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Cortex Pharmaceuticals 3 - 500 Beiträge pro Seite

ISIN: US2205243007 | WKN: 879005
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Hallo liebe Cortex Pharmaceuticals Freunde. Der alte Thread ist schon ziemlich lang geworden und ich möchte Euch bitten die Beiträge hier in diesem Thread zu posten.
Dieses Jahr stehen Für Cortex viele Entscheidungen an, die sich ganz gravierend auf den Kurs auswirken können. Es lohnt sich also ständig am Ball zu bleiben.

Zur Recherche zu dem letzten Thread folgender link
http://www.wallstreet-online.de/ws/community/board/threadpag…

Beiträge in Englisch aus dem Yahoo Board gibts unter folgendem link
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

Informationen direkt von Cortex Pharmaceuticals unter folgendem link
http://www.cortexpharm.com/main.html

Ich freue mich über jeden sinnvollen Beitrag zu unserem Thema.

Also machts mal gut
Erbse1
Vor einigen Tagen hat sich ein Cortex Investor Forum gegründet. Leider geht das nur mit Anmeldung. Neue Mitglieder sind stets willkommen. Sehr interessant sind die informativen DIAS von Cortex. Leider kann ich sie nicht kopieren. Also einfach anmelden unter folgendem link.

http://finance.groups.yahoo.com/group/CortexInvestorsForum/

Schönen Tag noch
Erbse


Weitere Informationen zu Cortex und vielen anderen Firmen gibt es hier. Bei Bedarf werden die Beiträge aktuallisiert. Guter Neuro-Börsenbrief, der sein Geld wert ist.

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

Schönen Tag noch
Erbse
Damit ihr nicht so lange suchen braucht, die wichtigsten links

Der Brief des CEO Roger Stoll an die Aktionäre für die zukünftige Entwicklung:
http://www.cortexpharm.com/html/investor/04letter.html


Überblick des Mitstreiters gfp927z aus dem Yahoo Board von der letzten Konferenz:
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…


Eine Zusammenfassung und Empfehlung vom Börsenbrief Biotech monthly :
http://www.cortexpharm.com/pdfs/Cortex%20%20Anniversary%2020…


Wenn ich Fragen beantworten kann, stehe ich für weitere Informationen gerne zu Verfügung.

Machts mal gut
Erbse
Habe eben noch ein bischen in Sachen Cortex gestöbert. Dabei viel mir eine medizinische Abhandlung auf.

Glutamate as a therapeutic target in psychiatric disorders.

Javitt DC.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d…

Dies ist deswegen so interessant, da Cortex mit Organon mit ORG 24448 in der Endphase der zweiten Testphase ist.
ORG 24448 wäre somit als Combotherapie mit allen anderen Schizophreniemedikamenten denkbar.
Aus einem kleinen Versuch mit psychotisch erkrankten Menschen ist bei CX516 keine nennenswerte Verbesserung der Positivsymptomatik sichtbar.
Hoffen wir also auf eine Verbesserung der kognitiven Performance bei ORG 24448. Dies würde dann auch die Theorie des Nobelpreisträgers Arvid Carlsson bestätigen, bei der von einer Störung des Dopamin- und Glutamatstoffwechsels bei Schizophrenie ausgegangen wird.
Dies wäre für Cortex ein riesiger Erfolg, da ORG 24448 als zusätzliches Medikament zu allen anderen Medikamenten gegeben werden müßte.

Schönen Tag noch
Erbse

Gary Lynch und Mitarbeiter

Hinter der ganzen Arbeit mit den Ampakinen steht der Cortex Mitbegründer Gary Lynch.
Viele Leute spekulieren darauf, daß er auch für seine Arbeit den Nobelpreis erhalten wird, zumindestens hätte er ihn verdient.
Hier kurz einige Sätze aus einer Abhandlung von Lynch zu den Ampa Rezeptoren.
AMPA receptor modulators as cognitive enhancers.

AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptors mediate fast excitatory transmission throughout the central nervous system. Positive modulation of these receptors can potentially enhance cognition by, firstly, offsetting losses of glutamatergic synapses; secondly, promoting synaptic plasticity; and thirdly, increasing the production of trophic factors. The advent of small molecules that selectively enhance AMPA receptors in the brain made it possible to test these hypotheses. Preclinical experiments indicate that the compounds accelerate the encoding of memory and have positive effects on models of cognitive dysfunction. Initial results with human subjects are also positive. AMPA receptor modulators thus represent an entirely new approach to cognitive enhancement and the treatment of diverse brain disorders.

Publication Types:
Review
Review, Tutorial

PMID: 15018832 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d…

Für Leute die sich noch weiter mit Gary Lynch beschäftigen wollen folgend der Link zu der Homepage.
http://lynchlab.ucicom.uci.edu/index.htm

Schönen Tag noch
Erbse1
Für mich eine Überraschung von Cortex Partner Organon bei den Ampakinen. Bisher war die Testphase mit ORG 24448 bei Schizophrenie und eine Testsubstanz in der frühen Phase bei Depression bekannt .
Aus dem letzten Analystenpapier von Organon ist neben ORG 24448 von zwei zusätzlichen Komponenten die Rede.

Quelle:
http://www.google.de/search?num=30&hl=de&newwindow=1&q=ampa+…

Ich bekomme den Artikel nicht direkt verlinkt. Gemeint ist der folgende Bericht.
Organon Research & Development Maximizing Productivity

Meine Frage geht dahin. Was ist die zusätzliche Testsubstanz und für welches Anwendungsgebiet ist sie bestimmt?

Werde der Frage mal nachgehen.

Schönen Tag noch
Erbse
Hallo Erbse

Ich wollte gern wissen was Du von PhytoPharm hälst ,das u.a. auch in bereich Demenz-Erkrankungen tätig ist.
Vor allem interessiert mich ob sich hier ein einstieg lohnt.

http://www.phytopharm.co.uk

http://www.phytopharm.co.uk/prod_develop.html

http://www.phytopharm.co.uk/press_releases.html

Danke

Gruss
B.M.
Hallo BrauchGeld, die Frage kann ich dir leider nicht beantworten. Letzendlich hängt das davon ab, ob ein Produkt auch alle drei Testphasen erfolgreich durchläuft. Ich kenne Deine Aktie leider nicht und habe mich noch nicht mit ihr beschäftigt. Ich denke mal es gehört auch eine ganze Menge Glück dazu aufs richtige Pferd zu setzen. Nur leider kann ich dir keinen Tip geben. Eine gute Recherche kann allenfalls die Chancen erhöhen. Ob ein Produkt auch erfolgreich besteht ist was ganz anderes.
Ich möchte dir das mal am Beispiel Titan Pharma erklären. Die habe ich super recherchiert und das Medikament wurde schon als das Psychosemedikament gehandelt. Nur hatte sie den Nachteil mit der Verlängerung des QT Intervalls beim Herzen . Jahrelange Arbeit waren dahin. Die Folgen waren halt ein totaler Absturz und die beste Recherche hat nichts genutzt.
Tut mir leid, daß ich dir leider nicht helfen kann.

Schönes Wochenende noch.
Erbse
Hallo liebe Cortex Freunde. Hier einige Grundlagen für Leute die sich in das Thema einarbeiten wollen. Bei mir ist es so, daß ich leider auch nicht jede Einzelheit verstehe

Glutamate receptors and nerve cell communication
Role of glutamate and AMPA receptors in nerve cell communication for non-scientists
http://www.bris.ac.uk/synaptic/info/glutamate.html




Cortex beschäftigt sich mit den AMPA Rezeptoren

Schönen Tag noch
Erbse
Habe in meinem Archiv noch etwas in Deutsch gefunden.

Die Familie der ionotropen Glutamatrezeptoren
Text von Jörg Geiger, Institut für Physiologie I der Universität Freiburg
http://neuro.biologie.uni-freiburg.de/Skriptum/4-5-5.htm
Memory enhancement: the search for mechanism-based drugs
Gary Lynch


Figure 1:
Targets for the development of memory-enhancing drugs.


The production of memory-related synaptic changes occurs in three stages. Step 1: induction. Released transmitter binds to AMPA-type glutamate receptors, which then depolarize the postsynaptic region and unblock NMDA-type receptors. Step 2: expression. NMDA receptors admit calcium and thereby modify AMPA receptors so as to increase the size of subsequent excitatory currents. Step 3: consolidation. NMDA receptors also trigger changes that stabilize the modifications to the AMPA receptors. A rapidly developing aspect of this (3A) involves adhesion receptors, whereas a more delayed component requires genomic events (3B). Current strategies for drug development (red asterisks) target the AMPA receptor component of induction or the gene-signaling component of consolidation.
Hallo liebe Cortex Fans. Exclusiv der Ampakine-Aricept Vergleich. Dies ist ein Versuch mit Affen und die Ergebnisse müßen halt erst noch in den einzelnen Testphasen bestätigt werden. Sollten sich diese Ergebnisse aber bestätigen, so werden wir mit Cortex noch viel Freude haben.

Schönen Tag noch
Erbse


Bild von der letzten Cortex Präsentation
Hallo liebe Cortex Fans, jetzt wird die Sache bei CX717 und Schlafentzug langsam spannend. Die Phase 2 wird wohl innerhalb von wenigen Monaten über die Bühne gehen. Gleich folgen ein paar beindruckende Schaubilder zu den Versuchen mit CX717.

Interesse gerade an diesen Versuchen zeigt die DARPA, die an einer militärischen Nutzung brennend interessiert ist.
Folgend die kurze Einlassung der DARPA.

Preventing Sleep Deprivation
http://www.darpa.mil/dso/thrust/biosci/cap.htm

Der Versuchsaufbau zu den Tests bei Schlafentzug


Die Ergebnisse von CX717


Ein beeindruckendes EEG


Noch beeindruckender der Vergleich mit Aricept


Schönen Tag noch
Erbse
Hier noch ein Bild für Fachleute als Ergänzung zu den gestrigen Schaubildern.



Schönen Tag noch
Erbse
Hallo liebe Cortex Fans. Folgender link führt zu der kompletten DIA Serie mit vielen Informationen des CEO Stoll von der letzten Präsentation. Das Volumen von Cortex zieht in letzter Zeit mächtig an. Kann ganz gut sein, daß Ergebnisse von Fragile X, Schizophrenie oder auch eine neue Auslizensierung anliegen.

http://www.vm-elsig.de/achim/1.htm



Schönes Wochenende wünscht Euch
Erbse
Hallo Erbse,
gleich vorneweg, ich hab keine Cortex Aktien. Ich finde
Deine Arbeit hier aber so klasse, daß ich mich nächste
Woche, da hab ich Urlaub, mal intensiv mit Cortex beschäftigen werde. Ich habe beruflich mit Demenzpräparaten
zu tun, aber dem NMDA-Antagonist- Wirkansatz.
Im Prinzip klingt das alles sehr spannend, ich melde mich
wieder.
Kala
Hier gehts zur Cortex DIA Show

Wenn ihr das Bild noch mal sehen wollt einfach auf der linken Seite kleines Vorschaubild anklicken.

http://www.vm-elsig.de/achim/dia0/

Viel Spaß beim Anschauen
Erbse
Letzte Aktionärsversammlung mit Media Player mit Ton Cortex Pharmaceuticals
http://www.cortexpharm.com/html/Webcast.html

Längere Präsentation von der letzten Aktionärsversammlung in Englisch. Sehr informativ. Dauert wohl etwas länger. Windows Media Player erforderlich. Eine kurze Zusammenfassung gibts in den zwei DIA Shows in den zwei vorherigen links ohne Ton.

Schönen Tag noch
Erbse
Interessanter Artikel aus der Ärztezeitung, bei dem bei verringertem Tiefschlaf von Gedächtnisdefiziten ausgegangen wird. Genau hier setzt Cortex bei Schlafentzug mit CX717 und Organon bei Schizophrenie mit ORG24448 an.

Schönen Tag noch
Erbse


Ärzte Zeitung, 20.01.2005


Je mehr Tiefschlaf, desto besser das Gedächtnis
Möglicher Therapieansatz bei Schizophrenie-Patienten mit Gedächtnisstörungen / Studie an der Uniklinik in Kiel
KIEL (nke). Wenn der Tiefschlaf gestört ist, zum Beispiel aufgrund einer seelischen Erkrankung, schadet das dem Gedächtnis. Den Zusammenhang zwischen Schlafstörung und Lernleistung haben Kieler Schlafmediziner bei Patienten mit Schizophrenie nachgewiesen.

Wer nicht genug schläft, kann nicht gut lernen. Denn während des Schlafs wird Gelerntes im Gedächtnis gespeichert. Grundsätzlich unterscheiden Gedächtnisforscher zwischen Gedächtnis, daß durch bewußtes Lernen entsteht, etwa beim Lernen von Prüfungsstoff, sowie Gedächtnis, das weitgehend unbewußt entsteht, etwa beim Lernen von Bewegungsabläufen. Für das bewußte Gedächtnis ist vor allem der Tiefschlaf, für das unbewußte Gedächtnis eher der Traumschlaf nötig, berichtet Dr. Robert Göder aus Kiel.

Bei Patienten mit Schizophrenie ist oft das bewußte Gedächtnis gestört. Die Patienten haben oft auch Schlafstörungen. Ob es einen Zusammenhang zischen Schlaf- und Gedächtnisstörungen bei Schizophrenie gibt, haben der Leiter des Schlaflabors der Kieler Universitätsklinik und sein Team jetzt bei 17 Patienten und 17 Gesunden untersucht (J Psychiatr Res 38, 2004, 591).

Vor dem Zubettgehen und nach dem Aufwachen mußten die Studienteilnehmer spezifische Gedächtnistests ablegen. Damit sollte die Lernleistung über die Nacht festgestellt werden. Dazwischen wurde der Schlaf dokumentiert.

Patienten mit Schizophrenie benötigten mehr Zeit bis zum Einschlafen, schliefen schlechter und hatten insgesamt weniger Tiefschlaf im Vergleich mit gesunden Teilnehmern. Die Gedächtnisleistung war, wie erwartete, ebenfalls schlechter als bei Gesunden. "Je mehr Tiefschlaf die Patienten hatten, desto besser war die Gedächtnis-Leistung. Je weniger, desto schlechter die Leistung", so Dr. Dunja Hinze-Selch von der Uniklinik Kiel zur "Ärzte Zeitung".

Unklar ist noch, ob die Dauer des Tiefschlafs oder der Anteil des Tiefschlafs an der gesamten Schlafdauer entscheidend ist. "Im Moment sieht es so aus, daß es beim Tiefschlaf einen Schwellenwert gibt. 20 bis 25 Minuten Tiefschlaf könnte so ein Wert sein, der für die maximale Lernleistung nötig ist."

Aus diesen Befunden ergibt sich auch ein neuer Therapieansatz für die Betroffenen. So könnten durch gezielte Beeinflussung des Schlafes, etwa durch Medikamente, auch das Gedächtnis verbessert werden. Denn die eingeschränkte Gedächtnisleistung belastet die Schizophrenie-Patienten sehr und behindert deren soziale Integration. Medikamente, die gezielt den Tiefschlaf fördern, gibt es jedoch noch nicht, es wird aber daran geforscht.

Wäre eine solche Pille, mit der man den Tiefschlaf verlängert, nicht auch für Gesunde interessant? Göder ist skeptisch: "Ob man als Gesunder viel besser lernt, wenn man noch mehr Tiefschlaf hat, ist sehr fraglich. Von einem solchen Medikament könnten vermutlich vor allem die Menschen profitieren, die aufgrund einer Erkrankung keinen Tiefschlaf mehr haben. Sie könnten eventuell einen Teil der Gedächtnis-Defizite wieder ausgleichen."

http://www.aerztezeitung.de/docs/2005/01/20/009a1301.asp?cat…
Ein sehr umfangreicher guter Artikel in der GEO Zeitschrift
Lernen-Serie, Teil 4: Doping fürs Gehirn

Wissenschaftler arbeiten an Arzneien, die einem schwindenden Gedächtnis aufhelfen und das Denken schärfen sollen. Aber wie weit dürfen wir gehen bei der Manipulation unserer grauen Zellen?
http://www.geo.de/GEO/medizin_psychologie/psychologie/2005_0…
Radiosendung vom Deutschlandfunk über Ampakine
http://www.dradio.de/dlf/sendungen/forschak/333410/
Media Player erforderlich. Dauer ca: 4:30 Min

Biochemische Gedächtnisstütze US-Mediziner testen Neurowirkstoff Ampakin Wer schon einmal mit Kindern Memory gespielt hat, wird sich daran erinnern kein Bein auf die Erde bekommen zu haben. Kein Wund ...

Schönes Wochenende
Erbse
Organon’s compound, Org 24448, selected to test efficacy of cognitive dysfunction in schizophrenia

Cortex hat ORG24448 an Organon auslizensiert

The National Institute of Mental Health (NIMH) sponsored network called Treatment Units for Research on Neurocognition in Schizophrenia (TURNS) has selected Organon’s compound, Org 24448, to undergo testing as part of its effort to facilitate the development of medications to enhance cognition in patients with schizophrenia.

Kompletter Text unter folgendem link
http://www.news-medical.net/?id=7455

Schönen Tag noch
Erbse
gestern kam ein Bericht zu dem Unternehmen auf SpiegelTV

recht interessant!
Nach der guten Nachricht von gestern, heute einige Informationen zu Fragile X. Die Ergebnisse mit CX516 dürften wohl in nächster Zeit veröffentlicht werden. Von den Daten wird allenfalls ein Hinweis auf die Wirksamkeit von CX516 erwartet. Es ist sehr schwach wirksam und muß also hoch dosiert werden. Aus den MCI Versuchen ist bekannt, daß viele Patienten über Magen-Darm Problemen klagten, da es sehr hoch dosiert werden mußte.
Außerdem ist bei CX516 über die sehr kurze Halbwertszeit zu klagen. Es baut sich also schon innerhalb weniger Minute im Körper ab.
Fragile X dürfte bei Cortex wohl eine der ersten "Orphan Anwendungen" sein. Ich denke mal, daß eine weitaus stärkere Substanz als CX516, das im Augenblick getestet wird, dafür gewählt wird.
Folgend noch einiges Wissenswertes über Fragile X und die Phase2 Versuche.



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

Dr. Berry-Kravis ist Leiterin des jetzt laufendes Versuches mit CX 516

Clinical Trial of a New Medication in Adults with Fragile X
http://www.fraxa.org/ra_Berry-Kravis.aspx

Weitere Informationen im nächsten link in einem ausführlichen Interview.
Fragile X/Autism Help -- Full-Length Doctor`s Interview
http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=8…

Ergänzend zu dem Interview bietet sich eine DIA Show mit viel Informationen von einer Cortex Präsentation an. Alles Wissenswete mit einigen DIAS.
Hier gehts zur DIA Show über FRAGILE X
http://vm-elsig.de/achim/Fragile/


Wünsche allen noch einen schönen Tag
Erbse
Kurze Frage!

Fragile - gehört das zu Cortex?!
Hallo Lisa,
Fragile X gehört nicht Cortex. Fragile X ist eine Erkrankung. Ein Wirkstoff von Cortex , CX 516, wird im Augenblick in einer Testphase 2 von FRAXA gegen einige Aspekte dieser Krankheit getestet. Es ist aber sehr wahrscheinlich, daß eine stärkere Substanz von Cortex letztendlich zur Marktreife gebracht werden soll.
Ich hoffe, ich habe Deine Frage richtig verstanden.
Liebe Grüße
Erbse
ja danke!

Was ist denn von den Gerüchten zu halten, Cortex habe kein Geld mehr weiterzutesten!?

Und ist nicht Roche an Bord?!
Nein Lisa, Roche ist bisher nicht an Board. Roche hat sich bei einem Konkurrenten Memory Pharma engagiert.
Geld ist nach einigen Kapitalmaßnahmen für ca 3 Jahre vorhanden.
Es ist geplant einige Substanzen an größere Pharmaunternehmen auszulizensieren und so den weiteren Erhalt der Firma zu sichern.
Diese Informationen stehen aber alle unter dem link an den Brief an die Aktionäre vom CEO Stoll.
Liebe Grüße
Erbse
Hier ein Abstrakt, der die Möglichkeiten der Ampakine aufzeigt:

Therapeutic potential of positive AMPA modulators and their relationship to AMPA receptor subunits. A review of preclinical data.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d…

Schönen Tag noch
Erbse
Hallo!

Hat denn jemand von euch auch nähere Infos zu der finanziellen Situation von Cortex?

Wie hoch ist die Cash-Burn-Rate und wie schätzt man die Chancen auf zukünftige Vermarktungen ein, etc. ect. etc...?

Wie seht ihr die Aktienentwicklung!? War das heute der Tiefpunkt bei 2,45 $ in den USA!? Wie ist die Aktie bewertet? Wieviele Stück gibt es?
Wie gut ist das Management dieser Firma? Kann man von ihnen ein schönes Wachstum für die Zukunft erwarten. Gibt es BWL`ler in der Firma oder ist der Laden durchweg von Forschern / Wissenschaftlern durchzogen?!

Beste Grüße und weiterhin viel Erfolg,

Thomas
Hallo Thomas,
du solltest Dir auch etwas Mühe machen. Ich poste seit drei Jahren regelmäßig zu Cortex. Lies bitte die letzten zwei Threads zu Cortex und es werden Dir fast alle Fragen komplett beantwortet. Ich habe wirklich keine Lust Dir eine komplette Analyse zu Cortex zu schreiben, nur weil du keine Lust oder Zeit zu eigener Recherche hast. An Deinen Fragen merke ich , daß Du noch nicht einmal diesen Thread gelesen hast..
Ich habe keine Lust dir Deine Arbeit zu machen. Du brauchst nur die links anzuklicken und die Fragen werden Dir beantwortet. Gehe doch auch mal auf die Cortex Homepage. Lies diesen Thread durch und klicke auf die links.
Liebe Grüße
Erbse
Hallo liebe Cortex Fans,
folgend ein link zur aktuellen Patentsituation in Europa mit dem Eli Lilly Disput.
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

Der nächste Bericht beschreibt die Planung für die nähere Zukunft und die finanzielle Situation von Cortex.
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

Schönen Tag noch
Erbse
News von Heute
Cortex Pharmaceuticals Receives FDA Permission to Commence Phase II Alzheimer`s Disease Imaging Study with AMPAKINE CX717
http://biz.yahoo.com/bw/050131/315195_1.html
Hallo liebe Cortex Fans,
hab eine interessante Seite gefunden, die sich unter Anderem auch mit unserer Thematik beschäftigt. Den Artikel über Cortex kopier ich mal hier rein. Weitere Hintergrundartikel gibts unter dem link.

Schönen Tag noch
Erbse

http://www.ams.or.at/wien/biz/vision/archiv/rund107.htm

Beispiele für konkrete Anwendungen

Neuro-Pharmakologie
Eigentlich ist es ein ganz normaler Prozess: Im Alter lässt das Gedächtnis nach. Wenn es jedoch immer mehr alte Menschen gibt, die zugleich immer jünger sein wollen, wird dieser Vorgang zu einem Problem.Und damit zu einer echten Herausforderung für die Neuro-Pharmakologie, deren Forscher dazu beizutragen versuchen, degenerative Hirnerkrankungen künftig wenn nicht zu heilen, dann doch zumindest wirksam aufzuhalten.Und damit gleichzeitig die Bedürfnisse all jener zu befriedigen, die sich in der Wissensgesellschaft der Zukunft auch als Gesunde nach einem effektiven Mittel zur Steigerung von Konzentrationsfähigkeit und Gedächtnisleistung sehnen.

Anti-Aging und Pro-Braining:
"Die Generation der heute 40- bis 60-jährigen Amerikaner hat sich wie keine andere vor ihr dem ehrgeizigen Ziel verschrieben, den Alterungsprozess aufzuhalten." Mit dieser Analyse bringt der Gerontologe Dr. Ken Dytchwald (in: "American Demographics" 5/03) auf den Punkt, was die Märkte in den USA und anderen westlichen Regionen in den nächsten Jahren am meisten umtreiben wird: das Bedürfnis ihrer alternden Bewohner nach Jugendlichkeit und Selbstverbesserung. In einer Gesellschaft, die konsequent auf die körperliche und geistige Fitness des Individuums ausgerichtet ist, wird Enhancement zur Selbstverständlichkeit.

Eine Sorge, die zwar verfrüht (der größere Teil der Alzheimer-Patienten ist heute über 80 Jahre alt), aber nicht ganz unbegründet ist: Allein in Deutschland leben mittlerweile bereits fast eine Million Demenzkranke, von denen zwei Drittel von der Alzheimer-Krankheit betroffen sind. Die steigende Lebenserwartung bringt es mit sich, dass sich diese Zahl bis zum Jahr 2050 auf mehr als zwei Millionen verdoppeln wird – sofern kein Durchbruch in Prävention und Therapie gelingt. In Österreich stellt sich die Situation vergleichbar dar: Demnach könnte sich die Zahl der Demenz-Patienten bis zum Jahr 2050 auf knapp 250.000 erhöht haben, noch in den 50er Jahren waren es nur 35.000, so die Ergebnisse einer Berechnung an der Wiener Uni-Klinik für Psychiatrie.

Kein Wunder also, dass die Pharma-Forschung in diesem Segment mit Hochdruck vorangetrieben wird und neben den Branchenriesen auch allerhand junge und kleinere Firmen fieberhaft an der Entwicklung neuartiger Gedächtnis- und Lernpillen arbeiten. Denn auch das zeichnet sich ab: Sollte es gelingen, die schweren manifesten Hirnerkrankungen mittels Neuro-Pharmakologie in den Griff zu bekommen, könnten davon auch all jene profitieren, die an milden kognitiven Störungen (MCI,Mild Cognitive Impairment), sprich der Altersvergesslichkeit, leiden – was auf rund 60 Prozent der Älteren zutrifft und inzwischen zumindest in den USA von der Federal Drug Administration sogar als Krankheit anerkannt worden ist.

Und nicht zuletzt werden sich auch die (noch) ganz Gesunden für die Medizin interessieren, die ihnen helfen kann, die Anforderungen in ihrem Alltag mit höchster Konzentration und Gedächtniskraft zu bestehen. Schon heute wird die "pharmakologische Optimierung überall eingesetzt: zur Verbesserung der Stimmung, der Wahrnehmung und von vegetativen Funktionen wie Schlaf, Appetit und Sex", fasst Neuropsychologin Dr. Martha Farah die Entwicklung zusammen (in: "Technology Review" 10/03). So dient etwa Prozac in den USA nicht mehr nur der Behandlung von schweren Depressionen, sondern wird auch von Menschen eingenommen, die sich davon mehr Selbstvertrauen und Lebensfreude erhoffen.

Stand der Forschung:
"Die großen Pharma-Unternehmen erforschen solche Substanzen nicht nur zur Behandlung von Demenzerkrankungen, sondern auch im Hinblick auf ganz normale Menschen – dort wartet der Profit. Die Behandlung der Demenzerkrankungen liefert ihnen die medizinische Rechtfertigung." meint Neurowissenschaftler Prof. James McGaugh in: "Technology Review" 10/03

• "Früher oder später wird es Medikamente geben, die zumindest Teile unseres Denkens verbessern", gibt sich Neurowissenschaftler Dr. Gary Lynch optimistisch und hat zum schnelleren Erreichen dieses Ziels das Unternehmen Cortex Pharmaceuticals gegründet. Der bislang größte Erfolg der Forscher dieser Firma: die Entwicklung so genannter Ampakine, einer Wirkstoffgruppe, die die Funktionen des Ionenkanals an der Nervenzelle verändern, so dass mehr Kalzium-Ionen hineinströmen können und damit das Signal zur Gedächtnisbildung verstärkt wird. Die ersten Tests mit Patienten verlaufen erfolgreich.

• Auch bei Memory Pharmaceuticals sind die ersten Tests mit Patienten angelaufen. Das Unternehmen arbeitet unter Federführung des Nobelpreisträgers Prof. Eric Kandel an der Entwicklung eines PDE-4-Hemmers. Der neue Wirkstoff soll den Abbau eines Signalmoleküls (cAMP) durch das Enzym Phosphodiesterase (PDE) blocken und so einen positiven Einfluss auf die degenerativen Hirnveränderungen ausüben. Mit beteiligt an der Entwicklung ist Großkonzern Roche.

• Zur Erreichung eines anderen Forschungsziels ist man bei der Firma Memory Pharmaceuticals eine Lizenzvereinbarung mit Bayer eingegangen, so dass das Leverkusener Unternehmen im Falle des Erfolgs die Vermarktungsrechte am Wirkstoff MEM 1003 besitzen wird. Auch dieser soll Veränderungen am Ionenkanal der Nervenzellen bewirken – die erste klinische Testphase ist inzwischen abgeschlossen. Schließlich arbeiten auch Forschergruppen bei den Pharma-Riesen GlaxoSmithKline, Johnson & Johnson und Merck sowie von zahlreichen jungen Pharma-Unternehmen wie Helicon, Axonyx oder NeuroLogic an der Erforschung neuer Neuro-Pillen.

Prognose des Zukunftsinstituts (Matthias Horx):
"Cognition Enhancer sind eine Zeitbombe" äußert der Alzheimer-Experte und Neuroforscher vom European Molecular Biology Laboratory in Heidelberg, Prof. Konrad Beyreuther. Schließlich rückt mit den neuartigen Hirnpillen auch die Essenz des Menschlichen in Griffweite: die pharmakologische Verstärkung und biochemische Lenkung der Hirnfunktionen. Doch was für die einen Anlass zu Besorgnis erregender Diskussion über die ethischen Aspekte eines solchen Brain-Tunings gibt, stellt für die anderen den größten Pharma-Markt der Zukunft dar. Die Möglichkeit, die eigene Kreativität und mentale Fitness zu verbessern, wird weltweit künftig noch mehr Menschen faszinieren. Und der wachsende Patientenstamm mit echten degenerativen Hirnerkrankungen pusht die Entwicklung zusätzlich.

(Der Zukunftsletter erscheint 12-14mal im Jahr, jeweils zum Preis von 15,24 Euro im Verlag für die Deutsche Wirtschaft AG, Theodor-Heuss-Str 2-4, D-53177 Bonn, Deutschland; http://www.zukunftsletter.de oder http://www.zukunftsinstitut.de; Oktober 2004)
Hallo liebe Cortex Freunde,
es tut sich langsam was bei den Fragile X Versuchen. Letzte Woche kam die Meldung, daß die Rekrutierung abgeschlossen ist.

Effects of CX516 on Functioning in Fragile X Syndrome and Autism
This study has been completed.

http://www.clinicaltrials.gov/ct/show/NCT00054730

Erfahrungsgemäß dauert es dann noch einige Zeit, bis die Ergebnisse ausgewertet sind.




Dazu die Meldung von FRAXA

<<<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 should be completed by the end of 2004; it will then take some time to analyze and publish the results.>>>
http://www.fraxa.org/ra_Berry-Kravis.aspx

Hintergrundinformationen zu Fragile X gibt es einige Postings zurück. Zu erwarten ist, daß wohl eine potentere Substanz als CX516 zur Marktreife gebracht werden soll. Gespannt bin ich aber trotzdem auf die Ergebnisse mit CX516.

Hier noch mal der link zu der DIA Show von einer Cortex Präsentation zu Fragile X.

http://vm-elsig.de/achim/Fragile/

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,

heute möchte ich mal einige Gedanken zu dem Gebiet Schizophrenie und der letzten Meldung zu ORG-24448 äußern.

Wissenswertes und einige Grundlagen zu dieser Erkrankung gibts unter folgendem link.

Grundwissen Schizophrenie
Was sind Psychosen?
http://www.bayervital.de/pages/therapiegebiete/schizophrenie…

Weitere Informationen zu dem Themengebiet Schizophrenie gibts unter den folgenden links.

http://www.biospace.com/news_rxtarget.cfm?RxTargetID=188
http://www.hubin.org/news/archive/index_en.html
http://www.docguide.com/news/content.nsf/PatientResAllCateg/…

Der nächste Bericht beschreibt die aktuelle Entwicklung im Bereich der Psychosemedikamente. Dies dürfte auch kalabrienfan interessieren, da hier auch Memantine aufgeführt wird. Memantine sowie einige andere Kandidaten werden in Testphase 2 gegen die kognitive Symptomatik getestet. Von Aricept ist mir bisher kein Test gegen die kognitive Symptomatik bekannt. Die Daten vom Schaubild können dann allerdigs nur als grober Hinweis gedeutet werden.

New Schizophrenia Medications in the Pipeline

http://www.schizophrenia.com/newmeds2004.htm

Interessant wird die ganze Tatsache dadurch, daß Aricept im Tierversuch gegen CX717 getestet wurde. Gleich folgt ein Schaubild zu diesem Test. Dieser Test wurde allerdings bei Schlafentzugsversuchen durchgeführt.
Es besteht allerdings ein Zusammenhang von Schlafstörungen bei Schizophrenieerkrankten und kognitiver Leistungsminderung.

Möglicher Therapieansatz bei Schizophrenie-Patienten mit Gedächtnisstörungen
Je mehr Tiefschlaf, desto besser das Gedächtnis
http://www.aerztezeitung.de/docs/2005/01/20/009a1301.asp?cat…
ORG24448 gehört zur gleichen Wirkstoffgruppe wie CX717 , so daß wir von einem ähnlichen Wirkprofil wie bei CX717 ausgehen können.



Es wundert mich also nicht, daß ORG24448 als einer von bisher zwei Kanditaten von Turns augesucht wurde.



<<<Two compounds were selected to move forward for inclusion in TURNS conducted clinical trials. Org 24448, developed by Organon Inc., modulates the activity of AMPA-R receptors in the glutamate system. TC-1734, developed by Targacept Inc., is a partial agonist of the alpha-4-beta-2 nicotinic acetylcholine receptor. The TURNS network is planning to study these compounds in separate trials during the spring and summer of 2005. >>>

Dabei werden folgende Aspekte untersucht.

Overview of Impaired Cognition in Schizophrenia

Schizophrenia is associated with a range of impairments in neurocognitive domains that include memory, attention, executive functioning, and psychomotor performance. These impairments appear to be a core feature of schizophrenia because such deficits are found in attenuated form in first-degree relatives of patients and because they are independent of the psychotic symptoms of the illness. Cognitive impairments are common at the onset of schizophrenia and can frequently be identified in childhood, well before psychotic symptoms emerge. In contrast to psychotic symptoms which are typically episodic, impairments in cognition appear to be a stable feature of the illness. Most contemporary models for conceptualizing schizophrenia recognize that impairments in neurocognition should be included as a distinct feature of the disorder, in addition to negative symptoms, positive symptoms, and thought disorganization.

Given the wide range of cognitive deficits in schizophrenia, there is uncertainty about which domains are the most important to measure and to treat. One of the key goals of the NIMH Contract: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS), is to identify the cognitive domains to be assessed in the NIMH consensus battery that will be used in TURNS, and in other clinical trials of pro-cognitive medications for schizophrenia. Based on a review of existing data sets, the MATRICS Neurocognition Committee concluded that there was empirical support for six separable cognitive domains: Verbal Learning and Memory, Speed of Processing, Working Memory, Reasoning and Problem Solving, Attention/ Vigilance, and Visual Learning and Memory. Based on responses from participants at the first MATRICS consensus meeting, held in April 2003, one additional domain was considered important to assess in the MATRICS battery: Social Cognition.

Cognitive impairments are important as a treatment target because they have a substantial impact on the outcome of schizophrenia. Literature reviews by Green and colleagues have demonstrated that there are consistent relationships between cognitive deficits measured in the laboratory and functional outcome in schizophrenia, including social outcome, vocational outcome, and success in rehabilitation programs. These relationships between neurocognitive deficits and functional outcome are found in both cross sectional and longitudinal studies. In contrast to cognitive deficits, clinical symptoms are only weakly related to functional outcome in schizophrenia. The magnitudes for the relationships between cognitive deficits and functional outcome are medium for individual cognitive constructs (such as those identified as separable factors by the MATRICS Neurocognition Committee) and the relationships can be large when summary scores (e.g., composites of several cognitive functions) are used. This literature on cognitive linkages to functional outcome provides a rather compelling rationale for intervention at the level of cognition.

Antipsychotic medications may lead to some improvement in cognition in schizophrenia, although the overall effects are relatively weak. A body of research suggests that second generation antipsychotic medications appear to have beneficial effects on cognition, at least when compared with first generation agents. However, patients with schizophrenia often perform two or three standard deviations below the mean of controls on neurocognitive tests and newer antipsychotic drugs only make up a fraction of that difference. This gap in the effectiveness of antipsychotic drugs for neurocognition has inspired a search for co-treatments that can be added to an antipsychotic to improve cognition.

Dies wars erstmal zu diesem Themengebiet

Schönen Tag noch
Erbse
Auch der Neuroinvestor hat sich gestern zu dem Themengebiet ORG24448 geäußert. Ich kopier den Artikel mal kurz hier rein.
Schönen Tag noch
Erbse

I think the schizophrenia story has moved beyond the `colossally speculative`. The decision by the NIMH sponsored TURNS group--whose task it is to find sz drug adjuncts that will improve cognition--was to choose two drugs for Phase II trials: They chose a nicotinic agonist from Targacept and Org24448.There were quite a number of candidates (who wouldnt want a Phase II run on NIMH`s dime--other than BPs?). This is--to me--the first independent indication that Org24448 has looked good in Phase II--the drug would not have been chosen without a look at that data. This may only be a proxy for having demonstrated efficacy, but it does say something beyond theoretical rationale. And it`s not like there aren`t a lot of companies looking to improve negative and cognitive sx in sz, I am preparing a review of sz right now, and it`s a hot area.

I believe schizophrenia could be the first major indication in which an Ampakine receives approval. It`s the only one in Phase IIb. I suspect Cortex`s royalties are tiered--I vaguely remember (my records are all in storage due to a relocation in progress) Vince Simmon making reference to the 8-10% range, but I believe Roger Stoll has reported `double digits`--perhaps it`s once sales reach a certain threshold. The problem with the Organon deal was not so much the royalty rates, as the paltry upfront and milestone payments--it was very backloaded, and Organon has been a sloth of a partner.

No one--even, so far as I can tell, Cortex--had gotten access to Organon`s Phase II sz data in detail until the TURNS committee did, and I personally am impressed that Org24448 was chosen. My understanding is that they would have been even happier to use CX717, but since Organon holds the schizophrenia license.....

COR management isn`t in a position to `trumpet` Org24448. And what biotech `experts` have seen the data? None--just the TURNS group. So their response does mean something to me, and it will mean something to BP companies assessing Ampakine partnership options. Will that in itself will add value to the stock price before the TURNS data comes out in 2006? Maybe not, but I am excited about it.

NeuroInvestment

Quelle:
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
Coverage initiated on Cortex Pharm by Rodman & Renshaw

09:38 COR Cortex Pharm: started with Outperform and $8 price tgt at Rodman & Renshaw (2.70 +0.11)

Rodman & Renshaw initiates COR with an Outperform and $8 price tgt. Firm notes that memory and cognition disorders impact approximately 200 mln people worldwide, and the so-called AMPA receptor appears to be the most validated memory target. They believe COR is the pioneer in the development of AMPA-modulating compounds. Following a recent setback of a competitor, firm believes that within 6-12 months, Cortex could have the most advanced AMPA modulator and memory enhancer in mid-stage development. With successful clinical results and a partner on board, firm believes Cortex`s enterprise value could jump from its current $60 mln to the $250 mln level.

Schönen Tag noch
Erbse
Der ehemalige CEO von Questcor Pharmaceuticals / QSC / 899085 soll CEO von Cortex / COR werden.

QSC halte ich als Turnaround-Kandidaten für sehr interessant.
Wenn ich das richtig sehe, ist Cortex CEO Stoll gelegentlich mit an Board als Direktor von Questcor

<<<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. Dr. Stoll obtained a B.S. in Pharmacy from Ferris State University and a Ph.D. in Biopharmaceutics from the University of Connecticut.>>>>

http://www.cortexpharm.com/html/corp/index.html

Wenn Deine Meldung stimmen sollte bitte mit Quellenangabe. Ich halte es einfach nur für ein Gerücht

Liebe Grüße
Erbse
Sorry, meine Fehlinterpretation eines Beitrags auf dem QSC-Yahoo-Board.
Der ehemalige CEO von QSC, Charles J. Casamento ist BOD-Mitglied bei COR, nicht CEO.

COR & QSC scheinen Verbindungen untereinander zu haben.

Bin seit 2004 in QSC investiert.

Turnaroundwert, Insiderkäufe, Fonds und das bei einem (noch) Pennystock...schaun wir mal
Es gibt drei Firmen/Aktien, die ich regelrecht hasse. Und Questcor ist eine von Ihnen, die einzige Biotech übrigens.

Wenn der Casamento CEO von Cortex wird, dann verkaufe ich die sofort. Der hat schon Cypros mit seiner spannenden Pipeline zerstört. Ich weiß nicht, wie es der Casamento immer wieder schafft, Geld zu beschaffen und Leute zu beeindrucken, aber der muß hypnotische Fähigkeiten besitzen.
Hallo puhvogel, kannst du deine Abneigung etwas präzisieren. Das sind für mich immer Hinweise, denen man mehr Beachtung schenken sollte als man dies hinlänglich tut.

Bin immer noch in Cortex investiert und möchte mich an dieser Stelle auch mal wieder bei Erbse für seine unermüdliche Arbeit bedanken (selbst bin ich bei HGRD nicht immer so fleißig ;-)).

Hatte mich dieser Tage mal mit einem Wissenschaftler aus der Neuropharmazie unterhalten, der Cortex als ein spannendes Investment sieht, ihnen aber nicht so viel zutraut, da er davon überzeugt ist, daß die Patente auf diese Ampakine auf Dauer nicht haltbar sind (seien wie ein Patent auf Wasser - aus wissenschaftlicher Sicht), und Ely-Lilli nur deshalb verloren hat, weil sie den Rechtsstreit mit Cortex unterschätzt hatten.

Er empfiehlt, sich mal mit Memory Pharma und Neurochem zu beschäftigen und diese als Diversifikation in ein Neuro-Pharma-Portfolio mit aufzunehmen. Werd ich mal recherchieren.

Gruß Coluche
Hallo Coluche,
schön mal wieder von dir zu hören. Zur Patentlage habe ich ein Schaubild von der letzten Cortex Präsentation. Es handelt sich dabei gar nicht um nur nur ein Patent, sondern um eine ganze Reihe. Streitig ist im Augenblick nur eins zur Erteilung in Europa.

Als zweites hänge ich noch ein Bild zur Aktienanzahl von Cortex vor der letzten Kapitalmaßnahme dran. Tatsächlich ist man jetzt bei einer Gesamtzahl von ca. 50 Millionen angelangt.

Schönen Tag noch
Erbse



Artikel zu Fragile X mit Ankündigung baldiger Veröffentlichung Der Phase 2 Versuche.

Grüße
Erbse

Research suggests brain drugs can ease a common mental defect

Scientists in the Phila. region used fruit flies to study the potential for fragile X treatments.

By Stacey Burling

Inquirer Staff Writer


New research lends support to the idea that medications aimed at fixing chemical abnormalities in the brain may one day help people with the most common form of inherited mental retardation: fragile X syndrome.

Scientists at the University of Pennsylvania, Drexel University and Albert Einstein medical schools found that treatment with several drugs improved learning in fruit flies that had the same genetic abnormality as people with fragile X. The drugs - lithium, a mood stabilizer often used to treat bipolar disorder, and several medications not approved by the FDA - are believed to improve connections between neurons in a chemical system important for learning and memory.

It`s difficult to know how the medications might affect humans, said Thomas A. Jongens, associate professor of genetics at Penn and senior author of the study published in today`s issue of Neuron. "The hope is that these drugs might actually ameliorate some of the symptoms of fragile X."

Other genetics experts cautioned that there are big differences between fruit flies and humans, but said the new study bolsters similar findings in mice.

Fragile X, caused by malfunctioning of the FMR1 gene, affects 1 in 4,000 males and 1 in 8,000 females. Characteristics include low IQ, short-term memory deficits, autistic behavior and attention problems.

In the experiment, Jongen said, normal male fruit flies were placed with females who had already mated. They were rejected in no uncertain terms. The males were traumatized by the rejection, Jongen said, and would not romance a virgin fly for at least three hours after the experience. Fruit fly experts consider this learning.

Under the same circumstances, flies with the fragile X-like mutation behaved as if they had never been rejected. But, after eating any of the five drugs, they acted like normal fruit flies, Jongen said.

Stephen Warren, a human geneticist at Emory University, said he and Mark Bear, a neuroscientist at the Massachusetts Institute of Technology, first theorized about two years ago that animals with the genetic malfunction have what are called overactive metabotropic glutamate receptors. These receptors, Warren said, tend to overproduce proteins which then disrupt connections between brain nerve cells.

Jongens` team tested four investigational drugs that block action at the receptors, and lithium, which disrupts the pathway farther down the line. The investigational drugs are unlikely to get FDA approval, he said, because of their side effects.

All the drugs seemed to be equally effective at improving memory in the flies who were missing the fly equivalent of the FMR1 gene.

Brenda Finucane, executive director of genetic services at Elwyn Inc., said short-term memory is a significant problem for people with fragile X. "It takes them many, many repetitions before they can get something into long-term memory," she said. Long-term memory functioning is quite good, she added.

Lithium is used in some people who have the disorder and bipolar symptoms. She said she had never heard of a dramatic change in thinking ability in people taking the medication. That doesn`t mean, she said, that "there couldn`t be subtle but important differences."

Jongens said clinical trials will now be done to evaluate the drug`s effect on cognition.

Cortex Pharmaceuticals, in Irvine, Calif., is testing another drug, called CX516, in people with fragile X syndrome. Results should be available "relatively soon," said Hank Mansback, the company`s chief medical officer.
Hallo liebe Cortex Fans,
Cortex präsentiert mal wieder. Es ist sehr gut möglich, daß hier die Ergebnisse von CX717 bei Schlafentzug präsentiert werden.
Außerdem stehen noch in nächster Zeit die Phase 2 Ergebnisse bei Fragile X mit CX516 an.

Schönen Tag noch
Erbse

NEW YORK--(BUSINESS WIRE)--March 7, 2005--Rodman & Renshaw is pleased to announce that its 2nd Annual Global Healthcare Conference will take place at the Intercontinental Hotel in Paris, from 4th May to 6th May 2005.

http://www.companynewsgroup.com/communique.asp?co_id=98975
Zu Fragile X gibt es eine Stellungnahme von Elizabeth Berry-Kravis. Dabei ist von CX717 als wirkungsvolleres Medikament die Rede. Gleichzeitig ist dies der Hauptkandidat zur Auslizensierung. Mal sehen wie Cortex dieses Problem löst.
Schönen Tag noch
Erbse

Folgendes posting ist eine Anfrage von dem user ombowstring aus dem Yahoo-Board.

I contacted Elizabeth Kravis-Berry, who is doing the CX516 study in Chicago for Fragile X. This was her response:

John - My hospital referral service for clinical trials forwarded your email to me. We just finished the CX516 study and are in the process of analyzing the data. The study was foremoest a safety study but we have some efficacy data. It will be written up for publication this Spring or Summer. I am in close contact with Roger Stoll at all times and we have discussed the possibility of a CX717 trial in fragile X as it is likely that compound will be more effective than CX516. Certainly if we can show an ampakine is helpful in fragile X, we would push for an Orphan Drug indication through the FDA. Thanks for your interest.

Liz Berry-Kravis

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
Hab noch einen tollen Artikel zu Schizophrenie gefunden.
Dank an den User gfp927z. Auch der Neuroinvestor schreibt diesen Monat zu diesem Thema.
Schönen Tag noch
Erbse

Schizophrenia / cognition / Ampakines

Using an Ampakine in combination with the current atypical antipsychotic meds is emerging as one of the most promising indications for Ampakines, and is in fact our most advanced clinical program (partnered with Organon).

The recent selection of Org-24448 (CX-691) by NIMH/TURNS for their combo Schizo Phase 2b was a major validation for Cortex`s low impact family of compounds and for the Ampakine platform as a whole. NIMH/TURNS undoubtedly based their decision upon seeing Organon`s as yet unpublished Org-24448 Phase 2 Schizo data, so their decision is a strong signal that Org-24448 has been helping these Schizo patients considerably, and has had good safety characteristics. NIMH/TURNS selected Org-24448 ahead of the large number of other drugs submitted. As we know, Org-24448 is a sister compound of CX-717, both developed by Cortex and the lead compounds in our low impact family.

Preclinical studies have shown that the activity of even subthreshold doses of antipsychotics like Clozapine are greatly enhanced by Ampakines (see post 18702).
In the glutamate/dopamine hypothesis of Schizophrenia, the dopamine pathways are seen as being overactive (causing delusions / hallucinations), while the glutamte pathways are underactive (contributing to cognitive impairment). In fact, beyond mere cognitive impairment, glutamatergic hypofunction (particularly of the NMDA receptor) may also contribute to the other major psychotic symptoms. Current antipsychotic meds do nothing to correct the glutamate underactivity, and often exacerbate the patient`s cognitive impairment, along with causing a host of other serious side effects.

Using an Ampakine not helps to upregulate the underactive glutamate pathways, but also may allow lower dosing of the atypical antipsychotics meds, thereby lessening their various side effects (weight gain, sexual dysfunction, diabetes, agranulocytosis, cataracts, etc).

Low impact type Ampakines are particularly well suited for Schizophrenia, since significant neurotrophin upregulation isn`t a requirement, but very high safety is. Ampakines also upregulate NMDA activity indirectly (NMDA receptors being part of the underactive glutamatergic pathways), since NMDA receptors are downstream of AMPA receptor activity. In addition, Ampakines may prove to be safer than direct NMDA agonists, in part because Ampakines are allosteric and as such don`t create their own neuronal activity, but merely amplify/prolong the normal neuronal activity that is already present

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
Hallo liebe Cortex Fans, habe zu der Fragile X Thematik eine Radiosendung gefunden. Es geht um den englischen Artikel mit den Fruchtfliegen.

Pille gegen Erbkrankheit

Gedächtnisstütze für kranke Fliegen
Von Volkart Wildermuth
Medizin. - Geistige Behinderung. Diese Diagnose ist immer ein Schock für die Eltern. Es gibt viele Hilfen für diese Kinder, aber keine Heilung. Mit dieser pessimistischen Prognose wollen sich viele Forscher nicht mehr zufrieden geben. Sie suchen nach Medikamenten, die dem Verstand auf die Beine helfen sollen. Noch wagen sie sich allerdings nicht an die Patienten heran. Sie versuchen zuerst einmal kranken Fliegen zu helfen, wie sie in der aktuellen Ausgabe der Zeitschrift "Neuron" berichten.>>>>

Den kompletten Artikel und die Radiosendung vom Deutschlandfunk gibts unter folgendem link.
http://www.dradio.de/dlf/sendungen/forschak/352924/

Schönen Tag noch
Erbse
Es liegt eine Stellungnahme zu den Fragile X Versuchen. Wie erwartet ist CX 516 nicht potent genug.

Ich denke mal dieses Ergebnis hat jeder erwartet.

Liebe Grüße
Erbse

Clinical Trial of a New Medication in Adults with Fragile X


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

This two year study was originally funded in 2001 and renewed in 2002 for a total of $144,000.





In June 2002, a two year clinical trial was started to evaluate the first specific treatment for learning and memory deficits in Fragile X and autism.

Over the past decade, several pharmaceutical companies have been developing a new class of medications, Ampakines, which seem to enhance learning. Ampakines may help improve learning and memory in Fragile X by correcting a defect in the strength of brain cell communications. The compound used in this trial, Ampakine CX516, is the first of a series of compounds developed by Cortex Pharmaceuticals.

This two-year study has concluded as of March, 2005. A total of 49 adults with fragile X at RUSH University and 8 at the University of California at Davis (funded by the MIND Institute) have taken either the drug or placebo (sugar pills) for a 4 week period. Dr. Elizabeth Berry-Kravis and her team are currently analyzing the massive amount of data that was collected during the study. The study was "double blind" which means that neither the participants nor the doctors knew which people were on drug and which were not.

In early March 2005, Dr. Berry-Kravis and her team officially broke the blind and they now know which participants were taking CX516. Although the data analysis will continue for several months, it does not appear that the drug had a significant effect on thinking skills in fragile X participants. Behavioral information is still being analyzed.

Although the drug did not show therapeutic effects on participants with fragile X, the team has obtained valuable information regarding how to best test individuals with fragile X syndrome in a medication study. This new knowledge will help immensely in designing upcoming medication studies.

What does this mean for the future of ampakines as treatments for fragile X? The compound used in this trial, CX516, has been demonstrated to be very safe but not potent. Weak ampakines needed to be tested initially to make sure they were not dangerous to people. In fact, the dose of CX516 might have to be as much as four times higher to see good effects on cognitive skills.

Because the drug was safe and did not cause side effects like seizures, future trials can be considered using more potent ampakines more likely to provide cognitive benefit. Potent ampakines which last longer in the body are currently being tested in the mouse model of fragile X (see research project of Dr. Julie Lauterborn). The outcome of this and other studies will help determine whether stronger ampakines may be effective in treating fragile X; new trials will be planned if stonger ampakines seem likely to help.

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.

Kompletten Artikel unter folgendem link
http://www.fraxa.org/ra_Berry-Kravis.aspx
Hallo liebe Cortex Fans, habe einen interessanten Artikel zu Schizophrenie und kognitiven Defiziten gefunden.
Das Manko bei dieser Erkrankung ist nun, daß sehr wohl die Positivsymptomatik, also die Wahnideen behandelt werden. Bei den kognitiven Symptomen dagegen sieht es dann nicht mehr so gut aus.
Es wird also sehr lange dauern bis die Krankheit Schizophrenie als Ganzes gesehen wird, also mit Positivsymptomatik, Negativsymptomatik und den kognitiven Defiziten.
Dies betrifft auch Cortex mit ORG24448. Sollten die Ergebnisse positiv ausfallen, so liegt ein langer schwieriger Weg bei der Vermarktung vor Organon und Cortex.
Es wird sich sicher auch nicht jeder die Medikamente leisten können, wenn sie dann einmal auf dem Markt sein sollten.
In der Psychiatrie allerdings dauert alles sehr lange. Dies dürfte auch bei ORG24448 der Fall sein.
Folgend noch der link zu dem Artikel.

Schönen Tag noch
Erbse

Common Schizophrenia Symptoms Often Overlooked By Physicians
http://www.docguide.com/news/content.nsf/news/8525697700573E…
Der Neuroinvestor meldet sich auch noch mal in Sachen Cortex.

Cortex
(March 2005 issue comment)

The share price remained surprisingly stagnant with little volume--given the events cropping up over the next several months. Data for CX717 in April should be enough to elicit--within the ensuing three to six months-- the signing of a deal between Cortex and one of the numerous Big and midsize Pharma companies interested in partnering. We have been asked by several investors and observers why we maintain such a high target given Cortex`s laggard price performance--the best answer is to look at Neurogen January 2003-April 2004. During that period they partnered their VR-1 pain program with Merck, for $30 million upfront (half in equity), even though it had--and has--not yet reached the clinic. The market cap over the following 15 months went from $60 million to $350 million, and has remained strong even though the complement and CRF programs have both had serious setbacks.
The confluence of IP interests and territory was important to Merck and Neurogen, and we would not be surprised to see a similar meshing of development priorities with the Cortex deal--which means the companies who have either R&D history with the area (Lilly, GSK), or CNS management with AMPA experience and interests (Amgen), As is discussed in this issue, the Organon-run AMPA modulator program in schizophrenia was one of two (along with a Targacept drug) to be chosen for clinical trials by the NIMH-sponsored TURNS program. Organon is already on record as saying that they want to outlicense/partner late clinical stage programs--Org24448/CX691 is nearing a suitable point. Cortex plus Organon`s schizophrenia rights (throwing in depression as a sweetener) would look great in a Big Pharma`s Christmas stocking. Our target remains 12.

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

Einen weiteren Überblick zu den Ampakinen gibts von gfp927z.

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

Jetzt ist erst mal Warten auf die CX717 Ergebnisse bei Schlafentzug angesagt. Viele rechnen schon im April damit.

Schönen Tag noch
Erbse
Hab noch einen interessanten Artikel zu MEMY und COR gefunden.

Wettlauf gegen das Vergessen: Forscher entwickeln Pillen für ein besseres Langzeitgedächtnis

http://www.wissenschaft.de/wissen/hintergrund/250429.html

Schönen Tag noch
Erbse
Hallo liebe Cortex Fans, jetzt wirds langsam ernst. Die Ergebnisse bei Schlafentzug Phase 2A stehen an.
Hier die Ankündidung vom letzten SEC Filing.

<<<The Company is currently underway in a Phase I/II pilot efficacy in sleep deprivation in the U.K. Cortex hopes to have results from this trial by the end of April 2005, which may provide it with a dose range for future efficacy studies. Cortex plans to conduct several small pilot efficacy trials with CX717 during the first nine months of calendar 2005.>>>

Das gesamte Filing gibts unter folgendem link. Jede Menge Recherchestoff für Neueinsteiger.
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=000…

Morgen gibts übrigens eine Konferenz von Cortex
Cortex to Host Conference Call to Discuss Results for the Six-Months Ended December 31, 2004
http://biz.yahoo.com/bw/050321/215253_1.html

Schönen Tag noch wünscht euch
Erbse
Hallo liebe Cortex Freunde, folgend eine Zusammenfassung von der gestrigen Konferenz. Es geht alles seinen normalen Gang. Hoffen wir mal auf gute Ergebnisse Ende April.

Schönen Tag noch.
Erbse

Dank an gfp927z für die ganze Arbeit

A brief summary of today`s Conf call -

1) Finances - Cortex had $28 mil at the end of 2004, and Dr. Stoll expects expenses for 2005 to be approx $14 mil, +/- $1 mil.

2) CX-516 Fragile-X trial - Based on what we now know about CX-516, to get efficacy in Fragile-X would have required approx 3 grams of CX-516 given 4 or 5 times per day (the trial only dosed at 900 mg 3xday). So there`s no way that there could have been much efficacy shown in that trial. When the Frag-X trial was originally designed, they knew that CX-516 was weak, but the data showing just how weak it was came well after the Frag-X trial was underway. Dr. Berry-Kravis is very interested in trying a potent Ampakine. A higher impact Cortex compound was found to elevate BDNF levels by 2-3 fold after only 5 days of dosing in rats, and there was a positive impact seen in rats engineered to have the Fragile-X gene deficiency.

3) CX-717 UK Sleep Dep trial - The trial is in its final (4th) phase, which will be finished at the end of next week. This trial is measuring 10 different efficacy parameters, involving memory, cognition, and attention. The trial was blinded, and used 3 different dosing levels against placebo. The trial proceeded well and enrollment was good. The principal investigator estimates that data lock can occur by mid April, and Dr. Stoll says we can expect to see top line results by the end of April/early May at the latest (Cortex will be at the May 4-6 R+R Conference).

4) AD Phase 2a trial - Is now under IRB review at the Univ of Michigan. The trial should get underway by late May/early June, with an interim analysis by the end of June/early July. The interim analysis will allow them to see how it`s going, and up the dose if needed (as we know, there`s plenty of leeway to raise the dose as needed).

5) ADHD Phase 2a trial - The protocol will soon be submitted to IRB. Study should be underway by June and will use multiple dosings.

6) DARPA/Sleep Deprivation - Based on the outcome of the UK study, Dr. Stoll anticipates that there will be an announcement relative to further studies in Sleep Dep with DARPA.

7) 3 month tox studies in 2 species (CX-717)- monkey dosing completed, all monkeys came through A-OK, waiting for histopathology analyses of organs/tissues. Rats are in 22nd day of dosing, proceeding uneventfully. Full analysis by the end of August, which will allow a Phase 2b human trial with 3 month dosing to start in the last quarter of 2005 in either ADHD or AD.


8) Question + Answer section -

a) Status of new compounds - Two of the low impact backup compounds to CX-717 being developed are CX-727 and CX-701 (at the SHM, Dr. Rogers showed a graph comparing CX-717, CX-727, CX-701, and Aricept in Dr. Deadwyler`s primate delayed match to sample tests). Both look very promising, and are going through metabolic/pre-tox workup prior to full tox studies. By early May they should be able to make a decision on which one of these compounds to move into full toxicolgy.
High impact - Cortex has a VERY significant ongoing program in the high impact area. As mentioned previously, a high impact compound was found to elevate BDNF by 2.5-3 fold after 5 days of dosing in rats. Longer term dosing studies with low impacts to see if they stimulate BDNF upregulation over time are also ongoing.

b) Compounds for in-house program - Cortex will try to resist outlicensing the 2nd compound. A program to produce additional low impact compound analogs is being kicked into gear also (most of Cortex`s available resources over the last several years were going into high impacts. Now we have the funds to do both simultaneously). A BP partner will probably have considerable interest in our high impacts as well as the low impacts.

c) BP partners - Dr. Stoll can`t say publicly how many interested BPs there are, only that interest is very strong. There are lots of contacts, consistent contacts from companies that have followed Cortex`s progress closely. Dr. Stoll wants a carve out for Cortex (in-house program/indication), and the BP deal must be of sufficient magnitude to provide Cortex with substantial funds to move strongly ahead with the in-house program after the BP deal. Sleep Dep data might be enough to get some BP offers, the question then is are these offers good enough for Cortex?

d) Patents - Many of the patents expire around 2017 (2016-2018). Dr. Stoll wants to have as much time on the market under patent protection as possible. Ideally he`d like to have 3 or 4 compounds in the clinic to give us numerous "shots on goal" to increase the chances for success.

e) IP situation in Europe (Lilly/Glaxo challenge) - could take several years to resolve. Univ of Calif is backing Cortex, and our eventual BP partner will also provide strong backing/resources.

f) Dr. Deadwyler`s Sleep Dep primate paper - Dr. Deadwyler had a disagreement with a journal reviewer and is submitting it to another prestigious journal for publication. The amount of data is very large.

g) Organon/Org-24448 - Phase 2b Schizo mono trial had enrolled approx 40 patients, and the NIMH/TURNS Phase 2b Schizo combo trial plans to enroll 100 patients. Both are substantial trials. Servier is in early Phase 2 with S-18986.

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
Hallo liebe Cortex Fans. Der Kurs schlägt ja einige Kapriolen in den letzten Tagen. Zur Beruhigung habe ich mir noch mal die Meldung von CX516 aus dem Jahre 2003 durchgelesen. Für mich wäre es sehr überraschend, wenn die Ergebnisse bei CX717 schlechter ausfallen würden

Positive Effects of CX516 in Human Sleep Deprivation Study

Preliminary findings suggest CX516, compared to placebo improves performance in dose-related fashion in healthy subjects after 31 hours without sleep

http://www.cortexpharm.com/html/news/03/10-21-03.html

Von FRAXA wird gemeldet, daß nach den Mausversuchen nun auch mit einer neuen Testphase bei Fragile X begonnen werden soll. Bis jetzt ist aber immer noch nicht veröffentlicht worden, um welche Substanz es sich handelt. Gerüchterweise ist von CX717 die Rede. Falls ich was Genaues weiß, werde ich es hier im Board posten.

<<< The new class of drugs called Ampakines, is an example: FRAXA has funded a trial of Ampakines in fragile X mice and now will fund a trial of this medication in adults with fragile X >>>

http://www.fraxa.org/research_summaryfindings.aspx

Bin jetzt selber gespannt auf die Ergebnisse mit CX717 bei Schlafentzug. Es kann sich dabei nur noch um wenige Tage handeln.

Schönen Tag noch
Erbse
Hallo liebe Cortex Fans.

Cortex präsentiert am Mittwoch nächster Woche auf einer Konferenz in Paris. Interessenten steht eine Live Übertragung zur Verfügung. Den link gibts in der Kopie der Meldung. Die Ergebnisse der Testphase 2a bei Schlafentzug sollen dort präsentiert werden.
Auf dem Yahoo Board geht eine Meldung um, daß kurz vorher eine Meldung von Cortex veröffentlicht wird.

Schönes Wochenende
Erbse

Press Release Source: Cortex Pharmaceuticals, Inc.


Cortex`s CEO to Speak at the Rodman & Renshaw 2nd Annual Global Healthcare Conference on May 4th, 2005 in Paris, France
Monday April 25, 9:00 am ET


IRVINE, Calif.--(BUSINESS WIRE)--April 25, 2005--Cortex Pharmaceuticals, Inc. (AMEX: COR - News) announced that Roger G. Stoll, Ph.D., Chairman, President and CEO will speak at the Rodman & Renshaw 2nd Annual Global Healthcare Conference in Paris on Wednesday, May 4th at 10:30 AM (local time) at the Intercontinental Hotel. Cortex is one of 180 invited companies to present at this conference to be held May 4-5, 2005.
Dr. Stoll will provide an update on Cortex`s AMPAKINE® clinical development program, with specific details related to CX717 and discuss upcoming clinical milestones. AMPAKINE compounds amplify the effects of glutamate, the primary excitatory neurotransmitter in the brain responsible for higher-order behaviors and cognitive activities, such as, thinking, smelling, touching and memory.

A live webcast of the presentation can be accessed by logging onto http://www.wsw.com/webcast/rrshq5/cor/ and a replay will be available for 45 days following the conference.
Cortex Reports Positive Effects of its AMPAKINE-R- CX717 in Human Sleep Deprivation Study
Monday May 2, 9:01 am ET
Preliminary analysis suggests CX717, when compared to placebo, increased wakefulness in a dose-related manner and improved performance of those subjects that were impaired
http://biz.yahoo.com/bw/050502/25417.html?.v=1

Schönen Tag noch
Erbse
Hallo liebe Cortex Fans.
Gleich noch mal die äußerst positive Meldung Von AP. Da kann man sich schon entspannter die weitere Entwicklung von Cortex anschauen. Weitere Einzelheiten gibt es Mittwoch Vormittag auf der R&R Konferenz in Paris. Den link zur Live Übertragung habe ich bereits gepostet. Die Übertragung beginnt am Mittwoch um 10.30
Hier noch mal der link. Da braucht ihr nicht so lange suchen.
http://www.wsw.com/webcast/rrshq5/cor/

Schönen Tag noch
Erbse

Cortex Says Drug Boosts Alertness in Study
Cortex Pharma Reports Ampakine-R-CX717 Wakefulness Drug Boosts Alertness in Clinical Study

IRVINE, Calif. (AP) -- Shares of Cortex Pharmaceuticals Inc. jumped Monday as the company said clinical data showed that its wakefulness drug candidate Ampakine-R-CX717 had a dose related effect in keeping sleep-deprived subjects alert.

The clinical study tested three doses -- 100 milligrams, 300 milligrams and 1,000 milligrams -- and found that low levels of performance were alleviated in subjects who were sleep deprived for 27 hours. In the study, 16 young healthy men were tested on memory, attention, vigilance, reaction time, and executive function.

At a 100 milligram dose, the study found that individuals had increased wakefulness overnight, but that the effect did not extend into recovery sleep the next morning. In the 300 milligram and 1000 milligram doses, the alerting effect of the treatment extended well into the recovery sleep the next day, the company said.

Cortex is focused on the development of Ampakine drugs, which are designed 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, attention-deficit hyperactivity disorder, or ADHD, and sleep disorders.

The company said it planned to conduct pilot studies in a variety of brain disorders that might benefit from Ampakine.

The National Commission on Sleep Disorders estimates that 40 million Americans are either chronically or intermittently affected with various sleep disorders, Cortex said.
Hallo liebe Cortex Freunde.
Folgend eine Zusammenfassung aus dem Yahoo Board von der heutigen Konferenz. Nochmals herzlichen Dank an den User gfp927z für seinen unermüdlichen Cortex Einsatz. Es schaut bis jetzt alles sehr sehr gut aus. Wir haben ja auch lange genug darauf gewartet.

Liebe Grüße
Erbse

In addition to what others have said already, here`s a brief summary of the topics presented by Dr. Stoll -

1) UK Sleep Dep trial - They`ve only had the results for ~1 week, but Dr. Stoll said that we saw some very good results in EVERY ONE of the patients who showed performance decline after being sleep deprived. Cortex wanted to sleep deprive for 42 hours, but the clinicians running the trial opted for a shorter 27 hours to be on the safe side, in spite of CX-717`s extremely high safety and complete lack of excitotocxicity potential in the Phase 1 (the upcoming larger DARPA trial will likely push the envelope much further). A few of the patients didn`t experience much of any cognitive decline from the shortened 27 hour protocol, but those who did all saw good improvement from CX-717, and the level of improvement was directly dose related, with the 300 and 1000 mg doses showing the best activity. The "maintenance of wakefulness" test was discussed (a key test which had been run on Provigil during its testing). At the 300 and 1000 mg doses, CX-717 showed considerable wakefulness effect even at 11:00 AM the next day, which is pretty impressive from a single dose (only Amphetamines would have a similar duration effect from a single dose). It sounded like Dr. Stoll had a few slides at the conference presentation that weren`t shown on the Internet, so perhaps we`ll see these at the next presentation. All in all it sounded like CX-717 performed very well in the study. One of the parameters they tested for was attention related, and Dr. Stoll said that these good results support the idea that ADHD may be a very good target for CX-717.

2) CX-929, a high impact compound, was shown to upregulate BDNF levels by 2.5 fold in rats, in both cortical and hippocampal areas of the brain.

3) Dr. Lynch recently was able to demonstrate that high impact Ampakines can prevent the age related loss of synaptic plasticity (LTP) that normally occurs in middle aged whole animals. With the Ampakine, the LTP decline that normally occurs from aging no longer occurred, and LTP remained at the same level as it is in the younger animals (there`s hope for us baby boomers yet folks :o)

4) CX-727, one of the low impact back-up Ampakines in development, was shown to upregulate BDNF levels 10-20% in whole animals, and may be able to upregulate BDNF by approx 30-40% when given over extended periods. Dr. Stoll said they`ve seen this demonstrated several times now, and they are convinced that low impacts can significantly upregulate BDNF over time (albeit less dramatically than a high impact, but 30-40 % is huge when combined with a low impact`s extremely high degree of safety). So the neuro "holy grail" concept may still be alive and well even without the high impact approach.

5) CX-717 vrs Aricept - Not discussed due to time constraints, the bar graph on slide 16 shows how vastly superior CX-717 is compared to Aricept in Dr. Deadwyler`s primate studies. As an ACHase inhibitor, Aricept has a high level of GI related side effects which severely restricts its dosing (in addition to having CNS activity, acetylcholine is a key neurotransmitter controlling GI motility).

6) Alzheimer`s pet scan trial - could start enrolling this month (interim analysis by early July, as estimated at the March 23 Conf call).

7) Shift Work Sleep Disorder trial - this was completely new news. Now going through IRB, the trial should initiate in July, and will be a multidosing study. Aimed at the Provigil market, this additional data could help enhance the overall partnering package. Provigil`s success has demonstrated to BPs just how lucrative the Sleep related area is. As I understand it, recent developments relating to Cephalon`s Provigil patent may delay the onset of generic competition, which would enhance the Sleep area`s profit potential for BPs.

8) ADHD trial - Starting this Summer, with a 3 week dosing protocol. Results of the attention parameters tested for in the Sleep study apparently suggest that ADHD may be a good target.

These 3 studies should be completed by the Fall, with ADHD being the last to be completed. The 3 month tox studies in two species will be completed by the end of August (this being required prior to doing longer term Phase 2b type studies).

9) As was noted by previous posters, slide 28 listed as a milestone goal for late 2005 the initiation of a 3 month CX-717 double blind, placebo controlled study in mild to moderate AD patients stabilized on Aricept. Dr. Stoll didn`t discuss this directly, only saying that a Phase 2b trial in either AD or ADHD is planned for late 2005, depending of course on the status of our BP negotiations.

10) Also not mentioned - one would expect that we should be hearing fairly soon about DARPA`s plans for a larger Sleep Dep trial with CX-717. DARPA`s interest in CX-717 was already extremely high, and should now be even greater.
Hallo liebe Cortex Fans.

Es beschäftigen sich jetzt immer mehr Sender mit unserer Thematik. Hier ein Beitrag vom WDR5. Leider habe ich nur ein Manuskript in Schriftform vorliegen. Feiner Beitrag unter Anderem zu Cortex und zu unserem Thema. Aus rechtlichen Gründen kann ich leider nur verlinken und keine Ausschnitte kopieren

Schönen Tag noch
Erbse


http://www.wdr5.de/sendungen/leonardo/manuskript/ms050414ged…
Nochmal ein Artikel zu den Schlafentzugversuchen. Langsam werden die Medien auf Cortex aufmerksam.

New drug offers jitter-free mental boost

A new class of drug may increase alertness without any of the jitteriness of over-stimulation, suggest the results of a small clinical trial released this week.

A compound dubbed CX717, a member of the new class called ampakines, significantly improved performance on tests of memory, attention, alertness, reaction time and problem solving in healthy men deprived of sleep.

The study was carried out by Julia Boyle at the Sleep Research Centre at the University of Surrey, UK, and her colleagues on behalf of Cortex Pharmaceuticals Inc., based in Irvine, California, US.

During the trial, 16 healthy young males were randomly assigned to take either 100 milligrams, 300 mg or 1000 mg of the drug, or given a placebo. By the end of the experiment, each volunteer had been assigned to all of the experimental groups, thus producing his own control scores.

The volunteers were hooked up to EEGs to measure brain wave activity and were put through a battery of tests. The first round of each session was after a good night’s sleep. Thereafter, they were tested every few hours throughout a sleepless night and into the next morning, during a total of 27 hours without rest.

The researchers found that the drug significantly improved performance on tests. And taking more of the drug improved performance for longer.

Short half-life
Ampakines work by binding to particular receptors in the brain, called AMPA-type glutamate receptors. This boosts the activity of glutamate, a neurotransmitter, and makes it easier to encode memory and to learn. And because of their short half-life - hours in this case - ampakines have few side effects.

The drug, which will have to undergo further clinical trials before being approved, is being considered as a possible treatment for narcolepsy, jet lag, attention-deficit hyperactivity disorder (ADHD) and even Alzheimer’s disease.

But it clearly has effects in the healthy population as well. “It generates a state of cortical wakefulness without stimulation,” says Gary Lynch at the University of California at Irvine, who invented ampakines.

Arthur Caplan, a bioethicist at the University of Pennsylvania in Philadelphia, US, sees no particular problem with people using such a drug to combat age-related memory loss. “Stimulating your brain with a reminder on a handheld digital device doesn’t seem that different to me from stimulating your brain with a drug,” he says.

http://www.newscientist.com/article.ns?id=dn7342
Hallo liebe Cortex Fans
Hier nochmals eine kurze Zusammenfassung der letzten Konferenz zu der weiteren Planung von Cortex. Ich kopiere mal die sehr schönen DIA von der Präsentation hier rein. Hier wird in wenigen Sätzen der weitere Ablauf klar.

Liebe Grüße
Erbse







Hallo liebe Cortex Fans. Hier noch ein Beitrag von der BBC mit einem Interview von Gary Lynch



`Memory pill` for the forgetful
US scientists have invented a pill that can boost memory.
http://news.bbc.co.uk/1/hi/health/4539551.stm

Schönen Tag noch
Erbse
Hallo liebe Cortex Fans. Ich melde mich noch mal mit einem Beitrag in deutscher Sprache.
Liebe Grüße
Erbse


Pille fürs Köpfchen
Ein neues Medikament verspricht ein besseres Gedächtnis und mehr geistige Frische.
http://focus.msn.de/hps/fol/newsausgabe/newsausgabe.htm?id=1…
Der Neuroinvestor meldet sich mit einem neuen Kommentar.

Cortex (2.26): We held publication long enough to receive the initial results of the 16 pt Phase IIa in sleep deprivation. All the ingredients--solid primate data, highly controlled variables, even CX516`s low-potency foray--pointed to the probability of success, but that did not equal certainty, particularly with such a small sample. But CX717 did show a dose-related effect upon cognition--in a variety of measures, in normal subjects sleep-deprived for 27 hours. This in itself was not expected to create a major valuation move, but the right major media story, and an eventual Big Pharma agreement, will. There are many companies looking, and this human proof of principle should seal the deal over the next six months. It most likely will end up engaging one of the companies who have either R&D history with the area (Lilly, GSK), or CNS management with AMPA experience and interests (Amgen), The interested parties want access to both the more established low impact (lower neurotrophic activity, better safety) and high impact (more neurotrophin production, more safety risk) platforms. While we never predict buyouts, since doing so has the same probability of success as neuroprotection trials, Cortex is a micro-company that could be an appealing `munch` for a larger firm. Our target remains 12, though that would be next year. A year-end price of 8 is within reach given the kind of deal that we expect, particularly with ADHD, narcolepsy, and Excessive Daytime Sleepiness (EDS) all now given support as viable indications for full Phase II study by this Phase IIa.

http://www.neuroinvestment.com/CORXcom.html
Hallo liebe Cortex Fans.
Es gibt eine neue DIA Präsentation von Cortex mit den CX717 Ergebnissen aus Paris. Die vollständige Auswertung der Ergebnisse dauert noch einige Zeit. Hier jetzt der link von der Paris Präsentation.

http://www.wsw.com/webcast/rrshq5/cor/

Stellvertretend für die vielen Meldungen hier zwei Artikel in Deutsch. Die Inhalte ähneln sich, da sie sich alle auf die selbe Quelle beziehen.

Gedächtnispille soll mentale Fähigkeiten verbessern
Ampakine auch für Behandlung von Alzheimer denkbar
http://www.pressetext.at/pte.mc?pte=050512044&source=rss_0.9…


Neuer Wirkstoff hält das Gehirn auf Trab
http://rhein-zeitung.de/on/05/05/12/news/t/rzo150321.html?a
Hoffen wir mal, daß sich die Veröffentlichungen auch mal signifikant im Kurs niederschlagen. Nochmals eine Veröffentlichung aus der Fachpresse.

Schönes Wochenende
Erbse


This pill will make you smarter

HAVING problems performing in the sack? Take Viagra. Got the jitters before that important presentation? Try beta blockers. Need to stay awake to finish that assignment? Pop a Provigil pill.

For those prepared to pay, the growing list of "lifestyle drugs" is shifting the boundaries of what bodies and minds are capable of. Now a small clinical trial of the class of experimental drugs known as ampakines suggests these brain-boosters are destined to blur that line still further by offering improved memory.

The success of the unrelated drug Provigil (also called modafinil) has proved there is a huge market for drugs that can improve mental performance. The US Food and Drug Administration has approved it for treating narcolepsy, sleep apnoea - disrupted breathing during sleep - and the sleepiness caused by shift work. But it is widely taken "off-label" by healthy people to stay awake and alert. Sales of the drug, produced by Cephalon of West Chester, Philadelphia, have more than doubled since 2002, and continue to skyrocket (see Graphic).

Some may feel uncomfortable with the increasing availability of such pharmaceutical pick-me-ups, but others see them as no different from performance aids such as palmtop organisers. "Stimulating your brain with a reminder on a Blackberry doesn`t seem that different to me from stimulating your brain with a drug," says Arthur Caplan, a bioethicist at the University of Pennsylvania in Philadelphia.

Ampakines work by boosting the activity of glutamate, a key neurotransmitter that makes it easier to learn and encode memory. They change the rules about what it takes to create a memory, and how strong those memories can be, says Gary Lynch of the University of California at Irvine, who invented the drugs. "We all have the same computer," he says, "but we`re running with different voltage levels." Ampakines up that "voltage".

The effects can be dramatic, as Julia Boyle at the University of Surrey, UK, and her colleagues have now shown. They tested an ampakine called CX717 on 16 healthy males aged between 18 and 45. The men were given either 100 milligrams, 300 mg or 1000 mg of the drug, or else a placebo. In repeated trials the volunteers cycled through the treatments so that their performance with different amounts of CX717 could be compared directly.

In each test session, the volunteers started with a full night`s sleep and the following morning and evening were given a battery of tests. These assessed memory, attention, alertness, reaction time and problem solving. Then, at 11 pm, the volunteers swallowed their pills and stayed up through the night. At midnight, 1 am, 3 am, 5 am and 9 am, they were re-tested on some of the tasks. And at 4 am, cruelly, they were tucked into bed in a darkened room and told to stay awake. The researchers measured heart rate and brainwave activity to monitor how alert the subjects were and whether they fell asleep.

“Even the lowest dose of CX717 improved the wakefulness and cognitive performance of sleep-deprived people”Even the lowest dose of CX717 significantly improved the sleep-deprived volunteers` wakefulness and cognitive performance. And the more ampakine they took, the more they improved and the longer the effect lasted. Roger Stoll, CEO of Cortex, the Irvine-based company in California that owns the drug, announced the trial results at an investors` conference on 4 May. While specifics were scant, he mentioned that in the dark room, for instance, most volunteers taking placebo dozed off within about 3 minutes, while some ampakine users stayed awake for the entire 15-minute test. And on a test of sustained attention, effects kicked in within an hour of consuming the drug, he revealed. Crucially, the subjects suffered none of the jitteriness that comes with caffeine or amphetamines. "It generates a state of cortical wakefulness without stimulation," says Lynch.

CX717 will have to undergo further clinical trials before gaining approval as a drug. Cortex is considering it as a possible treatment for narcolepsy, jet lag, attention deficit hyperactivity disorder, and Alzheimer`s disease.

Meanwhile animal studies hint at even more impressive effects. Research on rhesus macaques, carried out for the US military by Sam Deadwyler at Wake Forest University School of Medicine in Winston-Salem, North Carolina, found that sleep-deprived monkeys on CX717 actually performed better on reaction time and accuracy tests than when they were well rested. And non-sleep-deprived monkeys given the drug did better still.

From issue 2499 of New Scientist magazine, 14 May 2005, page 6
http://www.newscientist.com/channel/being-human/mg18624994.7…
Hallo liebe Cortex Fans,

ich habe die Paris Präsentation mal auf einen anderen Server gelegt und eine neue DIA Präsentation gemacht. So bleiben die Bilder auch länger erhalten, da der link von R&R bald nicht mehr funktioniert.
Für das nächste Bild einfach nur auf das kleine Vorschaubild klicken.
Am Schluß dieses Beitrages gibts den Kommentar des users gfp927z zu einigen Bildern.



Der folgende link zeigt die DIA Show der Paris Präsentation mit CX717 Ergebnissen
http://www.vm-elsig.de/achim/dia3/

Der nächste link ist der Tonbeitrag des CEO Stoll von der Paris Präsentation Dauer ca. 23 Min.
http://www.vm-elsig.de/achim/dia3/mm1.html

Es folgt der Kommentar von gfp zu einigen Bildern

The new slides have graphs/charts showing what Dr. Stoll discussed in the Paris presentation -
1) CX-614 and CX-929`s effects on raising BDNF levels in rats (slide 10). Nice big increases shown.

2) CX-929`s effects on reversing age related losses in synaptic plasticity (LTP) in whole animals (slide 11). This was recently demonstrated by Dr. Lynch. Very impressive.

3) CX-727`s effects on raising BDNF expression in rats (slide 12). This is a very good sign - that even low impacts can upregulate BDNF over extended dosing periods.

4) Human plasma concentrations for the various oral doses of CX-717 - 100, 300, 1000 mg (slide 16).

5) Diagram showing the design of the UK Sleep trial (slide 17).

6) Chart showing the alerting effect results (wakefulness) (slide 18). This shows a very clear dose related response.

7) Chart showing the persistent alerting effect at higher doses of CX-717 11-17 hours post dosing, measured by the polysomogram (slide 19).

8) Chart showing improvement in attention in subjects with impaired performance (slide 21). This slide is a little confusing, but a really surprising thing here was the tremendous improvement seen between the CX-717 group vrs placebo after the patients had their recovery sleep (17.5 hours post dosing). After sleeping, the subjects who received CX-717 showed big dose related attention improvements compared to the placebo group (ie - the placebo group remained very "groggy" even after recovery sleep, compared to the CX-717 group). What these folks really need is a cup of my Java (to quote Steve Martin :o)

Anyway, the data looks good. Will be getting even more detailed data soon according to today`s press release.

http://messages.yahoo.com/bbs?.mm=FN&action=m&board=16042432…

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde. Nächsten Montag ist eine Konferenz geplant.

Cortex to Host Conference Call to Discuss the Progress of AMPAKINE CX717 from the Most Recent Phase IIa Study
Call Scheduled for Monday, June 13, 2005 at 1:00 P.M. -EDT-
http://biz.yahoo.com/bw/050607/75504.html?.v=1

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde. Neuer Artikel in der Financial Times Deutschland



Doping fürs Gehirn

von Constanze Böttcher
Ein neuer Wirkstoff kann die Hirnleistung steigern und auch bei Gedächtnisverlust helfen. Bei Tests brachte das Medikament CX717 die Hirnleistung von Probanden auf Hochtouren.

http://www.ftd.de/rd/9503.html

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,
folgend die Präsentation vom 13.06. mit den CX717 Ergebnissen.
Angefügt innerhalb der DIA Show ist die Diskussion im Anschluß an die Präsentation.



http://www.vm-elsig.de/achim/dia04/

Liebe Grüße
Erbse
Super, die DARPA finanziert die nächste Runde

DARPA to Sponsor Evaluation of the AMPAKINE CX717 in a New Study in Shift Work

http://biz.yahoo.com/bw/050621/215583.html?.v=1

Schönen Tag noch
Erbse
Auszeichnung für den CEO von Cortex Roger. G. Stoll


Stoll Receives the Albert Einstein Award for Outstanding Achievement in Life Sciences

http://biz.yahoo.com/bw/050707/75409.html?.v=1
Hallo liebe Cortex Fans,
folgend ein kleiner Beitrag des Neuroinvestor aus der Juli Ausgabe.

Schönen Tag noch
Erbse

From the July 2005 issue:

We never expected that the price would be so constrained after successful Phase IIa data was released. One must wonder why, and the conclusion we have come to is that Cortex `cried wolf` for so long with CX516 that the novelty is gone, and the Market is habituated to the sound of Cortex making its case. But there are many companies looking, perhaps as many as twelve have interest, some of them quite ardent. We still expect the partnership deal to involve one of the companies who have either R&D history with the area (Lilly, GSK), or CNS management with AMPA experience and interests (Amgen), The interested parties want access to both the more established low impact (lower neurotrophic activity, better safety) and high impact (more neurotrophin production, more safety risk) platforms. The unknown is whether Cortex will get the upfront money they want before their Alzheimer`s, shiftwork, and ADHD trials wind up during 2H:05. While we never predict buyouts, Cortex is a micro-company that could be an appealing, and inexpensive, `munch` for a larger firm. Our target remains 12, though that would be next year. A year-end price of 8 is perhaps still within reach given the kind of deal that we expect, particularly with ADHD, narcolepsy, and Excessive Daytime Sleepiness (EDS) all now given support as viable indications for full Phase II trials by this Phase IIa. But it will require a groundswell of institutional interest fueled by media coverage to get there.

Quelle:
http://www.neuroinvestment.com/CORXcom.html
Cortex Commences Enrollment in Two Additional Phase IIa Studies with AMPAKINE CX717

ADHD and Alzheimer`s Disease Studies Are Underway

http://biz.yahoo.com/bw/050728/285204.html?.v=1

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,
leider ist der Kursverlauf in den letzten drei Monaten nicht nach meinem Geschmack und auf dem Yahoo Board wird viel über Hedge Fonds und über eine neue Kapitalmaßnahme im nächsten Jahr spekuliert.

Seitens des Militärs besteht ein großes Interesse an den Ampakinen.


Unter folgendem Link gibts einen kleinen Bericht zu der Schlafentzugsproblematik und der Rolle der Ampakine.

http://www.darpa.mil/dso/thrust/biosci/cap.htm
Preventing Sleep Deprivation


Anfang nächsten Monat gibts eine neue Konferenz von Cortex. Es ist sehr gut möglich, daß hier die Alzheimer Pet Scans präsentiert werden.

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,
hier aus dem Yahoo-Board ein kleiner Überblick zu den einzelnen Testphasen und eine Beurteilung des sehr gut informierten user gfp927z.
Machts mal gut
Erbse

1) If all the remaining Phase 2a studies are clearly positive, then a BP deal will happen.

2) If they`re all mediocre (very unlikely) then we have a problem, but the odds of this scenario are about zilch IMO. Looking at each trial -

a) AD - I`m fairly certain that CX-717 has already shown increased glucose metabolism in preclinical animal studies (I had a link to a paper on this but the link expired so I haven`t been able to review that paper), so the PET scan study should have a very good chance of success. Getting a decent, measurable improvement in cognitive functioning after only a single dose of CX-717 is a tougher hurdle, but certainly very possible. The PET scan results are the chief "endpoint" of the trial though, with any measurable cognitive improvement a nice bonus.

b) Shift Work - is very similar to Sleep Dep (and they will in fact be limiting the Shift Work patients to only 4 hours of recovery sleep per day), so that indication has a very good liklihood of success IMO. Plus we`ll be dosing once/day for 4 days, and the high dose is 1000 mg which should be enough to show good results (remember, the Sleep Dep study showed good results after only a single dose, in the patients who showed impairment. Just about everybody in this study should show some impairment).

c) ADHD - this is probably the riskiest of the 3 trials, but if there`s an effect to be seen, 800 mg BID should do it, since that`s a very high dose, and we`ll be dosing for 3 weeks. My concern about such a high dose causing side effects and dropouts is still there, and I would still prefer to include an intermediate dose (say 400-500 mg BID) just in case. But hopefully Dr. Mansbach and Quintiles knew what they were doing when they designed this trial. He has access to all the Phase 1 data, and has undoubtedly based the trial design on all the info available to him.

3) If it`s a split decision, with AD fair, Shift Work good/very good, but ADHD inconclusive or outright bad, then it`s a tough call and we might have to do an in-house Phase 2b to attract a sufficiently good BP deal. On the other hand, if only ADHD is questionable, and a particular BP doesn`t care much about ADHD anyway, then could still get a deal.

Summarizing - IMO, we`ll see good results in AD and Shift Work. ADHD will probably also be good, but is somewhat higher risk. In addition, I expect a PIPE before we get all the Phase 2a results, though I don`t think the PIPE will be greeted all that negatively (since it increases our negotiating position with BPs, hedges our clinical risk, and provides funds for an in-house Phase 2b if we need to do one). I also think the trials will take somewhat longer than expected, but this is something we`re already used to seeing. So, my scenario is for PIPE (Dec/Jan period), good (but slightly delayed) trial results (Jan/Feb), with the BP deal shortly thereafter (Spring). Anyway, that`s my (semi) educated guess.

Quelle:http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
Hallo liebe Cortex Fans,
falls es hier in Deutschland überhaupt noch welche gibt.
Es gibt einen weiteren guten Artikel über die Ampakine in der Zeitschrift Popular Science. Die Ausführungen über Lynch und Cortex befinden sich auf Seite 2.
Nächsten Mittwoch gibts eine Konferenz von Cortex.

Liebe Grüße
Erbse


Will Drugs Make Us Smarter and Happier?
A new understanding of brain chemistry could usher in an age of biologically enhanced humans
http://www.popsci.com/popsci/futurebody/article/0,20967,1088…
Hier der link auf Seite 2
http://www.popsci.com/popsci/futurebody/article/0,20967,1088…
... freilich gibt es die noch :)

Und bei dieser Gelegenheit mal wieder ein herzliches Dankeschön an Dich, liebe Erbse für deine Unermüdliche Arbeit.

Habe mir aktuell mal GPC auf die Watchlist gesetzt. Falls die mit Ihrem Prostataprojekt durchkommen ist die Liqui gesichert, und mit Axxima habe sie spottbillig einen kleinen Konkurrenten von Vertex bekommen, was noch keiner richtig bemerkt hat. Axxima war sehr gut unterwegs in der Kinase- und Protease-Inhibitorenforschung, ihnen ist leider die Liqui ausgegangen bzw. die Anteilseigner wollten nicht mehr nachlegen. ... nur so als Tip für die Watchlist.

Ansonsten denke ich, wird es bei Cortex in einigen Monaten richtig spannend.

Gruß Coluche
Hallo liebe Cortex Fans,
ganz besonders an Puhvogel und Coluche. Die Quartalsmeldung von Cortex ist raus. Im finanziellen Bereich läuft es wie geplant. Die einzelnen Testphasen fressen ganz schön Geld, liegen aber im erwarteten Rahmen.

Leider kann ich an der Konferenz nicht teilnehmen, doch ich erwarte Mittwoch nichts aufregendes. Wie Coluche erwähnt hat, werden die aufregenden Sachen wohl gegen Ende des Jahres anstehen.
Zum Stand der einzelnen Testphasen kopiere ich mal einen Ausschnitt aus der letzten Meldung.
Liebe Grüße
Erbse

As recently reported, Cortex has begun enrollment in its second and third Phase IIa studies with CX717: one in Attention Deficit Hyperactivity Disorder and the other in mild to moderate Alzheimer`s disease. These studies follow results from the first Phase IIa trial with CX717 that suggest that when compared to placebo, the compound increased wakefulness in a dose-related manner and improved cognitive performance in healthy male subjects that were deprived of sleep. A fourth Phase IIa study in simulated night shift work is scheduled to start enrollment at the end of August. Cortex anticipates that information relative to the outcome of these studies will be available toward the end of 2005 or sooner, depending on patient enrollment.
Cortex Reports Second Quarter Results
http://biz.yahoo.com/bw/050815/155783.html?.v=1
Hallo liebe Cortex Freunde,

ich konnte gestern an der Konferenz nicht teilnehmen. Ist nicht so schlimm, da gfp927z die wichtigsten Punkte für uns gepostet hat.
An dem Kursrückgang in den letzten Wochen ist wohl ein kanadischer Fond zuständig, der wohl weit über eine Millionen Aktien über die Börse abwickelt.

Folgend die Zusammenfassung von der Konferenz gestern.

1) At the end of July, Cortex had over $22 mil in cash, and should have approx $14 mil at year end.

2) ADHD study is enrolling very well. (This is good, since this is the study expected to take the longest - 60 patients, 2 period crossover study, with dosing / washout / dosing period of approx 7-8 weeks for each patient).

3) AD study is enrolling a little bit slower, but we`re trying to speed up enrollment (they only need a total of 12 AD patients for the study though, plus some age matched normal controls).

4) Shift Work study should get its final approval next week and should start enrolling in early September. This is slightly later than planned, but a military research organization is running this trial (DARPA funded). This shouldn`t be a problem though, since the trial only runs for 4 days (4 nights of shift work) on 48 subjects.

5) Recent PR activities include monthly meetings with analysts and fund managers (20 meetings in the past month). Also there`s a recent article on Cortex/Dr. Lynch in Popular Science magazine (on the newstands this week). Also - in NY, Cortex participated in a call-in meeting with anchors/commentators from 8 different television networks (PR was issued) and discussed memory/AD topics and Ampakines.

6) Dr. Deadwyler`s article on the effects of CX-717 and other Ampakines in primates is coming out in the next week or so. In addition, Dr. Lynch is about to publish a significant article on high impact compounds.

7) Over the past several weeks, there was a fund in Canada who recently had to liquidate several of their stock positions to raise cash. Cortex tried to put them in touch with other funds interested in increasing their position in Cortex, but they couldn`t come to an agreement on the price, so the Canadian fund had to liquidate its position on the open market (over 1 mil shares), and this has put some pressure on the stock in the last several weeks. The vast majority of these shares have already been sold into the market, and we should be through this situation very shortly. I`d like to personally thank the Canadian fund for giving me the opportunity to reload at attractive prices :o)

8) BP deal - we continue talking to a large number of large and medium size companies. Improving our chances for a good BP deal will be the Phase 2a data expected around year end, the completion of the 3 month tox study, and the availability soon of tablet dosing for CX-717 (tablets provide more consistent release dosing, and are more convenient than capsules. This is a plus for larger/longer studies). CX-717 is extremely stable, and there have been no shelflife concerns at all.

Q+A -

1) Dr. Deadwyler`s primate paper will be published in the Public Library of Science, Biology section, coming out in the next few weeks. This should be an interesting paper - there should be comparative data on not only CX-717 but also numerous other Ampakines compounds (we know he`s tested at least CX-717, CX-727, CX-1036, CX-701, Aricept, and probably some high impacts). Beyond the delayed match to sample tests, Dr. Deadwyler has also reportedly done PET scans, EEGs, spectral density tests, and direct intra-brain measurements in his primates.

2) Dr. Stoll doesn`t see any need for a financing in 2005. Next year we`ll need more money, but the goal is to obtain this cash from the BP deal.

3) High impact program - should have a viable lead compound by year end. The challenge is to get significant neurotrophin upregulation combined with an adequate safety margin, and we`re starting to see progress in achieving this.

4) We have a low impact backup compound progressing toward scale up. Then we can go into tox and then into a human Phase 1 next year. (I`m assuming this is CX-727, but he hasn`t publicly specified which compound it is yet).

5) ADHD trial timetable - so far the enrollment has proceeded very nicely and we`re extremely happy with how the enrollment is moving (Quintiles is the CRO). The protocol for this study has already been used successfully with Adderall, Concerta, and Strattera.

6) Dr. Tracy confirmed hearing that an NIMH funded trial for Depression is enrolling using Org-24448.

7) PET scan discussion - its value in showing changes in brain activity/cellular metabolism in regional areas of the brain. (The CX-717 AD trial is using the PET scan. The Org-24448 Depression trial will also reportedly be doing PET scans in some of their patients).
Hallo liebe Cortex Fans,
ich melde mich nochmal mit einem Abstrakt zu CX717 bei Schlafentzug.
Liebe Grüße
Erbse

Facilitation of Task Performance and Removal of the Effects of Sleep Deprivation by an Ampakine (CX717) in Nonhuman Primates.

Department of Physiology and Pharmacology, Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States of America.

The deleterious effects of prolonged sleep deprivation on behavior and cognition are a concern in modern society. Persons at risk for impaired performance and health-related issues resulting from prolonged sleep loss would benefit from agents capable of reducing these detrimental effects at the time they are sleep deprived. Agents capable of improving cognition by enhancing brain activity under normal circumstances may also have the potential to reduce the harmful or unwanted effects of sleep deprivation. The significant prevalence of excitatory alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamatergic receptors in the brain provides a basis for implementing a class of drugs that could act to alter or remove the effects of sleep deprivation. The ampakine CX717 (Cortex Pharmaceuticals), a positive allosteric modulator of AMPA receptors, was tested for its ability to enhance performance of a cognitive, delayed match-to-sample task under normal circumstances in well-trained monkeys, as well as alleviate the detrimental effects of 30-36 h of sleep deprivation.

CX717 produced a dose-dependent enhancement of task performance under normal alert testing conditions. Concomitant measures of regional cerebral metabolic rates for glucose (CMR(glc)) during the task, utilizing positron emission tomography, revealed increased activity in prefrontal cortex, dorsal striatum, and medial temporal lobe (including hippocampus) that was significantly enhanced over normal alert conditions following administration of CX717.

A single night of sleep deprivation produced severe impairments in performance in the same monkeys, accompanied by significant alterations in task-related CMR(glc) in these same brain regions. However, CX717 administered to sleep-deprived monkeys produced a striking removal of the behavioral impairment and returned performance to above-normal levels even though animals were sleep deprived. Consistent with this recovery, CMR(glc) in all but one brain region affected by sleep deprivation was also returned to the normal alert pattern by the drug. The ampakine CX717, in addition to enhancing cognitive performance under normal alert conditions, also proved effective in alleviating impairment of performance due to sleep deprivation. Therefore, the ability to activate specific brain regions under normal alert conditions and alter the deleterious effects of sleep deprivation on activity in those same regions indicate a potential role for ampakines in sustaining performance under these types of adverse conditions.
Hallo liebe Cortex Fans. Der komplette Artikel zu den CX717 Versuchen wurde veröffentlicht. Also jede Menge lesenswertes zu den Ampakinen.


Facilitation of Task Performance and Removal of the Effects of Sleep Deprivation by an Ampakine (CX717) in Nonhuman Primates.

http://biology.plosjournals.org/perlserv/?request=get-docume…

Schönen Tag noch
Erbse
Stellvertretend für die Menge an Meldungen hier nur ein Artikel von der BBC


Drug `reverses sleep lack effect`
A drug could reverse the effects of sleep deprivation in the brain, a US study of monkeys has suggested.

http://news.bbc.co.uk/1/hi/health/4173078.stm

Zusätzlich noch die Meldung von Cortex zu der Veröffentlichung
Publication in the Journal PLoS Biology Supports Cortex Pharmaceutical`s CX717 AMPAKINE Compound as a Potential New Treatment for Cognitive Impairments

http://biz.yahoo.com/bw/050823/235178.html?.v=1

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,

das Interesse im Augenblick ist riesengroß. Für Interessenten deshalb noch mal den Stand zu den einzelnen Testphasen. Der Artikel stammt von dem user gfp927z. Es lohnt sich also die letzten Beiträge mal zu lesen.
Liebe Grüße

Here`s a brief summary of the current clinical human trials for Cortex developed compounds -

CX-717 -

1) Sleep Deprivation - Phase 2a, 16 subjects (completed).

2) AD PET scan study - Phase 2a, 12 patients, completion approx September.

3) ADHD - Phase 2a, 60 adult patients, completion approx year end.

4) Shift Work - Phase 2a, 48 subjects, funded by DARPA, completion approx year end.


Org-24448 (CX-691) -

1) Schizophrenia - mono therapy, Phase 2b, (partner Organon).

2) Schizophrenia - combo therapy, Phase 2b, 100 patients, NIMH/TURNS, (partner Organon).

3) Depression - Phase 2b, 90/70 patients, NIMH, (partner Organon).


Other human trials of non-Cortex developed compounds -

1) S-18986 - Phase 2a study, likely in AD.
(partner Servier). S-18986 is a Benzothiadiazide.

2) Lilly - though Lilly has a ton of compounds (Biarylpropylsulfonamides), and have done a lot of preclinical work in the AMPA upmodulation area (AD, Parkinson`s, Schizo/Depression, etc), they currently have no human trials that I`m aware of. Lilly`s Alzheimer`s Phase 2 with LY-451395 was halted last year apparently due to excitotoxicity related side effects (a characteristic of their Biarylpropylsulfonamides).

3) Glaxo/NeuroSearch - no human trials yet that I`m aware of. NeuroSearch`s compounds appear to be similar to Servier`s (Benzothiadiazide and related families), though they may also have some Benzoxazine derivatives.

4) Boehringer Ingelheim - no human trials that I`m aware of. They appear to be working with Napthothiazines.


So Cortex`s super-safe low impact compounds are way ahead clinically, and of course Organon/Servier are both already partnered with Cortex. Both Lilly and Glaxo could benefit tremendously by gaining access to Cortex`s technology, compounds, and patents (via partnering or acquisition). In addition to Cortex`s low impact technology, they could get access to Cortex`s new high impacts. Amgen is another possibility, since they are seeking a presence in the neuro area, and their head of neuroscience came from Lilly (Dr. Fibiger, formerly Lilly`s VP of Neuroscience). Other interesting personnel interconnections among these companies include -

Dr. Mansbach - Cortex`s head of clinical development since Sept 2004, came from Glaxo (he was Glaxo`s Senior Director of Clinical Development, Neurosciences), and

Dr. Tollefson - he joined Cortex`s board in March 2004, and was a heavy hitter at Lilly.

Quelle:http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
Hallo liebe Cortex Freunde.

Ich melde mich noch mal zu den Meldungen der Schlafentzugversuchen. Die Artikel sind in Deutsch.


Medikament kehrt Folgen des Schlafentzugs um
Eine Arznei aus der Stoffgruppe der Ampakine soll helfen Schlafmangel zu überbrücken und dabei dennoch fit zu bleiben. Wer profitiert? Beispielsweise Schichtarbeiter und natürlich Ärzte, hoffen die Forscher.

http://www.aerztlichepraxis.de/artikel?number=1124793500


Kampferprobt kommen die Meldungen aus Österreich.



Muntermacher für den Krieg
US-Forscher finden ein Aufputschmittel ohne Nebenwirkung.

http://www.diepresse.com/Artikel.aspx?channel=h&ressort=ws&i…


Wie bereits von mir angekündigt findet am 8. September eine Konferenz von Cortex statt. Es ist sehr gut möglich, daß hier die Alzheimer PET Scans präsentiert werden.

Cortex`s CEO to Speak at the Roth Capital Partners New York Conference on September 8th, 2005

http://biz.yahoo.com/bw/050824/245166.html?.v=1

Schönen Tag noch
Erbse
Hallo liebe Cortex Fans, hier eine kurze Zusammenfassung der heutigen Konferenz von dem user gfp927z.
Die komplette Konferenz in Ton gibts im vorherigen Hinweis zur Konferenz.

Liebe Grüße
Erbse

Some highlights from today`s Roth Conf presentation -

Servier is looking for approx 3 high impact compounds from the ongoing collaboration with Cortex. CX-929 is apparently one of the high impact compounds that has come out this Cortex/Servier collaboration. Dr. Lynch has used CX-929 to demonstrate tremendous upregulation of BDNF in rats.

Dr. Stoll discussed Lilly`s previously published Parkinson`s preclinical studies using their high impact AMPA upregulators (LY-404187, LY-503430) which showed the reversal to normal of Parkinson`s symptoms, and the regrowth of lost brain tissue. This suggests that high impact compounds can reverse the effects of Parkinson`s disease.

CX-727 showed an elevation of BDNF of approx 10-20% after 2 months of dosing in animals, indicating that low impacts can also modestly upregulate BDNF.

A comprehensive review of the recently published Deadwyler primate data was given. These studies showed that CX-717 totally reversed the cognitive deficits of sleep deprivation. PET scans of these primates showed tremendous upregulation of glucose metabolism in certain areas of the brain (hippocampus, cerebral cortex, visual cortex), indicating that CX-717 was causing increased activity in the desired areas of the brain (the current AD PET scan trial will confirm that these same changes also occur in humans).

Review of the UK Sleep Deprivation trial results was given. Dr. Stoll also mentioned that the UK investigator had noted that CX-717 was the only drug they had ever tested which caused cerebral arousal without producing any systemic arousal/side effects (changes in blood pressure, heart rate, body temperature, etc).

Review of Phase 1 - CX-717 has a 9-10 hour halflife, excellent safety, linear kinetics.

AD trial - should have an interim analysis in a month.

ADHD - Enrollment is going very well, with half the patients already enrolled.

Shift Work - DARPA is paying all the trial costs. This trial is run by a military research organization, and got started slightly late, so the results might be just after the end of the year.

The CX-717 3 month tox study in 2 species is completed.

There are lots of licensing discussions underway, and a partnership should be coming to fruition.

Quelle:http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
Hallo liebe Cortex Fans,
der Neuroinvestor meldet sich auch mit einem weiteren Beitrag
Schönes Wochenende
Erbse

the September 2005 issue:

While there have been rumors of a term sheet in place, that is not true, about a dozen companies are still actively interested in the partnership. `Partnership` can mean something very different depending on the company involved: different firms have varying areas of interest, and a company pursuing Alzheimer`s may have no interest in ADHD, and vice versa, Indeed, it may be a rare animal that is interested in all of the major Ampakine indication possibilities.


The other issue has to do with how much data different companies want before being willing to set a term sheet in writing. Our hunch is that the PET scan data from Alzheimer`s patients, due this month, may be the key ingredient for the companies whose interests are indeed focused upon Alzheimer`s. On the other hand, we are quite sure that there are psychiatrically oriented partner candidates who are largely interested in schizophrenia, depression, and perhaps ADHD. If one of those companies steps up, the complicating factor will of course be Organon--both Cortex and Organon have to agree to sublicenses. Given that schizophrenia is the most clinically advanced program, we believe that this particular indication area would be the most valuable in a licensing deal. One other variable in play is the availability of CX717 for Cortex`s inhouse orphan indication program, Fragile X at the forefront of possibilities. The biggest `name` partners, those whose embrace would mean instant credibility, are less likely to cede any access to CX717 (and its backup CX727), they will want full control. Companies which are a tier or two down in size, albeit still enormous compared to Cortex, might be more flexible, which would allow instant entrance into clinical development for the orphans on Cortex`s part.

Would the credibility be worth the 18 month delay that giving up CX717 would require? That depends on the numbers. Cortex still believes a deal could be done by year-end, we think that is a 50/50 proposition at best. Both shiftwork and ADHD are likely to have their Phase IIa data late 2005, and the more conservative read of the situation is that the deal that Cortex really wants will not be there for the taking without Phase IIa corroboration. As we have noted before, Cortex is a micro-company that could be an appealing `munch` for a larger firm. We have been citing a target of 12, but because we believe profit-taking would be wise if the share were to get anywhere near 8, we are going to reset the target to 8, so that there is no confusion therein. And given that a Canadian fund sold off a large position, thus keeping the price near its lows, it would be an extreme optimist who would not start taking some profits at 5 and above.

Quelle:http://www.neuroinvestment.com/CORXcom.html
Hier eine Meldung aus Russland. Ist nichts Neues dabei,aber ich kann mir einfach nicht verkneifen die Meldung in diesem Thread zu posten.

Viele Grüße
Erbse



Wonder drug beats effects of sleep deprivation
http://newsfromrussia.com/science/2005/08/23/61600.html
Hallo liebe Cortex Fans,
ich melde mich noch mal mit einigen weiteren Erläuterungen zu den Versuchen mit ORG 24448. Organon hat diese Substanz von Cortex einlizensiert. Auf einer Schizophrenie Konferenz wurden noch einige Einzelheiten bekannt.

Liebe Grüße
Erbse



Cognition in Schizophrenia: The MATRICS Initiative

In the symposium, "Enhancing Neurocognition in Schizophrenia," Wayne S. Fenton, MD, of the National Institute of Mental Health (NIMH), introduced the Measurement and Treatment Research to Improve Cognition in Schizophrenia, known as the MATRICS Initiative.[11] He described it as, "a collaboration between NIMH, the University of California, Los Angeles, and the United States Food and Drug Administration to combine what we`ve learned on the basic science of cognition in schizophrenia and push translation toward treatment."

Keith Nuechterlein, PhD, of the University of California, Los Angeles (UCLA), said that this field has matured slowly because of methodologic uncertainties such as defining targets for intervention, measuring outcomes, and designing appropriate and meaningful studies.[12] He discussed the recent effort to create a standardized cognitive test battery by the MATRICS Initiative neurocognition committee. The committee targeted 7 cognitive domains most affected by schizophrenia[13]:

Speed of processing
Verbal learning and memory
Visual learning and memory
Reasoning and problem solving (executive functioning)
Attention and vigilance
Working memory
Social cognition


After considering more than 90 tests, the committee selected 20 for further study in the Psychometric and Standardization Study, which involved 176 patients with schizophrenia tested at 5 sites. The tests were evaluated on criteria like test-retest reliability; and relationship to functional outcome, such as community functioning. The proposed final battery of 10 tests, which takes about 1 hour to administer, is available online at a Web site set up by UCLA.[14] The federal agencies have received the final recommendations from the MATRICS committee and will require that clinical trials of cognitive enhancers for schizophrenia use this battery of tests to measure outcomes.

TURNS Institutions and Pharmacologic Agents
Robert Buchanan, MD, said that his institution, the Maryland Psychiatric Research Center, University of Maryland in Baltimore, is one of 7 research sites in the Treatment Units for Research on Neurocognition in Schizophrenia (TURNS).[15] These institutions will conduct studies of promising cognitive enhancers for schizophrenia as identified by the MATRICS neuropharmacology committee.[16] Criteria considered in selection of potential agents include efficacy, pharmacokinetics, safety, tolerability, and innovation. Of 50 agents identified, he called the 2 "front runners" ispronicline and Organon`s compound ORG 24448.

Ispronicline (Targacept, Inc., Winston-Salem, North Carolina) is an alpha-4-beta-2 nicotinic receptor partial agonist, more potent than nicotine at this receptor. It allows once-daily dosing and induces cytochrome P450 1A2. In animal studies, it shows no evidence of tolerance. Studies in normal humans as well as those with age-associated memory impairment and mild cognitive impairment have taken place. "The TURNS study will be the first evaluation of its use in schizophrenia," Dr. Buchanan said.

ORG 24448 is an allosteric modulator of the alpha-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) glutamate receptor and has been tested in animal models of cognition with no evidence of tolerance or proconvulsant activity. Human studies to assess maximum tolerated dose are underway.

According to Dr. Buchanan, subjects who participate in TURNS studies will need to have a DSM-IV diagnosis of schizophrenia and be stable on a second-generation antipsychotic other than clozapine or, in the case of ispronicline, olanzapine because of its anticholinergic effect. The studies will include men and women aged 18 to 55 years who have a MATRICS cognitive-test-battery score below a specific cut-off at baseline. The double-blind design includes 3 parallel arms -- 2 medication dosages, 1 placebo -- with outcomes measured by the MATRICS consensus cognitive battery, standardized scales for other symptoms of schizophrenia, and standardized measures of community functioning. Investigators will also follow biological markers such as functional magnetic resonance imaging, evoked response potentials, magnetic resonance spectroscopy, and prepulse inhibition to startle.

Quelle:http://www.medscape.com/viewarticle/504415_3
Eine weitere Empfehlung Cortex zu kaufen. Ich denke mal, daß die positiven Kommentare anhalten werden.

Schönen Tag noch
Erbse



Invest in the next miracle drugs

<<Cortex Pharmaceuticals (COR, news, msgs) is developing a drug that may improve alertness and memory by changing how nerve cells in the brain communicate. It could be used to treat problems like Alzheimer’s, sleep deprivation, autism and attention deficit disorder. Garren says that the drug`s animal-testing studies look promising, and that by end of year "we may know more about its efficacy in humans.">>>

Quelle:http://moneycentral.msn.com/content/P127491.asp
Hallo Erbse1

Du bist mir schon vor einigen Jahren im Yahoo Forum aufgefallen mit guten Kommentaren zu Coretx - vielen Dank. Leider habe ich nicht die Zeit alle Entwicklungen rund um Cortex mitzuverfolgen und beteilige mich daher auch nicht an den Diskussionen, welche ich aber als Informationsquelle sehr schätze.

Ich bin bereits seit bald 6 Jahren Aktionär von Cortex. Leider haben sich meine Hoffnungen in diesen Titel bis jetzt nicht bestätigt und ich bin immer noch unter Einstand. Und trotzdem glaube ich, dass dieser Titel eines Tages nach oben abziehen könnte, wenn die Produktentwicklung in Gang kommt. Dies ist auch der einzige Grund, weshlab ich diesen Titel (als einzigen) sol lange halte und mir gerade überlege ob ich noch zukaufen soll. Auf der anderen Seite wurde ich aber schon einge Male entäuscht. Immer wenn ich das Gefühl hatte jezt gehts nach Norden, kam der Hammerschlag und der Titel hat seine Gewinne wieder abgegeben.

Da ich Dir aufgrund Deiner gescheiten Postings einige Kompetenzen zutraue und ich weiss, dass Du diesen Titel seit Jahren beobachtest würde es mich interessieren wie Du die Lage einschätzt. Ich würde mich daher freuen etwas von Dir zu hören.

Beste Grüsse aus der Schweiz
pwoell
Hallo pwoell,
freut mich Dein Interesse an Cortex. Es ist schwer für mich die Lage bei Cortex einzuschätzen. Ich bin wissentschaflich gesehen ein Laie und ein miserabler Börsianer. Es bleibt mir also nur die Beobachterrolle bei Cortex.
Doch einige Gedanken sollten uns doch weiterhelfen.
Der damalige CEO Vincent Simmon hat es verpasst parallel zu CX 516 weitere Substanzen voranzutreiben. Nach dem Scheitern von CX 516 hatte Cortex große Mühe den Konkurs zu vermeiden.
Mit CX 717 und Roger Stoll ging es wieder bergauf und es wurden erfolgreich zur Liquiditätssicherung einige Kapitalmaßnahmen durchgeführt. Die Ergebnisse zu CX 717 kann man hier der aktuellen Presse entnehmen.

Zu den Zukunftsaussichten. Cortex ist im Augenblick mit ca 80 Mill. $ bewertet. Provigil wird auch bei ähnlichen Anwendungsgebieten in Verbindung gebracht wie CX 717 und macht dieses Jahr einen Umsatz von ca. 600 Mill. $. Sicher wird Cortex eine Vereinbarung mit DARPA haben, doch die Hälfte des Gewinns dürfte wohl bei Cortex verbleiben.
Rechnet man ca. das Achtfache des Umsatzes oder ca. das Zwanzigfache des Gewinnes so hat man einen Richtwert, mit dem Cortex bei erfolgreicher Zulassung bewertet werden düfte. In ferner Zukunft (4-8Jahre)rechne ich mit einer Bewertung die zwischen 2Milliarden und 10 Milliarden $ liegen dürfte. Dies ist davon abhängig in wie vielen Gebieten die Substanzen auch erfolgreich zugelassen werden. Allerdings besteht auch die Gefahr, daß Cortex von einem großen Pharmapartner aufgekauft wird.
Ich selber bin optimistisch eingestellt und hoffe, daß keine überraschenden Nebenwirkungen bei den weiteren Testphasen eintreten.

Jetzt noch einige Anmerkungen in eigener Sache. Einige Kollegen haben ein Board zu Cortex gebastelt, da wir uns unabhängig von den hiesigen Boardbetreibern machen wollen und das Yahoo Board wochenlang down ist. Wir befinden uns noch in der Testphase, aber es kann schon gepostet werden und man kann sich schon anmelden. Wir würden uns freuen, wenn ihr mal reinschaut.

Achtung Neues Cortex Board---New Cortex Board

http://www.erbse.vm-elsig.de/form/base/YaBB.pl

Mit diesem link kommt ihr zu dem neuen Cortex Pharma Board.

Schönes Wochenende
Erbse1
Hallo Liebe Cortex Freunde, hab noch einen schönen Artikel zu der Thematik Schlafentzug gefunden.

Clocking in Pillow Time without the Pillow

<<<If you snooze, you lose those uncomely grayish-brown crescents below your eyes. If you don`t snooze, you lose a lot more. The body can`t fight off infection, the muscles can`t regenerate as quickly, the mind can`t learn new words, and the eyes can`t focus on the road. You also gain things: a bad mood and increased risk for diabetes, high blood pressure, and heart problems. Indeed, the effects of sleep deprivation can be so serious that some sleep scientists liken lifetime sleep debt to a heavy backpack: every sleep hour missed adds an extra pound to your pack until it weighs you down.

For people without time for a daily eight hours in the sack, drugs that counteract the effects of sleep deprivation could serve as substitutes. In a new study, Sam Deadwyler and colleagues have explored this possibility by giving dog-tired rhesus monkeys a drug shown to improve the functioning of alert brains. They found that sleepy monkeys taking the drug performed tasks better and had increased metabolic activity in several regions of their brains. This suggests that the cognitive effects of sleep deprivation can be reduced chemically.>>>

Gesamter Artikelhttp://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=112705265…

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,

Cortex will sich 25.000.000 neue Aktien genehmigen lassen. Kann gut sein, daß diese Aktien für eine ausstehende Partnerschaft mit einer größeren Pharmafirma benötigt werden. Die Zukunft wird zeigen, wofür die zusätzlichen Aktien letztendlich benötigt werden.

The Board of Directors unanimously recommends that you vote FOR the proposal to amend the Restated Certificate of Incorporation to increase the authorized number of shares of Common Stock from 50,000,000 to 75,000,000

Quelle:http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=112840036…

Weiterhin gibts Neuigkeiten vom neuen Cortex Board zu vermelden. Wir haben zusätzlich einen Chat eingebaut, der natürlich auch von allen anderen genutzt werden kann.
Hier also nochmals der link zu dem neuen Cortex Pharma Board mit sehr vielen Artikeln.

http://www.erbse.vm-elsig.de/form/base/YaBB.pl

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde, der neue Brief des CEO Stoll an die Aktionäre ist da.

ROGER STOLL: TO OUR SHAREHOLDERS AND FRIENDS: 2005

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=113024743…

Steht vieles zur aktuellen Lage drin. Sehr lesenswert für alle Cortex Interessierte.

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,
unter folgendem link eine Veröffentlichung zu dem Thema Ampakine und Schizophrenie bzw. Psychose.

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=113041291…

Die nächsten drei vier Monate werden jetzt wohl extrem wichtig für Cortex. Ich poste jetzt nicht mehr regelmäßig hier im Wallstreet Board. Interessenten finden die neuesten Nachrichten im neuen Cortex Board oder auf dem Yahoo Board.Also einfach mal vorbei schauen.

http://www.erbse.vm-elsig.de/form/base/YaBB.pl
oder
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,
es gibt einen aktuellen Überblick vom user gfp927z. Nochmals herzlichen Dank an gfp927z für all seine Mühe sein Wissen mit uns zu teilen.

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=112736027…

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,
vor kuzem war Jahreshauptversammlung bei Cortex. Es geht alles seinen normalen Gang. Bemerkenswert ist, daß der CEO Stoll eine neue Strategie andenkt. Es soll eine weitere Substanz einlizensiert werden. So könnten dann die Ampakine als ganzes Paket auslizensiert werden. Dies ist nur eine zusätzliche Option zu der bisherigen Planung. Dabei wollte Cortex die großen Anwendungsgebiete auslizensieren und kleinere Anwendungsgebiete in Eigenregie zur Marktreife bringen. Bin selber gespannt welche Strategie dann letztendlich dann zum Tragen kommt.

Interessenten können sich die Jahreshauptversammlung unter folgenedem link aufrufen. Die Dauer beträgt ca. 1Std.25Min.

http://www.cortexpharm.com/html/news/index.html

Die Ergebnisse aus den einzelnen Versuchsreihen werden jetzt im ersten Quartal nächsten Jahres erwartet. Einzelheiten könnt Ihr ja aus der Jahreshauptversammlung entnehmen.

Machts mal gut
Erbse1
Hallo Cortex Freunde,

unter dem folgendem link gibts eine Zusammenfassung von der Jahreshauptversammlung von dem unermüdlichen user gfp927z.
http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=113353267…

Weiterhin gibts eine rege Diskussion auf dem Yahoo Board.
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

Schönen Tag noch
Erbse
Cortex Pressemeldung von Heute. Für Insider nichts Neues, trotzdem lesenswert.

Liebe Grüße
Erbse


Help for the Sleep-Deprived Brain

Monday December 5, 5:08 am ET

IRVINE, Calif., Dec. 5 /PRNewswire/ -- Sleep deprivation can take its toll on body and mind, leading to dull thinking and slower reaction times. That can be dangerous while driving and also at work. A regular pattern of restful sleep may be the solution. But for some shift workers, health care professionals, and military personnel, that`s not always possible.

Shift workers and military personnel disrupt their sleep-wake cycles on a regular basis, often remaining awake for 24 hours at a stretch or even longer. This leads to reduced hand-to-eye coordination that is astonishing similar to a blood alcohol content of 0.1.

"Since sleep disorders are a tremendous drain on the productivity and safety of our country, there is an urgent need for a solution that can help the sleep deprived regain cognitive and psychomotor functions," says Dr. Roger Stoll, CEO of Cortex Pharmaceuticals, a neuroscience company focused on innovative drug therapy including their leading ampakine compound, CX717 which targets various neurological and psychiatric disorders.

"CX717 is a type of drug called an ampakine. Ampakine drugs act to increase the strength of signals at key connections between brain cells," says Dr. Stoll. "Ampakine drugs are designed to up-regulate to the principle neurotransmitters in the brain. CX717 amplifies signals, and may also increase the amount of growth factors in the brain."

The U.S. Department of Defense Advanced Research Projects Agency (DARPA) recently tested CX717 in a sleep deprivation study in primates led by Sam Deadwyler, Ph.D, a senior researcher at the physiology and pharmacology department of Wake Forest University. The study, recently published in the Public Library of Science, Biology, found that CX717 administered to sleep- deprived monkeys improved cognitive performance and also reversed the delirious effects of sleep deprivation.

Through the first Phase IIa clinical trial conducted in the United Kingdom, the company gained evidence that CX717 promotes wakefulness may improve memory and attention, and was safe and tolerable. "We were particularly impressed in both the increased attention and vigilance scores and the cerebral arousal this first study identified in human subjects who had been sleep deprived," said Dr. Stoll.

America is arguably the most sleep-deprived nation in the world. The National Commission on Sleep Disorders estimates that 40 million Americans are either chronically or intermittently affected with various sleep disorders.

For more information about CX717, log on to http://www.cortexpharm.com
Hallo liebe Cortex Freunde,
noch eine Meldung von letzter Woche. Ist eigentlich nicht so interessant, aber der Vollständigkeit halber poste ich sie mal trotzdem. Cortex hat sich eine Erhöhung von 50 auf 75 Millionen Aktien absegnen lassen.

Schönes Wochenende noch
Erbse

Industry Expert Assesses Cortex`s
Orphan Drug Strategy

Webcast Of Presentation Available On-Line Until January 2

IRVINE, CA (December 13, 2005) — At the annual shareholder meeting for Cortex Pharmaceuticals, Inc. (AMEX: COR), the Company’s orphan drug strategy for the Ampakine® technology was discussed by the CEO, Roger G. Stoll, Ph.D. and a guest speaker, Curt Friehs, founder and president of Kronos Associates.

A webcast of the meeting is available now through January 2, 2006 via the following link http://www.investorcalendar.com/IC/CEPage.asp?ID=98161.

Mr. Friehs, who is a consultant to Cortex, is an industry renowned marketing expert with broad experience, most notably at Upjohn (now wholly owned by Pfizer), and at Wallace Laboratories. At the shareholder meeting, Mr. Friehs explained that orphan drugs offer Cortex an attractive commercial opportunity by addressing a distinct group of underserved patients, including those with Fragile X, excessive daytime sleepiness due to narcolepsy, loss of memory due to electroconvulsive therapy, as well as other possible orphan drug indications and further expansion into autism and post seizure therapy. Furthermore, Cortex’s strategy could facilitate the Company’s eventual transition to a larger organization that would be capable of marketing drugs for much larger patient populations.

Dr. Stoll, who hosted the meeting, stressed that the orphan drug approach may allow a small company like Cortex to get products to market faster, at less cost than the major indications often discussed for the Ampakine drugs. He also pointed out in detail the profound unmet medical needs for such orphan indications within central nervous system disorders and how they could be addressed by Cortex’s Ampakine technology platform, including the Company’s Ampakine compound, CX717. Dr. Stoll also reported on Cortex’s clinical development programs and anticipated licensing endeavors.

At this meeting the substantial majority of shareholders approved the proposed increase in the Company’s authorized shares from 50,000,000 common shares to 75,000,000 common shares and approved both the recommended board of directors and the Company’s external auditors.
Neue Studie von ORG24448 gegen Depression in der Planung.

Randomized, Placebo-Controlled Trial of an AMPAkine in Major Depressive Disorder

Further Study Details:
Primary Outcomes: Reduction of depressive symptoms as measured by the several depression rating scales at 8 weeks
Secondary Outcomes: Effect on neuropsychological functioning measured at 7 weeks

Study start: January 2006; Expected completion: January 2009

Major depressive disorder (MDD) is a common, severe, chronic and often life-threatening illness. Major depression contributes to significant morbidity and mortality. Available pharmacotherapies for major depression are suboptimal in terms of speed of onset, efficacy, and tolerability. Current medications for severe, chronic mood disorders are not based on pathophysiological models of illness, but rather are variation of monoaminergic-based therapies. Org 24448 represents a new treatment approach for depression, by potentiating the AMPA receptor subfamily of ionotropic glutamate receptors. This drug has been shown to have antidepressant features in preclinical models, as well as cognitive-enhancing qualities.

Source:
http://www.clinicaltrials.gov/ct/show/NCT00262665?order=2


Bis demnächst
Erbse
Hab gleich noch eine weitere Studie mit S18986 entdeckt. Servier hat von Cortex die Ampakine einlizensiert.
Schönen Tag noch
Erbse

Efficacy and Safety of S18986 in the Treatment of Mild Cognitive Impairment Patients

Quelle:http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=112702074…
Neuer Abstrakt von Gary Lynch. Klingt alles sehr kurz gehalten und optimistisch.

Grüße
Erbse


Glutamate-based therapeutic approaches: ampakines.

Lynch G.

University of California, Department of Psychiatry and Human Behavior, Irvine, California 92617, USA.

Ampakines are a structurally diverse family of small molecules that positively modulate alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)-type glutamate receptors, and thereby enhance fast, excitatory transmission throughout the brain. Surprisingly, ampakines have discrete effects on brain activity and behavior. Because their excitatory synaptic targets mediate communication between cortical regions, serve as sites of memory encoding, and regulate the production of growth factors, ampakines have a broad range of potential therapeutic applications. Several of these possibilities have been tested with positive results in preclinical models; preliminary clinical work has also been encouraging.
Hallo liebe Cortex Freunde,
der Neuroinvestor meldet sich mit einem kurzem Kommentar ins neue Jahr. Zu den Ergebnissen sinds jetzt nur noch wenige Wochen.
Liebe Grüße
Erbse

From the January 2006 issue:

Cortex is at various stages of discussion with sixteen suitors for the Ampakine platform. The 60pt ADHD Phase II that is completely enrolled stands to be the critical human trial. Enough of the interested companies have or want an ADHD franchise that we expect positive data to drive the final deal, if Cortex and a more impulsive BP company have not concluded a deal before that. Cortex is still committed to keeping CX717 for an orphan indication, and is also looking to inlicense a PhIII compound from a partner or other BP source. The DARPA funded sleep deprivation trial has begun enrolling strongly, and could report in late-February. But the AD PET scan study has gone almost nowhere (three patients enrolled) due to its exclusion of memantine patients. This is the best molecular platform and related IP currently for sale in the CNS industry.
Hallo Erbse,

zunächst einmal ein herzliches Dankeschön für deine unermüdliche Arbeit hier im Board im vergangenen jahr. Wünsche dir ein erfolgreiches und gutes Jahr 2006.

Habe über den Jahreswechsel dies meisten meiner HGRD`s in Cortex umgewandelt, hoffe es war kein Fehler.

Aber ich denke, der aktuelle Kurs bei steigenden umsätzen lästt auf positives hoffen.

In den nächsten Wochen wird sich bei Cortex hinsichtlich Meldungen und Ergebnisse einiges tun. Hoffe nur, daß sie das genehmigte Kapital für eine vernünftige Maßnahme im Sinne von uns Kleinaktionären einsetzen.

Gruß Coluche
Hallo liebe Cortex Fans, ich melde mich noch mal mit einem Artikel aus dem TIME Magazin.



Can You Find Concentration in a Bottle?

A guide to today`s brain-boosting pills and supplements and what`s in the pipeline

Quelle:http://www.time.com/time/magazine/article/0,9171,1147202-1,0…

Schönen Tag noch
Erbse
Ein Mark Varney von Sepracor ist zu Cortex als COO gekommen. Er hat gleich 700.000 Share-Options zum Einstandspreis vom 30.01. (ca. 2,95 $) bekommen.

Er soll wohl eine Coryphäe in der Entwicklung bei Sepracor gewesen sein, Vic-President. Wenn das dort die zweite Ebene ist, ist das o.k., wenns wie bei den Amibanken ist (zwischen Vice-President und COO noch ein Senior-Vice-President und ein Executive-Vice-President, also Ebene 4), wäre nicht so gut.

Aber nachdem der Kurs auf diese Meldung bei hohem Umsatz ansteigt, ist es eher postitiv zu werten.

Im übrigen muß er wohl bei Sepracor tatsächlich was zu sagen gehabt haben. Neuroinvestor berichtet, daß man dort große Stücke auf ihn gehalten hat/noch hält; war dann doch eher 2. Ebene. Die Logik scheint auch zu sein, daß wenn er von einer sicheren und gut dotierten Stelle eines mit ca. 5,5 Mrd. $ bewerteten Unternehmens zu Cortex wechselt, er dort deutlich höhere Chancen und Potenzial sieht.

3,14 $ ist immerhin ein guter Anstieg.

Gruß Coluche
...ach ja, Erbse, Dein Artikel aus der Times wird gerade im Yahoo-Board gesucht. ;)
Hallo liebe Cortex Freunde,
ich denke mal jetzt stehen die Ergebnisse an. Es kann sich jetzt nur noch um Tage handeln. Es gibt bei Schlafentzug weitere Veröffentlichungen. Im New Scientist und Scotsman.

Liebe Grüße
Erbse



Lifestyle pills that promise to end the need for sleep

IAN JOHNSTON
SCIENCE CORRESPONDENT
A NEW class of drugs that promise to "cure" the need for sleep are being developed to help people cope with the 24/7 society.

It is claimed that the range of lifestyle pills will abolish the need for sleep for days at a time by creating a form of sleep that offers the benefits of a good night`s rest in a fraction of the time.


The research, reported in the New Scientist magazine today, is partly being driven by the United States military`s quest for a "metabolically dominant soldier" who can fight on when the enemy falls asleep, and partly to help nightshift workers and others who are struggling with over-tiredness.

Researchers are hoping to build on the success of the drug Modafinil, a stimulant launched seven years ago that allows people to wake up refreshed after just four hours of sleep.

Unlike caffeine or amphetamines it appears not to leave people with the jitters, euphoria and eventual "crash", and does not require a "sleep debt" to be repaid. Sales have climbed from £14.2 million in 1999 to £330 million in 2005. A new drug, called CX717, is being tested by Cortex Pharmaceuticals in California. the drug appears to help people maintain normal alertness, despite extended sleep deprivation.

Tests on 11 rhesus monkeys showed that they were performing better after 36 hours of continual wakefulness than monkeys that had not been drugged were after normal sleep.

Professor Russell Foster, a molecular neuroscientist and sleep expert at Imperial College London, said: "What is exciting is we are beginning really now to understand the basic mechanisms under-lying sleep. It is very complicated - there are lots of different parts of the brain involved.

"But if we genuinely understand the mechanisms of sleep, we could attempt to mimic that with a drug. I have no doubt, at some level, we`ll be able to mimic sleep, but we are a long way off."

However, he cautioned that sleep was vital for the brain to function properly. "In a society increasingly dependant on creativity, we know sleep is crucial. We know that the ability to see new pathways and generate new ideas is critically dependant on a good night`s sleep," Prof Foster said.

He said that Modafinil had originally been developed as a treatment for narcolepsy, but was now being used as a stimulant. "It`s probably mimicking part of the arousal system of the brain," he said. "I`d be very careful about long-term use. It is now being pushed as a cure for sleep and it really isn`t. It is one way to override the need for sleep, short-term. You can become dependant on these drugs for normal cognitive function."

But Prof Foster said he doubted such concerns would stand in the way of new drugs coming on to the market.

"I`m a pragmatist. I don`t think we are going to be able to change the 24/7 society," he said. "The more we understand about the body`s 24-hour clock, the more we will be able to override it.

"In ten to 20 years, we`ll be able to pharmacologically turn sleep off. Mimicking sleep will take longer, but I can see it happening."

He said it was easy to tell if someone was getting enough sleep. "If you are woken up in the morning by an alarm clock, the answer is no. You should wake up normally," he said.

CX717 will be tested later this year by the US Defence Advanced Research Projects Agency based in Arlington, Virginia, which will push 48 volunteers to their limit on the drug.

But the prospect of a world where people are awake almost every hour of every day is alarming experts.

Neil Stanley, head of sleep research at the Human Psychopharmacology Research Unit at the University of Surrey, said: "I think that would be the most hideous thing to happen to society."

Quelle:http://news.scotsman.com/health.cfm?id=241212006

Weiter noch die Vorschau von New Scientist:



Article Preview
Get ready for 24-hour living
18 February 2006
Graham Lawton
Magazine issue 2539
A new wave of drugs will make it a breeze to go days without sleep, and give you a good night`s shut-eye in two hours - are you ready for 24-hour living?
SO MUCH to do, so little time. Between a hectic work schedule and a thriving social life, Yves (not his real name), a 31- year-old software developer from Seattle, often doesn`t have time for a full night`s sleep. So he swallows something to make sure he doesn`t need one. "If I take a dose just before I go to bed, I can wake up after 4 or 5 hours and feel refreshed," he says. "The alarm goes off and I`m like, let`s go!"

Yves is talking about modafinil, a stimulant that since its launch seven years ago has acquired a near-mythical reputation for wiring you awake without the jitters, euphoria and eventual crash that come after caffeine or amphetamines. Yves has been popping modafinil on and off for the past three years and says it is "tremendously useful". "I find I can be very productive at work," he says. "I`m ...

The complete article is 3505 words long.

Quelle:http://www.newscientist.com/channel/health/mg18925391.300
Cortex`s CEO Roger Stoll to Speak at the Roth Capital Partners 18th Annual Orange County Conference

IRVINE, Calif.--(BUSINESS WIRE)--Feb. 16, 2006--Cortex Pharmaceuticals, Inc. (AMEX: COR) Chairman, President and CEO, Roger G. Stoll, Ph.D., will speak at the Roth Capital Partners 18th Annual Orange County Conference at the St. Regis Monarch Beach Resort & Spa in Dana Point, CA. Cortex`s presentation is scheduled for 8:00 am PST (11:00 am EST) on Wednesday, February 22nd 2006. The conference will feature over 250 small-cap companies across a broad spectrum of sectors, including technology, healthcare, financial services and consumer products.

Dr. Stoll will discuss the status of the three Phase IIa studies with its lead AMPAKINE(R), CX717 in ADHD, Excessive Daytime Sleepiness (EDS) associated with simulated Shift Work and the PET Scan Study in mild-moderate Alzheimer`s disease. Dr. Stoll will also discuss the recent hiring of Dr. Mark Varney as COO & CSO, an update on corporate partnering efforts and the potential in-licensing strategy of a late stage non-AMPAKINE product candidate(s) for "Orphan Drug" indication(s), in which the Company`s AMPAKINE technology platform could be additive. Ampakine(R) compounds safely amplify the effects of glutamate. Glutamate is the primary excitatory neurotransmitter in the brain and is responsible for higher-order behaviors and cognitive activities such as, thinking, smelling, touching and memory.

A live webcast of the presentation can be accessed by logging onto http://www.wsw.com/webcast/roth7/cor/ and a replay will be available for 45 days following the conference

Bin mal gespannt auf die neue Einlizensierungsstrategie und was sich dahinter verbirgt. Ansonsten warte ich sehnsüchtig auf die Ergebnisse.

Schönen Tag noch
Erbse1
Hallo liebe Cortex Freunde,

folgend eine Abschrift der Roth Konferenz angefertigt von ryanfearfrost . Weiterhin eine kurze Zusammenfassung des users gfp927z. Im Anschluß daran noch ein kurzer Kommentar des Cortex CEO Stoll.

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=114076848…

Die wichtigsten Daten aber hier in wenigen Sätzen.

-ADHD Ergebnisse in ca. 10 Tagen.
-Schlafentzug Ergebnisse in ca 2-3 Wochen. Die Veröffentlichung der Daten kann noch etwas dauern, da die DARPA die Veröffentlichung absegnen muß.
- PET Scan Studien dauern noch etwas länger. Einzelheiten bitte aus dem obigen link entnehmen.

Schönen Tag noch
Erbse1
Hallo liebe Cortex Freunde,
habe den Newscientist Artikel auftreiben können. Es geht hier unter anderem um die DARPA, Cortex CEO Stoll und CX717

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=114006495…

Es tut sich auch Neues bei Organon. Es sollen bald Ergebnisse mit Org 24448 und Schizophrenie vorliegen. Nach Informationen des NeuroInvestor wird Ende März genannt.

Der Kursverlauf in den letzten Tagen ist zwar unerfreulich. Ob ein Zusammenhang mit den ADHD Ergebnissen besteht werden wir ja warscheinlich kommende Woche erfahren.

Machts mal gut
Erbse
Cortex Reports Positive Results with CX717 on the Primary Outcome Measure in Adult ADHD Study

IRVINE, Calif.--(BUSINESS WIRE)--March 6, 2006--Cortex Pharmaceuticals, Inc.`s (AMEX: COR - News), lead AMPAKINE® drug, CX717, showed positive results for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD). Forty-nine patients with ADHD completed the randomized, double-blind, placebo-controlled, two-way crossover design performed at seven US sites. Cortex undertook this Phase IIa clinical trial to assess both the dose of drug required and the effectiveness of CX717 in an adult ADHD population. The primary outcome measure was the ADHD Rating Scale (ADHD-RS) which evaluates both the inattentiveness and hyperactivity symptoms. The overall ADHD-RS score showed a positive trend in the 800mg twice daily (bid) dose group (n = 22) with a statistically significant effect on the hyperactivity subscale (p=0.050) compared to placebo. The 200mg bid dose (n = 27) did not show a significant effect. CX717 was well tolerated, and there were no serious adverse events or other significant safety concerns with either dose. Further, no increases in blood pressure or heart rate were observed on either dose of CX717.
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"The results from this Phase IIa study in adults with ADHD show that CX717 provided a clinically relevant response on the ADHD Rating Scale though the results will need to be verified in a larger study," said Lenard Adler, MD, the lead investigator of the study, Director for the Adult ADHD Program, and Associate Professor of Psychiatry and Neurology at New York University School of Medicine. "I am encouraged by the performance of CX717 which could lead to the development of a new pharmacotherapy for the treatment of ADHD."

"We are delighted that we achieved a response with the 22 completers in the 800mg bid dose group," said Dr. Roger Stoll, Chairman & CEO of Cortex. "It goes without saying that further studies with CX717 will be conducted in larger patient populations to further define the therapeutic dose and frequency of dosing. We believe that the market may be very interested in a non-stimulant ADHD drug with reduced cardiovascular concerns, which CX717 might offer. Where previous results reported for CX717 were in sleep deprived, normal subjects, this is the first study we have completed in a patient population with CX717 and represents real progress for Cortex ."

ABOUT THE STUDY

The study was a randomized, double-blind, placebo-controlled, multi-center, 2-period crossover. Each subject received placebo during one treatment and either CX717 200 mg bid or CX717 800 mg bid in the other treatment period. Each treatment period was 3 weeks with a 2 week washout in between. Sixty-eight subjects were randomized of whom 65 took either CX717 or placebo. Of those 65, 49 completed all assessments in both treatment periods. Most subjects who withdrew did so for non-treatment related reasons. The results presented here are for the primary outcome measure (the ADHD-RS). Analyses of other parameters are ongoing.

ABOUT ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a common psychiatric disorder characterized by inattentiveness, poor impulse control and hyperactivity. The disorder was historically thought of as a childhood illness. Longitudinal studies however have documented the persistence of symptoms into adulthood in a large percentage of childhood sufferers. The prevalence of ADHD is estimated at 2 - 4% of adults. ADHD exacts a significant toll on social relationships, education, and vocational attainment. Relative to those without the disorder, adults with ADHD tend to have higher rates of divorce, lower grade point averages in school, lower graduation rates, lower socioeconomic status, and more frequent problems with unemployment

Conference Call

Cortex will host a conference call and webcast on Wednesday, March 8th, at 10a.m. EST, 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, call (877) 407-0782. Internationally, call (201) 612-7415. An audio replay of the conference call will be available through Friday, March 24, 2006 by dialing (877) 660-6853 for U.S. participants and (201) 612-7415 for international participants. When prompted, participants should enter pass code 286 and conference ID number 195248. For the webcast please use the following link: http://www.vcall.com/IC/CEPage.asp?ID=102220. A replay of the webcast will be available through March 24, 2006.

Schönen Tag noch
Erbse
Es fehlen eine Menge Daten, speziell das Ergebnis beim ADHD-RS Score, und der Stoll betreibt ein wenig Data-Mining, aber soo schlecht sieht das nur auch nicht aus, dass man nun als Insider im Vorfeld verkaufe müsste.
Der Kursverfall der letzten Tage hatte also wohl andere Gründe. Momentan in der Frühbörse ein fettes Plus von 30 %.
Schneller Kommentar des NeuroInvestor.

The ADHD Phase IIa results came out better than we had dared expect. The dosing had tested the extremes, with extremely small sample sizes. The 200mg BID dose was a washout, but the 800mg BID dosing showed a "positive trend" on the overall ADHD scale score used as the primary endpoint-- will be of interest to see what `positive trend` means, although with n=22, that indicates a good magnitude of effect, reinforced by the crossover design. It won`t matter to a BP if it is 92% likely due to the drug, or 88%, here p=.05 would not be expected. It also was not expected on the hyperactivity subscale: p=.05 there is remarkable. Our conjecture had been that CX717 might end up primarily used with inattentive type ADHD, since the putative mechanism of this type of Ampakine would seem intuitively to be best suited for attentional symptoms. But these data suggest that it may be applicable across the board for both attentional and hyperactivity symptoms.
Not that it would be the first nonstimulant to do so, Provigil also showed efficacy in both subscales---albeit in studies involving 600+ patients, a far larger sample. It will be a while, and larger trials, before any reasonable comment can be made about their comparative magnitudes of effect. There had been some concern about the number of noncompleters, though the crossover design is harder for ADHD patients to adhere to, since they have to tolerate a washout, then return for a second treatment condition. Cortex has stated that "most" of the noncompleters were not due to drug, but it will be of interest whether those who were ended up skewed into the 800mg cohort. This is probably near the upper dosing limit, their partner will pay for Phase II trials looking at midrange doses.

In January we had reiterated that "this is the best molecular platform and related IP currently for sale in the CNS industry. These results validate that expectation. There are a number of Big Pharma companies which had been careful about the valuation of the Ampakine platform for attentional disorders. Now, those with interests in both attention/sleep deprivation, in the style of Cephalon`s Provigil, and in neurodegeneration, are going to be bidding up the value of a partnership that gives ample weight to both categories. With DARPA sleep deprivation data in three weeks, and the past Phase IIa data augurs well for those results; possible Organon information regarding their schizophrenia Phase IIb later this month, and a Big Pharma deal by the end of 2Q, the next few months will see Cortex finally live up to all of its predicted potential.

Machts mal gut
Erbse1
Hallo Erbse,

nach den Entwicklungen der vergangenen Tage gibt es für mich zwei Dinge festzuhalen:


1. An Dich ganz explizit ein ganz herzliches Danke !!! für alle Deine unermüdliche Arbeit hier im Board.



2. Wir sind mit Cortex auf einem guten Weg


Gruß Coluche
Hallo coluche, liebe Cortex Freunde,

danke erstmal für die Blumen.
Zur Meldung vom Montag einen Presseartikel von der LA.Times. Sieht prima aus die Lage bei Cortex. Es kann jetzt ganz schnell sehr hoch gehen. Ich denke heute legen wir erst mal eine kleine Pause ein.

Liebe Grüße
Erbse




Promising Results for Attention Drug

A medication from Cortex Pharmaceuticals significantly reduced symptoms in initial trials. Shares jump 32%.
By Terry McDermott, Times Staff Writer
March 7, 2006


Irvine-based Cortex Pharmaceuticals Inc. announced positive results Monday from initial clinical trials for a drug to treat attention deficit hyperactivity disorder.

The test, conducted on 65 people across the U.S., showed that the drug significantly reduced key ADHD symptoms, said Lenard Adler of the New York University School of Medicine, who ran one of the trials.

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Cortex immediately announced it would take the drug, one of a family of drugs called ampakines, into larger trials.

Shares in the tiny company jumped more than 32% to $3.04 after news of the trial was released, nearing a 52-week high.

Cortex has been working to develop ampakines almost since they were invented 15 years ago in the lab of Gary Lynch at UC Irvine, and the results by far made for the best day in the beleaguered company`s history.

Since it was founded in 1987, Cortex has had a new chief executive about every other year. The company has struggled financially and nearly went out of business more than once.

Current CEO Roger Stoll said the company had been in negotiations with pharmaceutical companies to license the compound, called CX717, even before the trial results were announced. He said eight or nine companies had expressed interest, with about half of those expressing new interest Monday.

Stoll said such a deal could eventually be worth several hundred million dollars to Cortex. The money would allow the company to develop ampakines for other disorders, which include Alzheimer`s disease, schizophrenia, Huntington`s and some forms of mental retardation.

Treatment of ADHD is a multibillion-dollar-a-year business. It affects an estimated 4% of the children in the United States. ADHD is thought to be caused by too much or too little production of certain chemicals, called neurotransmitters, in the brain. The main treatment to date has been the prescription of stimulants such as Ritalin and Adderall, which increase or inhibit production of one or more of the neurotransmitters.

More than 31 million prescriptions were written for the disorder last year, according to IMS Health Inc., a company that compiles pharmaceutical industry data. However, a federal Food and Drug Administration expert panel warned last month that the stimulants posed a risk for strokes and heart attacks and recommended that a strong warning accompany sale of the drugs. The FDA has not acted on that recommendation.

The Cortex drug is not a stimulant and theoretically would have no such risk. In fact, no significant side effects were uncovered in the trial.

Arvid Carlsson, a scientific advisor to Cortex who won a Nobel Prize for his studies of dopamine, one of the neurotransmitters involved in ADHD, said ampakines could be safer because they interact with different portions of the brain circuits that regulate behavior.

"It makes sense that if you have a very different target, some of the problems that are caused by these other drugs can be avoided," he said. "It`s an exciting — though preliminary — finding."

Quelle:http://www.latimes.com/business/la-fi-adhd7mar07,1,5402637.s…
Hallo liebe Cortex Freunde,

folgend ein Upgrade von Rodman&Renshaw. Ich denke mal, daß bald auch andere Analysten auf Cortex aufmerksam werden. Die Entwicklung der letzten Tage war einfach super. Wichtige Punkte, die in nächster Zeit anstehen.

-Ergebnisse Schlafentzugstudie in Zusammenarbeit mit DARPA
-Ergebnisse Schizophrenie Studie 2b in Zusammenarbeit mit Organon.
-PET Scan Studie Ergebnisse bei Alzheimer wird wohl erst im Sommer/Herbst vorliegen.
-Auslizensierung von CX717 an einen großen Partner.

Es lohnt sich also Cortex in nächster Zeit zu beobachten.
Schönen Tag noch
Erbse

R&R Cortex comment and upgrade

<<TRANSFORMATION IN THE MAKING Last Friday, we hosted a lunch with Cortex management. It is becoming clear that the company is about to undergo a significant transformation. In 12 months, lead compound, CX717 may be in advanced trials for multiple indications, presumably with a corporate partner. Cortex plan to retain rights and to further develop orphan indications with either CX717 or with follow on compounds. The company also anticipates to license in a Phase II/III drug candidate, which maybe synergistic with AMPAKINEs. A successfully executed strategy could elevate Cortex in line with peers that are currently valued in the $375MM range (see page 3-4). Therefore, we are increasing our 12-month price target from $8 to $12 per share and maintain our Market Outperform / Speculative Risk rating.



EXPANDING MARKET POTENTIAL & INTEREST We have come to realize that CX717 may indeed have blockbuster potential in multiple indications. Following the disclosure of the initial ADHD data, management received “significant” interest from potential licensing partners. We are not surprised.



VS. AMPHETAMINES & MODAFINIL It is likely, that amphetamine drugs may get a black box warning for potential cardiovascular issues. CX717 did not impact blood pressure and heart rate so far. Cephalon’s (CEPH, Outperform) non-amphetamine modafinil have failed in adult ADHD. Yet, in narcolepsy and excessive daytime sleepiness (EDSS), modafinil recorded sales of over $500MM last year. The drug is a scheduled substance. While so far CX717 does not appear to have reinforcing properties in animals or in humans, formal testing is required to prove this point.



VS. STRATTERA Efficacy seen with CX717 may be at par (if not better) with Eli Lilly’s (LLY, Not Rated) non-stimulant, Strattera. Strattera sales declined by 17% to $552MM in 2005, presumably because of the black box label warning on associated suicidal thoughts and associated liver toxicity. Should the upcoming CX717 shift-work study (within a month) be positive, we could begin to think of CX717 having the combined efficacy of modafinil and Strattera with a potentially benign side-effect profile. Nearly 40% of CX717-treated patients (BID) complained about insomnia. This bodes well for the shift-work study, where among others, wakefulness promoting property is being tested.



COMPRESSING TIMELINES From our conversations with management, we conclude that they might be leaning toward developing CX717 for ADHD and sleep disorders first, because of the inherently faster time to market. The observation period in a typical ADHD study is 8 weeks vs. 12-24 months in Alzheimer’s disease. >>

This is from Annie Li, biotech analyst at Rodman & Renshaw

Quelle:http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=112697844…
Hallo liebe Cortex Freunde,
nun ist auch der Aktionär auf diesen Wert aufmerksam geworden und hat ihn ins Musterdepot aufgenommen.
Ich denke mal, es wird nicht die letzte Empfehlung sein.

Schönen Tag noch
Erbse


Schnelle 60 Prozent

Mit einer Stop-buy-Order am Ausbruchsniveau soll dieser neue Musterdepotwert danach bis zum nächsten starken Widerstand durchmarschieren und dem Portfolio einen satten Gewinn einbringen.

Die Verantwortlichen für das Musterdepot von Der Darvas Investor wollen 1500 Aktien von Cortex Pharmaceuticals (WKN 879005) mit einem Stop-buy von 5,01 US-Dollar aufnehmen. Der Stop-Loss wird bei 4,64 Dollar gesetzt. Der nächste bedeutende Widerstand liegt bei gut acht Dollar und stammt aus dem Jahr 2000. Cortex entwickelt Pharmazeutika zur Behandlung von neurologischen und psychiatrischen Störungen, wie etwa Alzheimer, Schizophrenie, Depressionen oder Parkinson. Erfolgreich verlaufene Phase-II-Tests für das Mittel "CX717" gegen das Aufmerksamkeits-Defizit-Syndrom haben den Aktienkurs jüngst nach oben getrieben. Die Analysten von Rodman+Renshaw würden "CX717" Blockbusterpotenzial zutrauen und demnächst einen Kooperationsvertrag mit einem großen Pharmaunternehmen erwarten. Sollte sich "CX717" auch gegen Schizophrenie und Gedächtnisverlust als wirksam erweisen, sind noch höhere Kurse möglich. Doch schon jetzt hat Rodman+Renshaw das Kursziel von acht auf 12 Dollar erhöht und die Papiere mit "outperform-speculative-risk" eingestuft.
Noch ein Hinweis auf die Org 24448 Ergebnisse. Lassen wir uns überraschen, was die Ergebnisse bringen.

Schönen Tag noch
Erbse

Rodman & Renshaw
CORTEX PHARMACEUTICALS (COR)
BIOTECHNOLOGY
MARKET OUTPERFORM / SPECULATIVE RISK
COMPANY UPDATE
MARCH 21, 2006


COR: CORTEX COMPOUND MAY BE SHOWCASED BY ORGANON

CX691 (ORG24448) MAY SEE SPOTLIGHT Next Monday,
Organon will host an analyst day to discuss its clinical pipeline.
We believe that this may be an occasion to present progress
made with Org24448 (previously known as CX691), in Phase II
development for treatment of schizophrenia. If Org24448
proves effective in schizophrenia patients, this will bolster the
validity of the AMPAKINE platform. We expect Cortex to ink a
partnership agreement shortly on its lead molecule, CX717, and
reiterate our Market Outperform / Speculative Risk rating.
FURTHER VALIDATION Since Org24448 is a follow-on
compound to CX516, the original lead molecule from Cortex’s
AMPAKINE platform, positive results are likely to underscore
the therapeutic potential of the AMPAKINE molecules.
However, Org24448 is less potent, less stable and has a
shorter half-life than CX717, and therefore, if clinical efficacy is
seen with Org24448, this should only make expectations that
much higher for CX717 (see Table 1, Page 2). Even if
Org24448 does not prove effective, this should not dampen
expectations for CX717. We currently do not factor royalties
(single-digit?) on Org24448 into our valuation of Cortex.
AMPA MODULATION IN SCHIZOPHRENIA Schizophrenia is
a chronic, severe and disabling brain disease. Over 2MM
Americans suffer from the disease in a given year. Although
current medications are effective in treating positive disease
symptoms, such as hallucinations and delusions, the cognitive
impairments in schizophrenic patients are responsible for much
of the disease-associated disability and represent an unmet
medical need. A reduced level of glutamate-mediated
excitatory stimulation has been implicated in schizophrenia.
Org24448 was shown to markedly alleviate cognitive
dysfunction in earlier studies and restores excitatory stimulation
via its AMPA receptor-modulating activity.
CX717 PICKING UP SPEED We await further indications of
CX717’s efficacy in the DARPA-sponsored shift-work study,
and believe this compound to be the pre-eminent low-impact
AMPAKINE, combining efficacy and safety. From our
conversations with management, we conclude that they are
leaning toward developing CX717 for ADHD and sleep
disorders first, because of the shorter trial time. The
observation period in an ADHD study is 8 weeks vs. 12-24
months in Alzheimer’s disease.
KEY RISK Our recommendation for Cortex takes into account
that memory/cognition-related disorders represent one of the
most difficult-to-treat, and thus highest risk, therapeutic
categories. Cortex will need to partner its drugs to continue
their development in the absence of additional financing.
Hallo liebe Cortex Freunde,
am Montag steht die Konferenz bei Organon an. Es ist sehr gut möglich, daß hier Ergebnisse zu ORG 24448 veröffentlicht werden. Hierbei handelt es sich sehr warscheinlich um die Ergebnisse der Mono Therapie. Org 24448 wird auch als Kombi Therapie mit atypischen Neuroleptika getestet. Diese Versuche wurden meines Wissens später gestartet und dürften noch etwas dauern. Sollten die Versuche mit der Mono Therapie eine positive Wirkung bei Schizophrenie zeigen, dürfte dies am Montag eine große Auswirkung auf den Kurs von Cortex haben. Für Interessierte hier der link zur ORGANON Konferenz.
http://media.corporate-ir.net/media_files/nsd/akzoy/AKZONobe…

Zum weiteren Verständnis der Dopamin Glutamat Theorie gibt es zwei kleinere Beiträge von gfp927z und dem Neuroinvestor. Es lohnt sich hier mal reinzuschauen. Die Beiträge sind leider in Englisch.

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=112756146…

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=112736027…

Schönes Wochenende noch
Erbse
Antwort auf Beitrag Nr.: 20.945.520 von Erbse1 am 25.03.06 05:19:18Hallo liebe Cortex Fans,

bei der Organon Konferenz gabs nichts Neues. Einige Schaubilder, die die Wirkung der Ampakine zeigen. Ansonsten der Hinweis, daß alles normal weiter geht. Ein Schaubild deutet darauf hin, daß Org 24448 die kognitiven Defizite bei Schizophrenie zumindestens teilweise vermindert. Kein Hinweis darauf, daß Org 24448 auch gegen die Positivsymptomatik wirkt.
Interessenten können sich diese DIAS ja mal anschauen. Es handelt sich hierbei um die DIAS 30 - 36. Leider kann ich diese Bilder nicht kopieren.

http://www.akzonobel.com/NR/rdonlyres/9BED5F59-224C-4FA7-B68…

Ich denke mal, daß wir bei Organon noch viel Geduld brauchen.

In allernächster Zeit stehen aber noch die Schlafentzugergenisse von der DARPA an.

Weiterhin dann noch die Auslizensierung von CX717.

Schönen Tag wünscht euch
Erbse
Antwort auf Beitrag Nr.: 20.958.316 von Erbse1 am 27.03.06 13:30:16Meldung von Heute.
Cortex will die Zusammenarbeit mit Servier beenden. Kann gut sein, daß dies schon die Vorbereitungen auf einen Vertrag mit einem größeren Partner sind. Es stehen aufregende Zeiten ins Haus.

Liebe Grüße
Erbse

Termination of a Material Definitive Agreement

Item 1.02. Termination of Material Definitive Agreement.
On March 21, 2006, Cortex Pharmaceuticals, Inc. (the "Company" delivered notice to the Institut de Recherches Internationales Servier and Les Laboratoires Servier (collectively, "Servier" that, pursuant to the terms of Section 3.1 of the Research Collaboration Agreement between the Company and Servier dated October 13, 2000, as amended (the "Agreement", the Company has elected to terminate the research phase of the collaboration (the "Research Phase" and the Agreement effective December 7, 2006. The Company is currently having further discussions with Servier regarding the possibility of terminating the Research Phase and Agreement at an earlier date.

Under the terms of the Agreement, the Company and Servier collaborated to identify, evaluate and develop AMPAKINE compounds for use in the treatment of memory impairment associated with aging and neurodegenerative diseases. Under the Agreement, the Company currently receives approximately $2,298,000 per year (subject to the Company providing agreed-upon levels of research) and Servier is obligated to continue this level of support until early December 2006, or an earlier termination date, if agreed upon by Servier.

The Research Phase and the Agreement shall continue in full force until the termination becomes effective (in any event, no later than December 7, 2006) and the Company will not incur any early termination penalties as result of this termination. The Company shall make every effort to wind down the Agreement in a constructive manner, reflecting the good relationship that the Company has had with Servier. The Licensing Agreement, dated October 13, 2000, as amended to date, will continue in accordance with its terms.
Antwort auf Beitrag Nr.: 20.958.883 von Erbse1 am 27.03.06 14:13:54Klingt erst mal nicht gut. Ich warte erst mal weitere Nachrichten ab.
Erbse

FDA halts Cortex's experimental sleep drug trial
Mon Apr 3, 2006 8:47 AM ET
April 3 (Reuters) - Cortex Pharmaceuticals Inc. (COR.A: Quote, Profile, Research) on Monday said the U.S. Food and Drug Administration has placed the clinical trial of its sleep disorder drug, CX717, on hold due to concerns over some preclinical animal data.

The company said it was contacted by regulators on March 31 but has yet to receive a formal notification about the halt. The company expects to receive a written notification within seven to 10 days.

TEXT-Cortex Pharmaceuticals
The action is not related to results from any human clinical trials, the company said in a news release.
Antwort auf Beitrag Nr.: 21.053.446 von Erbse1 am 03.04.06 15:04:05Kommentar des NeuroInvestor zur jetzigen Lage.

Preclinical data is important--not more important, but important--because it is a proxy for the human experience. What would happen if you give someone x10 the therapeutic dose? Useful to know from a side effect viewpoint, and in case of future intentional or unintentional overdose. But since we can't try that with humans, it is done preclinically. More importantly, the high-dose, extended use tox paradigm is to some degree an accelerated course--not that the kinetics are the same, but if 1 dog out of 20 shows liver changes after three months at a very high dose, might there be some cumulative effect that would show up after two years in humans at the regular therapeutic dose? You feel better about the latter if you don't have the former.

Again--there could not have been a blatant, 'smoking gun' issue that came out of the CX717 tox studies--but there could be some anomaly that is viewed differently if you are an FDA reviewer who has been ordered to make damn sure that no 'FDA allowed dangerous drug to be given to humans in spite of animal warnings' headline will ever come up on their watch.

Because there was no blatant smoking gun, I believe that the odds are that this will be solvable, and that clinical trials will resume, and shareholders will be able to breathe again. What lab or preclinical work will be required to do so, and how long it will take, is impossible to say until we know what the problem is. I am guessing at least another three month animal study. I think we will know more by the end of this week. If not, I will be away all of next week, and will have little, if any opportunity to check in.

NeuroInvestment
Frisch von der NeuroInvestor Homepage
Cortex
4/3/06 The CX717 Clinical Hold

Cortex has to find out in detail what aspect of the preclinical data raised the red flag for the FDA--and then negotiates with the FDA as to what additional animal data they need to allay those concerns. I'm not assuming the best-case scenario, that they simply have to answer questions. It would be prudent to assume they have to run a confirmatory animal tox study at the very least.

I have seen clinical holds for other drugs based on: 1) a few mice died, they didn't know why, the drug is now in PhIII 2)Pfizer’s Lyrica issue, where animals developed tumors, humans didn't/don't--it is now marketed in the US and EU; 3) a drug which caused liver problems in dogs, and the company decided to go to another molecule.

Unless you believe Stoll was deceptive about the BP negotiations--and I do not believe that at all--BPs were pursuing a partnership, and all of them have all the data the FDA has, via Cortex---as well as data no one else has, that they obtain from their own inhouse vetting of the compound. If there was a smoking gun, BPs would have been backpedaling in a hurry. Now--they will want to know what the FDA wants, and the timeframe and difficulty of that will determine to what degree offers stay on the table; are rewritten; or are pulled entirely. The FDA would not have data on CX717 that Cortex does not have. But their interpretation of CX717 safety data could be influenced by data from other companies on other AMPA-modulator compounds that Cortex has not seen. To illustrate: using the dog liver enzyme hypothesis just as a model--let's say out of 20 dogs, 1 showed significantly elevated liver enzymes after three months of treatment. Cortex and its BP partner candidates could deem this a statistical fluke, a dog with a bad liver to begin with, and not anything that would show up in humans at human-level doses. If the FDA had (for example) information from Lilly or Organon regarding other AMPA-modulators that triggered a nonfluky, correlated association with liver changes, they might not buy the interpretation offered by Cortex. Even based on a different molecule, they could insist that Cortex do a bigger dog study (the study, not the dogs) to more carefully assess the CX717 association, or lack thereof, with liver issues.

But that is the extent of info to which Cortex would not be privy, but the FDA would be. Anything on CX717, they know about it, unless it was work done inhouse by a potential partner, which the FDA would not have access to. Again--there could not have been a blatant, 'smoking gun' issue that came out of the CX717 tox studies--but there could be some anomaly that is viewed differently if you are an FDA reviewer who has been ordered to make damn sure that no 'FDA allowed dangerous drug to be given to humans in spite of animal warnings' headline will ever come up on their watch.

Because there was no apparent, overt, ‘smoking gun’, I believe that the odds are that this will be solvable, and that clinical trials will resume, and shareholders will be able to breathe again. What lab or preclinical work will be required to do so, and how long it will take, is impossible to say until we know what the problem is. I am guessing at least another three month animal study. I think we will know more by the end of this week.

One thing this guarantees--this is an example of what Stoll worried about when contemplating keeping CX717 inhouse and taking it all the way for sleep dep/or ADHD. The risk of something unforeseen happening. And the bar for safety is set all the higher for a drug aimed at ADHD/sleep dep: the FDA is extremely vigilant about giving a drug to people who are otherwise healthy.

Quelle:http://www.neuroinvestment.com/CORXcom.html
Antwort auf Beitrag Nr.: 21.062.607 von Erbse1 am 04.04.06 06:19:24Hallo liebe Cortex Freunde,
Meldung von heute wird dankbar vom Markt aufgenommen. Interessenten bitte zum Yahoo Board wechseln. Hier wird heftig diskutiert.

Liebe Grüße
Erbse

Cortex Updates Progress on Clinical Hold of AMPAKINE CX717


IRVINE, Calif.--(BUSINESS WIRE)--Apr 13, 2006 - Cortex Pharmaceuticals, Inc. (AMEX: COR) indicated on April 3rd that the Company received a phone call from the U.S. Food and Drug Administration (FDA) that a clinical hold was being placed on AMPAKINE CX717 and further clarification would be outlined in a formal letter by the agency. The Company has now received this letter that reviews the rationale for the agency's action, which is based on preclinical animal data, and outlines the work required for the clinical hold to be removed. Based on the terms in the letter, the Company has begun the process to arrange for discussions with the appropriate experts within the agency to translate the request into specific acute preclinical studies related to the issues and recommendations provided by the agency.

Cortex is going to cooperate fully with the FDA and work diligently to address its concerns. After the FDA and Cortex have agreed upon a plan of work, the Company will inform shareholders of both the scope of the work involved and the anticipated timeframes for completing such studies. The Company's objective will be to have the FDA remove the clinical hold and allow Cortex to proceed with the clinical studies currently on hold as soon as possible.
Antwort auf Beitrag Nr.: 21.194.720 von Erbse1 am 13.04.06 16:47:37Hier direkt die Antwort von RODMAN & RENSHAW auf die Meldung von Heute.


Cortex Pharmaceuticals
COR, Price: $2.77 (04/12/06), Market Cap: $92 MM (04/12/06)
Rating: Market Outperform; Target Price: $12.00
Elemer Piros, PhD – Senior Biotechnology Analyst (212.356.0525)
Clinical Hold
Cortex Pharmaceuticals indicated on April 3rd that the firm received a phone call from the FDA that a clinical hold was
being placed on the lead AMPAKINE molecule, CX717, and further clarification would be outlined in a formal letter by
the agency. The firm has now received this letter that revi ews the rationale for the agency's action, which is based on
preclinical animal data, and outlines the work required for the clinical hold to be removed. Based on the terms in the
letter, Cortex will translate the request into specific acute preclinical studies related to the issues and recommendations
provided by the agency, following discussions with the appropriate FDA experts.
Our First Take
· The FDA’s recommendations relate to acute, not long-term, preclinical studies. The additional experiments
that would be necessary are therefore likely to take days or weeks, not months, to complete.
· The action taken by the FDA is related to concerns over some preclinical animal data and not to results from
any human clinical trials.
· Encouragingly, Cortex is willing to provide information regarding the status of its discussions with the FDA and
the timeline required to perform the experiments necessary to enable removal of the clinical hold on CX717.
· Cortex will discuss directly with the FDA to clarify what is required to resume clinical testing.
· We believe that, given the acute nature of the preclinical studies that would be required and the proactive
response of Cortex to the FDA’s action, the clinical hold on CX717 could be removed within a few months.
· We retain our Market Outperform rating with a target price of $12 per share
Vielleicht ist bei Cortex das Problem doch etwas schwerwiegender.
Langsam müßten auch zu Org24448 Ergebnisse vorliegen, so daß man vielleicht von dieser Seite her einige Hinweise auf dieses Problem erhält. Leider kann ich an dieser Stelle nicht hilfreich sein. Ich muß einfach abwarten, was sich aus diesem Problem ergibt

Liebe Grüße
Erbse

Dr. Garren issued an alert tonight on COR that was quite negative. He said the "acute" phraseology means that the new studies could be done quite quickly, but his fear is that if the issue is a liver toxicity issue, then it could be a very serious issue, because liver toxicity in animals is a good predictor of liver toxicity in humans. He predicted there would be no BP deal until all the issues with the FDA are resolved. He feels the recent run-up is completely unjustified.

Since he had urged subscribers to sell at $2.90 when the hold was first placed on the clinical trials by the FDA, I don't think his alert tonight will have any impact on the stock price.
Quelle:http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
Hallo liebe Cortex Freunde,
es gibt Neues zu vermelden von den Ampakinen und den angeordneten Halt von der FDA. Es werden zusätzliche Studien mit einer stärkeren Dosierung im Tierversuch eingefordert. Nach dem Kurs zu urteilen scheint Cortex die Problematik im Griff zu haben. Folgend noch der Kommentar des NeuroInvestor zur gestrigen Jahreshauptversammlung und anschließend noch ein link zu der Veranstaltung mit aktuellen DIAS zu den ADHD Versuchen.

Die Cortex kostet schon ganz schön Nerven. Ich glaube, ich werde langsam zu alt für die Börse.

Machts mal gut
Erbse

) Let me start with something that would be hard to be sure of from a conference call: the mood, There was no mistaking the upbeat confidence conveyed by Roger Stoll and Gary Lynch. Stoll made the necessary (and very true) statements that nothing is assured until they have corrective data in August, and the FDA responds in September. But had there been pessimism, the atmosphere would have been very different. He was also far more specific about timelines than I expected.
2) They have brought in three consultants who have worked at the FDA--including the woman who was in charge of tox studies under CNS Division Head Rusty Katz. They really could not do a better job in terms of getting 'into the culture' so as to not make any errors in their responses.
3) I wish that they would have been more specific about the histopathological 'fly in the ointment' . But Roger did concede that there were 12 monkeys in the high-dose group, which tells me that it was the high-dose group from which the (I think) single anomalous sample came. That's better than if it were one out of three, for example. The dosing does appear to be an issue (though not, so far as I can tell, Gfp, in relation to sleep deprivation)--and it is interesting that my joke about overdosing rats turns out to be true: the FDA really does want more data about just how much CX717 one can give a rat before they crumble. And it turns out that they tend to regurgitate before they ever reach that point, which makes it tougher to answer the FDA's question.
4) The notion of disease-modification via neurotrophin release was not as new as Gary Lynch made it sound--it's been discussed for years on this thread. But what was new was that they could return rats to 'normal' memory baseline with multiple exposures to a high-impact with a very short half-life--fifteen minutes or so. The only clear negative from the meeting was that the IND timeline for a high-impact is 2-3 years. Something has not gone as planned.
5) The ADHD data is better than previously thought, and DARPA is even slower.


Overall--I am not going to use the 'speed bump' term any more than I was willing to say 'slam dunk.' Any 'speed bump' that has a 5% chance of ripping the undercarriage from my car is more than just a bump. But a histopathological change in a single monkey organ from a high-dose group is a lot less worrisome than a trend towards liver enzyme elevations, for example. They had no idea there was a problem brewing--Gary Lynch told me that he'd been expecting that this SHM would be a celebration, with champagne. But from everything I can see, they are handling it well. While nothing can be promised, they made it clear they expect that this will be solved, and the clinical hold lifted.

NeuroInvestment

Folgender link führt zur Präsentation der Jahreshauptversammlung.

http://www.cortexpharm.com/main.html
Kommentar des NeuroInvestor.

Machts mal gut
Erbse


The CX717 Clinical Hold

The reason for the sudden clinical hold--and the FDA's own regulations require that it try to discuss the situation, first which they did not do--was some type of histopathological finding from an old high-dose primate study. Cortex has to look at tissue samples from that primate study, and do another one, literally giving monkeys CX717 until they vomit. The secondary issue, though this would not have in itself been reason for a hold, is that the Agency still doesn't think Cortex has done enough to find the absolute maximum tolerated dose of the drug. It's too safe. This is certainly a better scenario than the liver enzyme issue that we had speculated about. We were correct that there is no 'smoking gun' de facto doom for CX717.

In a review of clinical holds that have been made public, NI has found that at least 75% are resolved positively. Adding in the many issued to Big Pharma companies that are kept quiet, the rate is higher. The histopathological review of old samples will be the first thing to be completed, the additional primate and rat tox studies will be completed by early August, at which point Cortex will submit a report to the FDA, and in theory, the FDA has 30 days to respond.

The risk of course, small though we believe it is, is that another animal will show the same change, and this will no longer be a fluke. If that were to eventuate, that could be fatal for CX717. We are 95% confident that this will not occur. Our projection is that the clinical hold will be lifted by the end of September. Big Pharma discussions could begin earlier that month if the data is clean, and the path forward clear, even if not yet formally confirmed.
Cortex Announces Update on CX717 Clinical Hold


IRVINE, Calif.--(BUSINESS WIRE)--June 8, 2006--Cortex Pharmaceuticals, Inc. (AMEX: COR - News) announced that it has provided to the U.S. Food and Drug Administration the preclinical research plan for removal of the current clinical hold on AMPAKINE® CX717. The FDA recently provided a written response finding the proposed research plan to be acceptable. Both parties felt that the clarity of the proposed actions was sufficient such that a scheduled conference call for June 9, 2006 was no longer necessary.

"Cortex worked hard to address the concerns of the FDA and we are pleased that our proposals were on target in responding to the questions which the agency raised regarding CX717. We currently are on schedule with the timelines proposed for conducting the additional preclinical studies. In fact, Cortex has already completed the review of the relevant histological materials from a previously completed preclinical toxicology study, which was part of the FDA request to Cortex. As stated at our annual shareholder meeting, we plan to submit all the data to the FDA in September 2006. If the data obtained from the acute high dose toxicology studies are assessed positively by the FDA, we believe the FDA will remove CX717 from the current clinical hold," said Dr. Roger G. Stoll, President, CEO and Chairman of Cortex

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde. Es gibt einen guten Artikel in The Sunday Times:



Focus: What price a good night's sleep?

Gesamter Artikel unter folgendem link
http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=1150001624/0
>>
Scientists are on a quest to develop a pill that replaces the natural kip. John Arlidge reports on how shuteye has become a multi-billion-pound lifestyle product

Dr Roger Stoll is an explorer. He is boldly searching for a mythical land where the living is easy. At his suite of laboratories, he proudly introduces his expeditionary team — a bunch of plucky human guinea pigs from Guildford and some rhesus monkeys. His map consists of a series of squiggly graphs.
The land Stoll is searching for is Nod. In this pleasant place, the days and nights are long and full because people need only an hour or two of sleep.
Many people believe they need eight hours’ sleep a night to allow their brains to recover from the rigours of the day. But, it seems, there is not the time. Modern life is too demanding — and exciting — to turn out the light for eight hours, or even six, in every 24.
Wouldn’t it be wonderful if there were a pill that could replace sleep? There are illegal drugs that do so temporarily, but they leave you shattered later on. Stoll is trying to find the Viagra of sleep: a genuine shut-eye simulator that will make him a billionaire.

Stoll is the head of Cortex Pharmaceuticals, a US-based firm that is working with researchers at the University of Surrey to come up with the holy grail of behavioural medicine — a drug that mimics the effects and benefits of sleep.
He says brain scans on his monkeys and human guinea pigs suggest that the firm’s new drug, CX717, does just that — helping brains and bodies to recover without sleep.
“The potential is to help people to stay awake longer and sleep less,” he said.
Stoll is at the forefront of a growing army of medical researchers and entrepreneurs who are striving to make sleep a “new and improved” lifestyle product.
Pharmaceutical firms, which supply 3m prescription sleeping pills in Britain a year, are spending billions on research to win the race to develop the new simulated-sleep pill.

Drugs firms trumpet their success in creating pills that cure the need to sleep. Eli Lilly and Glaxo have joined the race with America’s Cortex.
There is more to this than just the hunt for a miracle pill. While we wait to be cured of the need for sleep, we have become obsessed with getting the best quality sleep that money can buy.
As a result, shut-eye — a subject that only insomniacs and sleepwalkers used to worry about — has become the fastest-growing sector of the £300 billion global pharmaceutical, leisure and wellbeing market.

In laboratories and boardrooms around the world sleep is being studied, graded, commodified, copied and packaged — and then sold as if it were a low-fat snack bar or a vitamin-enriched mineral water.
Mintel, the market research analyst, estimates that the sleep market has grown from £1.6 billion 10 years ago, when the height of slumber sophistication was a posturepedic bed, to more than £4 billion today, when even motels have their own pillow menu offering dozens of types of cover and filling. >>>

Allerdings möchte ich darauf hinweisen, daß im Augenblick Vorsicht angesagt ist bis die Differenzen mit der FDA ausgeräumt sind. Es ist ratsam die aktuelle Situation genauestens zu beobachten.

Schönen Tag noch
Erbse
Schlafentzugergebnisse werden am Dienstag präsentiert
Schönes Wochenende
Erbse

Quelle:http://messages.yahoo.com/bbs?.mm=FN&action=m&board=16042432…
RODMAN & RENSHAW

CORTEX PHARMACEUTICALS (COR)
BIOTECHNOLOGY
MARKET OUTPERFORM / SPECULATIVE RISK
COMPANY UPDATE
JUNE 16, 2006

COR: PRESENTATIONS AT SLEEP CONFERENCE

DATA ON CX717 TO BE PRESENTED Next Tuesday, June 20th,
Cortex representatives will present data on the activi ty of CX717,
Cortex’s lead AMPAKINE compound, in sleep deprivation studies at
the 20th Anniversary Meeting of the Associated Professional Sleep
Societies. The meeting is taking place in Salt Lake City, Utah.
CX717 is currently under clinical hold; Cortex aims to have the
entire data package addressing the FDA’s concerns submitted to
the FDA by the end of August. We reiterate our Market Outperform
/ Speculative Risk rating and $12 price target.
CX717 CONTINUES TO SHOW PROMISE Top-line results were
presented last year in a press release from a sleep deprivation
study involving 16 patients. The sleep deprivation data to be
presented at the conference includes further results from a study of
healthy volunteers who were deprived of sleep for 27 hours. CX717
showed activity at the highest dose tested (1000mg), enhancing
alertness, attention, information processing and sleep latency. (See
abstract on Page 3.) These results appear promising and confirm
the activity that was seen in studies of CX717 in sleep-deprived
monkeys. Coincidentally, according to previous guidance by
management, results from the 48-patient shift-work study conducted
by DARPA may be released near-term.
CLINICAL HOLD COULD BE REMOVED IN SEPTEMBER In
response to the FDA’s request for additional acute preclinical work
on CX717, Cortex has hired regulatory consultants, initiated
Maximum Tolerated Dose (MTD) studies in primates; begun
assessment of tissue from the previous primate study; and will begin
work on the rat MTD study in mid-May. A data package will be
completed by August and the FDA has indicated that it would
respond within 30 days. The clinical hold on CX717 could thus be
lifted in September.
EFFICACY ENCOURAGING CX717 showed encouraging results
in the Phase II study in patients with attention deficit hyperactivity
disorder (ADHD). Results were comparable to those obtained with
the Eli Lilly (LLY, Not Rated) drug Strattera in a pivotal trial. A
repeated measures statistical test showed that CX717 provoked a
statistically significant response on the overall ADHD Rating Scale
as well as both the hyperactivity and attentiveness subscales. No
safety issues were seen. Cortex should receive the data on CX717
performance in the DARPA-sponsored shift-work study shortly.
KEY RISK Our recommendation for Cortex takes into account that
memory/cognition-related disorders represent one of the most
difficult-to-treat, and thus highest risk, therapeutic categories.
Cortex will need to partner its drugs to continue their development in
the absence of additional financing.
Die Ergebisse scheinen auf den ersten Blick gegenüber Placebo nicht überlegen zu sein. Da hat auch keiner mit gerechnet.

Top-Line Findings on CX717 from the Darpa-Sponsored Shift Work Simulation Study Will Be Presented at Sleep 2006 Meeting
Wednesday June 21, 8:30 am ET
Additional CX717 Data from the UK Sleep Deprivation Study to Be Presented at the Same Meeting


IRVINE, Calif.--(BUSINESS WIRE)--June 21, 2006--Cortex Pharmaceuticals, Inc. (AMEX: COR - News), announced that results from two studies with its lead AMPAKINE® drug, CX717, will be presented at the Sleep 2006 meeting in Salt Lake City, UT. Dr. Thomas Balkin, Chief, Department of Behavioral Biology, Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, will briefly present the top-line findings from the simulated night shift work study conducted at WRAIR and funded by the Defense Advanced Research Projects Agency (DARPA). That study assessed the effect of CX717 on cognitive performance and alertness across 4 nights of simulated night shift work and restricted daytime sleep. The primary finding from the study was that CX717 did not enhance cognitive performance relative to treatment with placebo. However, similar to the observations in the previously reported UK sleep deprivation study, CX717 did alter the recovery sleep architecture as measured by EEG polysomnography in a dose-related manner. The 1000 mg dose of CX717 statistically (p less than 0.05) reduced the amount of slow wave sleep during each of the 4 recovery sleep periods and increased (p less than 0.05) the minutes of wake time after sleep onset during 2 of the 4 recovery sleep periods. CX717 was well tolerated, and no serious adverse events or other significant safety concerns were observed.

Additionally, two presentations will be made detailing the positive findings from the UK sleep deprivation study performed at the University of Surrey in the United Kingdom. Dr. Julia Boyle, Acting Head, Human Psychopharmacology Research Unit, University of Surrey, Guildford, UK will present the primary results from the study. Dr. Nicola Wright, Centre for Human Sciences, QinetiQ, Farnborough, UK will present new data using spectral EEG polysomnography to evaluate the effect of CX717 on the recovery sleep period during the study. In support of the key study findings, the spectral EEG analysis indicated that CX717 increased the level of arousal during recovery sleep.

Differences in study design and the implementation of certain study procedures may have contributed to some of the divergent results between the shift work simulation study and the UK study. While Cortex has received a study report from WRAIR, we look forward to receiving the full data set in order to compare the exact differences in drug performance between the two sleep studies.

From a business perspective, the Company's licensing discussions have focused on ADHD, Alzheimer's disease, and other neurodegenerative disorders. The top-line findings from the DARPA-sponsored study do not have a direct impact on the potential of CX717 in those disorders. Cortex's strategy has always been to retain the sleep deprivation uses as well as Orphan Drug uses of the low impact AMPAKINE® drugs for its internal development program. Cortex does not anticipate that future partnering discussions would include sleep disorder indications such discussions are unlikely to be affected by the shift work study findings.

"Our Phase II pilot program which included studies in sleep deprivation, ADHD, and Alzheimer's disease was designed to help us determine the most promising development pathway for CX717," said Dr. Roger Stoll, Chairman & CEO of Cortex. "While we are pleased to see some of the findings from the UK study confirmed in the DARPA-sponsored study, given the strong signal from our study in adults with ADHD our current plan is to prioritize ADHD in our future studies with CX717. We also remain committed to the program in Alzheimer's disease as we await the results from our Phase II study in that disorder. Moreover, we anticipate having the opportunity to conduct additional studies on sleep disorders with either CX717 or with CX701, a back-up compound that should enter clinical trials early next year."

Cortex will host a conference call and webcast later today, at 2:00 p.m. ET, to further elaborate on this information. 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, call (877) 407-0782. Internationally, call (201) 689-8567. An audio replay of the conference call will be available through Wednesday, June 28, 2006 by dialing (877) 660-6853 for U.S. participants and (201) 612-7415 for international participants. When prompted, participants should enter account number 286 and conference ID number 206297. For the webcast please use the following link: http://www.vcall.com/IC/CEPage.asp?ID=106039. A replay of the webcast will be available through June 28, 2006.

About the shift work simulation study

The shift work study was a randomized, double-blind, placebo-controlled, parallel group study in healthy young adult male volunteers. Fifty (50) subjects were assigned to one of three CX717 dose groups or placebo. Study medication was taken once per evening for four days. Each night subjects were assessed on a variety of cognitive parameters and tests of alertness in a protocol designed to simulate night shift work. The subjects' daytime sleep was restricted to 4 hours per day to mimic operational conditions involving chronic, restricted sleep

Schönen Tag noch
Erbse
Cortex's CX717 Clinical Hold Update

IRVINE, Calif.--(BUSINESS WIRE)--July 18, 2006--Cortex Pharmaceuticals, Inc. (AMEX: COR - News) has completed the in-life phase of both the one week acute primate study and the two week acute rat toxicology studies with its AMPAKINE® compound CX717. The tissue samples are now being prepared for histopathology assessments. These studies were part of the toxicology assessments requested by the FDA and are essential for a decision to lift the clinical hold.


Furthermore, the original tissue slides from the 13 week primate study have been assessed by an expert pathology working group of five histopathologists and a written consensus report has been prepared. In addition to these examinations, Cortex has completed the extended assessment of additional tissue samples from that same set of primates.

The timelines defined by Cortex at its annual shareholder meeting this past May for conducting the extra toxicology testing requested by the Food and Drug Administration are being met by Cortex and its contract research organizations. At present Cortex is on schedule for meeting its target date for submission of its complete response to the FDA by the beginning of September, 2006. The agency has committed to a 30 day review of this data upon such a submission.

Schönen Tag noch
Erbse
Kommentar des NeuroInvestor zur aktuellen Lage

7/17/06 The CX717 Clinical Hold

Cortex was having a landmark 2006 when the FDA's clinical hold stopped them dead in their tracks in early April. We continue to believe that the CX717 safety questions raised by the FDA are resolvable, and that the clinical hold will be lifted by early fall. There is of course always the small--but not nonexistent--possibility that another cellular anomaly could be found, in which case they will be starting over with another compound. The ADHD data was considerably better than anyone had reason to expect given its small sample size, and is the single biggest draw for a partnership. The negative top-line DARPA results diverged from the path laid out by the pilot sleep deprivation study, and with DARPA being as forthcoming with details (even to Cortex) as the North Korean government is regarding missile preparations, it is currently impossible to assess whether there is a fatal flaw in the sleep deprivation scenario or not. Cortex is still committed to keeping CX717 for an orphan indication, (and now has a much better chance at keeping narcolepsy) and is also looking to inlicense a PhIII compound from a partner or other BP source. Once the hold is lifted, a BP Pharma partnership will be signed, perhaps before year-end.

Schönen Tag noch
Erbse
Das ist mal eine tolle Veröffentlichung, wenns dann mal in der Praxis klappen sollte. Erst muß allerdings der aktuelle Disput mit der FDA geklärt werden.

Schönen Tag noch
Erbse

Drug Triggers Body's Mechanism To Reverse Aging Effect on Memory Process Age

A drug made to enhance memory appears to trigger a natural mechanism in the brain that fully reverses age-related memory loss, even after the drug itself has left the body, according to researchers at UC Irvine.

Professors Christine Gall and Gary Lynch, along with Associate Researcher Julie Lauterborn, were among a group of scientists who conducted studies on rats with a class of drugs known as ampakines. Ampakines were developed in the early 1990s by UC researchers, including Lynch, to treat age-related memory impairment and may be useful for treating a number of central nervous system disorders, such as Alzheimer's disease and schizophrenia. In this study, the researchers showed that ampakine drugs continue to reverse the effects of aging on a brain mechanism thought to underlie learning and memory even after they are no longer in the body. They do so by boosting the production of a naturally occurring protein in the brain necessary for long-term memory formation.

The study appears in the August issue of the Journal of Neurophysiology.

"This is a significant discovery," said Gall, professor of anatomy and neurobiology. "Our results indicate the exciting possibility that ampakines could be used to treat learning and memory loss associated with normal aging."

The researchers treated two groups of middle-aged rats twice a day for four days with either a solution that contained ampakines or one that did not. They then studied the hippocampus region of the rats' brains, an area critical for memory and learning. They found that in the ampakine-treated rats, there was a significant increase in the production of brain-derived neurotrophic factor (BDNF), a protein known to play a key role in memory formation. They also found an increase in long-term potentiation (LTP), the process by which the connection between the brain cells is enhanced and memory is encoded. This enhancement is responsible for long-term cognitive function, higher learning and the ability to reason. With age, deficits in LTP emerge, and learning and memory loss occurs.

Significantly, restoration of LTP was found in the middle-aged rats' brains even after the ampakines had been cleared from the animals' bodies. The drug used in the injections has a half-life of only 15 minutes; the increase in LTP was seen in the rats' brains more than 18 hours later. According to the researchers, this study suggests that pharmaceutical products based on ampakines can be developed that do not need to be in the system at all times in order to be effective. Most drugs used to deal with central nervous system disorders, such as Parkinson's disease, are only effective when they are in the body. Further studies will be needed to determine exactly how long the effect on LTP will be maintained after the ampakines leave the system.

The lingering presence of LTP also appears to contribute to BDNF remaining in the body, researchers said. "Ampakines work in two important ways to improve learning and memory," Lauterborn said. "They directly stimulate the connection between nerve cells, which has an immediate effect of boosting LTP. But they also increase the presence of this important protein, BDNF, that can stay in the body and keep boosting memory after the drug has worn off."

Collaborators on the study were Christopher Rex, Ching-Yi Lin, Eniko A. Kramar and Gary Rogers of Cortex Pharmaceuticals.

The study was funded by grants from the National Institute of Neurological Disorders and Stroke, the National Institute on Aging, and from National Institute of Mental Health. The ampakine drug was provided by Cortex

Quelle:http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=115405918…
Cortex präsentiert auf der Bear Stearns 19th Annual Healthcare Conference. Es stehen auch wichtige Entscheidungen an. Gespannt bin ich auf die Einlizensierung der nicht Ampakine Substanz.
Die Entscheidung der FDA zum weiteren Verlauf von CX717 steht an.
Lassen wir uns mal überraschen.
Liebe Grüße
Erbse

Cortex's CEO Roger Stoll to Present at the Bear Stearns 19th Annual Healthcare Conference


Chairman, President and CEO, Roger G. Stoll, Ph.D., will speak at the Bear Stearns 19th Annual Healthcare Conference to be held at The Grand Hyatt New York in New York City, NY. Dr. Stoll's presentation is scheduled for Monday, September 11, 2006 at 4:00p.m. EDT (1:00p.m. PDT) in Ballroom C (the Park Avenue Room). The conference will feature companies spanning all sectors of healthcare.

Dr. Stoll will provide an overview of Cortex's AMPAKINE® research program, including the progress related to the clinical hold status of its lead AMPAKINE®, CX717. He will provide an update on corporate partnering prospects and discuss the status of the Company's strategy to in-license late stage non-AMPAKINE central nervous system product candidate(s) for potential use in "Orphan Drug" indication(s). Such products would complement the activities underway with Cortex's AMPAKINE technology and strengthen the development pipeline for the company.

A live webcast of the presentation can be accessed by logging onto http://cc.talkpoint.com/BEAR002/091106a_cy/?entity=cortex and a replay will be available for 45 days following the conference.
Hallo liebe Cortex Freunde,
Cortex präsentiert bei dem Neuroscience Meeting 2006.



Es ist mit über 30000 Wissenschafler eines der größten Treffen überhaupt.
Die Ampakine und Cortex Pharmaceuticals sind mit ca. 10 Beiträgen vertreten. Einzelheiten könnt ihr den folgenden Abstrakten entnehmen. Hier gibt es jede Menge Neues. Die Beiträge sind leider alle in Englisch.

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=115726056…

Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde. Diesmal ganz besonders an die älteren Semester unter uns. Folgender Abstrakt macht wieder Lebensmut.

The Effects of AMPA-Type Glutamate Receptor Modulators on Sexual Behavior of Aged Male Rats

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=115730749…

Na dann schlaft mal gut
Erbse
Hallo liebe Cortex Fans, die Entscheidung der FDA rückt langsam näher. Die Daten sind von Cortex übermittelt worden.

Cortex Submits Complete Response to FDA to Address Clinical Hold on CX717

IRVINE, Calif.--(BUSINESS WIRE)--Sept. 11, 2006--Cortex Pharmaceuticals, Inc. has submitted to the Food and Drug Administration (FDA) the Company's complete response to each of the points raised by the FDA regarding certain toxicology issues on its lead AMPAKINE® compound, CX717. By its regulations, the FDA is required to respond within 30 days as to whether it will remove or maintain the clinical hold. Cortex has every confidence the FDA will meet the required timeframe.

"Cortex has worked diligently over the past few months to address the concerns of the FDA," said Dr. Roger G. Stoll, President, CEO and Chairman of Cortex. "While we believe the submitted data is sufficient to release the hold and resume our clinical trials program on CX717, that decision is ultimately one that will be made by the FDA."

The Company has met the timeline it defined at its annual shareholder meeting in May 2006 for conducting additional toxicology studies required by the FDA and its submission of the complete response to the agency by early September. Cortex will inform shareholders once it has received notification of the FDA's decision. Prior to the clinical hold being placed on CX717, the Company had reported positive results of a Phase IIa study for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD).

Schönen Tag noch
Erbse
Kommentar von Rodman & Renshaw

RODMAN & RENSHAW

Cortex Pharmaceuticals
COR, Price: $3.42 (9/8/06); Market Cap: $119MM (9/8/06)
Market Outperform, Target Price: $12

Complete Response Submitted on CX717 Clinical Hold
· This morning, Cortex Pharmaceuticals announced that the company has submitted to
the FDA the complete response to each of the points raised by the FDA regarding
certain toxicology issues on its lead AMPAKINE® compound, CX717. The FDA
originally placed CX717 on clinical hold in April of this year.
· By its regulations, the FDA is required to respond within 30 days as to whether it will
remove or maintain the clinical hold on the compound in light of the new data.
· We continue to believe that the FDA is likely to remove the clinical hold on the
compound in October.
· Once the clinical hold is lifted, we expect Cortex to resume discussions with potential
licensing partners for CX717.
· Prior to the FDA’s placing CX717 on clinical hold, Cortex reported results of a Phase IIa
study of CX717 in adults with ADHD. This trial showed significant efficacy of CX717 at
a dose of 800mg twice a day with no safety concerns.
· The compound was significantly more effective than placebo on the total ADHD Rating
Scale (p=0.0024) and on both the hyperactivity (p=0.0168) and inattentiveness
(p=0.0273) subscales.
· Results from this Phase IIa trial will be presented at the annual meeting of the American
Academy of Child and Adolescent Psychiatry in San Diego on October 27, 2006.
· We are encouraged by the timely submission of data to the FDA on CX717 and remain
confident that this information will prompt the FDA to remove the clinical hold from the
compound. We reiterate our Market Outperform rating and price target of $12 on
Cortex shares.

Weiterhin kurz eine Bemerkung des NeuroInvestor

That PR statement is all the more remarkable given Stoll's historical tendency to be rather understated in his commentary. It does indeed suggest that Cortex believes they are on the same page as the FDA, and probably are: and it is as far as Roger Stoll could go without tempting fate--or agency ire. It would not surprise me if it does not take the full 30 days to receive official word from the FDA--and I would now be profoundly shocked if the clinical hold is not lifted.

NeuroInvestment
Cortex' CX717 Released from Clinical Hold by FDA

IRVINE, Calif., Oct 09, 2006 (BUSINESS WIRE) -- Cortex Pharmaceuticals, Inc. (COR) received notification from the U.S. Food and Drug Administration (FDA) on the afternoon of Friday, October 6, 2006 that the clinical hold placed on its AMPAKINE(R) CX717 on March 31, 2006 was lifted. The Company may now resume the clinical trials that were underway at the time the clinical hold was put into effect. A detailed formal letter from the FDA is expected to follow within 10 days.

In agreeing to the lifting of the hold, Cortex committed to an FDA specified dose range for CX717. The Company expects to have further toxicological information available toward the end of this year, after completion of three-month toxicology trials in both monkeys and rats. The Company will then share those results with the FDA and mutually determine if the new information supports clinical investigations at higher dosage levels for CX717.

Roger Stoll, Ph.D., Chief Executive Officer of Cortex, commented, "The release from clinical hold is an important step for Cortex and the CX717 clinical program. It is fortunate that the Company had the foresight to initiate the three-month toxicology trials early this summer, so that we can have further information from these studies available before year end 2006."

After receiving the formal letter from the FDA regarding the lifting of the clinical hold, the Company will hold a conference call to update shareholders on the next steps with the CX717 program

Schönen Tag dann noch
Erbse
Schnell zu der heutigen Meldung der Kommentar des NeuroInvestor.

10/9/06 The CX717 Clinical Hold

As we had expected and predicted, the FDA lifted the clinical hold on Cortex's Ampakines today. Cortex had anticipated the request to conduct 3 month toxicity testing for a higher dose, and had already begun that testing, which means it will be done before year-end. We do not see that as a problem, if the FDA had seen anything of further concern in the testing done since the hold was put in place, the hold would not have been removed. It is the earmark of the current FDA emphasis on CYA that they wanted the additional three month tox testing done now. The lifting of the clinical hold allows the Big Pharma due diligence efforts to resume full-speed, although with the delay that has occurred, it is unlikely that the BP partnership will be consummated until 1Q:07.

Quelle:http://www.neuroinvestment.com/CORXcom.html
Cortex to Hold Conference Call on October 26 Following Release of CX717 from FDA Clinical Hold

Tuesday October 24, 10:10 am ET


IRVINE, Calif.--(BUSINESS WIRE)--Cortex Pharmaceuticals, Inc. (AMEX:COR - News) received the formal letter from the U.S. Food and Drug Administration on Monday, October 23, 2006 regarding the lifting of the clinical hold on Cortex's lead product candidate, AMPAKINE® CX717. The Company will host a conference call at 4:00 p.m. ET (1:00 p.m. PT) on Thursday, October 26th to review the steps it is taking to advance the development of CX717.
Quelle:http://biz.yahoo.com/bw/061024/20061024005770.html?.v=1

Hoffen wir mal auf einen positiven Ausgang.
Schönen Tag noch
Erbse
Hallo liebe Cortex Freunde,
es schaut erst mal nicht so gut aus. Im Augenblick scheint die Weiterentwicklung von CX 717 bei ADHD nicht möglich. Eine Zusammenfassung der Konferenz und den Kommentar des NeuroInvestor gibt es unter dem folgeneden link.

http://www.erbse.vm-elsig.de/form/base/YaBB.pl?num=116170383…

Bin selber gespannt, wie weit es heute wieder runter geht.
Ich selber bin jetzt fast sechs Jahre in Cortex investiert und wie es scheint brauchen wir noch eine Menge an Geduld und Durchhaltevermögen.
Liebe Grüße
Erbse
Weiterer Kommentar des NeuroInvestor. Leider gehts an der Börse selten logisch zu. Dennoch stimme ich im großen und ganzen den Ausführungen zu.
Trotz allem noch einen schönen Tag
Erbse

10/27/06 Additional Comment on the Status and Valuation CX717
Watching the Cortex price drop below 2.00 this morning led us to review what happened after the FDA clinical hold was announced in April. The lowest it dropped at any time was 2.43, giving a fully diluted market cap of about US$120 million. That was at a time when the clinical hold prohibited any use of CX717 in humans. It was not known how long it would be until the hold would be lifted, if ever; whether this was a toxicity issue that might apply to other Ampa-modulators. In other words, the entire platform was in question, for all indications, for an indefinite amount of time.

Fast forward to today. At about 2.00 per share, the fully diluted market cap is $100 million. The FDA has basically said that use in humans is OK at low doses, pertinent to Alzheimer's--but that they have yet to be convinced that higher doses are OK. There is a timeline for answering those questions. We also now know that there was a company which had been prepared to offer a possibly attractive partnership deal for Alzheimer's last spring. We have also been told that the Cortex backups, and Organon's Org24448 (also known as Cortex's CX691) do not show evidence of this problem-i.e. it is not a class effect.

And now Cortex is worth about 20% less than in April? That makes no sense. At some point, the disconnect will be recognized, and the share price will recover--at least to a point higher than the nadirs of mid-April.
Folgender Artikel beschreibt sehr treffend die aktuelle Situation bei Cortex,

Schönes Wochenende
Erbse

Cortex Dives After Agreeing To FDA Dosing Restrictions
By Aaron Lorenzo

FDA-imposed dosing limits are preventing Cortex Pharmaceuticals Inc. from more broadly studying CX717 in humans for now, causing the company's stock to lose more than a third of its value Friday, although the agency lifted a seven-month clinical hold on the drug in the process.
The shares (AMEX:COR) fell $1.20 to close at $1.85, a 39 percent plunge, after CEO Roger Stoll detailed the investigational compound's "conservative" dosing curbs.
Without divulging a specific ceiling, he told investors on a conference call that the limits would allow Cortex to test it only in Alzheimer's patients, for which lower amounts are acceptable to see a treatment benefit. But that also means that the company, of Irvine, Calif., would not be able to continue clinical testing of CX717 in attention deficit hyperactivity disorder (ADHD) for the near term, because those patients necessitate higher doses that exceed the FDA boundaries.

"We had to accept their dose limitations," he said, in order to get the agency to remove a clinical hold on the product that's been in place since March. So Cortex received "half a loaf instead of a full loaf," Stoll added.

He said Alzheimer's studies require doses between 1 mg/kg and 3 mg/kg, while ADHD trials necessitate a dose range of 10 mg/kg to 20 mg/kg.

Going forward, Stoll said the company plans to ask the agency to "liberalize" its dose restrictions after completing additional animal toxicology studies that already are under way. More specifically, Cortex expects three-month tox trials in both monkeys and rats to generate complete reports for the FDA by the end of next quarter in order to expand to higher dosage levels and begin ADHD testing again.

Prior to the clinical hold, which resulted from animal toxicology findings rather than clinical testing problems, the company had reported positive Phase IIa results in adults with ADHD, an indication to which potential partners had been attracted, Stoll said. He noted "tremendous interest" in CX717 for both Alzheimer's and ADHD, but conceded that "it doesn't make much sense" to form a collaboration at the moment.

Stoll also indicated that Cortex likely would seek some form of financing next quarter, since no partnership funding is expected anytime soon. The company had about $15.5 million in cash reserves through June 30. To date, Cortex has spent about $2.5 million in "additional unplanned funds" related to CX717's clinical hold, he said.

Preliminary toxicology findings from animal studies should start coming in near the end of this year, though such data would be used to inform the company and not get submitted to the FDA.

CX717 is an ampakine compound, a class of drugs that enhance memory and cognition by acting on chemical pathways that impact at least 85 percent of all the neurotransmission occurring in the brain.

Stoll noted that because the technology relates to "a new science," there would be bumps in the road. In addition, he noted that if the FDA again rejects Cortex's plans for testing higher CX717 doses in ADHD patients, the company would have "a roadmap" for backup compounds already in development.