Adeona mit guter pipeline und Finanzierung - 500 Beiträge pro Seite

[dottore]

hätte ich auch im Forum US-Hotstocks schreiben können.
Mein alter Thread gilt leider schon als historisch. Die dort genannten Fakten sind inzwischen weiter entwickelt und an der Kursentwicklung kann man erkennen, dass die Korrektur 2010 beendet ist, als auch dass hier interessante NEWS in Kürze erwartet werden.
http://www.wallstreet-online.de/diskussion/1158355-1-10/krac…
http://www.adeonapharma.com/
Besonders gut gefällt mir die bereits verpartnerte Studie mit Flupirtin zur Therapie bei Fibromyalgie.
Das Medikament wird bereits bei Rückenschmerzen sehr erfolgreich angewendet. Bei Fibromyalgie "off label" mit deutlich weniger Erfolg in meiner persönlichen Erfahrung, aber Erfahrung ist nicht das Gleiche wie eine Studie!
Ich gehe von postiven Nachrichten aus underwarte bereits im Vorfeld Kurse über 2 $.
Man müßte mal den FDA Kalender einsehen um rechtzeitig zu sehen, wann die Zulassung kommt. ....

[traumstrand]

Antwort auf Beitrag Nr.: 40.938.323 von dottore am 27.01.11 18:59:28

Flupirtin bei Fibromyalgie kannste vergessen, taugt nix dafür.

[dottore]

Zitat von traumstrand: Flupirtin bei Fibromyalgie kannste vergessen, taugt nix dafür.

deine Erfahrung? Als Betroffene/r oder als Anwender?

[dottore]

gestern noch war die Welt in Ordnung. Die Finanzierung sollte doch gesichert sein. Warum jetzt 4 Mio $ Kapitalerhöhung? Direktangebot an 2 Investoren und verbunden mit Waarants zum Tauschwert von 2 $.

Aber ich war schon so schön im plus

[dottore]

wieder ein heftiger Kursabschlag und ohne NEWS

Da werd ich langsam ungeduldig.

Mal sehen, ob ich mich rausekeln lasse oder nachkaufe. Der Bauch will raus, der Verstand sagt: Nachkaufen!

[traumstrand]

Antwort auf Beitrag Nr.: 40.941.817 von dottore am 28.01.11 10:44:23

klinische Erfahrung.

[Zukertort]

Bald ist Zinthionein Zeit !

Adeona Pharmaceuticals Addresses the Needs of Large Pharma
4 comments | by: M. E. Garza December 12, 2010 | about: AEN 1230
About this author:

Visit: BioMedReports.Com

With a diverse clinical program looking for new treatments in several different and key central nervous system disorders, Adeona Pharmaceuticals, Inc. (AEN) has great potential and some of those programs look quite likely move into a commercial deal similar to the one the Ann Arbor-based drug development firm locked up earlier this year. That was a $17.5 million deal with Swedish drug maker Meda, but there is likely to be more where that came from.

"The drugs are extremely exciting," says James Kuo, chairman and CFO of Adeona Pharmaceuticals. "They address the needs of large pharma."

Adeona Pharmaceuticals has five drugs in various stages of development and hopes to form another similar corporate partnership or two this year. It’s too bad their depressed stock price doesn’t reflect the progress they are making in the clinic and at their laboratory.

In fact, we’ve noticed that they are starting to become a little more active in their efforts for visibility (CEO is scheduled to start making the rounds and presenting at more conferences, for instance) and maybe that will resonate more with those who follow the company and it should certainly attract new followers and investors to the stock.


Adeona Pharmaceuticals is developing innovative medicines for the treatment of serious Central Nervous System (CNS) diseases. Their primary strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration – basically this means they develop their product candidates to attract large pharmaceutical partners with deep pockets.

Those looking for a good trade, need to look elsewhere. We see this as a low-risk, nice reward investment candidate. They have a robust pipeline that includes product candidates in spaces that represent some big markets and unmet needs: a prescription medical food for Alzheimer’s disease, and four drugs for multiple sclerosis, fibromyalgia, age-related macular degeneration and rheumatoid arthritis.

In May 2010, Adeona demonstrated their ability to attract a partner when they entered into a $17.5 million corporate deal with Sweden-based Meda AB for the development of their product candidate flupirtine for the treatment of fibromyalgia. They received an up-front payment of $2.5 million and are entitled to milestone payments of $5 million upon filing of a New Drug Application with the FDA for flupirtine for fibromyalgia and $10 million upon marketing approval. Adeona is also entitled to receive royalties of 7% of net sales of flupirtine approved for the treatment of fibromyalgia.
Below is a listing of the diseases and associated product candidates that they are working on. For those with nearer term potential additional comments have been included:

Treatment of fibromyalgia – Effirma (flupirtine):

•Partnered with Meda AB
•In the press release about the corporate partnership, the company stated that Meda estimates the US market for fibromyalgia to be near $1 billion at the time of potential launch of flupirtine
Dietary management of Alzheimer’s disease and mild cognitive impairment with a prescription medical food – Zinthionein (zinc cysteine):

•Enrollment is 100% complete in the clinical trial evaluating Zinthionein in patients with Alzheimer’s disease and mild cognitive impairment
•All 60 patients should complete their 6 month treatment by the end of March 2011
•They anticipate top-line clinical study results should be available after that.
•If this treatment is clinically successful, they expect to make the Zinthionein product commercially available as a prescription medical food for patients.
•The classification “prescription medical foods” is not heard about often, but in quick internet searches, prescription medical foods: 1) do have to demonstrate validated effectiveness using double-blind controlled clinical trials, 2) do have to have all of its ingredients designated as Generally Recognized As Safe (GRAS) by the FDA and 3) do need a prescription from a doctor.
•They have 5 peer-reviewed scientific articles that have recently been published supporting the role of copper toxicity and zinc deficiency in patients with Alzheimer’s disease and mild cognitive impairment.
Treatment of relapsing-remitting multiple sclerosis in women – Trimesta (estriol):

•115 of 150 patients have been enrolled in the clinical trial evaluating Trimesta in women suffering from relapsing-remitting multiple sclerosis.
•On their 3rd quarter 2010 conference call, the CEO said that they anticipate full enrollment by the second half of 2011; however, they give no assurances.
Treatment of age-related macular degeneration – ZincMonoCysteine (zinc-monocysteine):

•They continue additional work on manufacturing and scale-up of zinc-monocysteine to support the further nonclinical testing and cGMP manufacturing.
Treatment of rheumatoid arthritis – dnaJP1 (hsp peptide):

•They are currently conducting further preclinical activities and planning the clinical development strategy. In addition to drug development, AEN purchased a CLIA-certified diagnostic laboratory in July of 2009 (now called Adeona Clinical Laboratory) to measure metabolic serum zinc and copper levels. But, according to their 3rd quarter 2010 conference call, the business has really grown – the client base has increased from 5 to 9 health service providers and earlier this year the in-house diagnostic testing services were expanded to include a full array of microbiology testing. They said that these significant changes represent a 567% increase in laboratory revenues for the quarter ended September 30, 2010, compared to the same quarter in the previous year.
As of June 30, 2010, AEN emerged, for financial reporting purposes, from being a development stage enterprise with a $979,782 profit in second quarter of 2010, mainly due to the $2,125,000 of net license revenue received as a result of the Meda AB sublicense agreement.

Total net revenues for the three and nine months ended September 30, 2010, were $289,898 and $2,544,825, respectively, compared to $51,085 for both periods in 2009. The increase in total net revenues for the three months ended September 30, 2010 reflects a 567% increase in net laboratory revenues from the three months ended September 30, 2009.

The increase in total net revenues for the nine months ended September 30, 2010 reflects $2,125,000 of net license revenue received as a result of the Meda AB sublicense agreement of flupirtine for fibromyalgia during the second quarter of 2010 and increases in net laboratory revenues for expanded client services provided by Adeona Clinical Laboratory from the nine months ended September 30, 2009.

As of September 30, 2010, they had approximately $3.3 million in cash compared to approximately $2.7 million on December 31, 2009. And as reported in their 3rd quarter 2010 filing, their cash at October 31, 2010 was approximately $3.1 million.

In November 2010, an announcement came out that they were awarded two grants totaling $488,959 under the Qualifying Therapeutic Discovery Project Program to support their Alzheimer’s disease and multiple sclerosis programs currently in clinical testing. This was a pretty good amount for two clinical programs; Dr. Kuo even put it into perspective on their quarterly conference call when he said “these grants represent approximately 38% of our total research and development expenses based on trailing twelve month calculations. These grants are highly significant for us from an economic perspective, and in comparison to many of our industry peers, we appear to have covered more of our R&D spend.”

When it comes to risk-vs-reward, an investment in AEN seems like a smart play with multiple shots on goal. Best of all, the price appears to have bottomed out at these levels. In listening to Dr. Kuo on various webcasts, conference calls and presentations, things seem to be moving along and current longs seem happy with everything but stock performance- largely due to the fact that they have remained mostly undiscovered.

AEN has demonstrated success with corporate partnering, they have started actively promoting the progress and potential of the clinical programs. They have expanded current revenue potential with their own clinical lab and we see them diligently trying to preserve cash.

With several potential product candidates in the pipeline – it not only seems likely they should attract additional partners, they are actively working on it.

I’m keeping my eye on the prescription medical food, Zinthionein, for the dietary management of patients suffering from Alzheimer’s disease and mild cognitive impairment as it seems to have the most near-term milestone (Q2 or Q3 2011) and a different regulatory path through the FDA, which as we all know, can take a drug candidate years and years

MFG
Chali

[Zukertort]

Bei adeona sterben die besten Forscher einfach weg

ANN ARBOR, Mich., Feb. 27, 2011 /PRNewswire/ -- With deep regret, Adeona Pharmaceuticals, Inc. (Amex:AEN - News), announced today the passing of its Senior Vice President of Research & Development, David A. Newsome, M.D. Dr. Newsome invented and developed ZincMonoCysteine and was the first person to pioneer and demonstrate the benefits of oral high dose zinc therapy in age-related macular degeneration, the leading cause of blindness in older Americans. Oral high dose zinc containing nutritional products now represent the standard of care for age-related macular degeneration which affects over 10 million Americans.

During his career, Dr. Newsome spent over a decade in clinical and laboratory research at the National Eye Institute, becoming the Head of the Retinal Disease Section. As Associate Professor at the Johns Hopkins Wilmer Eye Institute, Dr. Newsome combined teaching and clinical work with his laboratory research. Dr. Newsome continued his passion of teaching, patient care, clinical and laboratory research as a full tenured Professor at Louisiana State University Medical School, New Orleans. After teaching there, Dr. Newsome formed his own surgical and medical retina disease private practice, and continued to perform clinical and laboratory research sponsored by the National Institutes of Health and private foundation grants. After the devastation of Hurricane Katrina in New Orleans, Dr. Newsome worked as a surgical ophthalmologist until joining the management team at Adeona in 2006. He earned an M.D. from Columbia University and a B.A. from Duke University, and completed an ophthalmology residency and a fellowship in retinal diseases and surgery at Harvard University. He also completed a retinal fellowship at the Bascom Palmer Eye Institute, University of Miami.

"On behalf of the Board of Directors and all of his colleagues at Adeona, I would like to extend our heartfelt condolences to David's family," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO. "David was a dear friend and cherished colleague. He will be remembered for his life's work to develop zinc-based therapies for patients. David will be greatly missed."

Chali

[dottore]

Antwort auf Beitrag Nr.: 41.121.535 von Zukertort am 28.02.11 22:23:07

der Kursrutsch darf aber nicht damit in Verbindung gebracht werden. Wolltest du auch nicht.

Charttechnisch wird es interessant nachzukaufen im aktuellen Bereich

[dottore]

Antwort auf Beitrag Nr.: 41.135.752 von dottore am 02.03.11 19:23:29

upps, und schon hab ich welche (wenn ich schon den Hype zum Ausstieg versäumt hatte, dann jetzt rein vor dem nächsten Hype)

2011 sollte ein großes Jahr für Adeona werden! Die Ampeln stehen jetzt auf Grün. Ein Störfeuer durch Kapitalmaßnahme sollte vorerst nicht zu erwarten sein.

Flupirtin hat sich bei Rückenschmerzen schon sehr gut bewährt und sollte es bei Fibromyalgie Wirkung zeigen, die in der Placebokontrollierten Studie bestätigt wird, dann sind 4 $ keine Übertreibung für diese Aktie.

[dottore]

gut, dass ich mir gestern noch welche dazu geholt habe. Wenngleich der Kurs wieder zurück gekommen ist, war er doch zwischenzeitlich 7 % im plus und das wird die Benchmark für den Börsenschlusskurs

[Spekulist]

http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

Adeona Receives Excellence in Science & Technology Award

-- Corp! Magazine Highlights Technology Leaders and Innovators --

ANN ARBOR, Mich., March 8, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that it received a Corp! Magazine 2011 Digital, Science & Technology Award. As an honoree, the Company is highlighted in the magazine's Special Edition e-Publication. The Corp! Magazine article featuring Adeona is available via the "Adeona in the News" section on the home page of the Company's website at www.adeonapharma.com.

SOURCE Adeona Pharmaceuticals, Inc.




Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[Spekulist]

Heute in der Spitze über 1,40. Fast 20%!
Warum?
Momentan immer noch gute 11% bei 1,33.

[dottore]

Die Zulassung Flupirtin gegen Fibromyalgie steht im Raum. Wann genau, könnte man im Kalender der FDA nachsehen.

Die vorläufigen Ergebnisse scheinen vielversprechend. Die persönliche Erfahrung ist da eher durchwachsen.
Im Vorfeld der Zulassung wird der Kurs hochgezogen.

[dottore]

Man das geht ja gut ab. Ist das nur Spekulation, oder weiß da jemand schon mehr? Im zweiten Fall kann der Kurs locker die 3 $ durchstoßen.

Fibromyalgie ist ein Schmerzsyndrom, dessen Usache nicht geklärt ist und es gibt ein Myofasziales Schmerzsyndrom, das dem sehr ähnlich ist. In beiden Fällen und auch bei Rückenschmerzen ist dieses Medikament -Flupirtin- vielversprechend. In Deutschland unter dem Namen Trancopal zugelassen. Unverschämt teuer In der Retardform kostet eine Tablette über 3 € und kommt deshalb nur in Frage, wenn ich keine Kombination normaler Schmerzmedikamente hinbekomme

Sollte die Studie jetzt den Beweis erbringen, auch in der Fibromyalgie zu wirken, könnte es weltweit zum blockbuster werden

[Spekulist]

Monster Run
Im Hoch bei 1,98 ,plus 35%
Aber da geht ja event. noch Einiges.
Denkt immer an HGSI

[dottore]

heute über 12 % wieder runter. Das ist nach dem gestrigen Anstieg nicht negativ! Jedenfalls nicht, wenn es jetzt wieder hoch geht. Und wie schon erwähnt: 3 $ sind zu knacken!

[dottore]

Adeona holt sich gerade die Verluste von gestern zurück (18% plus)

[Spekulist]

Hammermeldung!
Dr Bush,anerkannter Experte auf dem Gebiet der Alzheimerforschung billigt Adeonas Produkt erhebliches Potential zu.

Ashley I. Bush, M.D., Ph.D., Joins Adeona's Scientific Advisory Board

-- New Advisor to Provide Valuable Expertise Related to the Involvement of Metals in Alzheimer's Disease --

ANN ARBOR, Mich., March 24, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that Ashley I. Bush, M.D., Ph.D., has joined the Company's Scientific Advisory Board.

Dr. Bush is a National Health and Medical Research Council Australia Fellow and Head of the Oxidation Disorders Laboratory for the Mental Health Research Institute, University of Melbourne. He has been published in the journal, Science, and has been featured in a front page article in The Wall Street Journal. Dr. Bush theorizes that the buildup of insoluble protein, called amyloid, within the brain in Alzheimer's disease is caused by an imbalance in the import and export of the vital trace metals, such as copper, zinc and iron.

"Given my research in the area, I believe Adeona's product candidate for the dietary management of Alzheimer's disease, reaZin™, shows significant potential," said Ashley I. Bush, M.D., Ph.D. "I look forward to advising Adeona as they move their promising zinc-based product candidate through development for the treatment of Alzheimer's disease."

"We are very pleased to welcome Dr. Bush to our Scientific Advisory Board. He is a respected expert in the research and development of new treatments for Alzheimer's disease based on the regulation of particular biometals," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO. "We look forward to Dr. Bush's valuable advisory role in advancing our development and product commercialization plans in Alzheimer's."

About Ashley I. Bush, M.D., Ph.D.

Ashley I. Bush, M.D., Ph.D., is a National Health and Medical Research Council Australia Fellow and Head of the Oxidation Disorders Laboratory for the Mental Health Research Institute, University of Melbourne. He has also served as the Director of the Laboratory for Oxidation Biology, Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School. A board certified psychiatrist, Dr. Bush earned a Ph.D. in neuroscience at the University of Melbourne, and did postdoctoral research at Harvard. He is also a co-founding scientist of Prana Biotechnology, Ltd. Dr. Bush is the recipient of several awards including the Potamkin Prize for Alzheimer's disease research from the American Academy of Neurology, the Paul B. Beeson Award in Aging from The National Institute on Aging and the American Federation for Aging Research and the Senator Mark A. Hatfield Award for Clinical Research from the Alzheimer's Association, and has authored over 170 publications with over 14,000 citations.

SOURCE Adeona Pharmaceuticals, Inc.

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[Spekulist]

Adeona to Host 2010 Year End Investor Conference Call

-- Conference Call Scheduled for Thursday, March 31, 2011, at 4:30pm EDT --

ANN ARBOR, Mich., March 28, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that it will hold its 2010 year end investor conference call on Thursday, March 31, 2011, at 4:30pm EDT. James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer, will host the call.

Interested parties should call toll free1-800-860-2442 (U.S.) or 1-866-605-3852 (Canada), or from outside North America [phone], fifteen minutes before the start of the call to register and identify themselves as registrants of the 'Adeona' Conference Call. Any registered caller on the toll free line may ask to be placed in the queue for the Question & Answer session. The call will be simulcast on the web at http://www.videonewswire.com/event.asp?id=77882. If you are unable to participate during the live call, the webcast will be available for replay at www.adeonapharma.com for 30 days after the call.

SOURCE Adeona Pharmaceuticals, Inc.

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[Spekulist]

Zusage für die Finanzierung von Trimesta

Adeona's Multiple Sclerosis Trial Receives $409,426 Grant

-- Clinical Trial Evaluating Company's Drug Candidate, Trimesta™ (oral estriol), 85% Enrolled --

ANN ARBOR, Mich., March 28, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that the ongoing clinical trial of its Trimesta™ (oral estriol) drug candidate has received an additional $409,426 in grant funding from the National Multiple Sclerosis Society (NMSS). The clinical trial is led by, Rhonda Voskuhl, M.D., Director, University of California Los Angeles (UCLA) Multiple Sclerosis Program, UCLA Department of Neurology. Adeona also announced that as of March 1, 2011, the clinical trial evaluating the reduction in the rate of relapses in female multiple sclerosis (MS) patients is 85% enrolled.

"We are very grateful to the NMSS for its continuous support of this MS program, from the preclinical development to the pilot and multi-center clinical trials, and now this current grant funding," said Dr. Voskuhl. "Their commitment to pursuing estriol for MS could potentially lead to a new, safe and effective oral therapy for this debilitating disease."

This ongoing clinical trial previously received a $5 million grant from the NMSS in partnership with the NMSS's Southern California chapter, with support from the National Institutes of Health, and $860,440 in grant funding through the American Recovery and Reinvestment Act. In November 2010, Adeona announced that it was awarded $244,480 under the Qualifying Therapeutic Discovery Project Program to support research and development expenses related to the Company's MS program.

The 150-patient, randomized, double-blind, placebo-controlled clinical trial of Trimesta is currently underway at 15 centers in the United States. Investigators are administering either Trimesta or matching placebo along with glatimer acetate (Copaxone®), an FDA-approved therapy for MS, to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. With 127 out of 150 patients enrolled in the clinical trial by March 1, 2011, the Company anticipates full enrollment by the second half of 2011. Additional information regarding this multiple sclerosis clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204.

SOURCE Adeona Pharmaceuticals, Inc.




*

[traumstrand]

...na toll, die Studie läuft seit 2007 und ist noch nicht komplett enrolled trotz 15 Zentren und überschaubaren Ein- und Ausschlußkriterien. Geplante Datenauswertung 2.HJ 2013.

Nix, um heute Aktien der Fa. zu kaufen - außer daß die Finanzierung der Studie zu stehen scheint.

[dottore]

Antwort auf Beitrag Nr.: 41.286.010 von traumstrand am 30.03.11 00:19:46

wieso nix? Man erkennt doch recht gut, dass nicht einfach drauf los geforscht wird, sondern die finanzielle Seite zuerst abgesichert wird. Damit ist Adeona vor einem Jahr bei mir aufgefallen.

Die haben doch noch mehr in der pipeline. Da stehen auch aktuelle News bevor und nicht erst 2013

[traumstrand]

Antwort auf Beitrag Nr.: 41.289.216 von dottore am 30.03.11 13:50:48

Rel. kleine Studie in einer Erkrankung, die nicht sooooo extrem selten ist. Alle Patienten erhalten in der Studie kostenlos Copaxone (müssen also nicht relevante Eigenanteile selbst bezahlen, wie in den USA oft üblich) + zzgl. randomisiert das Studienmedikament. Also eigentlich sehr attraktive Studienteilnahmebedingungen. und trotzdem haben die 15 Zentren nicht mal je 10 Patienten in 3 Jahren zusammentrommeln können - das ist sehr schwach!!!

[Spekulist]

Sehn´ viele wohl anders.Die Àktie ist momentan jedenfalls sehr stark!!Im übrigen geht es bei Adeona ja nicht nur um Trimesta.
Wem die Aktie nicht zusagt,der braucht sie ja nicht zu kaufen - es wird ja niemand gezwungen.
Entscheidend ist - Der Markt hat immer recht: Performance seit dem 30.3. satte 20%!

Adeona Reports 2010 Year End Financial Results
-- $3.2 Million Net Revenues Reported for the Year Ended December 31, 2010 --
-- Investor Conference Call Scheduled for 4:30pm (EDT) Today --

ANN ARBOR, Mich., March 31, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative medicines for serious central nervous system diseases, today reported its financial results for the year ended December 31, 2010, as well as updates since the beginning of the 4th quarter.

Updates since the beginning of the 4th quarter include:

Clinical Programs

Alzheimer's Disease

* Adoption of "reaZin" as the new trademark for Adeona's zinc and cysteine-based oral tablet (formerly called Zinthionein) currently under development as a preion medical food for the dietary management of Alzheimer's disease and mild cognitive impairment.
* Completion of the treatment phase of the pivotal clinical trial evaluating the zinc and cysteine-based product candidate, reaZin™ in patients with Alzheimer's disease and mild cognitive impairment. Results from this clinical trial are expected to be presented at the 63rd Annual Meeting of the American Academy of Neurology in April of 2011 by Lead Principal Investigator, Diana Pollock, M.D.


Multiple Sclerosis

* Receipt of an additional $409,426 in grant funding from the National Multiple Sclerosis Society for the clinical trial evaluating Adeona's drug candidate, Trimesta™ (oral estriol).
* Enrollment of 127 of 150 patients (85%) in the clinical trial evaluating Trimesta in women suffering from relapsing-remitting multiple sclerosis, as of March 2, 2011. The randomized, double-blind, placebo-controlled clinical trial is currently underway at 15 centers in the United States. We anticipate full enrollment by the second half of 2011.


Operations

* Execution of an agreement for the sale of approximately 2.85 million shares of common stock at $1.40 per share to new institutional investors in a registered direct offering for gross proceeds of $4 million. Investors also received warrants to purchase approximately 1.42 million shares of common stock at an exercise price of $2.00 per share and are exercisable for a period of 13 months.
* Appointment of George J. Brewer, M.D., the Morton S. and Henrietta Sellner Emeritus Professor of Human Genetics and Internal Medicine at the University of Michigan, as Senior Vice President of Research & Development, following the unexpected passing of David A. Newsome, M.D.
* Expansion of the Scientific Advisory Board with the following appointments:
o Ananda S. Prasad, M.D., Ph.D., a pioneer of zinc therapy with over 50 years of experience devoted to the field.
o Ashley I. Bush, M.D., Ph.D., an expert in the research and development of new treatments for Alzheimer's disease based on the regulation of particular biometals.
* Execution of an agreement with Dr. Prasad providing access to clinical data from a 50 patient, 12-month, randomized, double-blind, placebo-controlled clinical trial that evaluated the prevention of infections in the elderly who were treated with an oral zinc therapy or matching placebo. The results at 12 months demonstrated a 67% reduction in the incidence of infection between the two groups (88 infections in the placebo group versus 29 infections in the zinc treated group) (p < 0.001).
* Termination of the dnaJP1 (hsp peptide) clinical development program as of March 31, 2011. While data from a Phase II clinical trial previously reported in November 2009 demonstrated safety and tolerability in patients with rheumatoid arthritis, the decision to discontinue this program was driven by strategic considerations as well as clinical and market potential.


Year Ended December 31, 2010 Financial Results

Total net revenues for the year ended December 31, 2010 were $3,164,512, compared to $103,089 for the year ended December 31, 2009. Total net revenues for the year ended December 31, 2010 consisted of $2,125,000 as a result of the Meda AB sublicense agreement of flupirtine for fibromyalgia during the second quarter of 2010, $550,553 of net laboratory revenues from the first full year of operations at Adeona Clinical Laboratory and $488,959 of grant revenues from the Qualifying Therapeutic Discovery Project Program to support Adeona's Alzheimer's disease and multiple sclerosis programs currently in clinical testing. Total net revenues for the year ended December 31, 2009 consisted of $103,089 of net laboratory revenues from Adeona Clinical Laboratory. Since purchasing Adeona Clinical Laboratory in July of 2009, the client base has increased and the in-house diagnostic testing services have been expanded to include a full array of microbiology testing.

Total costs and expenses for the year ended December 31, 2010 were $4,748,465, compared to $3,784,569 for the year ended December 31, 2009.

Research and development expenses increased to $1,579,891 for the year ended December 31, 2010, from $948,891 for the year ended December 31, 2009. This 66% increase is primarily the result of increased costs associated with the continued development of Adeona's product candidates, including outside manufacturing costs, consultant fees, license fees and patent costs. Research and development expenses also include a non-cash charge relating to stock-based compensation expense of $90,290 for the year ended December 31, 2010, compared to $188,166 for the year ended December 31, 2009.

General and administrative expenses decreased slightly to $2,700,951 for the year ended December 31, 2010, from $2,708,778 for the year ended December 31, 2009. General and administrative costs in 2009 included acquisition costs of $75,000 related to the purchase of Adeona Clinical Laboratory. General and administrative expenses also include a non-cash charge relating to stock-based compensation expense of $310,098 for the year ended December 31, 2010, compared to $135,770 for the year ended December 31, 2009.

Costs of laboratory services increased to $467,632 for the year ended December 31, 2010, from $126,900 for the year ended December 31, 2009. This increase is primarily the result of the increased costs associated with the expansion of the client base at Adeona Clinical Laboratory, including salary and supply costs. The year ended December 31, 2010 included 12 months of costs, compared to the year ended December 31, 2009, which only included 6 months of costs after the acquisition in July of 2009.

The net loss for the year ended December 31, 2010 was $1,711,159, or $0.08 per share, compared to $3,731,405, or $0.18 per share, for the year ended December 31, 2009. The decrease in net loss is the result of increased revenues for the year ended December 31, 2010, that included license revenue, increased laboratory revenue and grant revenue.

As of December 31, 2010, Adeona had approximately $2.6 million in cash compared to approximately $2.7 million on December 31, 2009. As of February 28, 2011, Adeona had approximately $6.0 million in cash, including the net proceeds of approximately $3.7 million from the January of 2011 financing.

"We continued to make significant progress in the clinical development of our product candidates for Alzheimer's disease and multiple sclerosis during 2010. We anticipate reporting results from patients who have completed their 6 month follow-up in the Alzheimer's disease clinical study in April of 2011, and, if the clinical results are positive, we intend to further our commercialization efforts of reaZin as a preion medical food. We also expect completion of enrollment in the multiple sclerosis clinical trial during the second half of 2011," stated James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer. "We achieved these clinical milestones while also increasing our revenues from various sources and carefully managing our operating expenses.

Dr. Kuo added, "With the addition of the net proceeds from the financing in January of 2011, we believe our current cash position should meet our planned operating needs for at least the next 12 months."

Adeona 2010 Year End Investor Conference Call

Adeona will hold its 2010 year end investor conference call today, Thursday, March 31, 2011, at 4:30pm EDT. James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer, will host the call. Interested parties should call toll free1-800-860-2442 (U.S.) or 1-866-605-3852 (Canada), or from outside North America [phone], fifteen minutes before the start of the call to register and identify themselves as registrants of the 'Adeona' Conference Call. Any registered caller on the toll free line may ask to be placed in the queue for the Question & Answer session. The call will be simulcast on the web at http://www.videonewswire.com/event.asp?id=77882. If you are unable to participate during the live call, the webcast will be available for replay at www.adeonapharma.com for 30 days after the call.

SOURCE Adeona Pharmaceuticals, Inc.

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[dottore]

ich hatte eine etwas zu groß geratene Position, weil ich bei ca 1,10 $ noch mal nachgelegt hatte. Bin gestern zu 2,15 $ mit 3/4 meiner Posi raus.
Der Rest fliegt zu Ostern raus, weil ich länger in Ferien fahre und vorher diese und noch eine Reihe anderer glattstellen will.

Was ich damit sagen will: Ich denke, dass es mit Adeona noch ein Stück raufgehen wird

[Spekulist]

Kursentwicklung sieht eigentlich sehr gesund aus.
Das war nicht immer so(vergl. die bisherigen Verläufe nach versch. Spitzen/Anstiegen).
Diesmal ist der Verlauf nach dem Anstieg ab ca. 1,25 im März nachhaltiger.Scheint was sehr Stabiles zu werden!
Ich werde Gewinne laufen lassen und vor allem den Stop nicht zu eng setzten.

[dottore]

Meldung von heute

Adeona Pharmaceuticals Executes Deal For Sale Of 1.688 Mln Shares At About $2.0725/Share

[dottore]

ein Abschlag von 8 %, obwohl für die neuen Aktien 2,0725 bezahlt wurden.

Im Laufe des Tages sollte die Stimmung wiedr besser werden und zum Handelsende wieder da sein, wo wir gestern waren.

Vielleicht kaufe ich in 1-2 Stunden welche!?

[dottore]

oh schade, ich wollte doch noch bei 1,90 zugreifen Die Amis schaukeln solche Werte oft im laufe des Tages. Deshalb dachte ich, in 2 Stunden den Tiefstpunkt zu sehen. Aber die sind schon jetzt fast wieder aus dem roten Bereich, was ich erst zu Handelsende erwartete.

Naja, dann geb ich mein Geld eben wo anders aus

[bierro]

Na, was meint Ihr zu den News von gestern?

"ANN ARBOR, Mich., April 14, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. , a developer of innovative medicines for serious central nervous system diseases, announced today top-line results from its clinical study evaluating reaZin for the dietary management of Alzheimer's disease (AD) and mild cognitive impairment (MCI). The clinical study met the primary outcome of increasing serum zinc and decreasing serum free copper. In addition, secondary outcomes of mental status as measured by three standardized cognitive tests all favored the treatment group versus the placebo group."

"These results confirm the previously reported results from Part 1 of the clinical study (April 14, 2010) that demonstrated reaZin was well
tolerated and superior to Galzin(R), an FDA-approved zinc preparation."

http://www.finanznachrichten.de/nachrichten-2011-04/19949685…

Der Kurs hat sich vor der (nachbörslichen)Veröffentlichung ja kaum bewegt, hmmm...

[dottore]

der Kurs bricht gerade um 20 % ein!

Was mag das zu bedeuten haben? Ich habe schnell meine letzten 1000 Stücke geschmissen, weil ich glaube, die gehen noch weiter runter und vor allem die kommen dann nicht so schnell wieder hoch. Bin ja eh im plus. ...


scheiße trotzdem

[bierro]

War wohl doch nicht so überzeugend, zumal reaZin kein Medikament ist, sondern ein "medical food supplement", also so eine Art Nahrungsgergänzungsmittel ohne FDA-Zulassung.

Egal, ich bin dringeblieben. Vielleicht erholt sich das Teil ja wieder. Mann, Mann, ich hätte in FRA zu 1,25 Euro verkaufen können, but - who knows?

Ich denke, die kommt wieder hoch, aber an die 2 $ glaub ich so schnell nicht mehr. Die KE hat viel Vertrauen gekostet.

[dottore]

bin zu 1,44 $ raus (noch mit Gewinn) und die fällt zur Zeit auf 1,35

ob am späten Abend der Kurs wieder bei 1,60 steht? Nicht auszuschließen.
Aber ich glaube nicht, dass ich weider einsteige, wenn nicht klar ist, wie der Kurseinbruch zustande kam. Am reazin allein kann es nicht gelegen sein.

[bierro]

Hier ist vielleicht die Antwort:

Unfortunately, the study's primary endpoint is obvious and clinically meaningless to Alzheimer's patients. Treatment with six months of reaZin increased levels of zinc and reducing levels of copper in patients' blood compared to a placebo, according to the study results. Of course, that's exactly what one would expect any simple and relatively inexpensive zinc tablet to do.

Mit anderen Worten: Die Wirkung ist gegenüber Placebos nur unwesentlich besser. Also könnte man auch ein billiges Zink-Präparat nehmen, den der Effekt wäre fast der gleiche.

http://www.thestreet.com/story/11083931/1/adeona-zinc-tab-fa…

[dottore]

jetzt kann man bei advfn Current report filing 8-k einsehen.

Das ist wohl der Grund, aber inzwischen wurden auch schon 3 Mio Stücke verkauft

[bierro]

Nun, das war ja bereits publiziert. Scheiße!

[KillingJoke]

Antwort auf Beitrag Nr.: 41.375.527 von bierro am 15.04.11 17:13:10

Oh, ich sehe, es gibt einen Thread zu AEN.
Tut mir natürlich leid, wenn hier teilweise Verluste entstanden sind.
Der ein oder andere kam ja noch mit Gewinn raus.
Ich bin seit 15.04. SHORT.

Hat hier noch jemand was Substantielles zur Verteidigung des Wertes zu sagen?
Ich könnte mir vorstellen, dass es noch weiter runtergeht.

[KillingJoke]

Antwort auf Beitrag Nr.: 41.388.643 von KillingJoke am 19.04.11 13:03:38

Meine Shortposition habe ich aufgelöst (von 1,91 auf 1,17 USD).
AEN hat eine Martkapitalisierung von 23 Mio USD. Das ist relativ wenig und immer für einen Sprung nach oben gut.
Ich kann ansonsten vor dieser Firma nur warnen.

Man möchte eine Tablette namens reaZin nicht als Medikament nicht über den "normalen" Zulassungsweg, sondern als "Medical Food" auf den Markt bringen. Entsprechend wird die Wirksamkeit des Medikamentes in klinischen Tests auch auch nicht überprüft.
Adeona weist in einem unvollständigen Test, der in seiner Auswertung nicht alle Testpersonen enthält (!) nach, dass die Einnahme von reaZin die Zinkmenge im Körper signifikant erhöht. Ein solches Ergebnis kann man vermutlich auch mit anderen Zinkprodukte aus der Apotheke erreichen.
Die Wirkung von erhöhtem Zink werden von Adeona mit positiven Auswirkungen auf Alzheimer oder "geringfügige kognitive Beeinträchtigung" assoziiert. Diese Ergebnisse sind jedoch überhaupt nicht signifikant.

Ich empfinde es geradezu als unverschämt und dreist, hier Tendenzen in Richtung Alzheimer "Heilung" zu Schlussfolgern.

[dottore]

bei dem Kursverlauf bin ich zwar froh, rechtzeitig mit Gewinn ausgestiegen zu sein, aber außer dem reazin gibt es noch mehr in der Pipeline und die Verpartnerung wurde schon frühzeitig abgeschlossen.

Ich gehe davon aus, dass noch einige Nachzügler vom Zug nach unten springen werden und ihn damit noch weiter runter bringen.

Irgendwann aber wird der Wert wieder fundamental interessant. Also bleibt der auf meiner watchliste. Bei etwa 75 Cent würde ich (vielleicht!) wieder einsteiegen .....

[dottore]

Reazin ist also ein Zink-Präparat.
Heute kam ein Rundschreiben von GSK wegen Corega Tabs. Die waren mit Zinkhaltiger Haftcreme verantwortlich gemacht worden - in Einzelfällen und nach jahrelangem Gebrauch - zu viel Zinkazfnahme zu verursachen und einen damit einhergehenden Kupfermangel auszulösen, der dann wieder auf das Nervenystem krankmachende Auswirkungen hat und Myeloneuropathie und Blutstoffwechselstörungen zu verursachen.

Die Zinkdosierung müßte also im Alzheimer auch begrenzt werden und es stellt sich die Frage, ob das wirklich der richtige Ansatz sein kann.

nur mal so ......

[Spekulist]

Meldung war doch eigentlich ganz gut!
Könnte noch weiter nach oben gehen.

http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…


Adeona Reports 1st Quarter 2011 Financial Results

-- Adeona Clinical Laboratory, a Wholly Owned Subsidiary, Achieves Profitability --
-- Trimesta™ Clinical Trial Receives $2 Million in New Grant Funding --
-- reaZin™ Commercialization Moving Forward --

ANN ARBOR, Mich., May 16, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative medicines for serious central nervous system diseases, today reported its first quarter 2011 financial results for the three month period ended March 31, 2011, as well as updates since the beginning of the 1st quarter.

Updates since the beginning of the 1st quarter include:

Clinical Programs

Zinc Deficiency Associated with Alzheimer's Disease

Clinical results: Top-line results from our clinical study evaluating reaZin for the dietary management of zinc deficiency associated with Alzheimer's disease were presented at the 63rd Annual Meeting of the American Academy of Neurology in April 2011.
As prospectively hypothesized, patients administered reaZin demonstrated increased serum zinc levels and decreased serum free copper levels, resulting in statistical significance of the primary outcomes of the clinical study.
The cognitive function of the placebo group, on average, declined over 6 months in comparison to patients managed with reaZin. The cognitive function trends favoring the patients managed with reaZin were observed in all three standardized cognitive tests utilized in our study and suggest that reaZin may provide an important benefit to the dietary management of zinc deficiency associated with Alzheimer's disease.



Commercialization plans: Based on the top-line results from this clinical study, we intend to further the commercial development of reaZin as a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer's disease.
In April 2011, we executed an agreement with TG United, Inc. of Brooksville, Florida, to provide commercial-scale manufacturing for reaZin.
We will also review the reaZin clinical study results with our scientific advisors to determine what further clinical studies might be warranted to support additional labeling claims.



Multiple Sclerosis

Grant funding: Our ongoing clinical trial of Trimesta (estriol) for relapsing-remitting multiple sclerosis (MS) in women has received grant awards from two organizations that should support the clinical trial to its completion.
$409,426 in grant funding from the National Multiple Sclerosis Society was received in March 2011.
$1,594,553 in grant funding from the National Institutes of Health/National Institute of Neurological Disorders and Stroke was received in May 2011.



Patient enrollment: 133 of 150 patients have been enrolled in the clinical trial evaluating Trimesta in women suffering from relapsing-remitting MS as of May 1, 2011. The randomized, double-blind, placebo-controlled clinical trial is currently underway at 15 centers in the United States.



Operations

The quarter ended March 31, 2011 represents the first quarter that Adeona Clinical Laboratory achieved profitability since its purchase in July 2009. This milestone resulted from the increase in total net revenues for the three months ended March 31, 2011 that reflects an approximate 438% increase in net laboratory revenues from the three months ended March 31, 2010.
Our cash position has been strengthened as a result of two financings, which should meet our planned operating needs for at least the next 12 months.
Completion of the sale of approximately 2.85 million shares of common stock at $1.40 per share to new institutional investors in a registered direct offering for gross proceeds of $4 million in February 2011. Investors also received warrants to purchase approximately 1.42 million shares of common stock at an exercise price of $2.00 per share and are exercisable for a period of 13 months from issuance.
Completion of the sale of approximately 1.69 million shares of common stock at $2.0725 per share to a new institutional investor in a registered direct offering for gross proceeds of $3.5 million in April 2011. Investors also received warrants to purchase approximately 844,000 shares of common stock at an exercise price of $2.0725 per share and are exercisable for a period of 13 months from issuance.



First Quarter Ended March 31, 2011 Results

Total net revenues for the three months ended March 31, 2011 were $323,138, compared to $60,039 the same period in 2010. This significant change resulted from an increase in the client base and the expansion of in-house diagnostic testing services to include a full array of microbiology testing at Adeona Clinical Laboratory.

Total costs and expenses for the three months ended March 31, 2011 were $1,749,712, compared to $1,154,590 for the same period in 2010.

General and administrative expenses for the three months ended March 31, 2011 were $1,273,536, compared to $742,021 for the same period in 2010. For the three months ended March 31, 2011, general and administrative expenses include a non-cash charge relating to stock-based compensation expense of $758,710, compared to $151,148 for the same period in 2010. The stock-based compensation expense for the three months ended March 31, 2011 includes a one-time charge of $397,767 relating to the modification of certain stock options, prior to expiration, held by a member of the Board of Directors.

Research and development expenses for the three months ended March 31, 2011 were $232,318, compared to $307,150 for the same period in 2010. This decrease is primarily the result of decreased costs associated with our product candidates. For the three months ended March 31, 2011, research and development expenses include a non-cash charge relating to stock-based compensation expense of $8,858, compared to $34,479 for the same period in 2010.

Costs of laboratory services for the three months ended March 31, 2011 were $243,858, compared to $105,419 for the same period in 2010. This increase is primarily the result of increased costs associated with the increased client base and expansion of in-house diagnostic testing services to include a full array of microbiology testing at Adeona Clinical Laboratory.

Other expense for the three months ended March 31, 2011 was $759,887, compared to $7,029 of other income for the same period in 2010. For the three months ended March 31, 2011, other expense included $809,857 relating to the estimated fair value of the warrants associated with the February 2011 financing, adjusted for the change in their fair value at March 31, 2011.

The net loss for the three months ended March 31, 2011 was $2,186,461 or $0.09 per share, compared to $1,087,522 or $0.05 per share for the same period in 2010. The increase in net loss is primarily attributable to the warrant liability and the one-time charge relating to the modification of certain stock options, and would have been negligible if these charges had not occurred.

As of March 31, 2011, Adeona had approximately $6.1 million in cash compared to approximately $2.6 million on December 31, 2010. As of April 30, 2011, we had approximately $8.9 million in cash, including net proceeds of approximately $3.25 million from the April 2011 financing. Our cash position should allow us to meet our currently planned operating needs for at least the next 12 months.

"I believe the operational and clinical milestones we achieved during the first quarter of 2011 should position us for future growth and increased shareholder value," stated James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer. "We are encouraged that Adeona Clinical Laboratory has expanded its operations into a profitable business subsidiary. With the top-line results from our Alzheimer's clinical study reported and a commercial-scale manufacturer of reaZin in place, we continue to advance our prescription medical food towards commercialization. We are anticipating the review of the reaZin clinical results with our scientific advisors and intend to identify a pathway that could provide for additional labeling claims. At the same time, we look forward to reporting the completion of patient enrollment in the Trimesta MS trial and to exploring new opportunities that could expand our MS clinical program."

Adeona 1st Quarter 2011 Investor Conference Call

Adeona will hold its 1st quarter 2011 investor conference call tomorrow, Tuesday, May 17, 2011, at 1:00pm (EDT). James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer, will host the call. The Company will be joined by special guest, Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) Multiple Sclerosis Program, UCLA Department of Neurology, and Lead Principal Investigator of the multi-center clinical trial evaluating Adeona's Trimesta (estriol) drug candidate for multiple sclerosis (MS) in women. Dr. Voskuhl is the investigator who discovered that the female sex hormone, estriol, could suppress MS-like symptoms in a mouse model of the disease. This preclinical research led to a 10-patient clinical study that showed an 82% decrease in brain lesions over a six month period. This clinical study was followed by a 150-patient, randomized, double-blind, placebo-controlled clinical trial of Trimesta that is currently underway at 15 centers in the United States. Dr. Voskuhl's preclinical and clinical work has been scientifically reviewed and awarded over $8 million in grant funding by organizations such as the National Institutes of Health, the National Multiple Sclerosis Society and other third party groups. In addition to providing an update of the Trimesta clinical trial, Dr. Voskuhl will share insights into her proposed new mechanism to treat MS patients and will take questions about her research.

Interested parties should call toll free1-800-860-2442 (U.S.) or 1-866-605-3852 (Canada), or from outside North America [phone], fifteen minutes before the start of the call to register and identify themselves as registrants of the 'Adeona' Conference Call. Any registered caller on the toll free line may ask to be placed in the queue for the Question & Answer session. The call will be simulcast on the web at http://www.videonewswire.com/event.asp?id=79592. If you are unable to participate during the live conference call, the webcast will be available for replay at the same URL (http://www.videonewswire.com/event.asp?id=79592) for 30 days after the call.

SOURCE Adeona Pharmaceuticals, Inc.

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[Spekulist]

Plus 16,25% ,zeitweise über 30% im Plus.
Neue Ergebnisse,womit die Aktie wieder besser gesehen werden sollte.


Adeona Announces Positive Alzheimer's Subgroup Analysis that Supports Additional Clinical Study of Proprietary Zinc-Based Therapy

ANN ARBOR, Mich., June 2, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today positive findings based on further analyses from the clinical study evaluating reaZin along with near-term plans for its Alzheimer's disease program. After reviewing the statistical analysis with the Company's scientific advisors, Adeona intends to conduct another Alzheimer's disease clinical study to evaluate its proprietary zinc-based tablet in patients age 70 and over. In parallel, Adeona intends to make reaZin commercially available as a preion medical food for the dietary management of zinc deficiency associated with Alzheimer's disease.

After presenting the top-line results in April from the clinical study evaluating reaZin that demonstrated, on average, that the cognitive function (as measured by three standardized cognitive tests) of the patients managed with reaZin remained relatively stable over six months, while the placebo group showed deterioration, Adeona conducted further analyses to determine if certain subgroups in the patient sample benefitted from reaZin more than others.

After analyzing a number of independent variables associated with the patients enrolled in the clinical study on a post-hoc basis, the strongest relationship was found to be between age and cognitive outcomes. Patients in the study ranged from 52 to 86 years of age. Patients in the placebo group, on average, showed age-related cognitive decline – the older the patient, the greater the rate of cognitive decline. In contrast, patients in the reaZin treatment group, on average, showed cognitive stabilization, no matter what their age. Therefore, the older the reaZin treatment patient, the greater the amount of cognitive benefit compared to the placebo patients of the same age.

These observations were supported by an age-related subgroup analysis that showed dosing-compliant patients age 70 and over (approximately the oldest three quartiles of the patients evaluable at the end of the study) demonstrated statistically significant improvements in two of the three cognitive scoring measurements in the reaZin treatment group compared to the placebo group. As presented below, in this subgroup, two of the three standard cognitive measures reached statistical significance (p < 0.05) as determined by the p-values (the average changes in cognitive scores from baseline to 6 months in the treatment group compared to the placebo group). The p-values were as follows:

ADAS-Cog - Alzheimer's Disease Assessment Scale - Cognitive Subscale p-value: 0.037
CDR-SOB - Clinical Dementia Rating Scale - Sum of Boxes p-value: 0.032
MMSE - Mini Mental State Examination p-value: 0.067



Based upon the apparent cognitive benefit observed in these older patients who were managed with reaZin in comparison to patients who received the matching placebo, Adeona is preparing a larger clinical study protocol to evaluate patients diagnosed with mild to moderate Alzheimer's disease who are age 70 and over. It is anticipated that the clinical study will enroll over 100 patients and that the evaluation period will be at least 12 months. The intention is to develop the Company's proprietary zinc-based tablet as a drug (in parallel with making reaZin available as a preion medical food) and to conduct this new clinical study under an Investigational New Drug (IND) application to be filed with the Food & Drug Administration (FDA).

"The biological availability of zinc is impaired in Alzheimer's disease as evidenced by significantly lower plasma zinc levels and deficiencies of neuronal zinc activities, each of which are further exacerbated with age. The recent clinical study of reaZin showed that the oral treatment is well-tolerated, and there are even trends to benefits in cognitive outcomes over the study period in several readouts. Based on the consistencies in these trends, the prevalence of abnormally low plasma zinc levels in the elderly, and the established detrimental effects of chronic zinc deficiency on cognition, I think it is very reasonable to test for the ability of reaZin to ameliorate cognitive decline in a larger-scale clinical trial," said Ashley I. Bush, M.D., Ph.D., Head of the Oxidation Disorders Laboratory for the Mental Health Research Institute, University of Melbourne and Adeona Scientific Advisory Board member.

"It is well documented that zinc deficiency increases as we age, and we as well as other clinical groups have shown that Alzheimer's patients are more zinc deficient in comparison to age-matched control patients. These observations support our belief that the older an Alzheimer's patient is, the more zinc depleted that patient is, and therefore, it is likely that patient will receive greater cognitive benefit when managed with our proprietary zinc-based tablet," said George J. Brewer, M.D., Senior Vice President of Adeona. "As we are currently witnessing an epidemic of Alzheimer's disease, such that well over 10 million Americans are affected, we are very excited to begin a larger clinical study intended to further demonstrate that reaZin is effective in preventing or slowing the loss of cognition in older Alzheimer's patients and therefore help stem the tide of this epidemic."

Top-Line Results from the Clinical Study Evaluating reaZin

The top-line results from Adeona's clinical study evaluating reaZin for the dietary management of zinc deficiency associated with Alzheimer's disease were presented at the 63rd Annual Meeting of the American Academy of Neurology in April 2011. As prospectively hypothesized, patients administered reaZin demonstrated increased serum zinc levels and decreased serum free copper levels, resulting in statistical significance of the primary outcomes of the clinical study (p < 0.0006). The cognitive function of the placebo group, on average, declined over 6 months in comparison to patients managed with reaZin. The cognitive function trends favoring the patients managed with reaZin were observed in all three standardized cognitive tests utilized in our study and suggest that reaZin may provide an important benefit to the dietary management of zinc deficiency associated with Alzheimer's disease.

About reaZin

reaZin is a proprietary, gastroretentive, sustained release, once-daily oral tablet formulated from zinc (150 mg) and cysteine (100 mg), an amino acid with potent anti-oxidant properties. reaZin was developed by Adeona to achieve the following: 1) the convenience of a once-daily dose, 2) high oral bioavailability (the quantity or fraction of the ingested dose that is absorbed by the body) and 3) superior tolerability which provides the ability to minimize the substantial gastrointestinal side effects and limitations associated with existing oral zinc therapy.

SOURCE Adeona Pharmaceuticals, Inc.

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[Resoli]

Zitat von bierro: War wohl doch nicht so überzeugend, zumal reaZin kein Medikament ist, sondern ein "medical food supplement", also so eine Art Nahrungsgergänzungsmittel ohne FDA-Zulassung.

Egal, ich bin dringeblieben. Vielleicht erholt sich das Teil ja wieder. Mann, Mann, ich hätte in FRA zu 1,25 Euro verkaufen können, but - who knows?

Ich denke, die kommt wieder hoch, aber an die 2 $ glaub ich so schnell nicht mehr. Die KE hat viel Vertrauen gekostet.

und hier auch in den miesen........

[Spekulist]

Interessante news.Auf zu neuen Ufern
Gestern über 40 % plus

Adeona Pharmaceuticals and Intrexon Announce Worldwide Exclusive Collaboration for Synthetic DNA-based Therapy for Pulmonary Arterial Hypertension


ANN ARBOR, Mich., and GERMANTOWN, Md., Nov. 21, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative disease-modifying medicines for serious illnesses, and the Human Therapeutics Division of Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, announced today the formation of a global exclusive channel collaboration through which Adeona intends to develop and commercialize a DNA-based therapeutic using Intrexon's UltraVector® platform and RheoSwitch Therapeutic System® for the treatment of pulmonary arterial hypertension (PAH).

Under the collaboration, Adeona will utilize Intrexon's advanced transgene engineering platform for the controlled, precise and continuous in vivo cellular production of prostaglandin synthase (PGIS), a specific effector enzyme that regulates the production of prostacyclin. PGIS expression is decreased in the lungs of PAH patients and deficiency in prostacyclin production is strongly implicated in PAH. Prostacyclin is a short-acting vasodilator and inhibitor of platelet aggregation that has demonstrated a survival benefit in primary pulmonary hypertension patients when administered by continuous central venous catheter infusion (p<0.003). DNA-based in vivo expression of PGIS has demonstrated the ability to increase prostacyclin levels and improve survival in animal models of PAH.[ii]

Intrexon employs its modular genetic engineering platform in the areas of therapeutics, protein production, animal sciences, industrial products, and agriculture products. The exclusive channel collaboration between Intrexon and Adeona has been established specifically for the in vivo production of PGIS for PAH. Under the collaboration, Intrexon will be responsible for technology discovery efforts and managing the patent estate as well as for certain aspects of manufacturing. Adeona will be responsible for conducting preclinical and clinical development of candidates, as well as for other aspects of manufacturing and the commercialization of the candidate product.

Intrexon's core synthetic biology technology is designed to create Better DNA™ at industrial scale, enabling unprecedented control over the function and output of living cells by providing external control over in vivo activation and regulation of potent effectors. This platform, called UltraVector®, provides speed, flexibility, consistency and precision to the design, production and testing of rationally designed complex transgenes and their encoded genetic circuits. These qualities allow an iterative and rational approach to transgene design, which can be continually engineered until the host cell performance is optimized. Through this process, Intrexon is able to overcome the challenges inherent in current therapeutic strategies, including recombinant protein therapies and constitutive gene therapies, thereby enhancing capabilities, improving safety and lowering cost for human therapeutics.

"Our collaboration with Intrexon is consistent with Adeona's strategy of building shareholder value through continuous evaluation of new product opportunities and acting upon those that meet Adeona's mission of delivering disease-modifying therapies for serious illnesses. We believe that this product opportunity and collaboration far and away exceeds these criteria, and we are pleased to be working with Intrexon to make this important new therapy available to PAH patients," stated Adeona's Chairman, Jeffrey Riley.

"Current sales of approved therapies for PAH are an estimated $3 billion per year. While current therapies may improve quality of life, they have for the most part shown only modest improvements in survival, if any. We believe that by having the ability to correct what is considered to be a critical pathophysiological defect in PAH, namely reduced expression of prostaglandin synthase, we may have the opportunity to fundamentally change the course of PAH. We further believe that the 'second generation' rational nature of Intrexon's genetic engineering technology provides the enabling technology necessary to make this goal a practical reality for PAH patients. We are pleased to be working with Intrexon in this exciting and potentially disease changing collaboration," stated James S. Kuo, M.D., M.B.A., Chief Executive Officer of Adeona.

"We are very pleased to collaborate with Adeona in this further demonstration of the breadth of Intrexon's UltraVector® platform and embedded controllable bioreactor approach to novel therapeutics. We are impressed with Adeona's demonstrated ability to operate efficiently and decisively and we believe these qualities will serve both parties well as we navigate through the drug development process and commercialization," stated Glenn Nedwin, President, Human Therapeutics Division at Intrexon.

Under terms of the agreement:

Subject to the pre-approval of the NYSE Amex, Adeona will issue to Intrexon at $0.001 par value per share, 3,123,558 shares of its common stock, representing 9.995% of Adeona's issued and outstanding shares following and after taking into account such issuance; Adeona has agreed to issue to Intrexon an equal number of additional shares of its common stock at $0.001 par value per share, representing an additional 9.995%, upon dosing of the first patient in an Adeona-sponsored U.S. Phase II clinical trial of the candidate product using Intrexon technology;
Intrexon has been granted the right to purchase up to 19.99% of securities offerings that may be conducted by Adeona in the future, subject to certain conditions and limitations;
Intrexon has been granted the right to make purchases of Adeona's common stock in the open market up to an additional 10% of Adeona's common stock; and
Subject to certain expense allocations, Adeona will pay Intrexon 50% of the cumulative net quarterly profits derived from the sale of products developed from the channel collaboration.

"Because of the very wide breadth of applications that our technologies may enable, we believe that we can play a democratizing role among companies within traditional life science industries and among those in other industries that look to life science to supply solutions that their existing industrial processes have been otherwise unable to provide," stated RJ Kirk, Intrexon's Chairman and CEO. "In therapeutics, in particular, we see many opportunities for game changing strategies to be deployed against indications both large and small, complex and simple. In consequence, and as part of our business strategy, we look for opportunities to align ourselves with smaller, more entrepreneurial companies around focused opportunities that may be fully explored at costs and on timelines that previously were not available. Our new collaboration with Adeona around PAH exemplifies such an alignment and we celebrate our partner's entrepreneurial spirit, vision and dedication to the service of patients as we begin the work of producing a meaningful improvement to the lives of people with this unfortunate but theoretically treatable condition."

If the NYSE Amex approval of the issuance of the securities described above is not received within 60 days of the date of the execution of the exclusive channel agreement, Intrexon has the right to terminate the exclusive channel collaboration.

Griffin Securities served as financial advisor to Intrexon in connection with the transaction.

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension is a progressive, disabling and life-threatening disorder characterized by abnormally high blood pressure (hypertension) in the pulmonary artery, the blood vessel that carries blood from the heart to the lungs. Hypertension occurs when most of the very small arteries throughout the lungs narrow in diameter, which increases the resistance to blood flow through the lungs. To overcome the increased resistance, pressure increases in the pulmonary artery and in the heart chamber that pumps blood into the pulmonary artery (the right ventricle). Signs and symptoms of pulmonary arterial hypertension occur when increased pressure cannot fully overcome the elevated resistance and blood flow to the body is insufficient. Shortness of breath during exertion and fainting spells are the most common early symptoms of pulmonary arterial hypertension. Despite current treatments, the outcome of PAH is generally very poor and associated with high rates of mortality within three to five years of diagnosis.

About Intrexon Corporation

Intrexon Corporation is a privately held synthetic biology company that employs modular DNA control systems to enhance capabilities, improve safety and lower cost in human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The company's advanced transgene engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly and optimization. More information about the company is available at www.DNA.com.

[Spekulist]

Läuft wie geschmiert.Möglicherweise sollte man ja noch einsteigen-bei der Meldung.
The trend is your friend.Wer weiss,was da an Potential noch möglich ist.Die Amis lieben sowas auf jeden Fall.Das ist Ihr neues Baby.

[Stockfinder]

Recht nette Nachricht von heute:

Positive Ergebnisse der klinischen Studie von Oral Zink Adeona ist für ALS Collaborator Reported
-- PNA Center for Neurological Research Clinical Study Results Presented at the 22nd International Symposium on ALS/Motor Neurone Disease -- - PNA Zentrum für neurologische Forschung Ergebnisse der klinischen Studie auf der 22. International Symposium on ALS / Motor Neurone Disease präsentiert -


ANN ARBOR, Mich., Nov. 30, 2011 / PRNewswire / -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative disease-modifying medicines for serious illnesses, announced today that the Company's clinical collaborator for amyotrophic lateral sclerosis (ALS), PNA Center for Neurological Research (PNA), reported top-line results from its pilot Phase I/II open label, three month safety study of oral high dose zinc therapy in ALS, also known as Lou Gehrig's disease. Ann Arbor, Michigan, 30 November, 2011 / PRNewswire / - Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), ein Entwickler von innovativen krankheitsmodifizierenden Medikamente für schwere Erkrankungen, gab heute bekannt, dass das Unternehmen die klinischen Mitarbeiter für amyotrophe Lateralsklerose Sklerose (ALS), PNA Center for Neurological Research (PNA), berichtete Top-Line-Ergebnisse aus der Pilotphase I / II Open-Label-, 3 Monate Studie zur Sicherheit von oralem Hochdosis-Zink-Therapie bei ALS, auch als Lou-Gehrig-Syndrom bekannt. The clinical study met its primary outcome as no safety issues related to zinc therapy were observed. Die klinische Studie erreichte ihren primären Endpunkt, da keine Sicherheitsprobleme im Zusammenhang mit Zink-Therapie beobachtet wurden. In addition, an average decrease in the monthly rate of disease progression was observed in the ALS patients on zinc therapy, compared to published historical controls, as well as compared to the average monthly rate of disease progression of the subjects prior to enrollment in the study. Darüber hinaus wurde eine durchschnittliche Abnahme der monatlichen Rate der Krankheitsprogression in der ALS-Patienten auf Zink-Therapie beobachtet, im Vergleich zu historischen Kontrollen veröffentlicht, sowie im Vergleich zu den durchschnittlichen monatlichen Rate der Krankheitsprogression der Probanden vor der Aufnahme in die Studie .

PNA's clinical study data was presented at the 22nd International Symposium on ALS/Motor Neurone Disease in Sydney, Australia on Wednesday, November 30, 2011 at 6:00 pm (Wednesday, November 30, 2011 at 2:00 am Eastern Standard Time), by David S. Saperstein, MD, and Nicole C. Hank, MHSM, from PNA. PNA Daten aus klinischen Studien wurde auf der 22. International Symposium on ALS / Motor Neurone Disease in Sydney, Australien auf Mittwoch 30. November, 2011 um 6:00 Uhr (Mittwoch 30. November, 2011 um 2:00 Uhr Eastern Standard Time) präsentiert, von David S. Saperstein, MD, und Nicole C. Hank, MHSM von PNA.

Ten patients diagnosed with sporadic ALS and on stable doses of RILUTEK® (riluzole) were enrolled in the open label, three month study of oral high dose zinc therapy. Zehn Patienten mit sporadischer ALS und auf stabilen Dosen von RILUTEK ® (Riluzol) diagnostiziert wurden, in der Open-Label-, drei-monatigen Studie der oralen hohe Dosis Zink-Therapie teil. The study was conducted under an Investigational New Drug application (IND) and was registered at http://clinicaltrials.gov/ct2/show/NCT01259050 . Die Studie wurde im Rahmen einer Investigational New Drug Application (IND) durchgeführt und war registriert http://clinicaltrials.gov/ct2/show/NCT01259050 . The rate of disease progression was measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a widely used, validated rating scale that assesses the progression of disability in patients with ALS, revised to also incorporate assessments of respiratory function. Die Rate der Krankheitsprogression wurde von der ALS Functional Rating Scale-Revised (FRS-R), eine weit verbreitete, validierte Skala, die das Fortschreiten der Behinderung bei Patienten mit ALS bewertet, überarbeitet, um auch beinhalten Einschätzungen der Atemfunktion gemessen. At baseline, the average ALSFRS-R score of these patients was 33 and the average time from symptom onset was one year. Zu Beginn der Studie betrug die durchschnittliche FRS-R Score von diesen Patienten 33 und die durchschnittliche Zeit von Symptombeginn betrug ein Jahr.

Patients were administered pills containing 90mg of elemental zinc per day, as well as 2 mg of copper every other day to prevent potential copper depletion. Patienten verabreicht wurden Pillen mit 90mg elementares Zink pro Tag, sowie 2 mg Kupfer jeden zweiten Tag, um potenzielle Kupfer-Abbau zu verhindern. Eight out of the ten patients enrolled completed three months of zinc therapy. Acht von den zehn teilnehmenden Patienten drei Monate des Zink-Therapie abgeschlossen. Two patients dropped out within the first month for reasons unrelated to the zinc therapy. Zwei Patienten brach innerhalb des ersten Monats Gründen nicht mit der Zink-Therapie. All patients reported taste disturbance (metallic taste) and two of eight patients reported nausea (both of whom were able to complete the study after reducing their dose to 60mg of zinc per day). Alle Patienten berichteten Geschmacksstörungen (metallischer Geschmack) und zwei von acht Patienten berichtet, Übelkeit (die beide in der Lage, die Studie nach Reduzierung ihrer Dosis auf 60 mg Zink pro Tag abgeschlossen wurden).

On average, the eight patients who completed the study lost 0.37 ALSFRS-R points per month during the three months of therapy. Im Durchschnitt verloren die acht Patienten, die die Studie abschlossen, 0,37 ALSFRS-R Punkte pro Monat während der drei Monate der Therapie. This represents a lower rate of monthly disease progression compared to the average 0.89 ALSFRS-R monthly rate of disease progression in ALS based on historical controls. Prior to enrolling in the study, seven of the eight patients for whom previous ALSFRS-R scores were available lost an average of 0.61 ALSFRS-R points per month. Dies entspricht einer niedrigeren monatlichen Fortschreiten der Erkrankung im Vergleich zum Durchschnitt 0,89 ALSFRS-R monatliche Rate des Fortschreitens der Krankheit ALS zu historischen Kontrollen. Vor der Einschreibung in der Studie sieben der acht Patienten, bei denen vorherige FRS-R Noten zur Verfügung standen verloren im Durchschnitt von 0,61 ALSFRS-R Punkte pro Monat.

Based on these findings, the neurologists at PNA hypothesize that high doses of zinc may slow disease progress in ALS and that a larger controlled clinical trial of zinc therapy in ALS patients is warranted. Basierend auf diesen Ergebnissen leiteten die Neurologen bei PNA, dass hohe Dosen von Zink kann Krankheitsverlauf bei ALS langsam und dass eine größere kontrollierte klinische Studie von Zink-Therapie bei ALS-Patienten gerechtfertigt ist. Preparations are currently underway to evaluate the safety and efficacy of Adeona's proprietary drug candidate, AEN-100, a gastroretentive, sustained-release, zinc tablet, in an adaptively designed, multi-center, double-blind, placebo-controlled Phase II/III clinical trial in ALS patients to be conducted under an IND. Derzeit laufen die Vorbereitungen auf die Sicherheit und Wirksamkeit von firmeneigene Medikamentenentwicklung Adeona Kandidat, AEN-100, ein gastroretentive, Retard-, Zink-Tablette, in einer adaptiv ausgelegt, multizentrische, doppelblinde, Placebo-kontrollierten Phase II / III zu bewerten klinischen Studie bei ALS-Patienten im Rahmen eines IND durchgeführt werden. It is anticipated that the trial will enroll approximately 65 ALS patients, who will continue on RILUTEK® (riluzole) as the standard of care treatment, and that the patients will be randomized into two treatment groups and one matching placebo group. Es wird erwartet, dass die Studie rund 65 ALS-Patienten, die auf RILUTEK ® (Riluzol) als Standard of Care Therapie fortzusetzen, wird und dass die Patienten werden in zwei Behandlungsgruppen und eine Placebo-Gruppe randomisiert anmelden. They will receive clinical trial medications for at least six months with periodic monitoring. Sie werden klinische Prüfmuster für mindestens sechs Monate mit regelmäßigen Überwachung erhalten. A small Phase I pharmacokinetic clinical trial of AEN-100 is planned for completion prior to initiating the multi-center clinical trial. Eine kleine Phase I pharmakokinetische Studie mit AEN-100 ist für die Fertigstellung vor Beginn der klinischen Multicenter-Studie geplant. It is anticipated that Adeona will provide the study medications and fund the clinical trials, which will be led by the neurology team at PNA. Es wird erwartet, dass Adeona wird die Studie Medikamente geben und finanzieren die klinischen Studien, die von der Neurologie Team PNA geführt werden.

"We are pleased to report that the use of zinc is safe in ALS patients, and we are also encouraged to observe that this small group of ALS patients demonstrated a reduced rate of change in their ALSFRS-R scores while taking zinc, suggesting a slower rate of disease progression," said Todd D. Levine, MD, President of PNA, Assistant Clinical Professor at the University of Arizona, Co-Director of the Banner Samaritan ALS Center in Phoenix, Arizona and Lead Principal Investigator of Adeona's planned clinical trial. "Wir freuen uns zu berichten, dass die Verwendung von Zink sicher in ALS-Patienten ist, und wir werden auch ermutigt, zu beobachten, dass diese kleine Gruppe von ALS-Patienten eine reduzierte Rate der Veränderung gezeigt, in ihrer FRS-R Scores während der Einnahme von Zink, was auf eine langsamere Rate der Krankheitsprogression ", sagte Todd D. Levine, MD, Präsident der PNA, Assistant Clinical Professor an der University of Arizona, Co-Direktor des Banner Samariter ALS Center in Phoenix, Arizona und Lead Principal Investigator der geplanten klinischen Adeona der Studie. "We look forward to initiating this larger clinical trial in ALS patients and to providing Adeona's proprietary zinc-based therapy that has already demonstrated clinical evidence of being very well tolerated by patients and of providing superior bioavailability." "Wir freuen uns auf den Beginn dieser großen klinischen Studie bei ALS-Patienten und die Bereitstellung Adeona proprietären Zink-Basis-Therapie, die bereits klinische Hinweise, dass sie sehr gut verträglich und bietet eine höhere biologische Wirkung gezeigt hat."

"Given the clinical results PNA presented today at an international symposium suggesting a safe and therapeutic role for zinc in ALS, we believe it supports our planned Phase II/III clinical trial of AEN-100 in ALS patients," said James S. Kuo, MD, MBA, Chief Executive Officer of Adeona. "Angesichts der klinischen Ergebnisse PNA heute auf einem internationalen Symposium was auf eine sichere und therapeutische Rolle für Zink in ALS, wir glauben, es unterstützt unsere geplante Phase II / III klinischen Studie der AEN-100 in ALS-Patienten", sagte James S. Kuo, MD, MBA, Chief Executive Officer von Adeona. "We are pleased to be working with the dedicated neurologists at PNA to evaluate the potentially revolutionary therapeutic benefit of AEN-100 for this devastating and fatal progressive neurological disease." "Wir freuen uns, mit den engagierten Neurologen arbeiten bei PNA, die potentiell revolutionären therapeutischen Nutzen von AEN-100 für diese verheerende und fatal progressive neurologische Erkrankung zu beurteilen."

About AEN-100 Über AEN-100

AEN-100 is Adeona's patent-pending gastroretentive, sustained-release oral zinc drug candidate intended for indications in which high dose zinc therapy may be appropriate. AEN-100 ist Adeona zum Patent angemeldete gastroretentive, Retard-oralen Zink Wirkstoffkandidaten für Indikationen, bei denen hohe Dosis Zink-Therapie sinnvoll sein könnte, vorgesehen. Based upon prior studies conducted by Adeona, the Company believes that AEN-100 provides far superior gastrointestinal tolerability and once-daily dosing convenience compared to existing zinc therapy products. Basierend auf früheren Studien von Adeona durchgeführt, glaubt das Unternehmen, dass AEN-100 weit überlegen gastrointestinale Verträglichkeit und eine einmal tägliche Dosierung Komfort im Vergleich zu bestehenden Zinktherapie Produkte bietet. Gastrointestinal tolerability (namely, nausea and vomiting) represents a major dose limiting factor of oral high dose zinc therapy. Magen-Darm-Verträglichkeit (nämlich, Übelkeit und Erbrechen) stellt eine wichtige Dosis limitierende Faktor der oralen hohe Dosis Zink-Therapie. Adeona also intends to file for orphan drug protection with the Food & Drug Administration (FDA) in the US and European Medicines Agency (EMEA) in the EU, which may provide for marketing exclusivity for a period of seven and ten years, respectively, following approval. Adeona will auch für Orphan-Drug-Schutz mit der Food & Drug Administration (FDA) in den USA und European Medicines Agency (EMEA) in die EU, die für die Marktexklusivität für einen Zeitraum von sieben und zehn Jahren vorsehen, bzw. Datei, folgende Genehmigung. In ALS, there is a demonstrated zinc binding defect of the ALS-implicated protein known as copper/zinc superoxide dismutase (SOD-1) as well as a demonstrated sequestration of zinc in the Lewy body-like hyaline inclusions that are characteristic of ALS.[ii] In ALS, es ist ein Beweis Zinkbindung Defekt der ALS-verwickelt Protein als Kupfer / Zink-Superoxid-Dismutase (SOD-1) sowie eine nachgewiesene Bindung von Zink in der Lewy bekannten Körper-wie hyaline Einschlüsse, sind charakteristisch für ALS. [ii]


About Amyotrophic Lateral Sclerosis (ALS) Über Amyotrophe Lateralsklerose (ALS)

ALS is a devastating progressive neurodegenerative disease that affects the motor nerve cells in the brain and the spinal cord of predominantly older people of both sexes. ALS ist eine progressive neurodegenerative Krankheit verheerend, dass die motorischen Nervenzellen wirkt im Gehirn und das Rückenmark von vorwiegend älteren Menschen beiderlei Geschlechts. It is estimated that as many as 30,000 Americans may have the disease at any given time. Es wird geschätzt, dass so viele wie 30.000 Amerikaner kann die Krankheit zu einem bestimmten Zeitpunkt haben. The progressive degeneration of the motor neurons in ALS eventually leads to the death of the patient. Die progressive Degeneration der Motoneuronen bei ALS führt schließlich zum Tod des Patienten. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. Motor Neuronen zu erreichen vom Gehirn zum Rückenmark und vom Rückenmark zu den Muskeln im ganzen Körper. When motor neurons die, the ability of the brain to initiate and control muscle movement is lost. Wenn der Motor Neuronen sterben, ist die Fähigkeit des Gehirns zu initiieren und zu steuern Muskelbewegung verloren. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed. Mit freiwilligen Muskelarbeit zunehmend betroffen sind, können die Patienten in den späteren Stadien der Erkrankung werden vollständig gelähmt.

While non-invasive ventilation and gastrostomy tubes prolong life by 6-12 months, the average lifespan from time of symptom onset is 2-5 years. Während nicht-invasiven Beatmung und Gastrostomie Rohre verlängern das Leben von 6-12 Monaten ist die durchschnittliche Lebensdauer von Zeit nach Einsetzen der Symptome 2-5 Jahre. Currently, RILUTEK is the only FDA-approved drug for ALS. Derzeit ist RILUTEK die einzige FDA-zugelassene Medikament für ALS. RILUTEK is an NMDA receptor antagonist and has been shown to prolong life in patients with ALS by 3 months. RILUTEK ist ein NMDA-Rezeptor-Antagonist und hat sich gezeigt, dass das Leben von Patienten mit ALS zu verlängern um 3 Monate. Presently, there is no cure for ALS, nor is there a known cause. Derzeit gibt es keine Heilung für ALS, noch gibt es eine bekannte Ursache. For more information on ALS, please visit the ALS Association website at www.alsa.org . Für weitere Informationen über ALS, besuchen Sie bitte die ALS Association Website www.alsa.org .


About PNA Center for Neurological Research Über PNA Zentrum für neurologische Forschung


PNA Center for Neurological Research (PNA) is an independent, not-for-profit organization based in Phoenix, Arizona. PNA-Zentrum für neurologische Forschung (PNA) ist ein unabhängiges, nicht-for-Profit-Organisation in Phoenix, Arizona. PNA was established by five of the neurologists from Phoenix Neurological Associates, Ltd., who are dedicated to discovering new treatments for patients with neurological diseases. PNA wurde von fünf der Neurologen von Phoenix Neurological Associates, Ltd, die die Entdeckung neuer Therapien für Patienten mit neurologischen Erkrankungen gewidmet sind etabliert. PNA's goal is to be a hub where philanthropists, advocates, organizations, family and friends of patients with a neurological illness could make donations that can support investigator-initiated clinical trials . PNA Ziel ist es, eine Drehscheibe, wo Philanthropen, Befürworter, Organisationen, Familie und Freunde von Patienten mit einer neurologischen Erkrankung Spenden, die von Forschern initiierte klinische Studien unterstützen können werden konnte. PNA hopes to optimize proper treatments in order to improve outcomes for patients with neurological diseases. PNA Hoffnungen, um die ordnungsgemäße Behandlung zu optimieren, um die Ergebnisse für Patienten mit neurologischen Erkrankungen zu verbessern. For more information about PNA, please visit its website at www.pnaresearch.org . Für weitere Informationen über PNA, besuchen Sie bitte unsere Website unter www.pnaresearch.org . For more information about Phoenix Neurological Associates, Ltd., please visit its website at www.phoenixneurology.com . Für weitere Informationen über Phoenix Neurological Associates, Ltd, besuchen Sie bitte unsere Website unter www.phoenixneurology.com .


About Adeona Pharmaceuticals, Inc. Über Adeona Pharmaceuticals, Inc.

Adeona is a pharmaceutical company focused on the development of innovative disease-modifying medicines for serious illnesses. Adeona ist ein Pharmaunternehmen, das auf die Entwicklung innovativer krankheitsmodifizierenden Medikamente für schwere Krankheiten fokussiert. Adeona is developing, or has partnered the development of, drug product candidates to treat pulmonary arterial hypertension, relapses in multiple sclerosis, cognitive dysfunction in multiple sclerosis, fibromyalgia, amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. Adeona entwickelt, oder hat eine Partnerschaft zur Entwicklung von, Arzneimittelkandidaten zur pulmonalen arteriellen Hypertonie, Rückfälle bei Multipler Sklerose, kognitive Dysfunktion bei Multipler Sklerose, Fibromyalgie, Amyotrophe Lateralsklerose (ALS) und Alzheimer-Krankheit zu behandeln. For more information, please visit Adeona's website at www.adeonapharma.com . Für weitere Informationen, besuchen Sie bitte Adeona-Website unter www.adeonapharma.com .


RILUTEK® (riluzole) is a registered trademark of sanofi-aventis US LLC. RILUTEK ® (Riluzol) ist ein eingetragenes Warenzeichen der sanofi-aventis US LLC.


This release includes forward-looking statements on Adeona's current expectations and projections about future events. Diese Pressemitteilung beinhaltet vorausschauende Aussagen, die auf den gegenwärtigen Erwartungen Adeona und Prognosen zukünftiger Ereignisse. In some cases forward-looking statements can be identified by terminology such as "may," "could," "potential," "positions," "continue," "expects," "anticipates," "intends," "plans," "believe," "estimates," and similar expressions. In manchen Fällen die Zukunft gerichtete Aussagen können an Begriffen wie "könnte", "könnte", "potenziell", "Positionen", "fortsetzen", "erwartet", "antizipieren", "beabsichtigt", "plant", "glauben", "schätzt" und ähnliche Ausdrücke. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the effects of zinc with regard to ALS, the intent to file for orphan drug protection and the anticipated trial enrollment for the planned Phase ll/III clinical trial. Diese Aussagen auf derzeitigen Annahmen, Erwartungen und Annahmen und unterliegen einer Reihe von Risiken und Unsicherheiten, von denen viele schwierig vorauszusagen sind und beinhalten Aussagen über die Wirkungen von Zink im Hinblick auf die ALS sind, um die Absicht für Orphan-Drug-Schutz-Datei und der erwarteten Studie Einschreibung für die geplante Phase II / III klinischen Studie. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Die zukunftsgerichteten Aussagen unterliegen Risiken und Unsicherheiten, aufgrund derer die tatsächlichen Ergebnisse erheblich von den hierin oder implizierten zukunftsgerichteten Aussagen abweichen. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, our failure to obtain regulatory approval or market approval of the use of AEN-100 as an orphan drug or in the treatment of ALS, failure to fully enroll patients in the Phase II/III clinical trial, failure to obtain approval to conduct the trial under the IND, failure of the clinical trial evaluating AEN-100 to have favorable result such as a failure to show benefits of zinc therapy in ALS patients, a failure of the treatment group to meet the planned primary and secondary endpoints, acceptable and superior levels of tolerability and efficacy of AEN-100 and as compared to existing over-the-counter zinc products such as that used in the present study, and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2010 and any other filings with the SEC. Wichtige Faktoren, aufgrund derer die tatsächlichen Ergebnisse wesentlich von jenen unterscheiden, in Adeona vorausschauenden Aussagen reflektierten könnten, zählen unter anderem unser Versagen der behördlichen Genehmigung oder Zulassung der Verwendung von AEN-100 als Orphan-Drug-oder in der Behandlung von ALS zu erhalten , nicht vollständig, Patienten in der Phase II / III klinischen Studie, das Versagen der Genehmigung zu erhalten, um die Studie unter dem IND Verhalten, Versagen der klinischen Studie zur Evaluierung AEN-100 zu günstigeren Ergebnis wie einem Ausfall müssen Vorteile von Zink-Therapie zeigen bei ALS-Patienten, ein Versagen der Behandlungsgruppe zu den geplanten primären und sekundären Endpunkte gerecht zu werden, akzeptabel und übergeordneten Ebenen der Verträglichkeit und Wirksamkeit von AEN-100 und im Vergleich zu bestehenden over-the-counter-Produkte wie Zink, das in der Gegenwart studieren, und andere Faktoren in Adeona Bericht auf Formular 10-K für das Geschäftsjahr 31. Dezember 2010 und alle anderen Einreichungen bei der SEC beschrieben. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. Die Informationen in dieser Pressemitteilung ist nur für den Zeitpunkt dieser Pressemitteilung zur Verfügung gestellt, und Adeona übernimmt keinerlei Verpflichtung, zukunftsgerichtete Aussagen in dieser Pressemitteilung aufgrund neuer Informationen, zukünftiger Ereignisse oder aus sonstigen Gründen zu aktualisieren, sofern dies nicht gesetzlich erforderlich ist.


Miller RG, Moore DH, et. Miller RG, Moore DH, et. al., Phase II screening trial of lithium carbonate in amyotrophic lateral sclerosis: examining a more efficient trial design., Neurology. al, Phase II-Screening-Studie von Lithiumcarbonat in Amyotrophe Lateralsklerose:. Prüfung eine effizientere Prozess-Design, Neurologie.. 2011 Sep 6;77(10):973-9. 2011 Sep 6, 77 (10) :973-9. Epub 2011 Aug 3., Appendix e-1. Epub 2011 3 August., Anhang E-1.

[ii]Chattopadhyay M, Valentine JS., Aggregation of copper-zinc superoxide dismutase in familial and sporadic ALS, Antioxid Redox Signal. [Ii] Chattopadhyay M, Valentine JS., Aggregation von Kupfer-Zink-Superoxid-Dismutase in familiären und sporadischen ALS, Antioxid Redox Signal. 2009 Jul;11(7):1603-14. 2009 Jul; 11 (7) :1603-14.

SOURCE Adeona Pharmaceuticals, Inc. SOURCE Adeona Pharmaceuticals, Inc.

For further information: CONTACT: James S. Kuo, MD, MBA, Chief Executive Officer, [phone] Für weitere Informationen: Kontakt: James S. Kuo, MD, MBA, Chief Executive Officer, [phone]
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forward-looking statements zukunftsgerichteten Aussagen


Werde den Wert mal auf meine WL setzen, die MK der Firma ist extrem niedrig und könnte durchaus Kurspotenzial bieten.

[Spekulist]

Und das

Adeona Reports Positive Results For Initial Zinc Trial In Lou Gehrig's Disease


(RTTNews) - Adeona Pharmaceuticals, Inc. (AEN) Wednesday said PNA Center for Neurological Research's pilot Zinc Therapy was found to be safe and recorded a slow disease progression in amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig's Disease.

The study was conducted under an Investigational New Drug or IND application and Adeona plans to begin a Phase II/III clinical trial of its zinc tablet AEN-100, and to file for orphan drug protection.

ALS is a devastating progressive neurodegenerative disease that affects the motor nerve cells in the brain and the spinal cord of predominantly older people of both sexes. It is estimated that as many as 30,000 Americans may have the disease at any given time. When motor neurons die, the ability of the brain to initiate and control muscle movement is lost. Patients in the later stages of the disease may become totally paralyzed.

According to Adeona, the average lifespan from time of symptom onset is 2 to 5 years. Rilutek is the only FDA-approved drug for ALS, prolonging life by 3 months. The pilot study enrolled ten patients diagnosed with sporadic ALS and on stable doses of Rilutek or riluzole. Eight out of the ten completed three months of zinc therapy.

Patients were administered pills containing 90 mg of elemental zinc per day, as well as 2 mg of copper every other day to prevent potential copper depletion. The rate of disease progression was measured by the ALS Functional Rating Scale-Revised or ALSFRS-R, that incorporates assessments of respiratory function. At baseline, the average ALSFRS-R score of these patients was 33 and the average time from symptom onset was one year.

At three months, the eight patients who completed the study lost on average, 0.37 ALSFRS-R points per month during the three months of therapy. This represented a lower rate of monthly disease progression compared to historical controls, which had demonstrated a average 0.89 ALSFRS-R monthly rate of disease progression.

Adeona is preparing to evaluate the safety and efficacy of its proprietary drug candidate, AEN-100, a gastroretentive, sustained-release, zinc tablet, in an adaptively designed, multi-center, double-blind, placebo-controlled Phase II/III clinical trial.

PNA's clinical study data was presented today at the 22nd International Symposium on ALS/Motor Neurone Disease in Sydney, Australia.

AEN is currently trading at $1.08, up $0.25 or 30.12%, on a volume of 1.7 million shares, on the AMEX. Over the past year, the stock traded in a range of $0.42 - $2.25.

For comments and feedback: contact [e-mail]

[Spekulist]

Läuft sauber weiter.Die Steigerung der letzten 10 Tage sieht beeindruckend und nachhaltig aus.
Charttechnisch auch bestens.Hab bei 1,11 nachgekauft.Lohnt sich m.M. nach auf jeden fall immer noch.

[Spekulist]

Kaufempfehlung für Adeona von Stockpikcr

http://www.thestreet.com/_nasdaq/story/11338224/1/5-stocks-u…

Läuft alles 1A

[Spekulist]

Momentan + 11% bei riesen Umsätzen
Beeindruckende Rally
Wird wohl auch noch mal ne Verschnaufpause,Rücksetzer geben.
Event. noch mal zum Nachkaufen!

[Spekulist]

Unglaublich stabil - bei der Börsenlage!
Unter 1,38 wird sofort alles zu Käufen genutzt.
Kann so weitergehen.

[Spekulist]

1,40 heute bei vergleichsweise hohen Umsätzen überwunden,z.Zt. 1,49.
Wenn der Bereich um 1,45 hält -event.Gewinnmitnahmen werden kommen-
wäre ca.1,75 das Ziel.

[bierro]

Wir sind mittlerweile bei 1,88 USD. Wer ist noch dabei?

[Spekulist]

Ja.Läuft wirklich nicht schlecht der stock.
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Adeona Begins Phase II Trial Of Trimesta For Cognitive Dysfunction In MS

(RTTNews.com) - Adeona Pharmaceuticals, Inc. (AEN) announced the initiation of the Phase II clinical trial of Trimesta (oral estriol) for treating cognitive dysfunction in multiple sclerosis, or MS.

The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates, whole brain atrophy determined by MRI and safety.

Dr. Voskuhl, Principal Investigator, said, "We are very excited to initiate patient enrollment in this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition. Statistics show that 50-65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability. The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working."

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Adeona Announces Initiation of Phase II Clinical Trial of Trimesta™ for Cognitive Dysfunction in Multiple Sclerosis


ANN ARBOR, Mich., Jan. 19, 2012 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, announced today the initiation of the Phase II clinical trial of Trimesta™(oral estriol) for the treatment of cognitive dysfunction in multiple sclerosis (MS). This clinical trial is intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients at University of California, Los Angeles (UCLA) and is being conducted at by Principal Investigator, Rhonda Voskuhl, M.D., Director, UCLA Multiple Sclerosis Program, Department of Neurology. There is currently no approved therapy for the treatment of cognitive dysfunction in MS.

"We are very excited to initiate patient enrollment in this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition. Statistics show that 50-65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability," said Dr. Voskuhl, Principal Investigator. "The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working."

This randomized, double-blind, placebo-controlled Phase II clinical trial is based on findings from a previously completed 10-patient, single-agent, crossover Phase I/II clinical trial conducted by Dr. Voskuhl and colleagues at UCLA. The results from the Phase I/II trial demonstrated a statistically significant 14% improvement from baseline in Paced Auditory Serial Addition Test (PASAT) cognitive testing scores in relapsing-remitting MS patients after six months of Trimesta™ therapy (p = 0.04). The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability and is widely used in MS to measure cognitive function. Estriol has also been shown to have neuroprotective benefits in animal models of MS, a property not generally shared by currently approved MS therapies.[ii]

The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta™ (oral estriol) or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates (the primary endpoint of the ongoing Phase II clinical trial of Trimesta™ for relapsing-remitting MS), whole brain atrophy determined by MRI and safety. Charitable organizations have pledged to financially support a majority of the new MS clinical trial. Detailed information regarding this clinical trial, including contact information for the clinical site, is available at http://www.clinicaltrials.gov/ct2/show/NCT01466114.

In addition to the clinical trial of Trimesta for cognitive dysfunction in MS, Trimesta™ is also the subject of a separate ongoing 15-center Phase II, randomized, double-blind, placebo-controlled clinical trial seeking to demonstrate Trimesta's ability to reduce relapse rates in women with the relapsing-remitting form of MS. With over $8 million in grant funding awarded to date, this separate ongoing Trimesta™ clinical trial should be funded to its completion. Additional information regarding the relapsing-remitting multiple sclerosis clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204.

"While our Board of Directors has strategically implemented several actions to prioritize our focus on the emerging field of synthetic biologics, our continued commitment to this important new MS clinical trial, having substantial external funding, is consistent with our mission of maintaining and building value for our shareholders," stated Jeffrey Riley, Adeona's Chairman of the Board.

About Trimesta™ (oral estriol)

Trimesta™ is Adeona's proprietary drug candidate for the treatment of relapsing-remitting MS and for cognitive dysfunction in MS, both in female patients. Estriol has been approved and marketed for more than 40 years throughout Europe and Asia for the treatment of post-menopausal symptoms. It has never been approved in the United States by the Food and Drug Administration (FDA) for any indication.

About Cognitive Dysfunction in Multiple Sclerosis

According to the National Multiple Sclerosis Society and the Multiple Sclerosis Society of Canada publication, Hold that Thought! Cognition and MS, it is fairly common for people with multiple sclerosis to complain of problems remembering things, finding the right words, concentrating on a task or something they are reading, or following a conversation. These are all cognitive symptoms of multiple sclerosis. Fifty to sixty-five percent of those affected by multiple sclerosis have cognitive dysfunction. Despite the fact that most symptoms are mild to moderate, they can have a significant impact on a person's ability to normally function. The overall cognitive dysfunction can be described as a reduction in mental "sharpness."

The major areas of cognition that can be dysfunctional include what are termed complex attention and executive functions. Complex attention involves multitasking, the speed with which information can be processed, learning and memory, and perceptual skills; executive functionsinclude problem solving, organizational skills, the ability to plan, and word finding. Just as the nature, frequency, and severity of multiple sclerosis-related physical problems can widely vary, not all people with multiple sclerosis will display these cognitive issues, and no two people will experience exactly the same types or severity of problems.


In December 2011, Adeona announced that the Board of Directors had taken several actions to prioritize the company's focus on its recent entry into the emerging field of synthetic biologics. As a result of its new primary focus, the Board approved a proposed name change of the company to Synthetic Biologics, Inc., to better reflect its new mission and primary business. Such name change is subject to stockholder approval.

Synthetic Biologics is a trademark of Adeona Pharmaceuticals, Inc.


For further information, please contact Adeona at [phone], Ext. 22.

Sicotte, Liva, Klutch, Pfeiffer, Bouvier, Odesa, Wu, Voskuhl, Treatment of multiple sclerosis with the pregnancy hormone estriol, Ann Neurol. 2002 Oct;52(4):421-8.

[ii] Gold and Voskuhl, Estrogen treatment in multiple sclerosis, J Neurol Sci. 2009 Nov 15;286(1-2):99-103. Epub 2009 Jun 18.



SOURCE Adeona Pharmaceuticals, Inc.

[bierro]

Es sah so gut aus!Und dann schmeißt ein Idiot 15.300 ins Bid. F...k!
Schlusskurs 2,04 USD.

[Spekulist]

Antwort auf Beitrag Nr.: 42.626.161 von bierro am 20.01.12 22:37:28

Hat nicht unbedingt was zu bedeuten,event. nur einer nervös geworden.
Es gab über 160.000 Käufe oberhalb von 2,04 ,sind also momentan noch genug feste Hände in dem Bereich.Hat übrigens danach schon wieder einer 1000 Stücke für 2,14 gekauft.
Also AH last 2,14

[bierro]

Na, wer hat den 20 % Absturz gestern erlebt? Unglaublich, und das ohne News. Das waren glaub ich 150.000 Stück, die da auf einen Schlag geschmissen wurden.

Ich bin mal auf heute gespannt.