob es überhaupt noch Cortex Interessierte gibt, sonst werde ich in Zukunft meine Recherchen für mich alleine machen. Auf eine Veröffentlichung kan ich dann auch verzichten.

Machts mal gut und liebe Grüße
Erbse1
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To Our Shareholders and Friends,


I would like to take this opportunity to introduce myself to you as the new chairman, president and Chief Executive Officer of Cortex Pharmaceuticals, Inc. Having sat on the board of directors for several months prior to my appointment, I have had time to think about the challenges as well as the many opportunities we have before us. I am enthusiastic about Cortex’s prospects for success, but recognize that fiscal year 2003 holds significant challenges, as it does for so many discovery and development companies in the biopharmaceutical sector.

When I accepted this position, it was clear to me that the company had a very significant financial challenge. We had signaled to the market that we would most likely run out of cash before year-end. We also had suffered a setback when Shire decided not to exercise its option to our AMPAKINE® technology. In the face of this substantial headwind, we nonetheless set about with our staff to work to find a financial solution, which up to that point had not been forthcoming.

Our best opportunities would be to find an attractive arrangement with one of our licensing partners that already understood the technology. We worked out several proposals that we then took to Europe to discuss with our licensees within two weeks of my arrival at Cortex. After substantial negotiations, we were able to find a meeting of the minds with our partner Servier. The agreement provides us with $4 million over a two-year period, paid in quarterly installments as research support. This was a significant vote of confidence by a very knowledgeable pharmaceutical company that already had over five years of experience with AMPAKINE technology. Also very important, it prevented us from having a severe financial crisis.

While we are delighted to have found a solution that provides two more years of research support, we recognize that our company needs much more financial support to assure us of success. We are currently continuing our efforts to raise more capital while we are keeping our expenses under tight control.

As we realize further improvements in our capital structure, we have two other goals that we feel are important to build a successful CNS specialty pharmaceutical business. First, we need to move several of our outstanding, high-potential compounds out of pre-clinical development and into human clinical trials. In our industry, it is almost axiomatic that a company needs five or six solid drug candidates to ultimately succeed in getting one to market.

Our lead compound, CX516, now belongs to Servier; the company selected it after Shire declined its option to the compound. The first new compound to be pushed into toxicology and, we hope, into the clinic will be CX717, which is approximately 50 times as potent as CX516. We have other compounds that also need to be promoted into clinical trials, but all this activity is dependent upon further successful financial support of our company.

The second goal we have is to improve our public and investor relations activities. While I am a firm believer that the value of our business is driven by substantive achievement and progress in developing our drug products, we need to improve and optimize the communication with both existing and potential shareholders. Since we do not have a very large shareholder base, this is a real opportunity for our company. Thus, we hope to be able to both improve the number of shares traded daily and broaden our shareholder base.

Clinical Development Update

Cortex now has AMPAKINE compounds in Phase II studies for four important indications:

MILD COGNITIVE IMPAIRMENT - As of this date, all six countries are enrolling patients into this trial, which is expected to complete enrollment by mid-2003. Under the terms of the agreement, Servier will pay nearly all the costs associated with the MCI cross-national study.

FRAGILE X AND AUTISM - On April 30, 2002, Cortex announced a collaboration with several leading research organizations including FRAXA Research Foundation, Rush Presbyterian-St.Luke’s Medical Center in Chicago, and the Child and Adolescent Psychiatry Department at the University of Chicago to evaluate the effectiveness of AMPAKINE CX516 or placebo in 100 patients with Fragile X syndrome and/or autism. There are currently no therapies to treat these two disorders, and research suggests that enhancing glutamate transmission may be clinically beneficial in treating these diseases. The primary mechanism of our AMPAKINE compounds is to amplify the effect of glutamate. It is anticipated that enrollment will occur over a two-year period.

SCHIZOPHRENIA - In October 2001, Cortex received notice of a two-year award of up to $770,000 from the National Institutes of Mental Health (NIMH) to support a Phase II study using CX516 or placebo in combination with the anti-psychotic drugs clozapine and olanzapine in patients with schizophrenia. Current anti-psychotic medications work by interfering with dopamine receptors with additional effects on serotonin receptors. Positive AMPA receptor modulating compounds work by potentiating glutamate receptors, which is a totally different mechanism. The combination of AMPAKINE compounds and antipsychotic drugs appears to have unexpected synergistic activity, which was the basis of a broad use patent received by Cortex in December 2000. We believe this study will provide useful information for our partner, N.V. Organon, in the development of one of its AMPAKINE compounds, Org 24448, and provide potential royalty revenue to Cortex. Results from this study are expected in calendar year 2004.


Our Partnerships

Cortex actively seeks new partners to expand the indications for our AMPAKINE drug pipeline, to increase our research and licensing revenue and to expand the scientific manpower to bring these new AMPAKINE products to market. An update on our existing partnerships follows:

Les Laboratoires Servier – In October 2002, in exchange for $4 million of additional research support, Servier expanded its rights to our AMPAKINE compounds to include the field of anxiety disorders in its territories, primarily Europe, Africa, and Asia. The $4 million will be paid in quarterly installments of $500,000 over a two-year period. The decision to license the AMPAKINE technology for the indication of anxiety disorders and to further invest in Cortex comes just three months after the announcement that Servier had selected CX516 as its Phase II lead AMPAKINE compound to treat MCI, Alzheimer’s disease (AD) and other neurodegenerative diseases in its licensed territories. Servier also has exclusive rights in its territory to the AMPAKINE compounds as a potential treatment for sexual dysfunction and dementias associated with other neurodegenerative diseases.

Servier’s decision to expand its licensing agreement provided a strong vote of confidence for Cortex’s AMPAKINE technology. Cortex retains the AMPAKINE rights for anxiety disorders, MCI, AD and other neurodegenerative disorders in Canada, the United States, Mexico, Australia, New Zealand, Latin America and South America, with the exception of Argentina, Brazil and Venezuela. It will also have joint access to the data developed in collaboration with Servier to use on its own or with a partner.

In the spring of 2002, we announced the initial enrollment in the 31-site Cross-National Collaborative MCI Study being conducted by Cortex and Servier in the United States and five European countries to determine the efficacy of the AMPAKINE CX516 in improving memory and cognition in patients with Mild Cognitive Impairment (MCI). The trial is well under way, and we expect to complete enrollment in mid 2003.

N.V Organon – In September 2001, Organon announced that it would continue to develop AMPAKINE Org 24448 by entering a Phase II trial for the treatment of schizophrenia. Under the terms of the agreement, Cortex immediately received a $2 million milestone payment. We continue to be pleased with the progress of Organon’s clinical development and hope to report results from this trial in calendar year 2004.

Organon also has exclusive worldwide rights to our AMPAKINE technology and compounds for the potential treatment of depression. Contractually, Organon has committed to an agreed-upon spending level for research and development of the AMPAKINE compounds in the field of depression. Like the agreement with Organon for the rights to schizophrenia, the agreement for depression includes milestone payments based upon clinical development and royalties on worldwide sales.

Shire Pharmaceuticals Group, plc – In late June 2002, Shire elected to not exercise its option to further develop the AMPAKINE technology and compounds for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Shire had initiated a Phase II study of the AMPAKINE CX516 in adult patients with ADHD, but terminated the study prior to reaching the anticipated enrollment levels. At the time of Shire’s decision to immediately terminate all treatments, 72 patients out of a planned 110 patient study target had been enrolled. Only 45 patients had completed the 28-day course of treatment required by the study design. Because the study design was broken by the sudden cessation of all treatments and only 45% of the patients completed the full treatment plan, the study could not be properly analyzed. As a result of Shire’s decision, all licensing rights were returned to Cortex. While we pursue new partners for ADHD, we are evaluating the potential of several other compounds in our pre-clinical phase as potential drug candidates for this significant disease area.


Our Patent Portfolio

Our patent portfolio includes a number of patents covering structures of AMPAKINE compounds (compositions of matter), as well as patents that protect the mechanism of action by which the compounds exert their effect. So far, broad clinical method-of-use patents have issued in the fields of schizophrenia, memory and cognition.

We continue to enhance our patent protection for the AMPAKINE technology. During fiscal year 2002, a total of eight patents were issued and one patent was allowed.

Our patent filing for the use of AMPA receptor potentiators to treat defects in memory and cognition has issued in the U.S., Mexico and New Zealand. Our patent representatives in the U.K. have informed us that the European Patent Officer examiner has invited us to file observations on a preliminary rejection of our broad claim. However, our representatives believe that there are numerous examples in the application that can be used to support our broad claims. While we cannot predict the ultimate outcome of the patent examination process, it is a normal part of the process to receive initial objections from an examiner, which later are overcome by an exchange of information and a careful review of all relevant facts.

Other composition of matter patents are continually being filed and processed and we will keep our shareholders informed on our progress in expanding our extensive patent portfolio.


Our Management Team

In an effort to further strengthen the company’s core leadership team, Cortex recruited several additions to its management this past year:

Arvid Carlsson, M.D., Ph.D., co-recipient of the 2000 Nobel Prize for Medicine, joined our scientific advisory board in April. Dr. Carlsson’s pioneering work with neurological and psychiatric disorders will help target our strategy as we continue to develop our AMPAKINE technology. Obviously, we already benefit from working closely with the developers of the AMPAKINE technology, Drs. Gary Rogers and Gary Lynch.

Cortex also announced the addition of Dr. M. Ross Johnson to its board of directors. Dr. Johnson’s extensive experience and success as an inventor, drug discoverer, executive and entrepreneur in the pharmaceutical and biotechnology industries will prove invaluable to Cortex as we continue to grow our company.

Joann Data, M.D., Ph.D., was appointed senior vice president of clinical development and regulatory affairs and will be responsible for interfacing with both our partners and the FDA to expedite the clinical trials and approval process for our AMPAKINE compounds.

We are pleased to welcome Drs. Carlsson, Johnson and Data to Cortex.


Our Financial Stability and Operating Strategy

As you know, the financial markets have experienced a severe downturn in 2002. Given these conditions, it will be essential for us to efficiently manage our resources while we seek opportunities for additional capital.

In the past, we have demonstrated our ability to operate effectively with funding provided through our corporate alliances. This funding will continue during fiscal year 2003 as we continue to collaborate on several research and development initiatives with our partner, Servier.

At the same time, we will seek additional financing opportunities to support the development of AMPAKINE compounds to attract alliances for other indications for our proprietary technology. Unlicensed areas where we believe that the AMPAKINE compounds may prove useful include the treatment of Attention Deficit Hyperactivity Disorder, stroke, autism, fragile X, traumatic brain injury, and Huntington’s disease. We will continue our efforts to secure a partnership for the development of the AMPAKINE technology in Mild Cognitive Impairment and Alzheimer’s disease in the Americas — territory not currently licensed that represents nearly half of the total market value.

I came to Cortex because I am a believer in the potential of the Company’s core technology. Our collective goal is to move the AMPAKINE compounds through our current clinical development and secure sufficient financing to allow us to bring forward new compounds that may potentially benefit patients who suffer from diseases and disorders – many for which there are currently inadequate or no treatment options available. That is our mission, and we welcome you to participate.

My role in the upcoming months and throughout the year will be to attract new financing alternatives, to maintain and strengthen our patent portfolio, to secure additional strategic partnerships, and to work with existing and new partners to move our AMPAKINE compounds through the clinical development process.

I am excited and proud to be part of Cortex’s future, and I look forward to sharing my vision as well as specific strategies for how we will work together to progress the company and shareholder value over the coming year.

On behalf of Cortex, I would like to thank all of our loyal shareholders, partners, board members and staff who continue to believe in this company and in the pursuit of better mental health for people around the world.


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[Erbse1]

Hallo liebe Cortex Fans. Ich stell mal ein unbestätigtes Gerücht von davidall aus dem Yahoo Board hier rein.
Dies erklärt den Anstieg der letzten Wochen.
Trotzdem sollte man solche Gerüchte immer mit Vorsicht genießen, solang sie nicht offiziell bestätigt werden.
Sollten diese Gerüchte stimmen, so können wir uns sehr auf die nächste Zeit freuen.
Dies in aller Kürze und jetzt noch das Posting von davidall
Liebe Grüße
Erbse1
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that Organon is planning a phase III for 2004-they must be pleased with the phase II results so far. In addition, they have an ongoing phase I trial with a next generation with an Ampakine for Depression. This supports their continued interest in BOTH of these indications. This is HUGE for Cortex and entering a phase III next year should significantly boost the stock(to put it mildly). The Europaen patent decision has galvanized BIG PHARMA interest in Ampakines and BIG PHARMA now knows it must pass through Cortex to commercialize this field. I am more bullish than EVER before for Cortex. Slowly but surely, the underpinnings for a GREAT company are coming together. First things first, we need the money and Stoll is working on a dual track strategy-a financing and/or major deal for MCI-and willl not settle for a rich deal for Cortex. Stay tuned folks. we have the potential for a 20-10 bagger in the next 18months! Enjoy the ride!
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[IchWeissDassIchNichtsWeiss]

Hallo Erbse,

danke für Deine ausgezeichneten Recherchen, ich lese sie schon seit der CORTEX Thread aufgemacht wurde mit Begeisterung. Weitere Infox über Cortex habe ich vom NeuroInvestment Börsenbrief.
Ich beobachte Cortex schon seit etwa 3 Jahren, war auch bis vor 3 Monaten investiert, bin dann ( mit Erfahrungen aus der Pleite mit NeoTherapeutics) rausgegangen und gestern nach einer deutlichen Empfehlung von NeuroInvestment wieder rein.
NI behauptet, dass die Anstieg aufgrund einer RoadShow von Cortex zustande kommt. Das Gerücht mit Organon wird auch erwähnt. Zudem berücksichtigt NI jetzt auch die Situation von Cortex in Europa stärker ( was sie laut ihren Aussagen bisher unterschätzt haben) Insgesamt hat sich die Meinung von NI zu Cortex deutlich verbessert, ihr Kursziel ist 5$ wobei sie sagen:
"...but that could turn out to be conservative."

[Erbse1]

Hallo liebe Cortex Fans. Mittlerweile wird mir der Anstieg der letzten Tage schon unheimlich. Innerhalb weniger Tage ein Anstieg von über 200%. Von Cortex selber immer noch keine Nachricht.
Der Neuroinvestor bringt bei den Ampakinen Merck ins Gespräch. Ich kopier den Kommentar mal hier rein.
Wünsche noch allen Cortex Investierten viel Glück und liebe Grüße
Erbse1
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The volume is hardly a deluge, but I do think the Dennis Choi quote in Fortune has helped the price along, because it gives Ampakines validation from a high-reputation source. He could have mentioned Kandel/Memory, Tully/Helicon, Sention, Saegis, etc., but it was only the Ampakines he noted along with the Merck inhouse GABA program. At the very least, it is interesting that Ampakines are what came to mind at that point, it is not as if they have reaped the majority of the popular press (Memory Pharma probably has done so). This does not in itself mean a Merck deal, but it is very intriguing that Ampakines were high enough profile in his mind to be mentioned. It makes me suspect that at the very least, Merck is one of several companies which has had conversations with Cortex, and they were sufficiently positive to have triggered long term potentiation on Choi`s part.

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[Erbse1]

Hallo Cortex Fans. Der Neuroinvestor veröffentlicht auf seiner Homepage die Ausgabe vom 1. 5. zu Cortex. Ich kopier den Artikel mal hier rein.
Neue Interessenten für Cortex sollten jetzt spätestens mit den Recherchen beginnen, denn das nächste Jahr ist für Cortex sehr entscheidend. Auch nach dem Kursanstieg von fast 200% innerhalb weniger Tage ist die Luft noch lange nicht raus. Cortex wird im Augenblick nach dem Anstieg mit ca 37 Millionen Dollar bewertet. Das Potential der Ampakine ist einfach riesig. Deshalb für alle Interessierte noch mal die Homepage von Cortex.
www.cortexpharm.com
Folgend noch der Artikel vom Neuroinvestor.

Liebe Grüße
Erbse1
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From May 2003 issue, published 5/1/03)

Cortex (1.11). The increase in volume and valuation makes it clear that the roadshow (which has included Gary Lynch) has been successful. As appears to have been the case for several observers, we have taken a fresh look at the import of the European regulatory decision upholding Cortex`s broad use patent, and have come to the conclusion that we had grossly underestimated its value when we described it in April as "modest". It is not. First of all, it does cement the Cortex use patent for AMPA-receptor mediated cognitive enhancement across the two largest pharmaceutical markets in the world, the US and Europe. The fact that Lilly, Boehringer Ingelheim, or NeuroSearch cannot go head-to-head against Servier or Organon in Europe greatly enhances those programs, and thus the downstream potential value to Cortex, or any Big Pharma bold enough to acquire worldwide rights. That is the core result, the value of the Ampakine franchise has now been defined. Before this, Big Pharma had understandable difficulty in assessing just what they would be buying if they did partner major Ampakine programs, now they know. In combination with an increased awareness of Ampakine potential, much of which can be credited to Lilly`s presentations and publications, Cortex now has great leverage, and is receiving much more attention. The sense of increased confidence within management is tangible. They believe that they have access to both shortterm and longterm (in the range of $30 million) financing options, and are using that backup option in assessing the outcome of talks with several Big Pharma companies with whom they are talking about a package for the major programs, including those all-important North American MCI/AD rights. CX717 appears well worth developing, but Servier apparently also has a potent, longer-duration (perhaps once-daily) molecule, S1896, which they would have to throw in the mix under the same terms to Cortex as would accrue to a Cortex molecule. Organon appears to be pleased with what they have seen from Org24448 thus far as well, since they appear to be making plans for Phase III in schizophrenia, and have started a separate Phase I in depressed patients. Target remains 5 for this year, but that could turn out to be conservative.
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[IchWeissDassIchNichtsWeiss]

Hier die neueste Einschätzung vom Neuroinvestor. Kursziel wurde von 5 auf 8$ erhöht


Cortex (1.78, recommended 2/99 at 2.75). That was quite a
ride, Cortex lurching up to near 2.50 before slipping back to
the 1.40-1.50/share range. We continue to believe that some of
this was due to a higher profile resulting from their road show,
though certainly, momentum players helped it move in both
directions. Cortex insists that they have enough cash to get
them through the calendar year if necessary, but they continue
working on parallel tracks for deals. Shortterm financing (in
the range of $2-3 million) seems necessary, regardless of how
far they could string out the current cash in a depowered
operational mode. Beyond that, both large-scale financing and
the major partnership are being brought along together. The
fact that Merck`s Dennis Choi named the Ampakines (along
with his own GABA program) as two promising MCI strategies
said at the very least, that the Ampakine profile has been
significantly raised. We suspect that Merck is one of the three
or four companies we believe engaged in active talks with
Cortex. The fact that Cortex`s negotiating position is weakened
by their fiscal status is more than offset by the now-reinforced
patent stranglehold that they have over AMPA modulation in
cognition. Lilly`s new and improved AMPA modulator
generation, which appears to have escaped the toxicity issues
that sank its predecessor, may be a match for the best molecules
developed by Servier (S1896, Phase I done) and Cortex
(CX717, CX691). It is very interesting that Lilly has decided to
enroll a 200pt Phase II trial of LY451395 in Alzheimer`s, a trial
that would have to cost them at least $4-5 million altogether.
Big Pharma companies do not initiate trials of compounds they
do not expect will ever see the light of day. Either via partnership,
or patent challenge, Lilly must believe that its AMPA
program has a future. But their best shot at Cortex`s use patent
was in Europe, and failed. They must be considered to be
actively in the partnership hunt as well. As has been discussed
in NI, one factor complicating the partnership is the fragmented
pastiche of partnerships already in place. Servier should
not be a problem in terms of acquiring rights outside of France.
We had speculated that Organon`s pharmaceutical development
might be deprioritized by Akzo Nobel`s CEO, who seems
to love paint above all else. But our contacts inside Organon
indicate that they expect the Organon AMPA program to
continue full-force, in both depression (for which a new
molecule is being used) and schizophrenia. Of course, there is
no guarantee that they are privy to all of the CEO`s rumination
on the subject, but this decreases the likelihood that Organon
would eagerly surrender its schizophrenia and depression
territories in a three way partnership deal. Target is raised to 8.

[Erbse1]

Hallo liebe Cortex Fans. Hab einen interessanten Artikel zu den Fragile X Versuchen gefunden.
Cortex hält sich ziemlich stabil und hat einen schönen Aufwärtstrend gebildet.
Die MCI Testphase 2 dürfte jetzt auch bald beendet sein, so daß wir wohl bald die Ergebnisse erwarten können.

@IchWeissDassIchNichtsWeiss, danke für die Einschätzung des Neuroinvestors. Wohl der beste Börsenbrief auf diesem Gebiet.
Ansonsten schönen Tag noch und liebe Grüße
Erbse1
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New Hope for Fragile X Patients?
Rob Wrona is active in sports, he enjoys fishing and has a girlfriend -like many young men.

But in other respects, Rob isn`t like his peers.

"He can probably talk as well and understand as well as say 16 or 17 but when you are talking about reading ability or his learning ability he`s probably on a 8-9 year old level. When you are talking about emotionally can he understand the things and act accordily he`s probably about 9 or 10," says Barbara Wrona, Rob`s Mother.

Rob suffers from Fragile X Syndrome.

It`s the most common inherited cause of mental retardation and learning disability.

Dr. Elizabeth Berry-Kravis is a pediatric neurologist at Rush Presbyterian St. Luke`s Medical Center.

"Sometimes the children may be slow to walk or um but more commonly a child with Fragile X is slow to talk and seems to behave in a more immature fashion than other children."

Rob`s parents adopted him when he was 6 days old and were frustrated that no one knew what was wrong with him until he was nine.

Rick Wrona, Rob`s father says, "We`ve gone to numerous doctors and no diagnosis was ever made.. this doctor we went to looked at rob for five minutes and told us he had Fragile X."

The disorder is called Fragile X because it`s a defect in the x chromosome.

It stops production of a protein important in brain functioning.

It`s seen in about one in four-thousand people ... but the severity of the disorder differs between the sexes.

"Women who have the syndrome tend to be more mildly affected b/c they have another x chromosome.. women have 2 x chromosomes and men only have one.. so women have a normal x chromosome which makes up for some of the affects of the abnormal x chromosome."

Speech and occupational therapy can help patients with fragile x.. some medications can help as well.

But this experimental drug, called cx516, may be the first to actually improve brain functioning.

Rob is involved in clinical trials of the drug at Rush.

Patients take it or a placebo three times a day... and come in for weekly physical and mental testing.

After four weeks in the trial, rob`s parents have noticed some changes.

"He`ll do things that he may not have done before like walk down a stairwell. Rob would never walk down a stairwell "

He`s even making phone calls.

He never did that before. He was always afraid to talk on the phone. these are just simple things yet they`re things he can attend to to make his life more livable.

And that, says Dr. Berry-Kravis is the goal.

Rush is still looking for patients to enroll in the drug trial — if you are interested call 312/942-4036.

Or for general information about fragile x syndrome go to www.fraxa.org

[Erbse1]

Hallo Puhvogel,liebe Cortex Fans hier eine kleine Abhandlung über die Ampakine. Ich könnte mir vorstellen, daß Dich das interessiert.
Ich könnte mir gut vorstellen, daß die Ampakine demnächst auch vermehrt mit Schlaganfallpatienten in Verbindung gebracht wird.
Im Augenblick ist Warten auf die MCI Ergebnisse angesagt.
Die nächsten Monate werden wohl sehr entscheidend für Cortex. Deshalb hier mal in Kurzform die zu erwartenden Meldungen
MCI Phase 2 Ergebnisse mit Servier
Schizophrenie Phase 2 Ergebnisse mit Organon
Entscheidung Organon, ob sie die Ampakine auf dem Gebiet der Depressionen testen wollen.
Ergebnisse Phase 2 als Kombotherapie Schizophrenie mit Olanzapine.(Zyprexa)
Etwas später dann die Ergebnisse Phase 2 bei Fragile X und Autismus.
Außerdem ist eine weitere Auslizensierung der Ampakine zu erwarten, zumindestens hoffe ich das. Dies ist enorm wichtig, da Cortex nur noch Geld bis Ende des Jahres hat und dringend auf neue Geldquellen angewiesen ist.
Das wars in Kurzform zum aktuellen Stand zu Cortex.

Grüße Erbse1
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Ampakine modulation of brain neurotrophin expression: a novel therapeutic strategy

PI Name: Christine M. Gall
Grant Number: biostar01-10168
E-mail: [e-mail]
Campus: Irvine
Award Total: $486,652
Project Period: 5/3/2002 - 5/2/2004

Non-technical Abstract: Neurotrophins are naturally occurring proteins in brain that support the health of brain tissue, reverse neurodegenerative effects of aging and protect brain cells from insults, (e.g., oxygen and glucose deprivation) that can occur over the course of a lifetime and in association with adverse events (stroke, heart attack). Evidence for such protective effects suggests that increasing neurotrophin content in brain may counteract degenerative conditions and protect neurons from during illness and aging. The applicant has shown that brain neurotrophin levels can be increased by drugs, known as "ampakines". During the last two years, studies in the Gall laboratory under BioSTAR award #S99-42 demonstrated that spaced ampakine treatments can increase neurotrophin protein levels for many days and that, during periods of elevated neurotrophin content, brain cells are less vulnerable to oxygen deprivation. We are now requesting funds to continue this research and, in particular, to test newly developed ampakine-drugs for their effects on neurotrophin content and brain vulnerability to insult. This research program is appropriate for the BioSTAR program at two levels. First, the research addresses health issues that impact millions of Californians personally, as they consider the devastation associated with neurological disease, and financially, as the burden of sustaining and giving care for afflicted individuals is assessed. Second, this work is co-sponsored by Cortex Pharmaceuticals, a small California based company that has licensed the ampakines for development in the treatment of neurodegenerative conditions. BioSTAR support would contribute to both the financial security and growth of the company and the success of research programs of investigators in the University of California system.
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[Erbse1]

Hallo liebe Cortex Fans.

Zuerst möchte ich mich mal mit einer Kritik bezüglich der Informationspolitik von Cortex melden. Ich selber bin auch kein Freund von inhaltlosen Meldungen, doch wichtige Ereignisse sollte man schon veröffentlichen.
Erst auf Anfrage eines Cortex Aktionärs wurde bestätigt, daß die Patienerfassung zu der MCI Phase 2 am 30. Juni abgeschlossen wurde. Danach dauert es noch ca 2 Monate bis der gesamte Versuch abgeschlossen wird und die Ergebnisse ausgewertet werden. Die Ergebnisse werden dann wohl im Dezember veröffentlicht.
Die Schizophrenie ,Fragile X und Autismus Ergebnisse werden Mitte nächsten Jahres erwartet.

Cortex besitzt noch Gelder bis ca Ende diesen Jahres. Ich denke mal, daß etwas Vorsicht angebracht ist. Dennoch glaube ich an eine kleine Kapitalerhöhung, um dann genügend Gelder für das nächste Jahr zu besitzen. Nach Vorlage mehrerer Phase 2 Ergebnissen ist dann wohl mit einer Auslizensierung an größere Pharmaunternehmen zu rechnen. Ein dicker Geldbatzen fällt dann nächstes Jahr auch fort, denn der CEO Wechsel hat Cortex 1,2 Millionen Dollar an Abstandszahlungen gekostet. Das ist mehr als ein Viertel des gesamten Cortex Etats.

Ein kleiner Tip noch für die Cortex Aktionäre hier in Deutschland. Cortex wird seit geraumer Zeit auch in Frankfurt gelistet und meist ein fairer Kurs gestellt. Letztens hat einer 550 Stück in Berlin für 1,35 verkauft. In Frankfurt hätte er 1,55 dafür bekommen. Es lohnt sich schon die Taxen zu vergleichen.

Machts mal gut und viele Grüße
Erbse1

[bushbear]

habe mir cor angeschaut, da ich aktien erst techn. und dann fundamental bewerte, kann ich sagen dass sie einen guten eindruck macht man wird sie kaufen können aber erst wenn die reaktion vorbei ist gruss bushbear

[Erbse1]

Hallo liebe Cortex Fans. Folgend ein kleiner Zwischenbericht von der Fraxa Foundation zu der Fragile X Testphase 2.
Die Ergebnisse zu MCI können wir dann ja im November/Dezember erwarten.

Machts mal gut und liebe Grüße
Erbse1
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Clinical Trial of a New Medication in Adults with Fragile X

Elizabeth Berry-Kravis, MD, PhD
RUSH University, Chicago

May 2002, $72,000 renewal for final year of the study; originally funded May 2001 for $72,000.
Over the past decade, several pharmaceutical companies have been developing a new class of promising medications, called "Ampakines", which seem to enhance learning. FRAXA`s very first 1994 newsletter featured an article by Dr. Michael Tranfaglia about the potential that Ampakines offered for people with Fragile X.

Since June 2002, a landmark clinical trial has been underway to evaluate this new potential treatment for Fragile X and autism. The compound being tested, Ampakine CX516, may help improve learning and memory in Fragile X by correcting a defect in the strength of brain cell communications. This is a two year clinical trial of the first specific treatment for learning and memory deficits in Fragile X. The trial will be completed in June 2004.


by Elizabeth Berry-Kravis, 6/2003


We have enrolled 26 subjects in our study of this new drug. One subject was autistic and all other 25 have Fragile X. No one has dropped out for any reason, which is quite good for a phase II study of a new drug. We have seen no serious side effects – the most significant thing being a slight increase in headache frequency in one patient. CX516, in fact, appears to be remarkably side effect-free in that we are monitoring patients with excruciating scrutiny for side effects and are not seeing much of anything. We have presumably treated about 12 or 13 patients with actual CX516 and I have not used any currently approved drug with which I could treat 12 consecutive individuals with Fragile X without side effects. So the safety profile of this medication appears to be excellent thus far.

We of course do not yet know who is on treatment and who is on placebo, but we have seen some patients do some new things during the study such as holding a conversation on the phone, putting shoes on the appropriate feet, learning to use the popcorn popper, increased complexity of comments about situations, and better school performance.


We are grateful to all the wonderful families and adult Fragile X subjects who have made the considerable effort required to participate in this study. They are helping lay the groundwork for future treatment of cognition in Fragile X syndrome.

Details of the study
Participants are adults with Fragile X between 18 and 50 years old. Each person takes either the drug or a placebo (sugar pill) for four weeks. During the study, no one - patient, family, or the investigators - knows whether placebo or drug has been taken, to guard against bias in interpreting the outcome. Before, during, and after the period of taking drug or placebo, patients are assessed with a variety of cognitive and behavioral tests to evaluate any changes in functioning. Medical assessment is also done to ensure that no ill effects are seen. This is a Phase Two clinical trial. Potential new drugs go through three phases of study:

I : testing for safety in normal adults (already completed for Ampakine CX516)

II: a small-scale trial in the target population, mainly to extend safety data but which may also give a preliminary idea of effectiveness (this study)

III: a larger-scale, longer-term study in the target population, mainly to determine effectiveness.

The current two-year study will include 50 people who have Fragile X and (pending additional funding sources) 50 people with autism. The trial is being run on a "rolling" basis; the study requires a lot of time from a limited number of specialized staff, so it was not feasible to conduct the entire trial in less than two years because of budget limitations. This trial at RUSH University costs over $144,000 over two years; FRAXA is funding the study and Cortex Pharmaceuticals is donating supplies of the drug, Ampkine CX516.

People are still welcome to enroll in this study. Prospective subjects can contact study coordinator, Tina Potanos, at 312-942-4036. Tina will explain the details, answer any questions, and set up the schedule for visits to Chicago for those who decide to participate. Dr. Berry- Kravis is also available at the same phone number to answer questions anyone may have.

Rationale for this study

Treatments specifically directed at the underlying brain defect in Fragile X are not presently available. But in the last few years, we have learned much about what FMRP does in the brain and specifically at synapses, the connections between brain cells. The relative strength or weakness of specific synapses appears to be very important in generating the "wiring" in the brain necessary for learning and higher intellectual and behavioral functions. Recent findings have identified specific neurochemical, structural and electrophysiological mechanisms at the synapse that are altered in the absence of FMRP. This new knowledge, coupled with new drug development in neuropharmacology, has allowed us to think about new medicines that might actually enhance cognitive functioning in individuals with Fragile X by targeting specific brain mechanisms deficient in the disorder.

In Fragile X syndrome, absence of FMRP leads to alteration in synaptic morphology (shape and structure) and strength and thus, deficient ability to maintain mature connections and eliminate unnecessary connections between brain cells. One specific abnormality of synaptic strength in the Fragile X mouse seems to be a decrease in AMPA-receptors in certain brain areas. Also, long-term depression (LTD), a process through which neurons regulate synaptic responsiveness and which is associated with down-regulation of AMPA receptors, is exaggerated in brain cells from the Fragile X mouse, implying that AMPA receptor activity is deficient. AMPA receptors mediate the level of excitability of brain cells at synapses. Maintaining the proper level of excitability or "strength" of these connections is important for normal learning to occur and for promoting the structural changes in brain connections which represent the "hard wiring" of the brain`s network.AMPA receptor activity is increased or decreased when synapses are activated and therefore represents one way brain cells can change the strength of selected connections, based on a specific experience.

Recently, a new class of medications which enhance AMPA receptor activity, called AMPAKINES or "AMPA-receptor modulators," have been developed. One of these medications, developed at Cortex Pharmaceuticals and called CX516 or Ampalex®, has been found to improve learning and memory in rats and also has produced improvements in rat models of schizophrenia and ADHD. Clinical trials have now been done in patients with early Alzheimer`s disease and schizophrenia, in which CX516 was helpful. CX516 activates AMPA-receptors only after the synapse has been stimulated and therefore results in experience-dependent synaptic stengthening, in a manner that would parallel learning or memory. Given the early results with CX516 in other models, and the recent data suggesting deficiency of AMPA-receptor activity in Fragile X syndrome, we thought that CX516 might partially correct a defined neurochemical defect in Fragile X, with resultant improvement in cognitive and behavioral functioning.

This treatment trial with CX516 represents the first ever attempt at treatment directly aimed at reversing the intellectual disability in Fragile X.

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[Erbse1]

Hallo liebe Cortex Fans. Es tut sich was Neues bei Cortex.
Plötzlich und unerwartet taucht eine Testphase 2 auf, von der so gut wie keiner wußte, daß sie überhaupt existierte.
Hierbei wird wohl CX 516 bei Auswirkungen des Schlafentzugs getestet.
Die Ergebnisse sollen Ende nächsten Monats veröffentlicht werden.
Ich habe mich mit diesem Anwendungsgebiet noch gar nicht beschäftigt, kann also auch keine Anmerkung zur Auswirkung machen.
Folgend noch aus einem Interview mit dem CEO Stoll der Hinweis auf das neue Anwendungsgebiet.
Der Kurs entwickelt sich in letzter Zeit prima.

Liebe Grüße
Erbse1
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TWST: As we look out over the next 18 to 24 months, what
is going to be the strategy at Cortex?

Mr. Stoll: We need to get adequate financing to allow us to execute
our business plan. This plan anticipates one more large out license
for our technology and a carve out of some selected therapeutic areas
which we need to implement quickly. Our business plan requires us to develop
AMPAKINE compounds for use in Fragile X and autism, and the development
of products for narcolepsy and other sleep disorder indications.
Both Fragile X and narcolepsy are indications which qualify for orphan
drug regulatory pathways. This means that the development of products in
this area will require somewhat smaller Phase III clinical trials and allow
us to get to the market faster, for less money, and still address a commercially
useful market. After we commercialize one of these products, we can
then expand indications for autism and EDS (Excessive Daytime Sleepiness)
based on the income we receive for the marketed product. We are
currently underway in testing CX516 in a clinical trial, evaluating its effect
on improvement in performance after sleep deprivation. This study is
being funded by DARPA (Defense Advanced Research Projects Agency).
Obviously whether CX516 would eventually be the therapeutic agent of
choice will depend greatly on the dose required to improve such performance
in humans. However, such products may not be required to be taken
chronically and as such may represent a possible avenue of the commercialization
of CX516. Animal tests have suggested that AMPAKINE drugs
may be a very useful agent for such uses. We expect to get the results from
this clinical trial by the end of September 2003. We have just completed
our scale up of a GMP process for producing CX717. We hope to initiate
toxicology studies in the near future and be in the position to take this compound
into clinical trials at the beginning of 2004.
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[Erbse1]

Hallo liebe Cortex Fans. Langsam aber sicher wird man auf Cortex aufmerksam. Gestern Nacht eine Sendung in den ABC News in Amerika, so daß sich auch für kurzfristige Trader hier eine Chance bietet. Es ist sehr gut möglich, daß wir nach dieser Nachrichtensendung die 2,50$ oder mehr erreichen.
Interessierte sollten unbedingt die aktuelle Diskussion auf dem Yahoo Board verfolgen.
Hier nochmal der Tip für neue Cortex Interessierte. Noch ist der Zug nach über 200 % Gewinn nicht abgefahren. Man sollte aber schleunigst mit der Recherche beginnen.

Folgend noch für Interessierte eine Meldung des Neuroinvestor.

Machts mal gut und achtet heute mal auf Cortex.

Erbse1
-----------------------------------------------------------
From August 2003 issue on Small-Molecule Neuroregeneration: It refers to Lilly`s program, but in the description of AMPA-modulating superiority over other putative mechanisms, says a lot about Cortex`s potential, particularly since they have the patent territory:

Lilly: While Cortex, Servier, Organon, and NeuroSearch have all had their own AMPA modulator programs, it is Lilly that has put the most effort into developing a range of molecules and to show the breadth of their impact. They have apparently surmounted earlier toxicity issues, and are initiating an Alzheimer`s Phase II study. Even more interesting is a paper published by Lilly researchers this past May in JPET. They took LY503430 through MPTP and 6-OHDA animal models of Parkinson`s, and reported significant improvement in behavioral function, even when the drug was given up to fourteen days after the lesion. It was clear that this demonstrated a neurotrophic rather than neuroprotective effect, and they pointed to upregulation of the trophic intermediary GAP-43 as key evidence of this. The writers blurred their own terminology when they wrote "Our inhouse comparisons indicate that LY503430 provides superior protection to all these other pharmacological interventions (antioxidants, nitric oxide synthase inhibitors, antiinflammatories, nicotine, neuroimmunophilins)". Even though they went on to indicate that they see the process as neurotrophic, not neuroprotective, this is heady stuff--Lilly`s molecule was compared with most currently available small-molecule candidates, and found superior. Lilly`s compound is highly potent, 1000X more so than CX516 (not a fair comparison, since Cortex, Servier, and Organon all have molecules far more potent than CX516), but Lilly`s avenue to commercialization is most likely going to be via an expensive toll road.

[Erbse1]

Die Ereignisse häufen sich in den letzten Tagen
Heute eine 5 Millionen Privat Platzierung.
Kurz die Meldung
Erbse1
-----------------------------------------------------------
Cortex Closes on a $5 Million Private Placement
Friday August 22, 8:58 am ET


IRVINE, Calif.--(BUSINESS WIRE)--Aug. 22, 2003--Cortex Pharmaceuticals, Inc. (AMEX:COR - News) announced that it has closed on a private placement with a select group of institutional investors with gross proceeds of $5 million. Cortex has agreed to issue 3,333,334 shares of its common stock at $1.50 per share and five year warrants to purchase 3,333,334 shares of common stock at a price of $2.55 per share. Rodman & Renshaw, Inc. served as the placement agent for the transaction.
"The proceeds from this financing will allow us to accelerate the development of some of our more potent second generation AMPAKINE® compounds," said Roger G. Stoll, President and Chief Executive Officer of Cortex. "The ultimate goal is to move these compounds toward FDA filing and the execution of our business plan, which is to focus internal development on potential orphan drug indications such as narcolepsy and Fragile X syndrome, while we continue to work on partnering the larger indications with major pharmaceutical companies."

-----------------------------------------------------------

[Coluche]

Hallo Erbse,
zunächst mal vielen Dank für die Aufrechterhaltung dieses Threads. Jetzt bin ich auch wieder deutlich über meinem Einstand (Februar 2002) und bin nach der Durststrecke überzeugt, daß da noch mehr draus werden könnte.

Dr. Stoll war ja bereits in der Führungsreige von Fresenius Medical Care einige Jahre tätig und hat dort seine Managementerfahrung unter Beweis gestellt. Denke er könnte es schaffen, aus der kleinen Cortex zwar keinen Big-Player, aber doch einen der Medium-Klasse(Marktkap. einstelliger Mrd.-Bereich) zu machen.

Übrigens als Tip: schau dir mal Axonyx (AXYX)an. Die sind ebenfalls in der Alzheimer-Forschung unterwegs (z.T. Phase III) und noch relaticv gering bewertet.

Aus dem Cortex-Thread in Yahoo hatte ich noch einen Tipp Anfang 2002 zu ASTA-Funding bekommen (ASFI). Ist zwar eine andere Materie (Finanzen, kaufen notleidende Froderungen und treiben das Geld ein) aber die haben einen traumhaften Cash-flow, verdienen richtig Geld und haben sich seither mehr als verdoppelt.

Gruß Coluche

[Erbse1]

Hallo Coluche, liebe Cortex Fans. Ist schon gigantisch was die letzten Tage mit Cortex passiert. Ich denke mal, daß dies erst der Anfang ist. Coluche, danke für Deine Tips. Freut mich wieder von Dir zu hören.
Anschließend noch der Kommentar vom Neuroinvestor zur gegenwärtigen Situation.
Ich freu mich für alle die so lange mit mir bei Cortex ausgehalten haben.
Machts mal gut und liebe Grüße
Erbse1
-----------------------------------------------------------
8/26/03 Cortex has gone from one extreme to the other in terms of trading and appreciation. It is deserved, because it had an excellent August. Prominent mention in Business Week plus acknowledgements on ABS World News Tonight and Scientific American gave it a media profile last seen during the previous millennium. Even more important was the completion of a $5 million private financing. It is hard to claim leverage in negotiations with Big Pharma when one has enough money to make it another quarter or so--and now that impediment is removed. They can go ahead with long-delayed IND preparations for the promisingly potent CX717. while continuing discussions with three Big Pharma suitors regarding North American MCI/AD rights. Roger Stoll did exactly what he said he would do, and then some--which makes the anticipation of a Big Pharma deal all the more realistic. With all the attention devoted to memory problems in the aforementioned publications, one fact needs to be noted: of all the companies focused on memory enhancement (we don`t bother counting the cholinesterase inhibitors, already DOA for MCI), only Cortex is publicly traded. It is the only way at present to participate in the MCI arena (we distinguish age-related MCI from the surgery-induced MCI being pursued by Pharmos, a different creature, a different mechanism).

-----------------------------------------------------------

[Erbse1]

Hallo liebe Cortex Fans. Im Augenblick nicht viel Neues. Mittlerweile können wir einen Anstieg von ca. 600 % innerhalb von 5 Monaten verbuchen.
Ich kopier mal ein Posting des Neuroinvestor aus dem Yahoo Board hier rein. Die sind wohl am besten informiert und immer wieder lesenswert.
Wünsche Euch noch einen schönen Tag und weiterterhin viel Erfolg mit Cortex

Liebe Grüße
Erbse1
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It was amusing quickly skimming through the hundreds of recent posts, some of which constitute some of the most inane and uninformed bashing I have seen in many months. Other than reminding us that some conscience-challenged people are sure to be reincarnated as lab rats, they are irrelevant.

As is likely no surprise, I do not think that even this pleasant upward tilt has brought Cortex anywhere near its real value. The one nearterm risk is the DARPA trial--we don`t know how large it is, and fatigue/alertness is an out of left field indication. Yes, Goff`s schizophrenia patients showed significant improvements on attention/concentration measures, which give some reason for optimism (the Shire results were not definitive in any direction), but this plays no role in my projections for Cortex.

But I have no doubt that if the trial is reported as having shown no significant benefit, some will take this as a harbinger of weakness in the platform overall. That would trigger a significant rollback. Success on the other hand opens up the Provigil arena, and the plethora of EDS indications would seem to add another billion per year in potential ( except there is some overlap, one of the biggest, if not the biggest, cohorts of Provigil users are depressed patients looking for an initial `kickstart` before SSRIs provide benefit--and that would fall under Organon`s umbrella). But still, EDS/alertness would open up another major area for partnering (so I do not expect a partnership before the DARPA data is reported and digested).

I also semi-suspect that Lilly will be heard from--they are very familiar with AMPA modulation and thus did not have to do the DD the other companies did, and thus can wait to see how the competition is heating up before making a move. I`d be somewhat shocked if they do not make one during the endgame.

This continues to be, dismissing the chaff which has blown in of late, the best Yahoo discussion thread I have seen. It is a pleasure to now see all the prognostication, discussion, and anxiety beginning to pay off as the Cortex story moves to a rapid climax over the next three months.

NeuroInvestment
www.neuroinvestment.com
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[Phear]

Hallo Erbse1, hallo Coluche, hallo Cortexfans,

ich bin ein eifriger und dankbarer Leser eurer Beiträge, wenngleich mir der fachliche Hintergrund fehlt, staune ich über euer Fachwissen und wundere mich umsomehr über die ja, Ignoranz dieser unheimlich interessanten Firma bislang in heimischen Gefilden.

Ganz nebenbei möchte ich vor allem Erbse1 ein ganz außerordentliches "WOW" und "Bravo!" sagen zu dieser Leistung, ein Unternehmen in dieser Klarheit und Detailverliebtheit so genau und vor allem uneigennützig dazustellen. Einfach Klasse.

Ich habe Eure Beiträge alle mehrfach gelesen.

Aber nicht nur deshalb bin ich zu der Überzeugung gekommen, daß Cortex ein ganz außergewöhnliches Unternehmen ist.

Auch ich kann natürlich keine Prognosen geben. Ich sehe und staune. Aber mit mir erkennen auch andere den wahren Wert des Unternehmens.

Wir dürfen gespannt sein.

Viele Grüße
Phear

[Erbse1]

Hallo Phear, Danke für die Riesenkomplimente. Es war auch ein wenig Absicht dahinter mit qualifizierten Beiträgen die pusher und basher aus diesem Thread fern zu halten und sich anständig über Cortex zu unterhalten.
Der Erfolg von Cortex hängt letzendlich auch von den einzelnen Testphasen ab.
Ich warte jetzt wirklich mit großer Spannung auf die Ergebnisse, die innerhalb des nächsten halben Jahres in den verschiedenen Anwendungsgebieten eintreffen.

Alleine das folgende Interview, das erst gestern wieder auf dem Yahoo Board veröffentlicht wurde, ist Grund genug, Cortex Pharmaceuticals mal ernsthaft zu recherchieren.

Das Interview wurde Mit Gary Lynch geführt, dem Mitbegründer von Cortex Pharmaceuticals.

Machts mal gut und liebe Grüße
Erbse1
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Q: for years, you have been working, here in Irvine, on a medecine that can improve the memory, and slow down the aging of the brain: Ampakine.
A: As I said: we have about 120 billion braincells, neurones, and every neurone can connect with up to 50000 other ceurones. When the brain ages, those connections - die. In the spring of one’s live, in the autumn, the leaves fall. That’s a tradegy.
Well, my product, Ampakine, makes sure those connections better; they keep the leaves green. As simple as that.
When I was a young brainscientist I investigated the ways of communication between the neurones, how the signals between ‘m would travel. A
There are hundreds of neurotransmitters, but relative to memory, glutamate is important: it’s the transmitters in over 90% of all cellcommunication. The other neurotransmitters, I leave in the hands of my estemed collegues.
For years we studied the molecular structure of the glutamate-receptor, but we reached a break-through when some Japanese collegues mailed me their suggestions: In less than six hours, I build, in my own lab, a new model. We did the first tests, and everything worked.
De next step was: to develop a product that could increase both the speed and the precision of the flow of information in the glutamate-receptor.It was a pure example of drug-design: we didn’t build a medecine on the basis of an illness, no, we build a molecule, we knew exactly how it had to look, to improve the glutamate-receptor
Q What are the effects of ampakine?
A Very simple: the informationflow goes faster through the neurones, and storage in the memory is better. It works in 10 minutes, as fast as alcohol.
Q Do you notice it’s impact?
A No, you don’t feel euforic, or exited. It’s just the brain that works better. We did a study in Germany on 70 year olds. Their score on the memory tests almost doubled. They did almost as well as 20 year olds – but only in the first two hours after they took it. When you administer Ampakine to young people, the effect is less dramatic: the memory capacity increases with about 20%.
Q Have you took it yourself.
A No (laughs mysteriously). Or better: no comment. I can’t answer that question.
Q I would like to do the test right now. Can I have one?
A No. The FDA would have me locked up. De FDA laws are very strict. We are now in phase II B of it’s development – only in phase III, would you be allowed to take the test.
Q I can hardly wait. But do continue.
A It doesn`t just improve the flow of information, it also creates new links. the brain is like a muscle: you have to train it, or else it loses its strenght and possibilities. Links that aren`t used, die. But the opposite is also true: when the brain is under pressure, and has to do a lot of work, it forces itself to create new links. Ampakine helps with this.
The harder, and more complex the brain is, the more neurone are in play, and the bigger the effect of ampakine is. It works like a multiplicator: a stupid person won`t become a genious, but a bright person will be given the possibilities to work faster, more thorough - and forget less. This is no tale, we have extensive publications, to support our claims.
The first test we did on rats: under influence, they started to show new, more sensible behaviour.
Q their brain became a superbrain
A No, their brain stayed the same, but they made better use of it`s possibilities. Say a rat manages to transport a signal over 3 neurones; with Ampakine the signal travel over 4 or 5 neurones.
Q This sounds like SF
A No, it`s the naked truth. All over the world, do people work on these kind of drugs: princeton, NC, Columbia, Harvard, Stockholm. I`m not alone here, I`m no wizard, of magician. The governement supports our research.
Q Within five years will Ampakine hit the market?
A Probably faster. We are approaching a new step in the history on humanity.
Q If you`re right, the world will change dramatically.
A I would agree. Sometimes the consequences scare me. take Sex: a very complex proces, in which the visual cortex works overtime, and in which all the other centers do their bit.
Q (laughs)
A don`t giggle. This is a serious matter (bursts out into laughter) Look, I believe a better functioning brain will provide better sex. And I believe it`s perfectly possible ampakine can jack up a dead libido.
Q Give it to me, mister professor.
A Laugh away, in the lab we saw how older male rats started to show interest for the females. We have developped about 200 different kind of variants of Ampakine. The ampakine that stimulates the brain, has other mechanisme in place than this kind of ampakine.
Q Ampakine plus! I can hardly wait. But let`s talk side effects. Cafëine and Amfetamines are well known stimulators for the brain, but they are addictive and you can`t get to sleep.
A Very simple: ampakine has no side effects. Caf and Amfet are non-specific stimulators: they don`t just poke up the brain, but also the heart rythm, blood pressure... Speed meanly works on the dopamine receptors - another neurotransmitter: you become euforic, you think you can handle more, but that`s an illusion. ampakine is stimulates specific centers, it works there where it we want it to work.
If you feed amfetamines to a rat, you start to notice immediate differences in its behaviour: it becomes restless and stress out. If you feed it ampakine, nothing differentiates it from other rats, apart from the ability to take on complex tasks.
Q There are no side effects?
A In normal, therapeutic dosage, no. we did double-blind tests. There was no difference in bloodpressure, heartbeat. If we overdose 30 to 100 times, epilepsy appears.
Three big farmaceutical firms are interested in the commercialisation of ampakine. The university is involved, money is flying around.

[Phear]

Hallo alle,

bei meinen Recherchen zum Thema fand ich eben folgenden Artikel bei Yahoo in der BusinessWeek; wohl schon vom 01. September 2003 aber durchaus informativ wie ich finde.
Weiter unten ist auch der link zur Seite.





SEPTEMBER 1, 2003 • Editions: N. America | Europe | Asia | Edition Preference



Cover Image: I Can`t Remember


COVER STORY

"I Can`t Remember"
Drugs to stave off age-induced memory impairment may be on the horizon

"We are who we are in good measure because of what we have learned and what we remember."
-- Nobel Laureate Dr. Eric R. Kandel

The 76-year-old California lawyer appears to be the very model of healthy aging. C.L., who asked that his name not be used, hikes two miles up a nearby mountain four times a week, is always reading two or more nonfiction books at a time, and boasts that his waist and chest measurements haven`t changed since he was 25. This take-charge guy expects a lot of himself. But for the past six years, his memory hasn`t measured up. He occasionally forgets a name, he loses his train of thought when there are distractions, and he has walked away from six pairs of expensive sunglasses. "People who are very well-trained intellectually notice when they begin to lose that ability to grab onto every word, every concept," he says. "It`s like a significant part of your life is erased."

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C.L. yearns for some kind of treatment -- and his determination sends a powerful message to the drug industry. Although he is functioning very well for his age, he lobbied hard to enter a clinical trial for an experimental memory drug developed by Cortex Pharmaceuticals Inc. (COR ) of Irvine, Calif. The compound, called CX516, is in Phase 2 clinical trials for people who suffer from frequent short-term memory lapses, a condition called mild cognitive impairment (MCI). It is an ominous diagnosis, even though the condition doesn`t interfere significantly with daily living, because it can be an early warning sign of something much worse. Every year some 15% of people with MCI go on to develop Alzheimer`s disease.

HUMAN TRIALS. C.L. took nine capsules of CX516 daily for 12 weeks this spring. The impact was immediate. "At the start of the trial, I could remember less than five words out of a list of 20. By the second week, I could get 14 out of 20. There was a very, very appreciable enhancement." He has since finished his part in the study and says it was "heartbreaking" to go off the drug. "I`ve been thinking of some other way to get it, and I don`t give a damn if it`s legal or illegal."

If he waits a few years, C.L. should be able to solve his problem legally. At least 60 pharmaceutical and biotech companies around the world are working on novel memory pills. Some 40 are in human trials, and the first of these could be on the market within the next few years. These drugs aim to do far more than relieve the occasional "senior moment." Neuroscientists are hoping that any pill that improves memory in the elderly will also protect against Alzheimer`s disease, the diagnosis old people fear most.

"Within five years, we will have treatments that slow the rate of decline or even delay the onset of Alzheimer`s by five years or more," predicts Dr. Leon J. Thal, chairman of the Neurosciences Dept. at University of California-San Diego. The drug industry is spending billions of dollars to come up with such a pill, and it`s not hard to see why. In 10 years, all 77 million baby boomers will be 50 or older, and as many as 25% of them may develop some form of dementia. They do not, however, show any interest in going gently into that good night. As Harry M. Tracy, publisher of the newsletter NeuroInvestment, notes: "This is a generation that does not accept decline."

FINAL FRONTIER. It`s also a generation that is approaching the danger zone. The brain reaches its maximum weight by age 20 and then slowly starts shrinking, losing 10% of its volume over an average lifetime. It`s virtually inevitable that mental glitches will show up by the time we are eligible for senior-citizen discounts, and people are noticing. Surveys have found that 75% of people over 50 believe they suffered memory problems over the prior year. Some of these people may be overreacting -- but a large proportion aren`t. At least 20 million Americans over 60 have some level of memory impairment short of dementia. Another 4.5 million are victims of Alzheimer`s, a progressive brain disease that over the course of a decade destroys memory and other cognitive functions until its victims are virtually helpless. The longer one lives, the greater the danger -- 50% of people age 85 and over end up with Alzheimer`s.

Since more of us are living to an old, old age, trend lines for memory loss all point upward. The Alzheimer`s Assn. estimates that by 2050 -- when the number of people over 65 will have doubled, to 70 million -- there will be 13.2 million Alzheimer`s victims. Run the numbers, and it`s obvious that a pill that promises to protect against this terrible malady would dwarf the $1.7 billion a year pulled in by Viagra, that other salve for an aging body.

That such pills are even in the pipeline is something of a scientific miracle. The human brain is medicine`s most daunting frontier. Made up of more than one trillion highly complex neurons, it remained obdurately opaque long after the body`s other tissues had given up many of their mysteries. But in the past decade, the code has been partially cracked. Using sophisticated imaging technologies, animal experiments, and genetic insights, scientists now have a road map of the complex process that is memory formation.

Products follow knowledge. The first drug able to improve the thinking abilities of people with advanced Alzheimer`s disease was approved in Europe last year and is widely expected to win the nod from the Food & Drug Administration this fall. Memantine, developed by the German company Merz, is no miracle cure, and it has shown no effect in Alzheimer`s patients in the earliest stages of the disease. But clinical trials demonstrated that the drug allows the most desperately confused patients to live independently for six months to a year longer than they would otherwise, with no debilitating side effects.




--------------------------------------------------------------------------------
Memory clinics are springing up around the U.S.
--------------------------------------------------------------------------------



That`s more significant than it may sound: Alzheimer`s is the No.1 cause of institutionalization in the U.S. Memantine marks the first big payoff of brain research carried out over the past decade. The three treatments for Alzheimer`s now on the market -- Pfizer`s (PFE ) Aricept, Novartis` (NVS ) Exelon, and Reminyl from Johnson & Johnson (JNJ ) -- all boost the levels of a brain chemical called acetylcholine, and first appeared in the early 1990s. These drugs can delay the downward trajectory of patients in early stages of the disease for several months, but they do not improve thinking power and can cause nausea, loss of appetite, and frequent bowel movements.

Memantine is a smart bomb by comparison. It targets a cell receptor that controls the intake of glutamate, a neurochemical that scientists believe is responsible for 75% of the communications between brain cells. "Memantine represents real progress, a meaningful therapeutic advance," says Dr. Pierre Tariot, a University of Rochester psychiatrist.

Neuroscientists eagerly anticipate more such advances. Even now, the contours of an enormous memory industry are coming into view. Just look at the herbal supplement ginkgo biloba: Annual sales reached an estimated $500 million in the U.S. last year, although clinical trials have disproved claims that it can boost memory. The three Alzheimer`s drugs now available had combined U.S. sales of more than $1 billion, despite their shortcomings. Memory clinics are springing up around the nation, headed by everyone from top-ranked neurologists to New Age practitioners, while bookstore shelves are stuffed with how-to guides on memory maintenance.

A CURE IN CURRY? Even the federal government is in on the act. The cost of caring for Alzheimer`s victims in the U.S. will total over $100 billion this year, making the disease a top priority of the National Institutes of Health. It is sponsoring a dozen or more clinical trials of potential memory enhancers in the hopes that something, anything, will be found that can delay the slide into dementia. Anti-inflammatory treatments such as aspirin and Celebrex are particular favorites for study, because inflammation in the brain is a hallmark of Alzheimer`s disease. Vitamin E also has attracted interest in the hope that it may protect brain cells from damaging molecules called free radicals that course through the blood and batter healthy cells.




http://yahoo.businessweek.com/magazine/content/03_35/b384700…

Viele Grüße und schönen Sonntag.

Phear

[Phear]

Michael Parness, auch als "Waxie" und inzwischen sogar als ein regelrechter Guru der Trader bekannt(Beherrsche den Markt, ISBN3-922669-45-X, deutsche Ausgabe), hat Cortex auch im Auge:
(mail vom 30.08.2003)

COR, as stated, is totally ROCKING!!!

Called at $2.33, the stock is now in the stratosphere!!! And,
based on Friday`s performance could very well ROCKET even more!
Our next target on COR is $6. While the stock could
pull back, there are clearly interested buyers.

From here, depending on what you paid, please trail your
stops at plus 80 cents here on the play no matter what!
This thing could easily see $10s, or pullback on declining volume
and then ramp up. Regardless, we are guarenteed winners here
basically and we still won the stock! I personally own 25,000
shares still and am VERY happy I`m riding this bucking Bronco!!!

Isn`t it time YOU gave yourself a chance for these kinds
of gains? When was the last time YOU or anyone else you know
made 70+% on a single stock in ONE WEEK?

Our STOCK & OPTION plays of the week are not only cheap
price wise, they have proved to be WELL worth the investment!!!

So, stop guessing and join the HOTTEST game in town -

TRENDFUND.COM

Ich persönlich sehe dies mit einem lachenden und einem weinenden Auge; lachend, weil der gute Mr. Parness Werbung macht und so den Bekanntheitsgrad von Cortex erhöht. Weinend, da hauptsächlich Trader angesprochen werden und nicht long term investors.


Viele Grüße
Phear

[Erbse1]

Hallo liebe Cortex Fans.
Hab mal wieder was zu den leidigen Nebenwirkungen der Psychosemedikamente gefunden.
Diesmal geht es um die gar nicht so ungefährliche Entzündung der Bauchspeicheldrüse, manchmal sogar mit tödlichen Ausgang.
Umso gespannter dürfen wir auf die Ergebnisse auf ORG 24448 sein. Die entscheidende Frage wird wohl sein, ob ORG 24448 auch wirkungsvoll genug gegen die Positivsymptomatik ( also gegen die Wahnideen ) sein wird.
Die Ergebnisse der Testphase 2 dürfen wir wohl Anfang nächsten Jahres erwarten.
Bei aller Hilfe mit den neuen Medikamenten für Schizophrene, werden leider auch immer wieder neue Nebenwirkungen bekannt.
Es könnte sein ( Ich schreibe extra es könnte sein, da wir die Testergebnisse noch abwarten müssen ), daß die Ampakine mittelfristig eine Alternative zu den atypischen Psychosemedikamenten werden.

Liebe Grüße
Erbse1
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Researchers reported yesterday that there may be a link between some newer drugs prescribed for schizophrenia and a dangerous inflammation of the pancreas.

The study, which looked at patients taking any of four antipsychotic drugs, examined all cases of pancreatitis that were reported to the Food and Drug Administration or written up in medical journals between January 1981 and February 2002. It found that more cases were associated with three newer drugs than with an older generation drug.


Of the 192 cases of pancreatitis the researchers found, 72 occurred in patients taking Clozaril, made by Novartis, 62 in patients taking Zyprexa, made by Eli Lilly, and 31 in patients taking Risperdal, made by Jannsen Pharmaceutica. These drugs are members of the newer generation of antipsychotics known as atypicals.

Twelve cases occurred among patients who took Haldol, the older drug. The remaining 15 patients took more than one antipsychotic drug.

Twenty-two of the patients with pancreatitis died, the study found. Most of the cases developed within six months of when the patients began taking the drugs.

The researchers cautioned that the study did not show a cause-and-effect relationship between the newer drugs and pancreatitis, an inflammation of the pancreas, the organ that produces insulin. The significance of the findings remains unclear, they said.

"We`re seeing differences in the number of cases reported with Haldol and with newer drugs but we don`t know why," said Dr. P. Murali Doraiswamy, chief of the division of biological psychiatry at Duke University and an author of the paper, published in the September issue of the journal Pharmacotherapy.

Doctors voluntarily report adverse drug reactions to the F.D.A., making it impossible to know how representative the cases are.

"Nothing in this report should deter or discourage anyone from the appropriate use of newer antipsychotics," Dr. Doraiswamy said. The study was led by Dr. Elizabeth Koller of the University of Nebraska College of Medicine.

The findings suggested reason for concern, said Dr. Donald G. Goff, an associate professor of psychiatry at Harvard and director of the schizophrenia program at Massachusetts General Hospital. But further research was required, he said, "to find out if this is a real connection or an epiphenomenon."

The number of cases of pancreatitis found in the study was tiny in comparison with the number of people who take antipsychotic drugs, Dr. Doraiswamy said. More than 15 million prescriptions were written last year for Zyprexa and Risperdal, the two leading atypicals, alone, industry figures show. More than 67 million prescriptions for Haldol were written during the period of the study, the researchers noted.

According to one estimate, about 200,000 Americans develop pancreatitis each year.

Experts said that many people with schizophrenia have other risk factors for the illness, including a sedentary lifestyle, a history of drug or alcohol abuse, or undiagnosed medical conditions like diabetes, elevated lipid levels or gallstones.

Studies over the last two years have linked several atypical antipsychotics with diabetes and hyperglycemia. But the drugs, other studies indicate, are less likely than older drugs like Haldol to cause side effects like tardive dyskinesia, a disabling movement disorder.

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[Phear]

Es gibt Neuigkeiten:

News

Cortex’s CEO to Speak at Annual UBS Warburg Global Life Sciences Conference on September 22, 2003

Irvine, CA, September 8, 2003 — Cortex Pharmaceuticals, Inc. (AMEX: COR) announced that Roger G. Stoll, Ph.D., Chairman, President and CEO of Cortex Pharmaceuticals, Inc., will speak at the 5th Annual UBS Warburg Global Life Sciences Conference on Monday, September 22nd at 2:30 PM (EST). The conference will be held at The Plaza Hotel in New York City in New York from September 22-25, 2003.


Cortex Pharmaceuticals has pioneered a new class of medicine called AMPAKINE® compounds, which enhance memory and cognition by acting on chemical pathways that impact at least 85% of all the neurotransmission occurring in the brain. Dr. Stoll will discuss Cortex’s AMPAKINE drug development platform, an update on the Company’s new business model, the status of the Company’s clinical programs, additional applications for these drugs and current activities with Cortex’s corporate partners.


A live audio webcast of the presentation will also be available on the UBS website at http://www.ibb.ubs.com/. An audio replay of the presentation will begin 3 hours after the presentation time and will be available until October 25, 2003.

About Cortex Pharmaceuticals:
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act on the AMPA receptors on neurons to increase the strength of signals at connections between these brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in various neurological and psychiatric diseases. The AMPAKINE compounds are currently being evaluated in clinical trials for treatment of Alzheimer’s disease, Mild Cognitive Impairment, schizophrenia, fragile X syndrome, autism and sleep deprivation effects. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including Mild Cognitive Impairment, Alzheimer’s disease and anxiety disorders. (http://www.cortexpharm.com/)

Forward Looking Statement:
Note — This press release contains forward-looking statements concerning the Company’s research and development activities, clinical trials and business development plans. Actual results may differ materially, depending on a number of risk factors, including the risks that the Company may be unable to obtain additional capital needed to continue its operations; that the agreements with Organon and Servier will not result in any commercial products or that any additional milestone payments will be earned by the Company; that the Company may be unable to arrive at additional corporate partnerships with other pharmaceutical companies on acceptable terms and therefore be required to independently fund clinical development of AMPAKINE compounds through the sale of additional equity securities or otherwise; that the Company’s proposed products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that competitors may challenge or design around the Company’s patents or develop competing technologies; and that clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not yet been shown to have efficacy in the treatment of any disease.


Contacts:

Roger G. Stoll, Ph.D.
Chairman, President and CEO
Cortex Pharmaceuticals, Inc.
[phone] Jane Lin/Dian Griesel, Ph.D.
The Investor Relations Group
[phone]

Quelle:
Cortex Homepage:

http://www.cortexpharm.com/main.html


Da bin ich mal gespannt.

Viele Grüße
Phear

[Erbse1]

Bin im Netz noch auf einen Artikel der New York Times getroffen. Werde ihn gleich mal kopieren.
Auf den 22.9. bin ich wirklich mal gespannt. Ich denke mal, daß hier die Ergebnisse der Ampakine bei Schlafentzug präsentiert werden.
Falls die Ergebnisse positiv ausfallen, bedeutet dies für Cortex einen riesen Sprung. Die DARPA Organisation könnte innerhalb kürzester Zeit eine Testphase 3 durchführen..., aber das ist reine Spekulation.
Machts mal gut
Erbse1
-----------------------------------------------------------
They are called smart pills or brain boosters or, to use the preferred pharmaceutical term, cognitive enhancers.

But whatever the name given to compounds created to prevent or treat memory loss, drug companies and supplement producers - eager to meet the demands of a rapidly growing market 0 are scrambling to exploit what they view as an enormous medical and economic opportunity.

Three drugs being prescribed for Alzheimer`s disease - donepezil (Aricept), galantamine (Reminyl) and rivastigmine (Exelon) - have been shown to delay somewhat the loss of mental abilities in people with the illness. So has the drug memantine, which has been used for years in Europe but has not been approved in the United States. Some experts also say that performing mental exercises and adding fish oil to the diet can delay memory decline.

Pharmaceutical companies are investigating dozens of other compounds to see whether they can help people who have memory difficulties but have not progressed to Alzheimer`s. Some researchers hope that drugs will eventually prevent the deficits that even healthy elderly people experience.

Much of the excitement among pharmaceutical companies, which have dozens of drugs in development, stems from advances in clarifying some of the brain processes and biochemical pathways that can hinder or help memory storage and retrieval, said Dr. Paul R. Solomon, a professor of psychology at Williams College.

"The basic research into the causes of memory disorders is going very rapidly," said Dr. Solomon, who is also co-director of the Memory Clinic at the Southwestern Vermont Medical Center in Bennington.

But it will probably be at least five years before any of those drugs meet the standards for approval by the Food and Drug Administration, researchers said.

Clearly, the market for memory enhancers is growing with the aging of the population.

Dr. Steven T. DeKosky, a professor of neurology and psychiatry at the University of Pittsburgh School of Medicine, says he has noticed a marked increase in anxiety among baby boomers, who are watching their parents descend into Alzheimer`s and hoping that new medicines will help them avoid the same fate.

"People in their 40`s and 50`s are saying: `How can you help my mother? And, by the way, how can I avoid this?` " Dr. DeKosky said. "Ten years ago, people wanted to know how frequently they should have their blood pressure checked and what sorts of food they should eat. Nobody ever asked what they should be doing to prevent themselves from getting a late-life dementia."

Even among those who are already suffering memory loss, Alzheimer`s is far from the only source. An estimated four million Americans have it, but millions more suffer from other disorders that can lead to dementia, including Parkinson`s disease, multiple sclerosis, stroke, head trauma and schizophrenia.

Experts estimate that an additional four million people have a syndrome called mild cognitive impairment, which may progress to Alzheimer`s. People with the impairment can function on their own but have gaps in their memories.

Economic imperatives are also driving the search for new and better treatments for memory disorders.

The current cost of Alzheimer`s alone runs $100 billion or more, said Dr. William Thies, vice president for medical and scientific affairs of the Alzheimer`s Association, a research and support group.

If no new medications for memory disorders are found, Dr. Thies added, the number of Alzheimer`s patients could quadruple by midcentury.

"That`s going to bankrupt our health care system," he said. "So there`s a need to find a way to short-circuit that impending disaster."

Except for extreme cases like advanced Alzheimer`s, memory disorders do not generally disrupt what is often called procedural memory, the ability to perform basic tasks or motor skills like riding a bicycle or getting dressed.

Far more vulnerable is episodic memory, the ability to recall specific information about people, dates and events. Many of the new compounds being scrutinized seek to improve the way recent memories are stored, transformed into long-term memories and brought back into consciousness when needed.

Drugs approved specifically for Alzheimer`s are being tested in patients who have mild cognitive impairment. But the medications can have side effects like nausea and diarrhea. So researchers are looking ahead to the second generation of memory enhancers, some of them now in clinical trials.

Some of the drug companies most involved in the search are small enterprises, focused on specific pathways or aspects of brain biochemistry. Memory Pharmaceuticals in Montvale, N.J., is developing compounds that maintain brain levels of a substance called cyclic AMP, which transmits intracellular signals and has been shown in mice to play a role in memory formation and retrieval.

Another company, Cortex Pharmaceuticals in Irvine, Calif., has two drugs in clinical trials that bind themselves to sites on nerve cells called AMPA receptors. The receptors respond to signals between cells carried by the neurotransmitter glutamate, and the drugs, called ampakines, are intended to enhance the strength of the incoming signal.

"It`s like an amplifier to a stereo set, and you can turn up the volume of brain activity quite a bit by using these compounds," said Dr. Roger Stoll, president, chief executive and chairman of Cortex.

Despite optimism among neuroscientists about eventual success, few expect memory enhancers to be a panacea. Many researchers acknowledge that even if they find effective treatments, there is no guarantee that the drugs will do anything for people who age normally.

There is even less optimism that these drugs will boost the brain power of younger people hoping to master a foreign language or excel on a calculus examination.

Although some drugs have clearly enhanced the ability of animals to learn and perform routine tasks, that does not necessarily mean the same medications will help people remember names and faces, said Dr. Rodney Pearlman, president and chief executive of Saegis Pharmaceuticals in Half Moon Bay, Calif.

"It isn`t clear that animals use the same kinds of memories that humans do," said Dr. Pearlman, whose company is developing several memory enhancers. "A mouse doesn`t have to remember a PIN number to get along during the day."

http://nootropics.com/smartdrugs/memorysave.html
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[Erbse1]

Ich stell mir zur eigenen Recherche einen Artikel hier rein.
Wer will kann ja mitlesen
Erbse1
-----------------------------------------------------------
Brain Res 2003;970(1-2)

Positive allosteric modulators of AMPA receptors are neuroprotective against lesions induced by an NMDA agonist in neonatal mouse brain.

Dicou E, Rangon CM, Guimiot F, Spedding M, Gressens P

INSERM E9935, Hôpital Robert Debré, Paris, France

Four positive modulators of AMPA-type glutamate receptors (cyclothiazide, CX614, LY404187 and S18986-1) given in acute or chronic manner exerted a neuroprotective effect in lesions induced in postnatal day 5 (P5) mice by intracerebral injection of ibotenate, an NMDA agonist. The neuroprotective effects were mediated via the MAPK pathway since coinjection of the MEK inhibitor, PD98059, blocked the neuroprotective effects. Administration of CX614 to neonatal mice was followed by upregulation of hippocampal and cortical BDNF expression.

PMID: 12706264[PM]

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[Erbse1]

Folgender Artikel ist nur zur eigenen Recherche.
Liebe Grüße
Erbse1
-----------------------------------------------------------
LY503430, a novel AMPA receptor potentiator for the treatment of Parkinson’s disease
Parkinson’s disease (PD) is a movement disorder resulting from neurodegeneration of the basal ganglia, the most prominent pathological change in Parkinsonian brains being the loss of dopaminergic innervation from the substantia nigra (SN) to the caudate and putamen of the corpus striatum.

According to the National Parkinson`s Foundation, Parkinson`s disease affects approximately 1 million Americans. A further 3 million people suffer the disease in the rest of the world. As the global population continues to age, the incidence of PD in persons over 60 is expected to increase. At the same time, however, the American Parkinson`s Disease Society has reported that the incidence among persons under 50 is also on the rise. This increased incidence means that the global market for PD therapeutics, already valued at around $1.4 billion market, is estimated to grow at 10% per year (for a full analysis of therapeutic and commercial opportunities in the field of neurodegenerative disorders click here).


There are several available therapies to treat the symptoms (i.e. replacement of dopamine), but none halt or even slow the progression of the disease. The exact mechanism of Lewy body formation (intracytoplasmic, eosinophilic, inclusions found in vacuoles of injured or fragmented neurons which are histological markers of the degenerative changes in PD) and subsequent nigral cell death and the role played by environmental and genetic factor remains to be elucidated. However, it is clear that agents that halt the progression or help repair the damage are urgently required and have the potential to expand the growing PD market still further.


The actions of neurotrophins in PD have recently been evaluated. Many investigators have reported that glial derived growth factor (GDNF) promotes dopamine neuron survival, while other studies have shown that brain derived growth factor (BDNF) can protect against behavioral, biochemical and immunocytochemical changes after nigrostriatal dopamine lesions. A major drawback to the therapeutic use of growth factors is their large size and therefore the need to administer these molecules directly into the brain. An alternative and perhaps more clinically relevant approach would be to use a small molecule that could up-regulate neurotrophin expression in the brain. Of direct relevance therefore is the recent report that activation of AMPA receptors increases the expression of BDNF.


Recently, a number of potent and selective AMPA receptor potentiators have been discovered which allosterically regulate AMPA receptor activity at least in part by suppressing the desensitization process of AMPA receptors. The potentiators, CX-546, LY392098 and LY404187 have all been shown to increase BDNF levels in vitro and in vivo and are expected to protect against nigrostriatal degeneration.


Lilly researchers have recently evaluated this concept through the use of a novel AMPA receptor potentiator, LY503430. This molecule, which is most potent at the GLU A2 subtype, potentiated AMPA-evoked responses of substantia nigra dopamine neurons in vitro, and when administered iv, enhanced responses of hippocampal neurons to iontophoretic AMPA. LY503430 was also effective in models of PD. For example, it prevented the loss of tyrosine hydroxylase immunoreactivity in the striatum and substantia nigra in MPTP-treated mice. The compound also reduced damage after 6-OHDA infused unilaterally into the striatum a model that produces a slow, partial retrograde degeneration of the cell bodies in the substantia nigra resulting in a loss in tyrosine hydroxylase positive cells and in marked ipsiversive rotations in response to amphetamine. Finally, oral adminsitration of LY503430 protected the dorsal and ventral striatum and limited functional decline after 6-OHDA was infused into the nigra. These effects could be maintained even when the treatment with drug was delayed until after cell death had occured (3 & 6 days). In agreement with this the functional effects in the striatum was mirrored by only a modest effect on the number of tryosine hydroxylase positive cells in the substantia nigra. This was suggested to result from an increase in BDNF in the substantia nigra (or other brain regions) and these trophic actions result in neurite outgrowth in striatal terminals.

These data are important since they provide the first evidence that AMPA receptor potentiators can provide functional and histological protection in rodent models of PD. Since these effects were related to neurotrophic action the further development of this therapeutic class is hoped to provide new opportunities in PD therapeutics by halting the progression or helping repair the neurological damage characteristic of this disease.


Entry date Monday, July 28, 2003
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http://www.leaddiscovery.co.uk/target-discovery/abstracts/Pu…

[Erbse1]

Der Jahresbericht von Cortex ist da.
http://biz.yahoo.com/e/030919/cor10-k.html
MCI Ergebnisse können sich um ein paar Tage verschieben. Falls mir etwas auffällt, melde ich mich noch mal
Liebe Grüße
Erbse1

[meislo]

2
"Doof bleibt doof, da helfen keine
Pillen" - ein böser Schulhof-Spott, der
vielleicht bald nicht mehr der Wahrheit
entspricht. Angesichts der rapide wachsenden
Zahl demenzkranker Senioren
haben die Pharmaunternehmen einen
neuen Massenmarkt im Visier. Auf rund 13
Millionen dürfte das Heer der Alzheimer-
Patienten allein in den Vereinigten Staaten
bis 2050 anschwellen, ergeben aktuelle
Hochrechnungen. Doch nicht nur
Pharmariesen wie GlaxoSmithKline, Johnson
& Johnson oder Merck haben ehrgeizige
Entwicklungsprogramme für hirnfördernde
Pillen aufgelegt. Allein in den
Vereinigten Staaten arbeitet ein halbes
Dutzend junger Neuro-Companys wie
Cortex, NeuroLogic, Helicon oder Axonyx
mit Hochdruck an neuartigen Gedächtnis-
und Lernpillen. Dabei geht es
keineswegs nur um schwere manifeste
Erkrankungen. Auch die milde kognitive
Störung wie die "normale" Altersvergesslichkeit,
an der angeblich bis zu 60
Prozent der Hochbetagten leiden, wird
nun zum Ziel der Pharmabranche.Ampakine
Die Nervenzellen des Gehirns kommunizieren
untereinander, indem sie kleine,
Neurotransmitter genannte Moleküle
aussenden. Diese binden an Rezeptoren,
die sich auf der Zelloberflöche der Nervenzellen
befinden, und lösen damit eine
Reaktion in der Zelle aus. Der wichtigste
Neurotransmitter ist das Glutamat, das für
75% der Zellkommunikation verantwortlich
ist. Eine Reihe verschiedener Rezeptoren
binden Glutamat und lösen unterschiedliche
Reaktionen der Zellen aus.
Einer davon ist der AMPA-Rezeptor, der
unter anderem bei der Gedächtnisleistung
eine wichtige Rolle spielt. Im Alter
und bei der Alzheimer-Erkrankung nimmt
die Wechselwirkung zwischen Glutamat
und den AMPA-Rezeptoren ab und die
Leistungsfähigkeit des Gehirns wird
geringer. Die Ampakine von Cortex erhöhen
jedoch die Empfindlichkeit der
AMPA-Rezeptoren und helfen diesen Verlust
ausgleichen. Auch bei Schizophrenie,
bei der ein Ungleichgewicht der
Neurotransmitter vorliegt, können Ampakine
ausgleichend eingreifen. In vorklinischen
Test wurden zusätzlich ermutigende
Resultate auch bei der Behandlung
von Depression, Sexualstörungen und
Herzinfarkt erhalten.
Die Pipeline
Cortex kann aus Geldmangel die Entwicklung
seiner Kandidaten nicht alleine
Im kalifornischen Irvine testen die
Forscher des kleinen Biotech-Unternehmens
Cortex Pharmaceuticals sogen.
Ampakine an gedächtnisschwachen Senioren.
1993 lizensierte Cortex die neue
Klasse von Wirkstoffen und die dazugehörige
Technologie von der University of
California.Cortex - Potenzpillen für’s Hirn
durchführen. Ein Wirkstoff (Org-24448)
wurde daher an Organon vergeben und
befindet sich in Phase II der klinischen
Tests. Den Wirkstoff Ampalex, auch
CX516 genannt, entwickelt Cortex
gemeinsam mit der französischen Firma
Sevier. Drei Phase I und zwei Phase II Tests
wurde bereits abgeschlossen. Zur Zeit
laufen weitere Phase II-Erprobungen an
Patienten, die häufiger an Ausfällen
ihres Kurzzeit-Gedächtnisses
leiden. Studienteilnehmer
berichten, dass bei der
Therapie die Wirkung sofort
einsetzte. Während sie sich
vor Beginn der Behandlung nur
fünf Worte aus einer Liste von
20 Worten merken konnten,
waren sie bereits in der zweite
Woche fähig 14 der 20
Begriffe zu behalten.
Bewertung
Sollte sich diese Wirkung
auch in weiteren und umfangreicheren
Tests bestätigen und keine
wesentlichen Nebenwirkungen auftreten,
hätte ein solcher "Brain-Booster" mit
Sicherheit das Potenzial zu einem
Blockbuster. Das Risiko besteht darin,
dass sich Ampalex noch in einer frühen
Phase der klinischen Erprobung befindet
und ein Scheitern durchaus möglich ist.
Auch hat Cortex eine Reihe von Konkurrenten,
die an ähnlichen Projekten
arbeiten und ein besseres Liquiditätspolster
aufzuweisen haben. Da Cortex
jedoch mit lediglich 70 Mio$ bewertet
ist, bietet sich dem langfristig orientierten
Anleger eine gute Möglichkeit frühzeitig
in ein vermutlich lohnendes Projekt einzusteigen.
Den hohen Risiken stehen grosse
Chancen gegenüber.


Name: Cortex Pharam WKN: 879005 Internet: www.cortexpharm.com
Kurs: 4,47 Dollar Marktkap.: 75 Mio. Dollar Einstufung: spek. kaufen
Schätzungen 2003 2004
Umsatz 5,4 Mio. Dollar 6,0 Mio. Dollar
Ergebnis je Aktie -0,07 Dollar -0,07 Dollar
KGV -- --
Fairer Wert: 6 Dollar Stopp: 3,50 Dollar Nächste Zahlen: Oktober 03
21. September 2003 SUNDAY-BIOTECH


gruss meislo

[Erbse1]

Hallo liebe Cortex Fans. Im Augenblick nicht viel Neues bei Cortex.
Cortex hat gestern auf der UBS Warburg Global Life Sciences Conference präsentiert.
Die Ergebnisse zur Auswirkung der Ampakine bei Schlafentzug sollen jetzt wohl erst im Oktober veröffentlicht werden.
Die MCI Ergebnisse wohl im ersten Quartal 2004.

@ meislo, danke für die Empfehlung von Cortex durch Sunday Biotech. Hast Du vielleicht einen direkten link zu diesem Artikel.

Liebe Grüße
Erbse1

[Erbse1]

Hallo meislo, habe bei aktiencheck eine Kurzform der Empfehlung gefunden. Für alle Interessenten hier der link.
http://www.aktiencheck.de/Analysen/default_an.asp?sub=4&page…
Liebe Grüße
Erbse1

[Erbse1]

Kurz noch ein Kommentar des Neuroinvestor zu den einzelnen Substanzen

-----------------------------------------------------------
I think there is a misconception on this board that Roger Stoll is arbitrarily dismissing the advanced CX516 for the untried CX717. For six or seven years I have heard Big Pharma comments that CX516 is not seen as a commercially viable drug for MCI/dementia. I believe Stoll`s attitude reflects a year of dealing with pharma companies and institutions that hold that belief, based on CX516`s halflife and lack of potency. One can debate whether he should have brought this up at UBS Warburg, but the more sophisticated institutional investors are already aware of this issue, and are not likely to be sold on a molecule they see as a weak candidate.

I do think CX516 still might be an option for Fragile X or autism, where the patients are supervised in their medication compliance. But Servier has its own better molecule, Organon has Org24448, and the Big Pharmas talking about North American MCI rights are looking for an equally potent candidate. CX516 is not going to be that drug, and Stoll is simply facing reality, not devising it.

NeuroInvestment

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[Erbse1]

Melde mich noch mal kurz zu den Psychosemedikamenten
Zyprexa muß eine Diabetes Warnung veröffentlichen.
>>Lilly drug to add diabetes warning
Best-seller Zyprexa and rival antipsychotic products must add disclaimer, FDA says.<<
Weiterhin sind alle anderen atypischen Medikamente betroffen.
>>Other drugs affected by the warning are AstraZeneca`s Seroquel, Bristol-Myers Squibb`s Abilify, Johnson & Johnson`s Risperdal, Novartis` Clozaril and Pfizer`s Geodon.<<
Den vollständigen Artikel gibts unter folgender Adresse

http://www.indystar.com/print/articles/4/075294-9894-105.htm…

Umso gespannter dürfen wir auf die Ergebnisse mitte nächsten Jahres mit ORG 24448 sein.

Machts mal gut und liebe Grüße
Erbse1

[Erbse1]

Hier kurz der Kommentar zur derzeitigen Situation und zur Präsentation von Cortex. Geht ja mächtig runter die letzten beiden Tage.
Machts mal gut und liebe Grüße
Erbse1
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Cortex
9/24/03 (Regarding Cortex presentation at UBS Warburg) Cortex tumbled yesterday and today on the heels of their presentation. One might have thought that a significant setback had been announced, but in fact, the only negative news was of delays in the timelines for MCI and DARPA/sleep deprivation clinical data. Expectations had been raised, and such expectations exact a toll when disappointed. But neither delay means anything material. The DARPA study data was set back two or three weeks due to a last minute problem enrolling the final patient in the trial. If anything, the monkey data discussed in the presentation raises great promise: sleep-deprivation data would be the inroad to the excessive daytime sleepiness broad spectrum Cephalon has been pursuing with Provigil. The $300 million in annual sales currently obtained by Provigil is a small proportion of the billion dollar plus market that is out there. It is only a 12 pt trial, thus statistical significance is not the priority, a strong trend would be enough. This is one of the targets Cortex now emphasizes as an inhouse project, and the potential revenues if they bring it to Phase III could rival their share of MCI sales. While we are as eager to see the data as anyone, the fact is that our enthusiasm for this new programmatic emphasis is higher than before the presentation. Fragile X could also be a major inhouse project, one where approval and market penetration could make it a major revenue source two years or more before MCI.

The ambiguity regarding the Servier MCI Phase II results is unfortunate, but is not under Cortex`s control. Servier has consistently acted as if there is no rush, and they certainly have no sense of fiduciary obligation to Cortex shareholders. After they have done the full analysis, after they have run those results by an independent data review board, then they will make them public. All of that is unlikely until January. However, if they happen to have surprisingly strong preliminary results on the primary endpoint, there is nothing to stop them (certainly Cortex will not object) from releasing them during late 4Q.

Some controversy has been stirred up regarding the positioning of second generation molecules as opposed to the grizzled forebear, CX516. CX516 was described as a short-duration, low potency compound. This is not news to anyone in the pharmaceutical or financial world who has paid attention to Cortex, and would certainly come up in DD prior to any major partnership or financing. CX516 could survive in some indications, especially if the MCI data shows a later onset of effect suggesting BDNF production at work. But for the past six years or more, Big Pharma companies have been clear with Cortex that CX516 did not meet their criteria for being a viable drug. But CX717 does, as do S1896, and Org24448, and that fact about more potent Ampakines is something to entice previously skeptical Big Pharma companies.

Cortex remains the only publicly traded company with a memory enhancing drug in Phase II, and others waiting in the wings. They are it (we do not include cholinesterase inhibitors or protectants, which we believe are not relevant to MCI), everyone else is private, and almost everyone else is far behind them in developing their pipeline. Problems with the CX516 clinical trials? A lot of companies would love to have those `problems`. We are certainly patience-challenged at times, but o ur recommendation of Cortex is, if anything, reinforced by yesterday`s presentation. It was a sell signal for anyone with less than a two week window for `investment`. For anyone with a longer timeframe, the content was neutral (CX516, time delays) to positive (DARPA study).


-----------------------------------------------------------

[Erbse1]

Hab einen interessanten Artikel gefunden. Es kommt nicht nur auf das richtige Merken oder Lernen an, sondern auch auf das richtige Vergessen. Leider wurde keine Aussage gemacht, was an der jüngeren Testgruppe dann auch besser klappte.

Liebe Grüße
Erbse1

-----------------------------------------------------------

Alte vergessen Wichtiges ...
... weil sie sich zu viel merken

Alte Menschen können sich schlechter an Wichtiges erinnern, weil sie auch Nebensächliches speichern. Das geht aus Studien zweier Göttinger Entwicklungspsychologen hervor, in denen sie die Fähigkeit zum "absichtlichen Vergessen" bei jungen und älteren Testpersonen untersuchten. Diese Fähigkeit gehe älteren Menschen zunehmend verloren, so dass sie sich im Kurzzeitgedächtnis auch eine Unmenge unwichtiger Dinge merkten und damit weniger Speicherplatz für Wichtiges übrig hätten, schreibt die Hamburger Wochenzeitung "Die Zeit".

"Die Fähigkeit, vergessen zu können, ist eine essenzielle Grundfunktion des menschlichen Gedächtnisses», sagt Marcus Hasselhorn. Das so genannte "directed forgetting", ein bewusstes "Entrümpeln des Oberstübchens", beherrschen Hasselhorns Untersuchungen zufolge bereits Kinder im Alter von sechs bis sieben Jahren.

Sein Doktorand Jörg Behrendt verglich die Erinnerungsfähigkeit zweier Testgruppen aus 20- bis 35-Jährigen und 60- bis 75-Jährigen: Beide sollten sich nacheinander verschiedene Wörterreihen merken, wobei während der Tests plötzlich eine dieser Reihen als hinfällig bezeichnet wurde und die Probanden nochmal von vorne anfangen sollten. Abschließend wurde jedoch alles, auch die "hinfällige" Reihe, abgefragt. Es zeigte sich, dass die älteren Probanden auch das als unwichtig Gekennzeichnete nicht aus ihrem Gedächtnis getilgt hatten - sie erinnerten alle Wörter gleich und das gleich schlecht.

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[Erbse1]

Cortex`s CEO to Speak at the Rodman & Renshaw Techvest Healthcare Conference on October 22, 2003

http://biz.yahoo.com/bw/031007/75082_1.html

Mal sehen, ob diesmal die Daten bei Schlafentzug präsentiert werden.
Liebe Grüße
Erbse1

[Erbse1]

Hallo liebe Cortex Fans, folgend ein paar interessante Anmerkung des Neuroinvestors

SFN abstracts
by: Neuroinv 10/08/03 07:27 pm
Msg: 8416 of 8424

My SFN abstracts arrived a couple days ago. On the AMPA modulating front, there were two papers which caught my interest and might catch yours:

Cortex: Wake Forest researchers will report on the primate study of CX717 in sleep-deprived monkeys, returning test performance to normal level even after 30-36 hrs of sleep-deprivation. These are the results that Dr. Stoll extolled in New York. They are impressive, hopefully the human data will be equally so.The cautions about the small sample size are well-advised. However, the presence of modafinil and even a generic mimic by no means closes the door to a second generation drug with a different mechanism of action.

Servier: Here was something I found interesting. They report on S-18986, and its effects upon the release of acetylcholine--enhancing it, perhaps contributing to learning effects. The interesting thing is: in young rats they needed 10mg/kg, in older ones 3mg/kg (why the older ones need less I haven’t figured out). The Cortex monkey study with CX717 used under 1.0mg/kg. Unless macaque monkeys metabolize ampa modulators very differently than rats (I am not aware of such a magnitude of difference) this infers that CX717 is considerably more potent than S18986 (at least 3X, maybe even 10X, since the macaques were not elderly.)

So Servier spotlighted their molecule, but CX717 may in fact be superior in its potency. This could be relevant to negotiations regarding which molecule is developed by whom, where, and for what.

NeuroInvestment
www.neuroinvestment.com

http://finance.messages.yahoo.com/bbs?.mm=FN&board=160424327…

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Weiterhin noch ein kleiner Hinweis zum Wachstum von Cortex

Cortex Pharmaceuticals, Inc. Tops Deloitte & Touche Orange County Technology Fast 50 Ranking of Fastest-Growing Technology Companies, With 4,848 Percent Growth Over Five Years

http://cbs.marketwatch.com/tools/quotes/newsarticle.asp?guid…

Ich denke mal, es dauert nicht mehr so lange bis zu den Ergebnissen bei Schlafentzug und MCI.

Machts mal gut und liebe Grüße

Erbse1

[Erbse1]

Hallo liebe Cortex Fans. Folgend kurz einige medizinische Abstrakte.
Liebe Grüße
Erbse1
EFFECTS OF SLEEP DEPRIVATION ON GLUTAMATERGIC TRANSMISSION IN HIPPOCAMPAL NEURONS.
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

Abstract View
THE POSITIVE ALLOSTERIC MODULATOR OF AMPA RECEPTORS, S 18986, IS NEUROPROTECTIVE AGAINST LESIONS INDUCED BY GLUTAMATERGIC AGONISTS IN NEONATAL MOUSE BRAIN.

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

AMPAKINES IMPROVE COGNITIVE PERFORMANCE AFTER SLEEP DEPRIVATION IN NONHUMAN PRIMATES.

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

[Erbse1]

Hallo liebe Cortex Fans. Es gehen gute Nachrichten im Yahoo Board rum. Die ORG 24448 Ergebnisee über Schizophrenie sollen schon Ende diesen Jahres vorliegen.
Gerechnet wurde damit erst gegen Mitte bis Ende 2004.
Ich werde erst mal die Ergebnisse abwarten und dann mal eine Zusammenfassung der bisherigen Schizophreniemedikamente und deren Vor- und Nachteile posten.
Einiges lesenswertes steht auch im ersten Beitrag dieses Threads.
Folgend noch die Anmerkung des Neuroinvestors, der in der Regel doch sehr gut informiert ist.

Machts mal gut und liebe Grüße

Erbse1
-----------------------------------------------------------
Re: Partnership possibilities
by: Neuroinv 10/12/03 04:42 pm
Msg: 8481 of 8493

I agree with most everything you said. Org-24448 is the only second generation compound to have completed a Phase II. And it has been my understanding that Phase III would be starting late this year, not late-2004.

I posted something in the past here about the fact that the optimal deal would involve more than just Cortex and a Big Pharma. The best of all worlds would have Organon, Servier, and Cortex all licensing their rights (except that Servier would keep French rights, yawn) to a Big Pharma-Lilly would be the best choice, because of their experience and the fact that would eliminate litigation risks--but I really dont care which one, so long as it is large enough to handle all of these immense development projects. The usual suspects, Merck and Pfizer, spring to mind as well. But Pfizer is still digesting Pharmacia, making them less appealing. GSK is still trying to get some efficiency from its decentralization efforts, but they would be a high quality option as well. Roche is off the board since they are so committed to Memory Pharma. Novartis has lost a lot of its CNS people and seems a bit aimless since the iloperidone debacle, I wouldn`t rank them in the first tier of possibilities. This is not an exhaustive list by any means.

Organon is more important to the deal than Servier. My Organon contacts clearly think that they are going ahead with their own development program, but they would not be in the loop if the Akzo Nobel parent were contemplating a major sale. You do raise a good point about co-development, they could decide to split the burden and eventual reward rather than take all the risks themselves, it does not have to be an all or none choice.

Mind you, this post is predicated upon what I would like to have happen, which does not necessarily bear any relation to reality as it eventually unfolds.

NeuroInvestment

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[Erbse1]

Hier mal einige Ausführungen zu den psychischen Erkrankungen. Ich denke mal, daß auch die deutschen Bewohner ein falsches Bild von dieser Erkrankung haben.
Interessant finde die Aussage, daß 72 % der Psychotiker unter Ihrer Medikation leiden. Mich interessieren jetzt die Ergebnisse von ORG 24448 und ob sie in Mono oder Kombotherapie durchgeführt werden. Auf diese Ergebnisse bin ich wirklich gespannt. Laut Neuroinvestor sollten wir ja Ende des Jahres in Testphase 3 gehen
Machts mal gut und liebe Grüße
Erbse1
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http://www.usatoday.com/news/health/2003-10-14-nasal-spray-o…

Survey Finds Many Americans Misunderstand Mental Illness

(NUE) - Do you know someone with a mental illness? You probably do. One in five Americans experiences a mental illness each year.

Mental illness knows no age limits, economic status, race, creed or color. But many people with mental health needs do not receive the care, support or respect they deserve. Instead of compassion and acceptance, many are faced with misunderstanding, discrimination and hostility.

This is especially true for the 2.2 million Americans who are living with schizophrenia and for their families.

A recent national survey by the National Mental Health Association revealed that misconceptions strongly influence how the general public views schizophrenia. The survey found only 14 percent of the general public believes that people with schizophrenia can hold jobs and raise families. Further, only 27 percent of the general public believes that schizophrenia is treatable. In turn, this stigma impacts the ability of people with schizophrenia to access the treatments and services they need, such as:

* A place to live: Three-fourths (74 percent) of people with schizophrenia report having had difficulty finding a place to live.
* Community services: Less than half (48 percent) of people with schizophrenia and only one-third (35 percent) of caregivers think that adequate services are provided for people with mental illnesses.
* Quality health insurance: Only half (52 percent) of people with schizophrenia and one-fifth (21 percent) of caregivers agree that insurance coverage for mental illness is as good as the coverage for physical illness.
* Improved care: Nearly three-fourths (72 percent) of people with schizophrenia said that medication side effects significantly impact their lives.

The truth is that schizophrenia is a serious disorder that affects a person`s thoughts, feelings and actions. Someone with schizophrenia may have difficulty distinguishing between what is real and what is imaginary.

The person may be unresponsive or withdrawn and may have difficulty expressing normal emotions in social situations. But schizophrenia is not the same as split personality or multiple personality. The vast majority of people with schizophrenia are not violent and do not pose a danger to others. More often, they are likely to be the victims of crime.

Finally, schizophrenia can be effectively treated and many people with this illness do lead productive and fulfilling lives. You can help eliminate the stigma surrounding schizophrenia and other mental illnesses.

To get all the facts, contact your local mental health association or the National Mental Health Association at 1-800-969-NMHA or visit www.nmha.org.

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[Erbse1]

Habe leider den falschen link zur vorherigen Meldung gepostet. Hier also der Richtige.
http://www.flatoday.com/sections/healthmedicine/1013mental.h…

[Erbse1]

Neues vom Neuroinvestor. Es lohnt sich wirklich mal auf diese Seite zu gehen. Es ist wohl der beste Börsenbrief auf diesem Gebiet.
Liebe Grüße
Erbse1

Cortex
From October 2003 Issue

There was a shift of emphasis towards excessive daytime sleepiness in Cortex`s UBS Warburg presentation. This is going to be the main indication carved out of the broad Ampakine licensing agreement still being negotiated. It also implies confidence in the DARPA trial, though the fact it is a 12 pt trial means expectations for any statistical significance should be tempered. The monkey data was quite strong, and our optimism is fairly high. The data release is now likely to occur early this month. Cortex is still negotiating with several Big Pharma companies regarding MCI/AD rights, and is insisting on $30-40 million in guaranteed funding over 3-4 years. This is higher than we anticipated, it will be interesting to see if they can get it without modifying their royalty expectations.The eventual funding, be it from a partner or from (less desirably) further financing, will allow them to pursue the very large EDS market and the small but still important Fragile X trial. The EDS indication is the road surveyed by Cephalon, and the fate of Cephalon`s sNDA will influence the view of the CX516 DARPA data. The broader Cephalon`s label is, the better it is for everyone in that space. Since there is still the possibility that the FDA will throw up extra hurdles for MCI, Fragile X is their best shot at getting a drug on the market before 2007-8. The Servier analysis of the MCI data is taking an unconscionable amount of time, data release has now been predicted for 1Q:04, partly because Servier is going to present the data to an independent data review committee before making it public. The glacial Gallic pace is galling, but is out of Cortex`s hands.

http://www.neuroinvestment.com/CORXcom.html

[Erbse1]

Langsam taucht Cortex auch in anderen Medien auf.
Kann sein, daß heute die Ergebnisse zum Schlafentzug präsentiert werden.
Machts mal gut und liebe Grüße
Erbse1
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Ask doctor about all-but-forgotten memory drug


Dear Mr. Berko: My 74-year-old father`s memory has markedly declined in the past year, and it is becoming very embarrassing and unsettling for him.

Several months ago, Father seems to recall a new drug called (he thinks) "Alphaplex." I asked our family physician about this name and several others but drew blanks. Father insists that I write you because he believes you may know the drug and the company that makes it because your son (who is a doctor) has helped you write some columns on this in the past.

So what is this drug? Does it work? What is the name of the company? How can I get it for Father? And would the company be a good investment?

— RR, Destin, Fla. Dear RR: Novartis has a drug called Exelon, Pfizer has a drug they named Aricept and Johnson & Johnson`s drug uses the name Reminyl.

If you surf the TV channels, you might recall that Pfizer, Johnson & Johnson and Novartis are spending millions encouraging you to waste you insurer`s money on these prescriptives. Each boosts the level of acetylcholine, a brain chemical, but it only delays the progression of early-stage Alzheimer`s for a few months. They do not improve memory or cognitive ability, and the associated nausea symptoms make you want to forget. I don`t think these are the drugs to which you refer.

Perhaps the potion your father may have heard about is called Ampalex, which, according to my son the doctor, belongs to a new class of drugs called ampakines; the leader in this field is a small pharmaceutical company called Cortex Pharmaceuticals Inc. (COR-$3.25).

According to my son, Ampalex seems to work by increasing the focal activity of AMPA receptors, which assist the brain in maintaining normal concentrations of a messenger chemical called glutamate. Apparently, low levels of glutamate inhibit the brain`s memory and cognitive functions and high levels of glutamate "overstimulate" the cells, causing the brain cells to die.

Alzheimer`s involves both excesses and deficiencies of glutamate at different times and under different circumstances. Supposedly, Ampalex allows the brain to compensate for various patterns of glutamate by enhancing the ability of AMPA receptors to respond to changing levels. That`s as technical as I`m going to get.

Ampalex is in Phase II trials. I was told about a 75-year-old participant whose memory problems had become a terrible business, social and familial embarrassment. This person was healthy as an ox, physically strong and continued to work a full week. The effect of Ampalex was immediate and profoundly appreciable. Within two weeks, this person experienced a near-perfect recovery that was excitedly noticed by business associates, friends and family members.

At the completion of the trial study period, Ampalex became legally unavailable, and within a month, this person`s faculties heartbreakingly reverted to pretrial levels.

COR has that drug, COR has the supporting research and Ampalex is one drug that may be effective. COR recently completed a $5 million private placement with the brokerage firm of Rodman & Renshaw. COR also has a European patent application and as well as U.S. patent protection on the use of any drugs that focus on AMPA receptor activity.

COR has 17 million shares outstanding and less than 2 percent of the shares are owned by institutions or mutual funds. And unlike Abgenix, Protein Design, QLT, Noven, Amylin, Cytogen, Forest Labs, Galen Holdings, etc., which have huge support from the major drug companies, COR has to go begging for funds.

While COR has no debt, it badly needs cash. COR doesn`t have a following on Wall Street, and I don`t know of any brokerage firm that has assigned an analyst to the stock, which one might argue, is an excellent reason to own it.

However, there are more than 60 companies looking for the Holy Grail to memory and cognitive recovery and some 40 of them are currently conducting human trials. COR`s Ampalex is the only drug I know (remember there are 60 plus companies diligently searching) that appears to work.

I think the stock is a rank speculation, but a reasonable rank speculation. The stock price in the past five years ranged between 25 cents and $8, and if you can afford to risk $3,000, I don`t have a single good reason to say "no." But don`t expect the stock to run up to $19, $11 or $7 a share any time soon.

I can`t tell you how to get Ampalex for your father. You might discuss this with your father`s physician, who may have some influence with Cortex Pharmaceuticals.


Please address your financial questions to Berko at P.O. Box 1416, Boca Raton, FL 33429 or e-mail him at [e-mail].
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http://www.suburbanchicagonews.com/business/e19berko.htm

[Erbse1]

<<Pfizer and Akzo Nobel`s Organon Enter Global Collaboration for Potential New Psychotropic Treatment
Monday October 20, 6:14 pm ET


NEW YORK, and ARNHEM, Netherlands, Oct. 20 /PRNewswire/ -- Pfizer Inc and Organon, the human pharmaceutical business unit of Akzo Nobel, today announced they have entered into a global agreement for the exclusive worldwide development and commercialization of Organon`s asenapine, a potential new psychotropic medication for the treatment of a variety of disorders that is beginning Phase III trials in schizophrenia and bipolar disorder.
Under terms of the agreement, which is subject to government approval, the companies will collaborate on the clinical development and manufacturing of asenapine, and co-promote the product in the United States, European Union, Japan and other markets. Pfizer will make an initial payment of $100 million and up to $270 million in milestone payments contingent upon regulatory approvals and launch of asenapine in the U.S., Europe and Japan as well as attainment of certain agreed-upon sales levels. Further terms of the agreement were not disclosed. >>

NeuroInvestment

Sehr interessante Meldung. Einige Leute auf dem Yahoo Board meinen, daß hier eine Entscheidung zu ungunsten von ORG 24448 gefallen ist.
Bei Asenapine handelt es sich um ORG 5222, einen Multi Dopamin Serotonin Antagonisten, den Organon schon vor den Ampakinen getestet hat.
Bei den herkömmlichen atypischen Psychosemedikamenten werden jeweils nur ein Dopamin und Serotonin Rezeptor besetzt. Bei ORG 5222, oder Asenapine sind es halt mehrere.
Interessant ist weiterhin der Partner Pfizer. Von Pfizers Medikament Geodon (Ziprasidon) ist halt die Verlängerung des QT Intervalls bekannt, neben all den anderen Nebenwirkungen der Psychosemedikamenten. Iloperidone von Titan hat genau aus diesen Gründen Schwierigkeiten mit der Zulassung.
Ich denke mal, daß Pfizer eine Alternative zu Geodon sucht, da mit Abilify ein mächtiger Konkurrent ins Haus steht, bei dem diese gravierende Nebenwirkung nicht auftreten.
Bei Organon sind zur Zeit die Gelder sehr knapp und man hat sich auf diesem Gebiet einen starken Partner mit ins Boot geholt.
Organon entwickelt schon seit Jahren ORG 5222 und ORG 24448 parallel. Ich denke mal, daß dies kein Grund zur Sorge ist.
Machts mal gut und liebe Grüße
Erbse1

[Erbse1]

Gute Nachrichten, auf den ersten Blick
Erbse1
Positive Effects of CX516 in Human Sleep Deprivation Study

http://biz.yahoo.com/bw/031021/215203_1.html

[Erbse1]

Hallo Cortex Fans.
Der Neuroinvestor korrigiert sein Aussage bezüglich des Zeitfensters bei Schizophrenie Testphase 3 mit Organon. Wie ursprünglich von Cortex selber gemeldet, werden sie wohl erst gegen Ende 2004 und nicht Ende 2003 die Phase 3 beginnen.
Interessant sind aber die Aussagen, daß ORG 24448 als Mono und Kombitherapie, also mit einem anderen Psychosemedikament zusammen getestet wird.
Von der Konferenz wird nicht so viel Neues berichtet. Interessenten können sich ja auf dem Yahoo Board schlau machen

Grüße
Erbse1

Auszug aus dem Neuroinvestor
<4) Mea culpa. When I met with Stoll, Lynch, and Coleman in April, I believed that I had heard reference to Organon beginning a sz Phase III by the end of this year. I was wrong. I asked Roger Stoll, and he said that he has consistently held (per Organon`s input), that they will start a Phase III at the end of 2004. They are doing both monotherapy and polytherapy trials.>
Hier noch ein Bericht von der Konferenz gestern
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

[Erbse1]

Hab was Neues gefunden
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Denken auf Rezept
Medikamente zur Behandlung von Alzheimer erfreuen sich wachsender Beliebtheit als leistungssteigernde Hirnpillen.

Von Ulrich Bahnsen

Manchmal fühlt sich Konrad Beyreuther als Versager. Das sind verlorene Tage, da bin ich meinen Job nicht wert“, gesteht der baden-württembergische Staatssekretär. Er klingt dabei immer noch ziemlich fröhlich. Denn jeder Mensch hat Phasen, in denen der Groschen pfennigweise fällt. Derlei Schwankungen der intellektuellen Tagesform, meint der Alzheimer-Experte und Neuroforscher vom European Molecular Biology Laboratory (EMBL) in Heidelberg, gehören schlie0plich zur Individualität jedes Menschen.

Beyreuthers Einsicht in naturgegebene Unzulänglichkeiten der höheren Hirnfunktionen ist nicht nur unbekümmerter Heiterkeit geschuldet, sonder auch dem Unvermögen seiner Fachkollegen, solchen Malaisen wirksam entgegenzuwirken. Bei intellektueller Minderausstattung – angeboten oder erworben-, bei Lerndefiziten u7nd Gedächtnisschwächen konnten Neurologen. Psychiater und Pädagogen bislang kaum auf pharmazeutischer Schützenhilfe hoffen.

Auch die im kognitiven Totalausfall mündenden Altersgebrechen wie Alzheimer und sonstige Demenzerkrankungen können Medikamente bislang bestenfalls verzögern. Vom Aufhalten oder Heilen solcher Hirnleiden ist keine Rede. Bis jetzt. Angesichts der rapide wachsenden Zahl demenzkranker Senioren haben die Pharmaunternehmen einen neuen Massenmarkt im Visier. Aug rund 13 Millionen dürfte das Heer der Alzheimer-Patienten allein in den Vereinigten Staaten bis 2050 anschwellen, ergaben aktuelle Hochrechnungen des US-Forschers Denis Evans.

Noch gelten die Forschungsprojekte dem Wohlergehen dieser und anderer Schwerkranken. Doch mit den neuartigen Hirnpillen rückt auch die Essenz des Menschlichen in Griffweite: neuro-enhancement, die pharmakologische Verstärkung und womöglich auch die biochemische Lenkung der Hirnfunktionen. Mit dem Griff zur Pille dürften demnächst Intelligenz und Gedächtnis, Lernfähigkeit und Gefühle auch bei Gesunden zur Disposition stehen. Cognition enhancer sind eine Zeitbombe. Das Thema wird die gleiche Bedeutung bekommen wie die verbrauchende Embryonenforschung“, prophezeit Hirnforscher Beyreuther.

Glaubt man den Prognosen der Biofirmen, so gehört die Zukunft nicht dem Gendaten-Business, sondern dem Geschäft mit revolutionären Hirnpillen….Allein in den Vereinigten Staaten arbeitet ein halbes Dutzend junger Neuro-Companys an neuartigen Gedächtnis- und Lernpillen. Dabei geht es keineswegs nur um schwere manifeste Erkrankungen. Auch die milde kognitive Störung, vulgo Altersvergesslichkeit, an der angeblich bis zu 60 Prozent der Hochbetagten leiden, wird zum Ziel der Pharmabranche. Die Betroffenen haben Schwierigkeiten, sich Telefonnummern zu merken, verlieren in unbekannten Stadtteilen die Orientierung und verlegen ständig Brille, Schlüssel und Gebetbuch. Oft mündet derlei Schusseligkeit später doch in die Alzheimer-Demenz, warnen Fachleute. Für Pharmaexperten ist dies Grund genug, das Übel umsatzträchtig schon an der Wurzel zu packen. Erste Produkte haben die Labors bereits verlasen und werden an Patienten der Wirksamkeitsprüfung unterzogen: Memory Pharmaceuticals, eine erst 1998 in Montvale bei New York gegründete Pharmafirma, will dem Gedächtnisverlust mit einem so genannten PDE-4-Hemmer entgegenwirken. Der neue Wirkstoff blockt den Abbau eines Signalmoleküls (cAMP) durch das Enzym Phosphodiesterase (PDE). Zusammen mit dem Pharmagiganten Roche plant Memory-manager Axel Unterbeck, noch in diesem Jahr Tests an Patienten zu starten.

Wissenschaftlicher Mentor des aufstrebenden Unternehmens ist der Nobelpreisträger Eric Kandel von der New Yorker Columbia University. Das Gedächtnis werde die erste kognitive Fähigkeit des Menschen sein, „ die wir auf molekularer Ebene vollständig verstehen“, prognostiziert der 73-jährige, einst vor den Nazis geflüchtete Wiener. In fünf Jahren werde die erste Gedächtnispille marktreif sein.

Dieses Ziel hat man auch bei der Konkurrenz fest im Blick. Im kalifornischen Irvine testen die Forscher der Neurofirma Cortex Pharmaceuticals so genannte Ampakine bereits an gedächtnisschwachen Senioren. Die Wirkstoffe sollten die Empfindlichkeit der Nervenszellen für den gedächtnisbildenden Signalstoff Glutamat erhöhen. Auch die Cortex-Manager haben hochrangigen Beistand: Ihr wissenschaftlicher Berater ist der schwedischer Nobelpreisträger Arvid Carlsson.

Der Vormarsch an der Forschungsfront ruft indessen nicht nur Begeisterung hervor. Gesundheitsexperten warnen, die neuartigen Brain-Booster könnten bald als Modedrogen missbraucht werden. Denn was die kognitiven Defizite ernsthaft Erkrankter lindern soll, könnte gesunde Menschen zu Höchstleistungen anstacheln.

Test an gedopten Nagern

Wie ambitioniert die Durchleuchtung des komplexen Zusammenspiels von molekularen Faktoren in den Nervenzellen des Gehirns bei der Gedächtnisbildung tatsächlich ist, erfuhr ein Forscherteam bei Lernversuchen mit Laborratten. Die Molekularbiologen maßten bei den Nagern Tausende Gene im Hippocampus, einem für die Gedächtnisbildung entscheidenden Hirnteil. Nachdem die Tiere gelernt hatten, durch ein Wasserlabyrinth zu schwimmen, hatte sich die Aktivität von immerhin 140 Genen im Hippocampus der Ratten schalartig verändert – praktisch alle gehörten zur Kommunikationsinfrastruktur der Neuronen. Besonders auffällig erschien die Betriebsamkeit im FGF-18-Gen (Fibrolast Growth Factor 18). Die Forscher injizierten einigen Tieren eine geringe Menge des Botenmoleküls – prompt bewältigten die gedopten Nager ihre Aufgabe in der Hälfte der Zeit.

Zwar ist keineswegs sicher, dass solche und andere Stoffe auch beim Menschen wirken. … Dennoch werden solche Befunde derzeit zuhauf erhoben. Sie bieten Pharmakologen mannigfaltige Ziele für präzisere Eingriffe in die Vorgänge im Gehirn. Die bisher verfügbaren Alzheimer-Medikamente zielen vor allem auf die Erhöhung des Botenstoffes Azetylcholin im Zentralnervensystem. Doch damit ist allenfalls eine moderate und befristete Verbesserung der Krankheitssymptome zu erreichen. Keines der Präparate wie Memantine., Donezepil. Galantamine oder Rivastigmine kann der Verlauf der Erkrankung aufhalten.

Ein Ende im Fiasko

Im Fiasko endete vorläufig gar der erste Versuch, das Alzheimer-Leiden wirklich zu stoppen. Ein im Tierversuch Erfolg versprechender Impfstoff hatte bei einer Reihe von Patienten so schwere Nebenwirkungen hervorgerufen, dass die Studie abgebrochen werden musste. Allerdings zeigen Zwischenanalysen bei bereits geimpften Patienten, dass die Vakzine womöglich bei einigen tatsächlich funktioniert hat. Fachleute hoffen seither auf künftige Erfolge mit verbesserten Impfstoffen.

(Quelle: „DIE ZEIT“, 21. August 2003)

http://www.alzheimer-forschung.de/weltalzheimertag/forschung…

[Erbse1]

Hab noch einen sehr interessanten Artikel gefunden. Ideal für Leute die sich in das Thema einarbeiten wollen. Einen kleinen wichtigen Ausschnitt kopier ich mal. Den gesamten Artikel gibts für Interessenten im Link nach dem Artikel

Liebe Grüße
Erbse1
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Ins Visier gerieten die vergesslichen Alten. Mit dem Alter lässt das Kurzzeitgedächtnis nach - ein völlig normaler Prozess. Am anderen Ende der Skala steht die Demenz, am häufigsten in Form der Alzheimer-Erkrankung, die den Betroffenen ein selbstständiges Leben unmöglich macht. Dazwischen wurde nun eine neue Patientengruppe definiert, Menschen mit so genannter leichter kognitiver Beeinträchtigung: Von MCI (Mild Cognitive Impairment) gilt ein Mensch dann als betroffen, wenn er im Vergleich zu seinen Altersgenossen überdurchschnittlich viel vergisst, aber noch nicht dement ist.
Das eröffnet ganz neue Marktchancen für Medikamente, die das Gedächtnis verbessern. Eine große Zahl so genannter "smart drugs" gibt es bereits. Sie werden in Online-Apotheken feilgeboten, und in San Francisco und New York in "smart bars" als Cocktails serviert. Doch bislang haben sie alle eines gemeinsam: Ein Nutzen ist wissenschaftlich nicht erwiesen. "Es gibt keine Wirkstoffe, die uns intelligenter machen", urteilt Experte Gary Wenk. Das könnte sich ändern, dank Wirkstoffen, die an den elementarsten Mechanismen des Lernens ansetzen. Die bahnbrechenden Erkenntnisse darüber wurden bereits in den siebziger Jahren von Eric Kandel gewonnen und im Jahr 2000 mit dem Nobelpreis gewürdigt. Erinnerungen entstehen durch einen fortlaufenden Paarungstanz der Nervenzellen, die durch wiederholte Anregung und Signalweiterleitung an den Kontaktstellen, den Synapsen, zunehmend festere Bindungen zu ihren Nachbarn eingehen. Kandel erforschte diese Mechanismen an einem vergleichsweise simplen Organismus, der Meeresschnecke Aplysia. Später zeigte sich, dass die molekularen Abläufe bei Fruchtfliegen, Mäusen und Menschen ähnlich verlaufen. Timothy Tully, Kandels jüngerer Rivale, schuf genetisch veränderte Fruchtfliegen, in denen ein molekularer Signalgeber, das CREB-Protein, dauerhaft aktiviert ist. Normale Fliegen benötigen zehn Versuche, um zu lernen, dass in einer Kammer mit einem bestimmten Geruch ein elektrischer Schock auf sie wartet. Tullys Superfliegen brauchten nur einen Versuch. Sowohl Tully als auch Kandel haben inzwischen eigene Unternehmen gegründet. Helicon Therapeutics und Memory Pharmaceuticals entwickeln Substanzen, die den Superfliegen- Effekt auch ohne genetische Veränderung erzeugen. Unter dem Einfluss der neuen Wirkstoffe beginnen alternde Mäuse, schneller durch ein Labyrinth zu laufen.
Auch die großen Pharmaunternehmen sind inzwischen auf diese viel versprechenden Substanzen aufmerksam geworden. Kandels Unternehmen Memory Pharmaceuticals, ging im September 2001 mit Bayer eine Lizenzvereinbarung ein, die die Weiterentwicklung der Substanz MEM 1003 erlaubt und Bayer im Falle eines Erfolgs die Vermarktungsrechte garantiert. Im Juli letzten Jahres folgte eine Allianz von Memory und Roche, um den Wirkstoff MEM 1414 zur Marktreife zu bringen. Die Erprobung dieses Wirkstoffs soll schon in diesem Jahr beginnen. Aber weder Bayer noch Roche wollen sich zu ihren Forschungsprojekten äußern. James McGaugh, Neurowissenschaftler an der Universität von Kalifornien in Irvine, ist sich allerdings sicher: "Die großen Pharmaunternehmen erforschen solche Substanzen nicht nur zur Behandlung von Demenzerkrankungen, sondern auch im Hinblick auf ganz normale Menschen - dort wartet der Profit. Die Behandlung von Demenzerkrankungen liefert ihnen die medizinische Rechtfertigung." Er ist davon überzeugt, dass die wichtigste Zielgruppe ganz gewöhnliche Menschen sind, "die sich einfach ein besseres Gedächtnis wünschen".
McGaugh, der selbst seit mehr als 40 Jahren auf dem Gebiet arbeitet, hält es allerdings für unwahrscheinlich, dass die Leistungsfähigkeit des menschlichen Gehirns durch Medikamente grundlegend gesteigert werden kann. "Das menschliche Gehirn arbeitet bereits sehr nahe am Optimum, dafür hat die Natur gesorgt." Um dem Nachlassen der Gehirnleistung entgegenzusteuern, propagiert der 75-jährige Wissenschaftler eine rezeptfreie Therapie: "Halten Sie ihr Gehirn auf Trab, hören Sie nicht auf, neue Dinge zu lernen", rät er alten Menschen. "Lernen Sie eine neue Sprache, lernen Sie, mit einem Computer umzugehen, lösen Sie Rätsel, treffen Sie sich mit Freunden und führen sie viele Diskussionen - das hält das Gehirn aktiv." Ungeachtet solcher Ratschläge läuft die Forschung weiter auf Hochtouren.
"Das Argument, geistige Prozesse wären unter dem Druck der Evolution optimiert worden, hat mich nie überzeugt", sagt Gary Lynch, ebenfalls Neurowissenschaftler an der Universität von Kalifornien in Irvine. "Früher oder später wird es Medikamente geben, die zumindest Teile unseres Denkens verbessern." Im Rennen um die erste Gedächtnispille könnte Cortex, das von Lynch gegründete Unternehmen, ganz vorne liegen. Lynch hat Moleküle entworfen, die ebenso wie die Substanzen von Kandel und Tully an den elementarsten molekularen Mechanismen ansetzen. Im Gegensatz zu den meisten Neuropharmaka wirken die von Cortex entwickelten Ampakine vergleichsweise subtil. Sie binden an den AMPA-Rezeptor, einen Ionenkanal in den äußeren Membranen von Hirnzellen. Als Antwort auf einen Reiz öffnet er sich für wenige Millisekunden, sodass Kalzium-Ionen in die Nervenzelle einströmen und die weiteren Prozesse in Gang setzen können. Ampakine "modulieren" die Funktion des Ionenkanals, er bleibt dann etwas länger als gewöhnlich geöffnet. So strömen mehr Calcium-Ionen in die Nervenzelle, das Signal zur Gedächtnisbildung wird stärker. Die Wirkung eines Ampakines mit dem Namen CX516 wird bereits an Menschen untersucht - klinische Studien der Phase II an Alzheimer-Patienten laufen zurzeit. Im Auftrag von Cortex schluckte bereits eine kleine Gruppe von gesunden 65- bis 75-Jährigen CX516 an einem Berliner Forschungsinstitut. Zweck der Studie war eigentlich nur, Informationen über mögliche Nebenwirkungen des künftigen Präparats zu erhalten, doch am Rande wurde auch ein kleiner Test durchgeführt. Den Probanden wurden zehn bedeutungslose Wortsilben vorgelesen, fünf Minuten später sollten sie möglichst viele dieser Silben nennen. Junge Menschen erinnern sich bei einem solchen Test im Durchschnitt an etwas mehr als vier Silben. Die älteren Berliner Probanden erinnerten sich ohne CX516 im Durchschnitt an kaum mehr als eine Silbe; doch unter Einfluss von CX516 erhöhte sich diese Zahl auf drei.
Auch wenn noch offen ist, welche der neuen Substanzen letztlich Erfolg haben und welchen Nutzen wir daraus ziehen, so ist der Trend nicht zu übersehen. Viele kerngesunde Menschen schlucken bereits psychoaktive Medikamente, und mit der Entwicklung von immer gezielter wirkenden Substanzen mit immer weniger Nebenwirkungen wird diese Tendenz weiter steigen. Während in Deutschland das Thema noch weit gehend unbekannt ist, entbrennt in den USA bereits eine breite Debatte unter Wissenschaftlern, Bioethikern und Philosophen.
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http://www.heise.de/tr/artikel/print/40436

[Erbse1]

News von Cortex. Die Ergebnisse zum Schlafentzug sollen auf einer Konferenz diskutiert werden.
Erbse1

Press Release Source: Cortex Pharmaceuticals, Inc.


Cortex to Host Conference Call to Discuss Sleep Deprivation Study Results and Upcoming Stockholders Meeting
Thursday October 23, 8:30 am ET
Call Scheduled for Tuesday, October 28, 2003


http://biz.yahoo.com/bw/031023/235045_1.html

[Erbse1]

Folgend ein link mit Anmerkungen zu den Fragil X Versuchen und Problematik. Dient nur zu eigener Recherche.
Liebe Grüße
Erbse
http://www.fragilex.org/14_PsychopharmMed.pdf

[Erbse1]

Ampakine – eine neue Substanzklasse in der Therapie schizophrener Erkrankungen?
Eine Störung im dopaminergen System wird am häufigsten für die Entstehtung der Schizophrenie verantwortlich gemacht (Carlosson, 1988). Im Unterschied zu vielen anderen Neurotransmitternsystemen liegt die Funktion des Dopamins nicht in der Übertragung von sensorischen oder motorischen Signalen, vielmehr moduliert dieser Botenstoff die Eigenschaften der entsprechenden Nervenzellen in der Art, dass erregende wie hemmende Neurone in ihrer Aktivität verstärkt werden. Eines der Hauptargumente für die Störung des Dopamin-Systems liegt in den klinischen Befunden zur Pharmakologie der in der Schizophrenie-Behandlung eingesetzten Neuroleptika; diese haben eine sehr hohe Bindungsaffinität an Dopamin-Rezeptoren. Die vielfach diskutierte Glutamat-Hypothese der Schizophrenie kann am besten als Ergänzung zur Dopamin-Hypothese verstanden werden, da auch sie ein Ungleichgewicht zwischen dem dopaminergen und dem glutamatergen System im Zentralnervensystem betont. Glutamat ist der wichtigste erregende Neurotransmitter im Gehirn der Säugetiere. Er wird hauptsächlich im Cortex und im Hippocampus genutzt. Als erregender Neurotransmitter ist Glutamat die Voraussetzung für die immense Informationsverarbeitung im Cortex und spielt somit eine entscheidende Rolle bei allen kognitiven Funktionen im Organismus. Die Ampakine repräsentieren eine Substanzklasse, mit denen am Menschen erstmals das glutamaterge System verstärkt wird. So haben u. a. pharmazeutische Unternehmen in den U.S.A. (z. B. Irvine, CA, USA) am Menschen in einer klinischen
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Page 2
APIS lifescience - www.apis-lifescience.de - [e-mail] 2Studie versucht zu zeigen, dass das Amapkin CX516 zur Stimulation von Lernen, Gedächtnis und Aufmerksamkeit bei schizophrenen Patienten geeignet ist. In der Partnerschaft mit Organon (Oss, Niederlande) sollen nun weitere Studien zur Wirksamkeit von Amapakinen durchgeführt werden. Die bei schizophrenen Erkrankungen bei einigen Patienten zu beobachtende Abnahme der kognitiven Leistungsfähigkeit könnte mit Ampakinen verbessert werden. So zeigen Experimente zu Gedächtnisleistungen bei älteren Menschen, dass diese sich durch die Gabe des Ampakins CX516 verbessern lassen. Bei Alzheimer-Patienten soll dieses ebenfalls klinisch untersucht werden. Zum Mechanismus der Gedächtnisverbesserung (Modulation) lässt sich folgende Vermutung anstellen: etwa 45% aller glutamatergen Rezeptoren reagieren auf AMPA als Agonisten. Diese Rezeptoren werden im Zusammenhang mit Lernen und Gedächtnis und höheren kognitiven Leistungen in Zusammenhang gebracht. Ferner können AMPA-Rezeptoren eine weitere wichtige Rezptorklasse positiv beeinflussen, den NMDA-Rezeptor, der häufig im Zusammenhang mit Bewusstsein diskutiert wird (Flohr, 1995).
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Page 3
APIS lifescience - www.apis-lifescience.de - [e-mail] 3Literaturnachweis: Carlsson, A. (1998): The current status of the dopamine hypothesis of schizophrenia. Neuropsychopharmacology, 1, 179-186 Flohr, H. (1995): Sensation and brain processes. Behav. Brain. Res. 71, 157-161., H.:

[Erbse1]

Noch was zu eigener Recherche
Erbse1
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Schizophrenia and Glutamate: An Update

Blynn Garland Bunney, Ph.D., William E. Bunney, Jr., M.D. and Arvid Carlsson


INTRODUCTION


There is a growing body of evidence suggesting that alterations in neurotransmitter systems, possibly reflecting defects in early neurodevelopmental processes, may play an important role in the etiology of schizophrenia (36, 78). A current focus of research is on two major brain neurotransmitters, dopamine (DA) and glutamate, both of which may be altered in schizophrenia. Briefly, the dopamine hypothesis attributes hyperdopaminergic function as a possible cause of schizophrenia, whereas the glutamate hypothesis proposes a hypofunctional glutamate system. There is substantial evidence for both hypotheses, but some of the most impressive data are from observations that certain classes of drugs can produce schizophrenic-like symptoms in normals. Of all the compounds administered to man, the two classes of drugs that produce the symptoms most similar to those of schizophrenia are the dopamine agonists (e.g., amphetamine) and glutamate antagonists (e.g., PCP). In general, the glutamate antagonists produce somewhat more positive and negative symptoms than the DA agonists, which—when given acutely—fail to produce some of the core symptoms of schizophrenia, such as formal thought disorder and negative symptoms (33). Consequently, a great deal of research emphasis is being placed on the role of glutamate in schizophrenia. Nonetheless, to date, the current antipsychotics do not have significant glutamatergic activity, although promising research at the NMDA receptor site (e.g., the glycine transport inhibitors [5, 39]) may provide new clues for the development of future antipsychotics.

Formulation of the Glutamate Hypothesis

The origins of the glutamate hypothesis of schizophrenia probably can be traced to the observations that the dissociative anesthetic, phencyclidine (PCP, Sernyl) produced psychotomimetic symptoms in a subgroup of surgical patients (40). Anecdotal data compiled by Johnstone et al. (40) revealed that: (a) 7.5% (4/30) of the PCP-treated patients experienced drug-related hallucinations; (b) psychotomimetic effects occurred within 30 minutes of PCP administration (10 mg, intramuscular); and (c) young males were particularly vulnerable to the hallucinatory effects of PCP, especially at higher doses (greater than 20 mg i.v.) [40]. These PCP-related effects appeared to resemble symptoms of schizophrenia and attracted the attention of Luby et al. (54, 67) and others (19), who conducted clinical studies in research settings to determine the relationship between the PCP drug effects and the illness.

http://www.acnp.org/g4/GN401000116/CH114.html

Den ganzen Artikel gibt es unter diesem link

[Erbse1]

Pivotal Brain Processor Decreased In Schizophrenia
Lower Levels Could Explain Disruption in Mental Function; Study Points Toward Better Treatments



New York, NY (August 14, 2002) -- Levels of a pivotal signal processor in the brain are reduced significantly in people with schizophrenia, a study by scientists at The Rockefeller University, Weill Cornell Medical College and University of California at Irvine has found.

The findings suggest that the processor, which helps regulate key neurotransmitters in an area of the brain linked to schizophrenia, could eventually play a key role in reversing the brain dysfunctions associated with the disease. The study appears in the August issue of Archives of General Psychiatry.

Dr. William Bunney, the Della Martin professor of psychiatry at UCI; Dr. Paul Greengard, professor of neuroscience at Rockefeller University; and Dr. Hugh Hemmings, professor of anesthesiology at Weill Cornell, and their colleagues found the processor, a chemical called DARPP-32, was reduced in the brains of deceased victims of schizophrenia.

DARPP-32 is the subject of increasing scientific scrutiny. The neurotransmitters dopamine, glutamate, and serotonin; the antidepressant Prozac; and even drugs of abuse like cocaine, opiates, and nicotine all have been found to work on the brain through the actions of DARPP-32. The molecule is suspected of integrating information throughout the brain and providing a blueprint for physiological activity. Dr. Greengard won the Nobel Prize for Medicine in 2000 for his work on DARPP-32.

"DARPP-32 is a key regulatory protein, involved in controlling receptors, ion channels, and other physiological factors, and is activated and de-activated ultimately by neurotransmitters that are implicated in the development of schizophrenia," Dr. Greengard said. "A reduction of DARPP-32 required for functions in the brain could contribute to the cognitive dysfunction seen in the disease."

The researchers studied the brains of 14 deceased people who had schizophrenia before they died. DARPP-32 was found to be reduced significantly in an area of the brain called the dorsolateral prefrontal cortex, which has consistently been associated with the symptoms of schizophrenia. The researchers found low levels of DARPP-32 in people who had had schizophrenia, but normal levels in people who did not have the disease. DARPP-32 was not found to be reduced in another area of the brain also associated with schizophrenia.

"This is the first study to show reduced levels of this important regulatory molecule in schizophrenia," said Dr. Bunney. "If DARPP-32 plays such a key role in controlling physiological activity in this part of the brain, perhaps there could be methods we could use to eventually maintain normal levels of the molecule."

The DARPP-32 molecule is known to control the actions of two neurotransmitters linked to schizophrenia -- dopamine and glutamate. Schizophrenia affects about two million people in the United States; its cause is unknown. The dysfunctions in schizophrenia often result in severe social problems, delusions, hallucinations, reduced emotional responses, and grossly disorganized behavior, according to the National Association for Research on Schizophrenia and Depression.

"This study showed us the DARPP-32 is reduced in an area of the brain most often linked to schizophrenia," Dr. Hemmings said. "But it does not tell us that DARPP-32 causes this disease. We need to study whether it is a cause or another adaptation of the existing disease, and gain a more detailed understanding of its regulatory effects in the brains of schizophrenic patients and of people without the disease."

The researchers` work was supported by a number of gifts and grants, including those from the National Association for Research on Schizophrenia and Depression and the National Institutes of Health.

The researchers` colleagues in the study included Katherine Albert and Anna Adamo of Cornell, and Steven Potkin, Schahram Akbarian, Curt Sandman, and Carl Cotman of UCI.

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http://www.rockefeller.edu/pubinfo/081402.php

[Erbse1]

Untersuchungen und Ergebnisse zu Psychosemedikamenten
http://www.google.de/search?q=cache:Tb7xynOXxEkJ:neuro.web.p…
Hallo liebe Cortex Fans. Ich kopiere mir nur wichtige Artikel in diesen Thread. Sie haben alle einen direkten oder indirekten Bezug zu Cortex. Wer Lust hat kann ja mitlesen, ansonsten einfach ignorieren.
Liebe Grüße
Erbse1

[Erbse1]

Cortex rückt immer öfters ins Interesse von Zeitungen und anderen Medien.
Hier ein Artikel von Heute aus der Los Angeles Times

Alzheimer`s may respond to new drug


http://www.latimes.com/features/health/la-he-lab27oct2722142…

[cyberx]

alles shön und gut was Du hier schreibst....nun wo sind die Investoren warum will sich keine grosse Pharma Firma an Cortex oder Cortex produkten...nicht beteiligen wenn diese produkt/e so geil ist...?Warum betailigt sich Pfizer an Oregon produkten und nicht an Cortex...?hmm so dumm sind die da nicht!und vor allem wenn es um ein potezienelle Blockbuster gehts!das die so eine chance verpassen werden glaube ich nicht...

sorry für mein deutsch ist nicht meine Mutter sprache Gott sei dank

gruss cyberX

[Erbse1]

Überblick von der Konferenz heute. Einige verkaufen, da weitere Kapitalerhöhung geplant und alles so lange dauert.http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

[cyberx]

Cortex gibs bald wieder für 1,70$ -2,30$ dann kann mann versuchen aber nicht vergessen Cortex bleibt ein Penny stock = Highrisik....

mfg CyberX

[Erbse1]

Hallo cyberx,Cortex ist bestimmt eine Aktie mit hohem Risiko. Das hat hier gar keiner bestritten. Aber jetzt auf die Idee zu kommen, daß Cortex keine Chancen hat, dazu ist es einfach zu früh. In ca. 4 Jahren sind wir beide schlauer.
Noch was für Leute, die sich mit Schizophrenie beschäftigen
Erbse1
Three new genes for schizophrenia found (10/29/03
German researchers say they have found three new genes that may be associated with schizophrenia. The genes codes for three proteins called dysbindin, neuregulin and G72.
Source: ABC NEWS ONLINE, Thursday, October 23, 2003
http://www.abc.net.au/news/newsitems/s973351.htm

[puhvogel]

@cyberx: Du tust ja geradezu, als hätte Pfizer noch nie eine Fehlinvestion getätigt und kein Biotechunternehmen ohne Beteiligung von Pfizer ein erfolgreiches Produkt entwickelt hätte. Solche Firmen wie Eli Lilly und Co. beteiligen sich meist erst an einem Medikament, wenn erfolgreiche Phase 3 Studien vorliegen.

Pfizers dreistelligen Millioneninvestitionen in Inhale waren zB nicht gerade gut angelegtes Geld.
Biotech ist halt Venture Kapital.

[Erbse1]

Meldung von gestern. Leider kenne ich diesen Herrn Drake nicht.
Liebe Grüße
Erbse1
Cortex Appoints Peter F. Drake, Ph.D. to Board of Directors

IRVINE, Calif., Oct 31, 2003 (BUSINESS WIRE) -- Cortex Pharmaceuticals, Inc. (AMEX: COR), a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders, has appointed Peter F. Drake, Ph.D. to its Board of Directors. The appointment increases the number of directors on the company`s board from five to six. Dr. Drake brings several years of experience and expertise in neuroscience and the financial healthcare arena.

http://news.nasdaq.com/news/newsStory.aspx?&pageName=Company…

[Erbse1]

Kurz von der Cortex Homepage


IN THE LAB
Alzheimer`s may respond to new drug

By Linda Marsa, Special to The Times

People with Alzheimer`s disease received some encouraging news this month when the U.S. government approved the first drug for those in the late stages of the disease.

That medication, Namenda, or memantine, may be just the beginning. A new type of drug called ampakines promises not just to treat Alzheimer`s but also to prevent memory loss in healthy people and combat other neurological ills that afflict millions.

http://www.cortexpharm.com/html/news/03/10-27-03.html

Heute steht meines Wissens wieder eine Fernsehsendung an.
Liebe Grüße
Erbse1

[Erbse1]

Hallo liebe Cortex Fans. Der Quartalsbericht von Cortex ist raus.Die wichtigsten Punkte.

Organon testet die Ampakine bei Depression, wobei mir noch nicht klar ist, welche Substanz sie da nehmen und leisten Milestones von 2 Millionen $ an Cortex.

<In order to retain its rights to the AMPAKINE technology in the field of depression, the agreement with Organon requires a $2,000,000 milestone payment to Cortex on or before January 13, 2004. Organon has notified the Company in writing of its intent to pay this milestone, which Cortex will record as revenue upon achievement.>

Für die Ergebnisse von Servier bei MCI wird jetzt ein Zeitfenster letztes Quartal 2003 bis erstes Quartal 2004 angegeben.

<Together with its corporate partner, Servier, the Company conducted a cross-national clinical study with the AMPAKINE CX516 in patients with MCI. Preliminary results are expected in either late calendar year 2003 or early calendar year 2004. Servier has agreed to incur the bulk of the related costs for the study. Remaining Cortex commitments for Phase I/IIa clinical studies on the AMPAKINE compounds are not significant>

Den gesammten Bericht gibts unter folgendem link

http://biz.yahoo.com/e/031110/cor10-q.html

Machts mal gut und liebe Grüße
Erbse1

[Erbse1]

Meldung von heute mit den wichtigsten Sätzen.
Erbse1

Cortex Reports First Quarter Fiscal 2004 Results

During the quarter ended September 30, 2003, Cortex completed a private placement of its common stock for gross proceeds of $5,000,000. With this financing in place, Cortex immediately initiated further development of its second-generation AMPAKINE compound, CX717.

"The initiation of toxicology studies for CX717 during the quarter was a very important milestone for us as we begin to take the necessary steps to advance our second-generation, more potent compounds into humans," said Roger Stoll, President and CEO of Cortex.

Dr. Stoll continued, "We are pursuing an aggressive, two-prong strategy to develop our AMPAKINE technology. We will internally develop our second-generation compounds to treat orphan diseases such as narcolepsy and fragile X syndrome. Orphan disease filings typically involve reduced clinical development requirements as compared to standard regulatory filings, which allows for a faster and more economical development pathway. Concurrently, we will expand development of AMPAKINE compounds with existing and potentially new external collaborators to target larger indications."

Folgend der gesamte Bericht

http://biz.yahoo.com/bw/031111/115356_1.html

[Erbse1]

Hab einen Artikel über Cortex in Deutsch gefunden. Es geht hauptsächlich über den kürzlich vergebenen Wachstumspreis.

<Biotech-Kolumne: Cortex - 4.848 Prozent Wachstum in fünf Jahren
Cortex Pharmaceuticals steht mit einem Wachstum von gigantischen 4.848 Prozent in den letzten fünf Jahren ganz oben auf der Liste der am schnellsten wachsenden Technologie-Unternehmen im Kalifornischen Orange County. >

Cortal Consors sagt mir allerdings noch nichts. Werde mal etwas nachhaken.
Liebe Grüße
Erbse1


http://www.cortalconsors.de/research/magazin/_newsData/ek200…

[puhvogel]

Hi!
Cortal Consors ist die ehemalige Consors Onlinebank, die vom französischen Riesen BNP aufgekauft wurde.
Die Meldung an sich hat leider keinerlei Bedeutung, da Biotechs sich da immer oben in solchen Ranglisten befinden.

[Erbse1]

Folgend ein Artikel, der zu eigener Recherche dient.
Erbse1
Bei der nächsten Substanz handelt es sich um Ampakine, die noch nicht näher bezeichnet sind. Diese Versuche sind wohl als Ergänzung zu CX 516 bei Fragile X gedacht.

Effects of Positive AMPA Receptor Modulation in the Fragile X Knockout Mouse
Julie Lauterborn, PhD
University of CA at Irvine, $40,000

This study complements
Dr. Berry-Kravis’s clinical trial of the Ampakine drug CX516.
Dr. Lauterborn aims to understand the actions of newer Ampakine compounds which are not yet tested for human use but which are more potent than CX516.

http://www.fraxa.org/html/research_Lauterborn.htm

[Erbse1]

Hallo liebe Cortex Fans. Hier ein Brief von dem CEO Stoll an alle Aktionäre. Ich kopiere ihn mal ohne Kommentar. Ich denke mal, der Brief spricht für sich.
Liebe Grüße
Erbse1
-----------------------------------------------------------
2003 Shareholder Letter

To Our Shareholders and Friends,


Over the past year, our senior management team and I have been working diligently to set a new course for Cortex Pharmaceuticals. If any of you saw the recent ABC World News Tonight with Peter Jennings or read the Business Week article titled "I Can’t Remember", you may have shared my excitement in seeing our small, but innovative company singled out for its breakthroughs in a broad range of neurological and psychiatric diseases.

At this time last year, after I assumed the offices and responsibilities of the President and CEO, I worked with the management of Cortex to define three objectives that would help steer our company toward success. First, we needed to solve the financial problems that we faced; second, we had to develop a financially viable business plan and sell it to the financial community; and third it was critical that we improve our focus on public and investor relation activities.

Major Accomplishments

During the past twelve months since the last shareholder meeting, Cortex achieved a number of significant objectives:

Raised $9 million dollars to improve a weak financial position
Developed a viable business plan that the financial community supports

Improved investor relations substantially and increased the visibility of the company to a broader financial community

Improved the share price four to five fold and the daily trading volume of the common stock by a factor of 10

Increased the market capitalization for Cortex from $12 million to $70 million

I would like to elaborate on these successful activities and invite you to read this letter that traces our progress over the past twelve months. I also hope that I can convey the excitement we have about our next steps for Cortex and our plans to make the goal of becoming a leading neuroscience pharmaceutical company a reality.

Our Business Strategy

We are now ready to initiate the second phase of our strategy to make Cortex a major player within the CNS pharmaceutical market segment. This new phase should span the next three to four years and includes a two-pronged approach to developing value for Cortex and our shareholders — internal business development and external licensing.

Over the past year, we controlled our expenditures, spending under six million dollars overall. Our entire senior management team took a 20% pay cut for over one-half of the year, and I relinquished my full salary for several months until we were able to obtain additional financial support through the private placement we completed in August. This says something about how tight our finances were, and about our personnel and their belief in our AMPAKINE® technology. The $5 million private placement included some high quality healthcare institutional investors. The funds raised will allow us to develop some of the very outstanding compounds that we have in preclinical development, but previously had been unable to push into clinical trials.

The first drug candidate that is undergoing toxicological evaluations is CX717. We plan to file an IND for evaluating this compound clinically during the second quarter of calendar 2004. While it costs millions of dollars to move a compound through clinical trials and eventual submission to the FDA, we only have sufficient funds to start this process at this time.

Our business plan envisions developing some of our products for Orphan drug indications, which indications are defined as having less than 200,000 patients in the United States. Several factors caused us to focus on pursuing these indications. First, the cost of developing a compound for an Orphan drug indication is somewhat less than a standard indication because the Phase III clinical development requirements are reduced, saving us both time and money. Second, we can have a small, focused sales effort if such a product is approved, which again would require less funds than building a large marketing and sales group within Cortex. Finally, while the markets for fragile X, autism, and narcolepsy are not billions of dollars in size, they do nonetheless provide a substantial target for a small startup like Cortex, and are in the neighborhood of $250-$350 million of potential annual revenue for each indication. The faster speed to market also conserves patent life, providing us with a longer payback period. One only has to look at how successful Genzyme (GENZ) has been to see the type of business and market value that can be obtained by following an Orphan drug regulatory approach. That company has built a $1.5 billion business with a market cap of $10 billion by pursuing Orphan drug indications.

But even these more modest development plans would require Cortex to obtain approximately $30 million to $40 million over the next three to four years. We have to find a way to obtain such funding in order to secure the value of our patents — and to provide Cortex with a path toward financial success and increased value to our shareholders. In summary, Cortex plans to develop selective AMPAKINE compounds for narcolepsy, fragile X, and a series of day time sleepiness indications that are caused by numerous etiologies. We plan to out-license the remaining larger indications to other pharmaceutical companies because the financial requirements to develop and market such products are well beyond the means of a small biotech startup.

Sound Capital Structure

A significant point that we need to emphasize with each and every shareholder of Cortex is that without the capability to fund the clinical development of our compounds, there is no way to create more value for you. Simply looking at share dilution will destroy this company. The existing license agreements do not support any development programs for Cortex. The agreements have some milestones that may or may not be met by the licensees. Obviously, there is also the potential of a royalty stream, but that is unlikely for at least 5 years — when some products may reach the market. We are a very long way from obtaining sufficient funds from our existing licensees to adequately support a development program. Waiting for them to succeed before we move forward will cause us to lose years of patent life and value.

An early stage pharmaceutical company needs to generate positive clinical trial results in order to drive its market value in a positive direction. While good publicity is critical, it must be based on factual data to create value over the long haul. Cortex needs adequate funds in order to pursue such results and we have had a long history of being under-funded. That is why we are asking you to support the proposed increase in authorized shares.

Before I joined Cortex, I was impressed with some of the early proof of principle studies with CX516 that indicated the AMPAKINE compounds can work in humans. After I evaluated the data, it became clear that the doses required, the frequency of dosing, and possibly the cost of goods associated with CX516 relegate it to a compound that can be a proof of principle, but not a viable therapeutic agent. It is a major accomplishment for a company to prove that its technology works in humans, and that has thankfully been accomplished. However, virtually every large pharmaceutical company we have spoken with during the past six months only looks at CX516 for its activity in human clinical trials, none has any interest in the molecule. While we continue to evaluate the potential of CX516 in some selective i.v. uses in the critical care setting, even such uses would require new clinical trials. Obviously, this was a difficult issue to communicate to the market and our loyal shareholders, but it is critical that we move forward and get this issue behind us. We need to hook the fortunes of our company and our technology to compounds that can lead us toward success. Having the knowledge that the technology works in humans is a strong base from which to drive the business forward.

We are an event driven business. With the additional common shares, we have the flexibility to pursue additional financing to develop compounds such as CX717 and to pursue clinical results that potentially may enhance shareholder value. Without such support, we may not be able to adequately develop what I believe is extremely promising technology. All shareholders would suffer from inaction at this point.

Our past technology out-licenses were secured under the duress of inadequate funding, which forced us to accept deals without sufficient funds to develop our compounds. The licenses were critical for the survival of the company, but we have paid a price in time lost getting to the market and in trading away license rights with huge potential for relatively little gain to Cortex. While someday we may get a nice revenue stream from the royalty associated with these agreements, as your CEO I do not want Cortex to ever be in the same position as when I joined this company in 2003. I ask for your support of the increase in share authorization because it is the vehicle that will allow us to optimize our opportunities to create value. Sufficient capitalization will help us obtain the right value for our intellectual property and multiply our chances for success by (a) taking control of our destiny by developing selected compounds for Orphan drug indications as an internal program, and (b) moving other compounds from preclinical development into early clinical trials and thereby creating far superior value for potential license agreements with large pharmaceutical companies These approaches would allow us to negotiate from a position of strength with potential licensees and optimize the value of the technology for Cortex and our shareholders.

Clinical Development Update

The following discussions focus primarily on CX516, because that is the only compound currently in the clinic for Cortex. We now have AMPAKINE compounds in Phase II studies in five important indications that may provide excellent proof of principle data, and most importantly one new compound being developed for clinical testing in early 2004. Our licensees have two other compounds in development, Org 24448, which Organon is advancing in trials for schizophrenia, and S18986, which Servier is developing for mild cognitive impairment and Alzheimer’s disease. But we can only report on those studies under our control and must wait for our licensees to report their findings in the studies that they have underway.

Enhanced Performance After Sleep Deprivation
Sleep deprivation causes both mental and physical exhaustion. Day time sleepiness is a problem for people with narcolepsy, sleep apnea, shift work and jet lag. In October, we reported on a sleep deprivation study with CX516. Preliminary findings in that study suggest that CX516, compared to placebo, improves performance in a dose-related response. The study involved 10 young healthy men deprived of sleep for 31 hours before they received the drug or placebo dose. Similar studies have already been completed in primates with promising results. Further work is ongoing and we anticipate that complete results will be reported by Dr. Mark George at the American College of Neuropharmacology (ACNP) meeting in December 2003. We expect that considerably more work in this area will be carried out with CX717 next year when we get it into clinical trials.

Mild Cognitive Impairment (MCI)
A total of 175 patients completed enrollment into the MCI trial by the end of June 2003. Results from the data currently under analysis should be available sometime by year end 2003 or early 2004. Under terms of the agreement with Servier, they are paying virtually all the costs associated with this cross-national trial. Cortex will face a difficult decision with CX516, the compound used in this study, no matter what the results of this trial show. Current issues with the low potency and short half-life of this drug dictate that it would not be a viable compound to move forward into Phase III clinical trials. While we hope to show proof of principle of an effect on MCI, the dosage regimen may dictate that the cost of goods required for therapy also may be beyond what any average patient could afford.

Schizophrenia
In October 2001, Cortex received notice of a three-year award, as extended, of up to $770,000 from the National Institutes of Health (NIMH). This award will support a phase II study using CX516 versus placebo in combination with the antipsychotic drugs clozapine and olanzapine in patients with schizophrenia. Dr. Donald Goff at Harvard University is the principal investigator on this study, which was a follow on to the positive pilot study that he completed in 2001. In September 200l, Organon announced that it would continue to develop AMPAKINE Org 24448 by entering a Phase II trial for the treatment of schizophrenia. Both studies are currently underway and we hope to have some results late in calendar year 2004 or early 2005. Organon is evaluating the compound both as a mono therapy and as a combination therapy with other antipsychotic agents.

Fragile X and Autism
A study is underway evaluating the effect of CX516 versus placebo on a group of patients with fragile X syndrome and a few patients with similar symptoms whom are autistic. The study is supported by FRAXA Research Foundation and the Mind Institute at UC Davis. The two centers involved are Rush Presbyterian St. Luke’s in Chicago and the University of California at Davis. The target is to enroll at least 100 patients and we anticipate that enrollment should be completed by the end of 2004. We will learn a great deal about how to evaluate a compound in fragile X patients from this study and that may serve as a springboard for some newer analogs in our library of compounds.

Alzheimer’s Disease
A study is underway to enroll up to 35 patients in a trial being conducted by Dr. Thomas Chase at the National Institutes of Mental Health ("NIMH") and supported by NIMH funds to evaluate CX516 in Alzheimer’s disease after treatment for 3 months. This study expands on the preliminary positive results obtained by Dr. Chase in a pilot study conducted in patients over a 28 day testing period.

Preclinical Development — CX717

With our new funds we have been able to scale up CX717 and produce over 12 kilos of drug during the past few months. In CX717, we have a unique AMPAKINE compound that has approximately 50 times the potency in animal models as compared to CX516. Additionally, we think that the half-life of CX717 in humans should prove to be at least 6 to 7 times that of CX516. What this all adds up to is a compound that should be much more effective with once or twice a day dosing, at doses 50 times less than any one of the daily doses required by CX516. CX717 may provide a path toward developing a very profitable drug product.

The chart below compares the potency, toxicity, and metabolic stability of CX717 to CX516:



CX717 is only one of the compounds that builds on the information that we have gathered with CX516 in Alzheimer’s and other diseases. We are currently aware of four AMPAKINE compounds in clinical development by Cortex, its licensees, and one major competitor, as shown below:

Current Clinical Status:


Cortex – CX516
- Ongoing Phase II – U.S. and Europe

Organon – ORG24448
- Ongoing Phase II – U.S.

Servier – S18986
- Entering Phase II – France

Lilly – LY451395
- Ongoing Phase II – U.S.

We believe that we can accelerate the development of some of the newer AMPAKINE agents through a regulatory pathway for uses in Orphan drug disorders, where new therapies are badly needed. The ongoing discussions with some potential out-licensees always involve our second generation compounds and indicate a keen interest in the AMPAKINE technology. The issues that prevent us from closing such a deal revolve around the fact that most of our drugs are in preclinical development, and lack the kind of clinical information required in order to secure a reasonable value for Cortex. This again reinforces the concept that we need to add more capital to bring some of these compounds through toxicology and into early clinical trials in order to bring some significant value to our shareholders.

Our Patent Portfolio

Our patent portfolio includes over 32 patents covering various structural approaches for literally hundreds of compounds for agents that behave as AMPAKINE compounds
(composition of matter patents), and 11 patents that protect the mechanism of action by which AMPAKINE compounds elicit a response at the AMPA receptor (method of use patents). During 2003, Cortex received a notice of allowance from the European Patent Office ("EPO") for use of AMPA receptor potentiators to treat defects in memory, cognition, and libido. A similar patent previously issued in the U.S., Mexico, Australia and New Zealand. Cortex successfully fought a significant battle to persuade the EPO that this patent should be allowed, while its allowance was being challenged by a very large competitor. This patent should issue in Europe during the middle of November 2003.

Summary

In conclusion, during the past year we developed a new business plan that is making sense to an informed investment community. We finalized an agreement with Servier for an additional $4 million of funding and completed a $5 million private placement of our common stock. We hired a new team of professionals, The Investor Relations Group, based in New York to reintroduce our company and its business plan to pre-qualified analysts and fund managers, as well as other members of the financial community around the country.

Both Jim Coleman and I conducted countless face-to-face meetings with financial professionals to detail the new directions for Cortex. We have had numerous other meetings that included other staff members and Cortex’s co-founder, Dr. Gary Lynch, supporting us in gaining recognition for our new approach and for the outstanding technology that is the basis of our company. I made presentations at the UBS Warburg 5th Annual Global Life Science Conference and the Rodman and Renshaw Techvest Healthcare Conference, which contributed to renewed interest in Cortex.

As you know, Cortex also was highlighted in the media this year with numerous exclusive stories on radio and television, as well as in magazines and newsletters. Most notably, Cortex was featured in an ABC news segment on World News Tonight with Peter Jennings and also in a related cover story in the September 1, 2003 issue of Business Week titled, "I Can’t Remember".

As a whole, our visibility in both the financial and public community has improved greatly. We increased our market capitalization from $12 million to approximately $70 million and increased our daily shares traded from 12-15 thousand shares to over 200 thousand shares.

While we have much more to do to bring success to all of our shareholders, our ambitions and plans go well beyond what we have done so far. The accomplishments and sacrifices made by the company during the past twelve months are worth building upon. We know how to improve shareholder value and the past twelve months can attest to that fact. The company’s value has increased five-fold in twelve months. Now we ask for your support to help us to continue our work and potentially achieve new clinical milestones for the technology. Please vote for increasing the authorized shares for Cortex and allow the building process to continue.


/s/ Roger G. Stoll

ROGER G. STOLL, Ph.D.
President, Chairman and Chief Executive Officer

November 10, 2003

-----------------------------------------------------------

[Coluche]

Hallo Erbse, hallo Cortex-Fans,

das Statement finde ich offen und sehr sympathisch. Es zeigt, daß der CEO mit beiden Beinen und einem gesunden Realismus auf dem Boden der Tatsachen steht und versucht, das beste aus der Situation zu machen. Dabei hat er einen vernünftigen und strategisch guten Gedankengang. Bisher hat er das Unternehmen gut geführt, das vor einem Jahr kurz vor dem Abgrund stand und es wieder auf einigermassen sichere Beine gestellt.

Eine Kapitalerhöhung macht in dieser Situation Sinn, wenngleich es die Anteile der bisherigen Aktionäre sehr verwässert. Schlauer Weise haben sich die bisherigen Manager gleich mal einen riesen Schluck aus der Pulle genommen und sich mit einem stattlichen Volumen an share-options mehr als 8 % am Gesamtkapital gesichert.

Aber gerade das gibt mir persönlich ein starkes Vertrauen in das Unternehmen/die Aktie. Die würden sich keine Anteile über diese Summe kaufen, wenn sie nicht überzeugt wären, daß dieses Unternehmen zu einem großen Erfolg kommt. Ich schätze, der CEO hat mittlerweile mehr als eine Mio. US-$ in dieses Unternehmen investiert. Und er wird wohl am besten wissen, in was er hier investiert hat und das Risiko auch am besten einschätzen können.

Andere, wie z.B. Mr. Levin von Millennium Pharma stossen ihre Aktien in 5-stelliger Paketstückzahl ab.

So denke ich, sollten wir Geduld haben. Die Strategie über Orphan-Drugs (Quasi Nischen-Medikamente mit vereinfachter Zulassung) finde ich momentan ganz gut und gesund für Cortex.

Gruß und "stay long", Coluche

[Erbse1]

Hallo Coluche,
freut mich wieder von Dir zu hören.
Ich finde die Strategie mit den Orphan Drugs die beste für die Aktionäre überhaupt.
Der Fehler wurde vorher von Cortex gemacht und jahrelang an CX 516 festzuhalten, obwohl die kurze Halbwertszeit und die sehr hohe Dosierung bekannt war. Nach Außen hin wurde aber der Eindruck vermittelt, daß ein großes Interesse an CX516 besteht.

Was wäre denn mit Organon und ORG 24448 zu erwarten. Organon ist selber in Augenblick finanziell nicht sehr gut gestellt und hat ORG 5222, ein herkömmliches Psychosemedikament an Pfizer auslizensiert. Ich denke mal, daß ORG 24448 bis ca Ende nächsten Jahres bei Schizophrenie getestet wird. Danach schließen sich die Tests bei Depressionen an. Wie jetzt schon ersichtlich, Organon hat sehr sehr viel Zeit, und dann werden Sie ORG 24448 zur Testphase 3 an einen dritten Partner auszulizensieren. Bis dahin wäre Cortex pleite.

Bei Servier sieht es ähnlich aus, zumal hier nochmal mit Testphase 2 und einer neuen Substanz begonnen werden muß.

Cortex selber hat keinen Einfluß auf die Zeitplanung der großen Anwendungen.
Wie schon oft beobachtet lassen die Großen die Kleinen am ausgestreckten Arm verhungern.
Ich finde die Idee mit den Orphan Anwendungen den einzig gangbaren Weg um langfristig einer totalen Abhängigkeit oder Pleite zu entgehen. Leider dauert dies auch bei Orphan Anwendungen noch ca 4-5 Jahre um ein Medikament zur Marktreife zu bringen. Die Kapitalisierung von Cortex ist noch so gering, daß mich die Verwässerung durch eine Kapitalerhöhung nicht besonders stört. Das Potential der Ampakine ist einfach zu riesig. Nur dauert dies eben seine Zeit.
Bleibt nur zu hoffen, daß mit CX717 keine Komplikationen auftreten.
Liebe Grüße
Erbse1

[Erbse1]

Kleiner Recherchebericht zu einigen Aspekten bei Schizophrenie
Erbse1
Cognitive Impairment in Schizophrenia
There is an abundance of data showing substantial cognitive impairment in schizophrenia, and cognitive impairment is a predictor of poor outcome. While the atypical anti-psychotics have a positive impact on cognitive deficits in schizophrenia, experts said they don’t do enough. Clozaril has been shown to have a beneficial effect on selected neuropsychological tests and actually enhances performance on a broad range of domains, leading to improvement in verbal but not visual memory. Visual memory may worsen with Clozaril. Risperdal and Zyprexa exhibit selective cognitive benefits. None of these drugs restores normal cognitive functions. Thus, experts are searching for other adjunctive therapies
http://www.google.de/search?q=cache:yyeMCrPslFoJ:www.trends-…

Cognitive impairment. Currently, schizophrenia is viewed by the FDA as a single clinical target, and new anti-psychotics are approved for “the treatment of schizophrenia.” Cognitive deficits are acknowledged as one aspect of the schizophrenia syndrome but are not teased apart as a distinct target, and they are not even a part of the DSM-IV criteria for diagnosing schizophrenia.

[Erbse1]

Das ganze noch mal schön sortiert als pdf Datei.
http://www.trends-in-medicine.com/June2003/NCDEU063p.pdf

[Erbse1]

Positive association of the AMPA receptor subunit GluR4 gene (GRIA4) haplotype with schizophrenia: linkage disequilibrium mapping using SNPs evenly distributed across the gene region.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d…

[Erbse1]

Interessante Meldung für Betroffene und Psychiater.
Hat zwar nichts mit Cortex zu tun. Aber für alle, die sich mit Schizophrenie beschäftigen lesenswert.

Dose reduction effective against chronic schizophrenia

Reducing the dose of antipsychotic medications for those who had been treated with high-dose antipsychotic polypharmacy: an open study of dose reduction for chronic schizophrenia.

Suzuki T, Uchida H, Tanaka KF, Tomita M, Tsunoda K, Nomura K, Takano H, Tanabe A, Watanabe K, Yagi G, Kashima H.

SUMMARY: Antipsychotic medications are often used at higher than the recommended dose and sometimes in a combination regimen to treat schizophrenia. However, in general, high-dose therapies have been abandoned in recent clinical studies. In this study, dose reduction of antipsychotic medication was implemented for patients with chronic schizophrenia, most of whom (81%) had been treated with an antipsychotic high-dose polypharmacy regimen consisting of more than 1000 mg/day in total amount. The results show that merely reducing the amount of antipsychotic led to favourable outcome in 23 out of 41 cases (56%), with another 13 cases (32%) showing no change. Dose reduction ended in failure in only five subjects (12%). Overall, the amount as well as the number of antipsychotic medications was significantly reduced from 1984 mg to 812 mg per day (reductions of 59% and from 3.6 to 2.2, respectively; both P<0.0001). The Global Assessment of Functioning scale improved from 30.6 to 37.2, which reached significance (P<0.001). Accordingly, the Severity of Illness improved from 4.7 to 4.2, and was also significant (P<0.01). Dose reduction is an encouraging strategy to consider for those patients with schizophrenia who have chronically been treated with high-dose antipsychotic polypharmacy, even if judged unavoidable in the past.

PMID: 14571152 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d…

[Erbse1]

Hirnschrumpfung durch Haldol. Da kann einem Betroffenen nur schlecht werden. Nur haben die neuen atypischen Medikamente auch eine ganze Latte von Nebenwirkungen. Doch Hirnschrumpfung muß wirklich nicht sein.
Machts mal gut
Erbse1

SFN: Haloperidol, not Olanzapine, Linked With Brain Shrinkage in Schizophrenia

By Roberta Friedman, PhD

NEW ORLEANS, LA -- November 11, 2003 -- Haloperidol may exacerbate the shrinking of the brain that scientists are beginning to link with schizophrenia. Findings of a multi-center study comparing first- and second-generation treatment for schizophrenia were announced here November 9th at the Society for Neuroscience 33rd Annual Meeting.

Haloperidol and olanzapine, a newer agent, both provided relief of symptoms for patients experiencing their first bout of psychosis. Remission rates were 80% with olanzapine, and 66% with haloperidol. A total of 263 patients were randomized to the treatments. The average age of participants was 24 years, with 80% being male. The analysis employed cognitive testing and brain imaging.

Only olanzapine treatment was associated with a statistically significant increase in cognitive function. The imaging studies showed that the brain shrank in the schizophrenics, with "virtually all the effect occurring in the haloperidol group," said investigator Jeffrey Lieberman, MD, professor of psychiatry, radiology, and pharmacology, University of North Carolina at Chapel Hill, United States.

Mean change in brain volume averaged a 14-cc reduction with the use of haloperidol, primarily affecting the frontal lobe. No change was apparent with olanzapine. In fact, olanzapine appeared to increase the volume of the temporal lobe. "We believe this disease is associated with a volume reduction, and treatment may ameliorate that," Dr. Lieberman said.

Olanzapine doses ranged from 5 to 20 mg per day, and haloperidol from 2 to 20 mg per day. Acute treatment was for 12 weeks, and patients were assessed at 12, 24, 52, and 104 weeks for symptoms and cognitive performance; they were also imaged by magnetic resonance imaging.

Dr. Lieberman said that the study has replicated previous reports that haloperidol increases the volume of the caudate. "We think it has to do with compensation for chronic blockade [of dopamine by the drug]," he speculated.

Dr. Lieberman added that the logical extension of these results is to never use haloperidol, yet many developing countries cannot afford the newer drugs. "Haloperidol is better than nothing," he said, for patients with schizophrenia.

Dr. Lieberman receives support for his research from Upjohn Pharmacia, Bristol-Myers Squibb, Novartis, Eli Lilly, Janssen, Pfizer, Hoechst, and AstraZeneca.


[Study title: Antipsychotic treatment effects on progression of brain pathomorphology in first episode schizophrenia. Abstract 234.6]

http://www.docguide.com/news/content.nsf/news/8525697700573E…

[Erbse1]

BDNF and Alzheimer`s Disease—What`s the Connection?
By Nicole C. Berchtold and Carl W. Cotman
Why Is BDNF interesting?
The protein brain-derived neurotrophic factor (BDNF) has been the focus of intense interest in the Alzheimer`s field for a number of years. BDNF belongs to the neurotrophin family of growth factors and affects the survival and function of neurons in the central nervous system, particularly in brain regions susceptible to degeneration in AD. BDNF improves survival of cholinergic neurons of the basal forebrain, as well as neurons in the hippocampus and cortex. This discovery kindled hope in the early 1990s that Alzheimer`s could be slowed or halted if brain levels of BDNF could be increased. The idea gained support with the observation that BDNF gene activity and protein levels are reduced in AD brains.

Den kompletten Artikel gibts unter folgenedem link


http://www.alzforum.org/res/for/journal/cotman/default.asp

[NYSEBUY]

Ist ja ziemlich ruhig hier geworden.

Hat irgend jemand Informationen oder plausible Begründungen für die extrem starken Ausschläge, sowohl nach oben, als auch leider nach unten, in den letzten 2 Wochen ?

[Erbse1]

Hallo NYSEBUY, habe auch keine Erklärung für den Kursverlauf. Gestern wieder intrayday hoch auf 3,40$, danach wieder runter auf 3,05$. Ich werde mir das in Ruhe anschauen. Uns als Kleinanleger bleibt sowieso nur die Beobachterrolle.

Warte noch auf die Ergebnisse von CX 516 bei Schlafentzug.

Etwas bedenklich stimmt mich der Verkauf des Cortex Mitbegründers Cotman von 16000 Stück. Allerdings wurden auch mächtig Options verteilt, so daß die Anzahl bei Cotman sogar noch etwas angestiegen ist.

Folgend noch die Meldung zur Patenterteilung in Europa und drei weitere Patenterteilungen.

Machts mal gut
Erbse1

AMPAKINE Broad Use Patent for Enhancement of `Memory and Cognition` Issued to Cortex by the European Patent Office

http://biz.yahoo.com/bw/031210/105308_1.html

[NYSEBUY]

Hallo Erbse1,
es ist zumindest schon mal gut, dass es überhaupt mal wieder hoch ging, nachdem der Kurs sich völlig vom Gesamtmarkt abgekoppelt hat in den letzten Wochen bei auffällig hoher Volatilität und spärlicher Nachrichtenlage.

Vielleicht sorgt die Meldung ja zumindest mal für etwas mehr Kursstabilität. Werde wohl vorerst investiert bleiben.

Irgendwie interessiert sich niemand sonst hier für COR oder hat eine Einschätzung

[Erbse1]

Hallo liebe Cortex Fans. Folgend der Kommentar des Neuroinvestors zur aktuellen Lage bei Cortex.
Liebe Grüße
Erbse1
Cortex retraced some of its dizzying ascent. There is anticipation of price erosion as recent investors take some profits in December, as another private placement is devised, and given some risk of failure in the MCI trial run by Servier. All of the clinical data thus far raises optimism that even in this small, short-duration trial, CX516 will show at least a trend (p=.10 or better) towards efficacy. And that is all we, or Big Pharma partnership candidates, would need to see. But if the results do not reach p=.05, we anticipate selling by some who are underinformed. So long as the trend is established, it would not jeopardize a partnership, all the discussants understand the limitations of the compound and of the trial. In that circumstance, if there is a kneejerk decline, we would see that as a fertile buying opportunity. The MCI trial is far less important than it once seemed to be. Even though Servier denied to us that they have made a final decision regarding which molecule to develop, their actions (beginning Phase II in AD with S18986) speak loudly enough. News regarding a partnership and perhaps widened access to the more clinically advanced candidates (there are a total of four AMPA modulators in Phase II, CX516 is the weakling of the lot) will be far more important. We still expect a deal major partnership in the next few months. Given that Merck`s inhouse gamble misfired, and the weakness of their pipeline exposed, they should be more enthusiastic than before. Lilly will be heard from before long, they have too much invested to take a pass on Ampakines. Intriguingly, one of Lilly`s eminent Ampakine researchers has moved over to Amgen to run their neuroscience program. Amgen has more cash on hand than Lilly, and at some point has to diversify beyond the neurotrophic protein quagmire where they have been rooted, adding small molecule programs. This would be a fine start.

http://www.neuroinvestment.com/CORXcom.html

[Erbse1]

Folgend der link zu einigen Ausführungen von Eli Lilly zum Ampakine Programm.
Wünsche allen ein frohes Weihnachtsfest und einen guten Rutsch ins nächste Jahr.
Erbse1

Chemical Ablation versus Transgenic Animal Models in Developing New Treatments

http://spring.parkinsons.org.uk/spring_news/2003/28_jul_2003…

[Erbse1]

Akzo Nobel NV`s human pharmaceutical business Organon announced Wednesday that the 30-day waiting period under the Hart-Scott Rodino Act for the collaboration with Pfizer Inc (NYSE:PFE - News) on asenapine has expired and that the collaboration will continue to move forward.
http://biz.yahoo.com/djus/031224/0246000392_2.html
Die Thematik hatten wir schon mal vor Kurzem.
Die Frage wird sein was Organon mit ORG 24448 macht, wenn die Testphase 2 abgeschlossen ist. Bekannt ist, daß Organon aufgrund knapper Gelder Partnerschaften mit anderen BIO Firmen eingeht.
Asenapine ist ein herkömmliches Antipsychotikum, auch unter ORG 5222 bekannt, der herkömmlichen Art. Also eher als Ergänzung zu den bestehenden Medikamenten zu sehen.

Gespannt sein kann man wohl darauf, wie Organon weiter mit ORG 24448 verfährt. Werden sie auch ORG 24448 auslizensieren, oder wird dies in eigener Regie durchgeführt? Die Testphase 2 soll Ende 2004 abgeschlossen sein. Bis dahin werden wir uns gedulden müssen.

Im Januar erwarten wir die MCI Ergebnisse von Cortex.Der Kursverlauf der letzten Monate läßt zumindestens keine überragenden Ergebnisse erwarten, aber dies ist reine Spekulation meinerseits.

Liebe Grüße
Erbse1

[Erbse1]

Wie von Cortex angekündigt. Organon testet die Ampakine bei Depressionen und leistet milestones in Höhe von 2 Millionen.
Liebe Grüße
Erbse1

IRVINE, Calif.--(BUSINESS WIRE)--Jan. 7, 2004--Cortex Pharmaceuticals, Inc. (AMEX: COR - News) announced that it has received the milestone payment from NV Organon to retain the worldwide rights to develop and commercialize the Company`s proprietary AMPAKINE® technology for the treatment of depression. This $2 million milestone payment comes three years after Organon exercised its option to do additional research and development with various AMPAKINE compounds in various depression pre-clinical models.
http://biz.yahoo.com/bw/040107/75314_1.html

[cyberx]

das sind gute News! erste kleine Erfolg....wir brauchen aber meher solche meldungen....

Gruss CyberX

[Erbse1]

Das war sehr schnell nach der letzten Kapitalmaßnahme. Gemessen an den Zukunftsaussichten hält sich die Verwässerung durch die Kapitalmaßnahme noch in Grenzen.
Liebe Grüße
Erbse1
Cortex Announces $19 Million Private Placement
http://biz.yahoo.com/bw/040109/95091_1.html

[Erbse1]

Folgend der Kommentar des Neuroinvestors zur KE.
Liebe Grüße
Erbse1
Those of you who like to think of me as whoring for COR management can load your slingshots again--because I am nearly ecstatic about this. Sure, I would have liked to see the warrant strike price higher. But then again,a lot of PIPES (e.g. the recent Pharmos deal) involve a significant discount to the recent market price. I would have been unhappy to see the 7 million shares sold at a 15-20% discount, but at an average market price, that`s an above average deal for a tiny microcap.

Dilution, dilution. The question that has to be asked is--what do you get for the added shares? CX717 accelerating into PhI so that pharmacokinetic data necessary for a good, front end loaded North American deal can be ready before mid year. Secondly, money to bring a high-impact compound into the clinic by late 04. Why does this matter? Lilly`s Parkinson`s results surprised everyone, but Cortex is better off showing that it has a molecule in development that matches Lilly`s in potency. The more preclinical data they have, the more value added to that Big Pharma deal, since PD in NA will be wrapped into it.

There are complaints that the deal was priced during tax selling, prior to MCI data. Let`s contemplate the possibility that the MCI data is negative (as I`ve said before, it`s possible). I believe investors came to Stoll very recently, this deal was not on the table in mid December--so they might not have waited anyways. But had they waited, what effect do you think that an MCI failure would have on the stock price? I`d guess low 2`s, Cortex would than have been under even more pressure to do a deal or accept subpar terms, and the `dilution` would have been far more onerous. So, we can wish the deal was at 4.00-4.50 post positive MCI results, and we can be relieved that it is not at 1.90-2.00 post negative MCI results.

What is obtained is an internal locus of control--Cortex can do its inhouse development program regardless of Big Pharma squeezes, and now BP will know it. Plus, the info that can be added to BP`s due diligence package makes the chances of a more lucrative deal higher. I personally am willing to trade `dilution` now for higher upfront money nearterm and higher royalties/milestones longterm.

As for `we`d love to have this kind of deal for shareholders`...well, if we had $19 million, we could have.

By the end of 2004, if not before, the complaints about this deal will seem silly in retrospect.

NeuroInvestment

[Erbse1]

Von der Neuroinvestor Homepage

Liebe Grüße
Erbse1

Comment on financing

The $19 million raised at the mean market price frees Cortex to move aggressively in its preclinical preparations of CX717 and a new BDNF-maximizing Ampakine, and to take an equally aggressive stance in its negotiations with Big Pharma regarding North American MCI/AD/PD rights. For the first time ever, it has control over its own destiny. The warrants that were issued are in line with what is currently paid for private financing these days, and is worth it, when one considers the leverage Cortex now has. We do not expect this to slow the process of partnering, in fact it accelerates it. Once CX717 has human pharmacokinetic data--unless S18986 enters the picture first--a deal is probable, and on terms that still include the $30 million upfront Cortex has sought. That may still happen by midyear. BP cannot now wait to see if Cortex will panic as the financial hourglass trickles down, because they have money for a couple of years of upramped development. Had they waited for the MCI data (still expected end of January), they ran the risk of the investors walking away, or the MCI data being less than what is hoped for, causing the offer to be downsized. The principle in the microcap bioworld is: take the money when you can get it. Priced at market, without any adjustible death spiral convertible options, this was an excellent deal, one that could not be dismissed.


http://www.neuroinvestment.com/CORXcom.html

[Erbse1]

Folgend noch die maschinelle Übersetzung des folgenden Artikel in englisch aus dem französischen Artikel
Erbse1

PROTECTION OF WHITE SUBSTANCE PERI-VENTRICULAIRE OF SOURICEAU NOUVEAU-NE BY A MODULATOR ALLOSTERIQUE OF THE RECEPTEURS WITH THE GLUTAMATE OF THE TYPE AMPA. Affiliation joint authors = has INSERM E 9935, Hôpital Robert Debré, Paris; B IRIS, the Neuilly-on-Seine. Introduction: in a murine model of leucomalacie périventriculaire (LPV), the "brain-derived neurotrophic Factor" (BDNF) protects the white substance via the way from the "mitogen-activated protein kinases" (MAPKs). However, the BDNF is a large molecule which does not pass the hematoencephalic barrier (BHE), requiring to resort to a strategy of vectorization for a possible clinical use. An alternative strategy would rest on ḻutilisation d’AMPAkines (modulating allosteric positive of receivers AMPA of the glutamate) which is small molecules able to cross the BHE and which increases the cerebral production of BDNF.
Objective: to determine if ḻadministration intrapéritonéale (IP) d’une AMPAkine, S18986, protects the white substance from the excitotoxic lesions via the synthesis of in situ BDNF. Material and methods: the souriceaux ones 5 days receive an intracerebral injection (ic) d’iboténate, a glutamatergic agonist of receivers NMDA, only or in partnership respectively with 50ng BDNF (ic), 10mg/kg S18986 (IP), 10mg/kg S18986 (IP) + 1µg anti-BDNF antibody (ic), 10mg/kg S18986 (IP) + 3µg PD98059 (ic; inhibitor of MAPKs). Transcribed for the BDNF are quantified by RT-PCR after treatment by S18986 or saline plug. Results: the size of the lesion of the white substance is reduced 78% by S18986 and 66% by the BDNF. These neuroprotecteurs effects are completely abolished by the Co-administration anti-BDNF d’anticorps or of PD98059. L’analyse in quantitative RT-PCR is currently in hand. Conclusion: in a model of LPV, S18986, a positive modulator allosteric of receivers AMPA, protects the white substance néonatale, probably via an increased cerebral production of BDNF.


PROTECTION DE LA SUBSTANCE BLANCHE PERI-VENTRICULAIRE DU SOURICEAU NOUVEAU-NE PAR UN MODULATEUR ALLOSTERIQUE DES RECEPTEURS AU GLUTAMATE DE TYPE AMPA.
Affiliation co-auteurs = a INSERM E 9935, Hôpital Robert Debré, Paris ; b IRIS, Neuilly-sur-Seine.

Introduction: dans un modèle murin de leucomalacie périventriculaire (LPV), le « brain-derived neurotrophic factor » (BDNF) protège la substance blanche via la voie des « mitogen-activated protein kinases » (MAPKs). Toutefois, le BDNF est une grosse molécule qui ne passe pas la barrière hématoencéphalique (BHE), nécessitant de recourir à une stratégie de vectorisation pour une éventuelle utilisation clinique. Une stratégie alternative reposerait sur l’utilisation d’AMPAkines (modulateurs allostériques positifs des récepteurs AMPA du glutamate) qui sont de petites molécules capables de traverser la BHE et qui augmentent la production cérébrale de BDNF.

Objectif : déterminer si l’administration intrapéritonéale (ip) d’une AMPAkine, le S18986, protège la substance blanche des lésions excitotoxiques via la synthèse de BDNF in situ. Matériel et méthodes : des souriceaux de 5 jours reçoivent une injection intracérébrale (ic) d’iboténate, un agoniste glutamatergique des récepteurs NMDA, seul ou en association respectivement avec 50ng BDNF (ic), 10mg/kg S18986 (ip), 10mg/kg S18986 (ip) + 1µg anticorps anti-BDNF (ic), 10mg/kg S18986 (ip) + 3µg PD98059 (ic ; inhibiteur des MAPKs). Les transcrits pour le BDNF sont quantifiés par RT-PCR après traitement par S18986 ou tampon salin. Résultats : la taille de la lésion de la substance blanche est réduite de 78% par le S18986 et de 66% par le BDNF. Ces effets neuroprotecteurs sont totalement abolis par la co-administration d’anticorps anti-BDNF ou de PD98059. L’analyse en RT-PCR quantitative est actuellement en cours. Conclusion: dans un modèle de LPV, le S18986, un modulateur allostérique positif des récepteurs AMPA, protège la substance blanche néonatale, probablement via une production cérébrale accrue de BDNF.


http://www.siliconinvestor.com/stocktalk/msg.gsp?msgid=19675…

[Erbse1]

Hallo liebe Cortex Fans. Eine sehr erfolgreiche Woche liegt hinter uns. Ich möchte Euch einen Artikel aus dem Yahoo Board von gfp927z kopieren. Er beantwortet die Frage, was demnächst bei Cortex ansteht. Machts mal gut und liebe Grüße
Erbse1

-----------------------------------------------------------
Near term -

1) MCI results. Supposed to be by the end of January, though could be a little later based on past experience with timelines. We could get some great additional media coverage if the results are good. My theory, FWIW, is that the PIPE guys saw good things coming soon and that would most likely be related to the MCI results. On the other hand, if the results are decent but are not received well by the market, we might get a great buying opportunity.

2) Servier/Cortex announcement of a new R+D funding deal (extension of the previous deal). The bigger question is will this announcement include a new licensing deal that includes S-18986? A much longer shot is whether Servier will make S-18986 available for N.Amer, but this looks unlikely for now.

3) Dr. Lynch`s paper on long term BDNF upregulation could be published soon.

4) We`ll probably get a PR on a new hiring to enhance our clinical staff.

Mid-term -

1) By Spring, CX-717 should be done the final tox work and be ready to start Phase 1.

2) We might see the new high impact neurotrophic Ampakine moving into tox studies.

3) Could be something from DARPA on CX-717 - perhaps some funding for the Phase 1.

4) Summer - here things could get really interesting if Lilly has finished and analyzed their LY-451395 Phase 2. If they decide to go into Phase 3, a licensing deal with Cortex would be likely. Another BP might step forward sooner, but without S-18986 available, and CX-717 still not ready (and low impact), I think Lilly is still our most likely partner.

Longer-term -

1) By the end of 2004, we should see the FRAXA funded CX-516 Fragile X trial completed. Then the decision will be to start a Frag-X trial with CX-717, or else with our new neurotrophic compound in 2005.

2) 2005 will be most interesting, with Organon`s Schizo Phase 2 results/ Phase 3 decision. A major event.

3) Servier`s S-18986 Phase 2 will be well along in 2005, and depending on what happens with Lilly, might be ready for Phase 3 in late 2005.

4) Organon`s Depression Phase 2 could be nearing completion in late 2005.

5) Perhaps something from Servier for the Anxiety indications?

6) DARPA Sleep Dep trials using CX-717 could be moving into high gear in 2005.

The biggest event of all would be a deal with Lilly in 2004. That would give us an additional Phase 3 in 2005 (LY-451395) to go along with Organon`s Schizo Phase 3. We would also inherit Lilly`s Parkinson`s program, which might conceivably enter Phase 1 in 2004. We could see a total transformation in the next 2 years - from a tiny 70 mil company to a 500 mil+ Ampakine powerhouse. And that would only be the beginning. JMHO.

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

[Erbse1]

Folgend ein Artikel, der zur Recherche dient.
Liebe Grüße
Erbse1

1. Int J Geriatr Psychiatry. 2003 Sep;18(Suppl 1):S15-21

Glutamatergic systems in Alzheimer`s disease.

Francis PT

Centre for Neuroscience Research, King`s College London, London, UK. [e-mail]

Glutamate is the major transmitter of the brain and is involved in all aspects of cognitive function since it is the transmitter of cortical and hippocampal pyramidal neurones. Furthermore, glutamate and glutamate receptors are involved in long-term potentiation, a process believed to underlie learning and memory. Histological studies indicate loss of pyramidal neurones and their synapses in Alzheimer`s disease (AD), this together with biochemical evidence suggests presynaptic (and postsynaptic) glutamatergic hypoactivity. This represents a `double blow` as the activity of glutamatergic neurones is heavily influenced by the cholinergic system, which is also dysfunctional in AD. The clinical relevance of these changes is emphasised because glutamatergic and cholinergic dysfunction are strong correlates of cognitive decline in AD. The mechanism by which glutamatergic (and cholinergic) cells die is likely to be a combination of necrosis and apoptosis caused by a range of factors which include tangle formation and the effects of too much and too little glutamatergic neurotransmission.

PMID : 12973746 [PubMed - Indexed for MEDLINE]
http://www.accelerated-learning-online.com/research/glutamat…

[Erbse1]

Servier Extends Cortex Collaborative Research Support for Two Years



IRVINE, Calif.--(BUSINESS WIRE)--Jan. 20, 2004--

S-40929 Selected as a Lead Developmental Candidate From
Collaboration

Cortex Pharmaceuticals, Inc. (AMEX:COR) announced that Les Laboratoires Servier ("Servier"), France`s largest privately held pharmaceutical company, has extended their funding of the Collaborative Research Agreement with Cortex. The initial research support began on December 7, 2000 and expired on December 6, 2003. Under the terms of the newly amended Agreement, Cortex will receive approximately $4.3 million of support over the next two years. Thereafter support will continue on an annual basis unless either company wishes to terminate the Agreement. This support is in addition to Servier`s eight quarterly payments of $500,000 that commenced on October 2002 to find an AMPAKINE(R) compound that has specific anti-anxiety properties.

In addition, Servier and Cortex have selected an AMPAKINE collaborative compound, S-40929, as an advanced, preclinical development candidate. In memory tests carried out in primates, S-40929 is about 2000 times more active than CX516, and based on its effects on AMPA receptors, it is considered more likely to increase the levels of neurotrophins, such as BDNF.

"This additional investment in Cortex by Servier is a strong vote of confidence in our AMPAKINE technology and in a very productive partnership," said Dr. Roger G. Stoll, Chairman, President and CEO of Cortex. "Servier is a company that has a great deal of knowledge and experience about AMPA receptor upmodulators from their preclinical and clinical work with their compound, S-18986," added Dr. Stoll. "With the additional payments, Cortex will be in a position to capitalize on what has been learned during the past three years, in which hundreds of new high impact AMPAKINE compounds have been generated and characterized in this collaboration."

http://news.nasdaq.com/news/newsStory.aspx?&pageName=Company…

[Erbse1]

Hallo liebe Cortex Fans.
Bei mir tauchen nach der Meldung von gestern zu Cortex einige Fragen auf.
Wie ist der Stand von CX 516 bei der MCI Testphase 2 von Servier. Die Meldung hierzu steht noch aus. Anscheinend spielt CX 516 keine Rolle mehr.
Welche Substanz ist weiterhin von Servier bei MCI und AD geplant. Dies wird in der gestrigen Meldung nicht klar.

Welche Substanz ist bei welchem Anwendungsgebiet geplant?

Bei AD kommt wohl S-40929 in Frage. Dazu folgender Artikel, den ich vor kurzem gepostet habe. Welche Rolle soll demnächst S-18986 spielen? S-18986 war bisher nach vorliegenden Informationen ebenfalls bei AD geplant.
-----------------------------------------------------------
BDNF and Alzheimer`s Disease—What`s the Connection?
By Nicole C. Berchtold and Carl W. Cotman
Why Is BDNF interesting?
The protein brain-derived neurotrophic factor (BDNF) has been the focus of intense interest in the Alzheimer`s field for a number of years. BDNF belongs to the neurotrophin family of growth factors and affects the survival and function of neurons in the central nervous system, particularly in brain regions susceptible to degeneration in AD. BDNF improves survival of cholinergic neurons of the basal forebrain, as well as neurons in the hippocampus and cortex. This discovery kindled hope in the early 1990s that Alzheimer`s could be slowed or halted if brain levels of BDNF could be increased. The idea gained support with the observation that BDNF gene activity and protein levels are reduced in AD brains.

-----------------------------------------------------------

Das ist nur reine Spekulation von mir, aber es würde passen.
Ich werde die Situation mal auf dem Yahoo Board weiter verfolgen und Neuigkeiten hierzu in diesem Board posten.

Liebe Grüße
Erbse1

[Erbse1]

Hallo liebe Cortex Fans. Hier noch mal eine tolle Zusammenfassung von Cortex von gfp927z. Interessenten sollten auch mal ins Yahoo Board schauen. Das ist wirklich lohnenswert. Vielen Dank an gfp927z.
Liebe Grüße
Erbse1


Just an estimate, but Cortex should now have approx $20-25 mil in cash. The annual burn rate for years was approx $5 mil, but was being raised to approx $9 mil (per Dr. Stoll in the TWST interview last Summer). So we have at least a good 2 years worth of cash, not counting additional sources (a BP deal for our N.Amer AD/MCI rights could bring in an additional $30-40 mil).

The # shares fully diluted I think is getting toward 40 mil, though this is just a guesstimate. (Includes the 6.6 mil shares/warrants from last Summer, the 11.7 mil shares/warrants from the recent PIPE, and the various unexcercised outstanding options). The recent 11.7 mil shares/warrants and the unexcercised options are not available for trading in the float yet.

Cortex and our partners Organon and Servier have the following clinical trials underway;

1) Organon - Schizo multi Phase 2b (mono and combo) using Org-24448.

2) Organon - Depression Phase 2.

3) Servier - MCI/AD Phase 2 completed with CX-516, results expected in several weeks.

4) Servier - AD/MCI Phase 2 using S-18986.

5) FRAXA - Fragile-X Phase 2 using CX-516.

6) NIMDS/Dr.Chase - Alzheimer`s Phase 2 with CX-516.

7) NIMH/Dr.Goff - Schizo combo Phase 2 with CX-516.

8) DARPA - Sleep Deprivation with CX-516, completed Fall 2003.

Lilly, a competitor/potential future partner, has an ongoing AD/MCI Phase 2 with LY-451395 which should be completed this year, perhaps by Summer. Lilly has also done a lot of preclinical work with AMPA modulators for Parkinson`s and Depression. Cortex has the broad use patents for the technology, so it is believed that Lilly should eventually have to either partner with or obtain a license from Cortex. Lilly challenged Cortex`s patent in Europe, lost, and is apparently attempting to re-challenge.

Cortex is currently completing tox studies on a new compound - CX-717, which should start Phase 1 in the Spring. Also, we have a new neurotrophic compound with Servier - S-40929, which is in development. Cortex said it plans to have an in-house program for orphan indication(s) like Fragile-X. These new compounds could also be licensed out to larger BPs. Once CX-717 is ready, it is hoped that DARPA may want to continue trials for Sleep Deprivation. Cortex has retained the lucrative N.Amer MCI/AD rights, for which it is seeking a partner.

Ampakines act at the AMPA receptor, amplifying its signals. AMPA receptors are found in great quantity in the cortex and hippocampus - areas involved in higher brain functions - memory, cognition, learning, reasoning. Ampakines facilitate/enhance LTP (long-term potentiation) - the process by which memories are formed. AMPA receptors are not found in the rest of the body, nor are they involved in lower brain functions. So Ampakines can produce selective cerebral arousal without causing somatic arousal or non-specific cerebral arousal (ie - very few unwanted side effects). They are also allosteric, which means that they don`t originate neuronal activity, but amplify the existing neuronal activity.

Perhaps most importantly, Ampakines have been found to upregulate various neurotrophic growth factors (BDNF, NGF, GDNF). This could have profound implications for the treatment of many degenerative neurological diseases like Parkinson`s and Alzheimers. BDNF also seems to play a central role in the mechanism of action of antidepressants. Stroke and traumatic brain injury might also benefit from upregulating neurotrophins. Since neurotrophins are so key to the survival and functioning of the central nervous system, their enhancement/upregulation has been called the "holy grail" of neuroscience.


http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

[Erbse1]

Hallo liebe Cortex Fans. Ich habe eben mal einen neuen Cortex Thread eröffnet, da für einige Leute die Ladezeiten einfach zu lang werden. Ich möchte Euch bitten zu Cortex im neuen Thread zu posten.
http://www.wallstreet-online.de/ws/community/board/threadpag…

Danke und liebe Grüße
Erbse1