Klein,aber fein: Adeona Pharmaceuticals

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

Adeona Pharma (AMEX:AEN): Late-Stage Pipeline Targeting Large Markets

Written by Michael Vlaicu    
Friday, 04 September 2009 01:25
biomedreports.com/articles/most-popular/...-large-markets.html

Adeona Pharmaceuticals, Inc. (Public, AMEX:AEN) StocksHaven Investments takes a look at Adeona Pharmaceuticals, Inc. which currently has three blockbuster drugs in phase III, and are coming close to NDA status.


The first being Trimesta, which tackles Multiple Sclerosis (MS) and Post-partum Depression. Secondly, Zinthionein, a product seeking treatment for Age Related Macular Degeneration (AMD). Lastly, Oral dnaJP1 which is an immunotherapy for rheumatoid arthritis (RA) patients. If these products aren't enough to entice your way into purchasing this stock, take a look at the recent $5 million dollar cash infusion from the National Multiple Sclerosis Society (NMSS), billions of dollars in product market potential, purchasing of Hartlab LLC, an independent Chicago-area CLIA-certified clinical reference laboratory, an experienced management team that will have you feeling like a kid in a candy store, and to top it all off a stellar balance sheet comparative to other small caps. Simply put, Aedona offers the complete package to any biotech investor's portfolio.


Trimesta is perhaps the company's bread and butter. It is a drug which is being used and researched as a treament for both Multiple Scleroris (MS) and Post-partum Depression.

Trimesta Treatment for Multiple Sclerosis (MS) They are developing Trimesta as an oral immunomodulatory therapy for female relapsing-remitting MS patients that can be used either alone or in combination with other agents or during the post-partum period following pregnancy. There are currently five FDA-approved first line therapies for the treatment of relapsing-remitting multiple sclerosis: Betaseron®, Rebif®, Avonex® and Copaxone®. These therapies provide only a modest benefit for patients with relapsing-remitting MS and therefore serve to only delay progression of the disease. All of these drugs require frequent (daily to weekly) injections on an ongoing basis and are associated with unpleasant side effects (such as flu-like symptoms), high rates of non-compliance among users, and eventual loss of efficacy due to the appearance of resistance in approximately 30% of patients. An estimated two-thirds of MS patients are women.

Clinical Trial Results of Trimesta Trimesta™ has completed an initial 10-patient, 16-month, single-agent, crossover, phase II clinical trial in the U.S. for the treatment of MS.

* Decrease in Volume and Number of Myelin Lesions - The median total enhancing lesion volumes decreased by 79% (p=0.02) and the number of lesions decreased by 82% (p=0.09) within the first three months of treatment with Trimesta™. Over the next three months, lesion volumes decreased by 82% (p=0.02) and the number of lesions decreased by 82% (p=0.02) compared to baseline. During a three-month re-treatment phase of this clinical trial, relapsing-remitting MS patients again showed a decrease in enhancing lesion volumes (88%) (p=0.008) and a decrease in the number of lesions (48%) (p=0.04) compared to baseline

* Improvement in Cognitive Test Scores - During this phase II clinical trial, a 14 percent improvement in Paced Auditory Serial Addition Test (�PASAT�) cognitive testing scores (p=0.04) was observed in these MS patients at six months of therapy. PASAT is a routine cognitive test performed in patients with a wide variety of neuropsychological disorders such as MS.

* TRIMESTA is currently the subject of a double-blind, placebo-controlled phase II/III clinical trial that will take place at seven sites in the U.S., enrolling up to 150 female MS patients. Investigators will administer TRIMESTA to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS.

* This clinical trial has received a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health (NIH).

Market Opportunity for Multiple Sclerosis MS is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and virtually every hour someone is newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times more often than men. Worldwide, MS may affect 2.5 million individuals. According to the National MS Society, the economic cost of care for MS patients in the United States including medical and non-medical care, production losses, and informal care exceeds $23 billion annually, or more than $57,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities. During 2006, combined sales estimates of FDA-approved injectable MS therapies, which include Avonex, Betaseron, Copaxone, and Rebif, totaled approximately $5.0 billion. Trimesta Treatment for Post-partum Depression Based upon the observations of our clinical investigators of mood-elevating benefits of Trimesta™ and the dramatic decline of estriol levels immediately post-partum, we also intend to commence a phase II/III trial of Trimesta™ for the treatment of post-partum depression. Market Opportunity for Post-partum Depression Postpartum depression is considered to be a major depressive episode that may be associated with anxiety, persistent depression, irritable mood, or prolonged anxiety. It presents with typical depression symptoms, which can include poor concentration, problems with memory, difficulty with decision-making, irritability, decreased appetite, loss of sleep, loss of pleasure in usual daily activities, low self-esteem, negative thinking, worrying, persistent sadness, helplessness, and feelings of hopelessness. Another aspect of postpartum depression is the mother’s feeling of significant impairment or inability to care for her newborn baby or herself. The mother may also experience difficulty socializing. Some suggest such problems arise as the mother tries to adjust to the realities and demands of her new baby. Recent research also suggests that delivery of the fetus and expulsion of the placenta results in an abrupt decrease in levels of hormones such as estriol, and that these decreasing hormone levels are responsible for postpartum depression. The difference between postpartum “blues” (also referred to as “baby blues”) and postpartum depression is that postpartum blues is short-lived and ends without treatment in a short period of time. It is estimated that the postpartum blues affects 50% of all births and postpartum depression affects 25% of all births. According to a recent U.S. census, there were over 4 million new births in the U.S.

Zinthionein (Oral ZMC), the second product is an novel covalently linked form of zinc-monocysteine complex that has been developed by Dr. David Newsome, a leading clinical scientist and inventor of Ovuvite and Preservision, two marketed products for the treatment of AMD. Adeona is developing Zinthionein (oral zinc monocysteine), an orally active compound for the treatment of dry age-related macular degeneration (AMD). Oral ZMC increases the activity of antioxidant enzymes catalase and glutathione peroxidase, and the antioxidant protein metallothionein in cultured retinal pigment epithelial cells more efficiently and potently than currently available zinc formulations. These complexes are the subject of a recently issued U.S. Patent covering its composition of matter and a patent application and various uses thereof. Oral ZMC has completed an 80 patient phase II clinical trial for the treatment of Dry AMD. Clinical Study - Age-Related Eye Disease Study (AREDS) This proprietary molecule builds on the success of the Age-Related Eye Disease Study (AREDS), a randomized, placebo-controlled clinical trial funded by the National Eye Institute. AREDS evaluated over 4,757 patients between the ages of 55 and 80 for an average of 6.3 years. Scientists found that people at high risk of developing advanced stages of AMD, lowered their risk by approximately 25 percent when treated with a high-dose combination of anti-oxidants and zinc. In the same high risk group, which includes people with intermediate AMD, or advanced AMD in one eye but not the other eye, this combination reduced the risk of vision loss caused by advanced AMD by about 19 percent. The AREDS study also demonstrated that reduced vision in advanced AMD patients was also correlated to reduced cognitive function. Market Opportunity for Age Related Macular Degeneration (AMD) Macular degeneration is a progressive eye condition affecting as many as 15 million Americans and millions more around the world. The disease attacks the macula of the eye, where our sharpest central vision occurs. Age Related Macular Degeneration (AMD) is the number one cause of vision loss and legal blindness in adults over 60 in the U.S. As our population ages, and the "baby boomers" advance into their 50's and 60's, we will see a virtual epidemic of AMD. Perhaps 14%-24% of the U.S. population aged 65-74 years and 35% of people aged 75 years or more have the disease.

Oral dnaJP1 Oral dnaJP1 is a once-daily epitope specific immunotherapy for rheumatoid arthritis (RA) patients. Oral dnaJP1 contains the five amino acid cassette present on most of the HLA class II alleles associated with RA. In preclinical work, the most relevant epitope was mapped and showed its contribution to pro-inflammatory T cell responses in vitro in patients with active RA. The mechanistic hypothesis is that mucosal tolerization to dnaJP1 could determine immune tolerization primarily of T cells and secondarily of APC. The effects of immune tolerance are initially peptide-specific but affect secondarily non-epitope specific pathways. Immune tolerance could translate into clinical benefit. Highly Successful Phase II Trials Below is a summary of the response data from the phase II clinical trial for oral dnaJP1 at the ACR20 endpoint along with the percentage of ACR20 response at day 112, 140 and 168 as well as day 112, 140 and 168 and day 196 follow-up without further drug therapy.
Oral dnaJP1    ACR20
AUC Days 112, 140, 168 and 196    P=0.04
AUC Days 112, 140, 168    P=0.09

ACR20 is a composite endpoint developed the American College of Rheumatology and generally accepted as an FDA approvable scoring criteria. Consistent with the disease modifying process of active immune tolerization, there was a progressive separation between treatment and placebo groups for both ACR20 and ACR50 endpoints was after day 112. Oral dnaJP1 treated patients achieved a 40.7% ACR20 response at follow up versus 21.5% of placebo-treated patients (CMH test p=0.007, GEE p<0.001). The proportion of dnaJP1-treated patients who achieved an ACR20 response at Days 112, 140, 168, and follow up was significantly higher than that of placebo-treated patients (CMH p=0.03; GEE p=0.0005). From an immunologic standpoint, oral dnaJP1 also demonstrated an 80% reduction in the production in-vitro of TNF-alpha by T cells (p<0.007), a hallmark cytokine of inflammation. Additionally, oral dnaJP1 treated patients demonstrated an increase in tolerogenic cytokines and immune response genes, including IL-10 and FoxP3 production. Market Opportunity for Rheumatoid Arthritis Rheumatoid arthritis is a chronic inflammatory disease that leads to pain, stiffness, swelling and limitation in the motion and function of multiple joints. If left untreated, rheumatoid arthritis can produce serious destruction of joints that frequently leads to permanent disability. Though the joints are the principal body part affected by rheumatoid arthritis, inflammation can develop in other organs as well. The disease currently affects over two million Americans, almost 1% of the population, and is two to three times more prevalent in women. Onset can occur at any point in life but is most frequent in the fourth and fifth decades of life, with most patients developing the disease between the ages of 35 and 50. Over 20 million people suffer from rheumatoid arthritis worldwide. Rheumatoid arthritis treatments comprise a $13 billion market. Enbrel, a leading injectable rheumatoid arthritis treatment sold by Amgen and Wyeth, reported US sales in 2007 of about $3.2 billion. Financial Analysis Comparative to other small cap biotech stocks, Adeona stands in a class of its own with its superb balance sheet. Current assets of $4,514,604, and Liabilities of only $574,404 ensures the company has enough cash on hand to sustain ongoing operations through rigurous research and development of its innovative drugs. As well, marketing and mass production shouldn't be a problem, especially if more grants roll in such as the $5 million dollars from the National Multiple Sclerosis Society (NMSS). Aedona also decreased its Q2 net loss. They have reported a net loss of $879,550 or $0.04 per share, for the second quarter of 2009, compared to a net loss of $1.11 million or $0.05 per share, for the second quarter of 2008. The company has also reported a net loss of $2 million, or $0.09 per share, for the first half of 2009, compared to a net loss of $4.86 million, or $0.24 per share, for the same period of 2008. Max Lyon, president and CEO of Adeona, said: "We are pleased with our progress in the second quarter, particularly the acquisition on Hartlab which now gives us the near term opportunity to enter the market with the only comprehensive diagnostic test panel available for determining the copper and zinc status of patients with neurodegenerative diseases such as Alzheimer's disease, dementia and mild cognitive impairment. "Based on the new data we presented at the International Conference on Alzheimer's isease, combined with the existing peer reviewed data available, we believe that the comprehensive determining of copper and zinc status combined with the appropriate follow on therapeutic actions could have a significant impact on the progression of these diseases." Experienced Management and Board of Directors A truly unparamount list of well versed individuals, who have been through the thick and thin of the biotech industry many times before:

Steve H. Kanzer, CPA, Esq Chairman & Chief Executive Officer Mr. Kanzer is our co-founder of Adeona and served as our President from our inception in February 2001 until May 2006. From September 2004 through July 2008, Mr. Kanzer also served as Chairman and Chief Executive Officer. Mr. Kanzer has also been ... Read full bio »

Nicholas Stergis, M.S. Vice Chairman of the Board Mr. Stergis is our co-founder, Vice Chairman of our board of directors, and Chief Executive Officer. Mr. Stergis previously served as our Chief Operating Officer from our founding during 2001 until October 2006. From 2003 until 2007, Mr. Stergis w... Read full bio »

Jeffrey J. Kraws Director Mr. Kraws is a director of Adeona. Mr. Kraws was our Vice President of Business Development during 2006. Mr. Kraws is Chief Executive Officer and co-founder of Crystal Research Associates. Well known and respected on Wall Street, Mr. Kraws has ... Read full bio »

Jeffrey Wolf, Esq. Director Mr. Wolf, currently serves as one of the directors of Adeona. Mr. Wolf has substantial experience in creating, financing, nurturing and growing new ventures based upon breakthrough research and technology. Mr. Wolf is the founding partner of See... Read full bio »

James S. Kuo,M.D., M.B.A. Director James S. Kuo, M.D., M.B.A. is the Chairman and Chief Executive Officer of Cordex Pharma, Inc., a publicly-traded company focused on clinically developing new pharmaceuticals for cardiovascular diseases. From 2003 to 2006, he served as founder, Cha... Read full bio »

Overall Sentiment

With the company engaging in products targeting billions of dollars in market potential, on a surface level it is easy to see why this stock has a 52wk high of $1.10. However, the real gem lies within the company, rather than what the eye can see. The sound balance sheet intermixed with its uncanny ability to attain grants worth millions of dollars to ensure ongoing operations, acquisitions of Colwell Clinical Laboratories and Hartlab LLC which broadens Adeona's target market, and last but not least a management team which can effectively lead towards a successful future. Expect short term, and long term prices to rise, reaching the $1 mark as Adeona gains exposure. Simply put, an investment like Adeona comes once in a blue moon.
The company is mainly a development-stage, specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of autoimmune and central nervous system (CNS) diseases. Their strategy is to exclusively in-license proprietary, clinical-stage drug candidates that have demonstrated clinical efficacy for the treatment of unmet medical diseases. They are specifically focused on developing oral therapies for the treatment of rheumatoid arthritis (RA), multiple sclerosis (MS), dry age-related macular degeneration (AMD) and fibromyalgia

MFG
Chali

Gute Arbeit.
Wie ich schon geschriben habe
Ct einwandfrei im moment.
Das wegen FFm Handel muss ich mir noch ansehen

moin moin,bin noch wach,hehe!

Handelbar ist adeona in Frankfurt und Berlin,aber meisgtens mit einem spread von über 10%,aber das macht mit nichts,ich habe in Frankfurt immer im ask gekauft,und viel wichtiger als der chart sind die erwarteten top-Line -Results zu Alzheimer,die voraussichtlich ab März 2011 kommen werden,dann könnte sich hier eine zweite HGSI entpuppen,warte mal ab .....

MFG
Chali

Warst Du das, der da zweimal 66 Stück gekauft hat letztens in Ffm., Chalifmann ?

:-))

Ich nehm alles,was ich kriegen kann !

Adeona has entered into an agreement with Dr. Prasad that provides the Company with access to clinical data from a 50 patient, 12-month, randomized, double-blind, placebo-controlled clinical trial that evaluated the prevention of infection in patients age 55 to 87 who were treated with an oral zinc therapy (45 mg elemental zinc per day away from food) or matching placebo. The clinical trial was conducted by Dr. Prasad and co-investigators. The primary endpoint of the clinical trial was the rate of infections between the placebo and zinc treated groups. 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 less than 0.001).(1)

Adeona's Portfolio of Zinc-Based Therapies for Diseases in the Elderly

Adeona is developing a portfolio of proprietary oral zinc-based therapies that is expected to offer superior benefits including improved convenience, bioavailability and gastrointestinal tolerability for major diseases of the elderly. The Company considers zinc deficiency of the elderly to be a major public health issue, with zinc deficiency implicated in age-related macular degeneration, Alzheimer's disease, complications of diabetes mellitus and impaired immune function.(2) Declines in serum zinc levels and impaired zinc absorption in the elderly are well documented in multiple clinical studies. Adeona is currently conducting a controlled clinical trial to test its proprietary zinc-based therapy for Alzheimer's disease and mild cognitive impairment. All 60 patients should complete their 6 month treatment by the end of March 2011 and it is anticipated that top-line clinical study results should be available shortly thereafter. Adeona's product candidate for age-related macular degeneration has been successfully evaluated in an 80 patient, randomized, placebo-controlled clinical trial. This trial demonstrated statistically significant improvements in multiple parameters of retinal function.

Adeona believes that the product opportunity announced today represents a natural extension of the Company's leading position in developing oral zinc-based therapies for major diseases in the elderly. According to the U.S. Centers for Disease Control, infections attributable to influenza and pneumonia represent the 4th leading cause of death of people age 65 and over in the United States. Influenza and pneumonia alone are estimated to claim the lives of 58,000 seniors a year and infections in seniors are also a major burden on the public health care system.(3)

"We are excited to add a product candidate for the prevention of infection to our zinc-based portfolio. Utilizing our clinical experience from our Alzheimer's disease and age-related macular degeneration zinc-based product candidates, we have increased opportunities to address the unmet need of zinc deficiency in the elderly," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO. "We are also very pleased to have Dr. Prasad, an esteemed pioneer of zinc therapy with over 50 years of experience devoted to the field, accept our invitation to join our Scientific Advisory Board, and we look forward to his valuable contributions."

MFG
Chali

was ich hier entdeckt habe,könnte noch weitaus besser laufen als Caliper !

MFG
Chali

bis jetzt !

MFG
Chali

Na,wie gefällt euch das ?

MFG
Chali

der Kurs steigt an der Amex,du blindfisch,Frankfurt hat zu !

MFG
Chali

Trimesta von Adeona könnte besser sein als Avonex von biogen,was mag hier noch auf uns zukommen,fangt mal an zu rechnen !

Zu haben für 0,93€ ; US Kurs 1,40$

MFG
Chali

Na,wer ist eingestiegen,ausser mir ?

MFG
Chali

und ich will hoffen, daß es kein Fehler war

gutes Händchen gehabt. Die geht ja ab wie eine Rakete. Meine Talon dagegen will nicht so recht aus dem Startloch kommen. Na ja, kann ja noch werden :-)))

The shares and warrants are being offered in a registered direct offering under the Company's effective shelf registration statement previously filed on Form S-3 with the Securities and Exchange Commission (SEC).  This offering will be made by means of a prospectus supplement and the accompanying base prospectus, copies of which may be obtained, when available, from www.sec.gov.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction

MFG
Chali

nur hoffen, daß sich zwei Investoren finden, die scharf auf 2,85 Millionen Aktien sind. Wäre für die Investoren ein schöner Gewinn, wenn man bei 1 Euro kauft und in zwei Jahren 20 Euro beim Verkauf erlöst.

Wollen wir hoffen,dass das auch stimmt mit 20€ in 2 Jahren ....

Ihr wisst ja, wie das in den US-Foren ist, man kriegt keine genauen Infos(Links).

Lediglich das hab ich gefunden:

AEN expecting results of Zinth study in March. This could take the stock to new highs...

www.crainsdetroit.com/article/201...

Auf jeden Fall: Der Kurs ist um 10 % gestiegen.

reaZin was selected as the new trademark as it is a homophone to the word reason, a high level cognitive function affected by Alzheimer's disease that Adeona's product candidate seeks to address. In addition, the "Zin" root is suggestive of the product's zinc origin, one of the two major constituents of the proprietary, gastro-retentive, sustained-release tablet. The new branding for reaZin will be unveiled at the Company's Investor Day on Zinc Deficiency in Alzheimer's Disease, taking place this afternoon in Ann Arbor, MI.

"The large gathering of neurologists at the American Academy of Neurology's 63rd Annual Meeting is an excellent scientific venue to present the pivotal clinical study results of our zinc and cysteine-based prescription medical food product candidate for Alzheimer's disease and mild cognitive impairment," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO. "We are delighted that our clinical investigator has been accepted to present this important clinical data."

About the American Academy of Neurology

The American Academy of Neurology, an association of more than 22,500 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer's disease, epilepsy, Parkinson's disease, and multiple sclerosis. For more information about the American Academy of Neurology, visit www.aan.com. For more information about the American Academy of Neurology's 63rd Annual Meeting set for April 9 - 16, 2011, at the Hawaii Convention Center, visit www.aan.com/go/am.

About the Pivotal Clinical Study Evaluating reaZin™

reaZin (zinc cysteine), formerly named Zinthionein, is a proprietary oral tablet formulation of zinc and cysteine, an amino acid with potent anti-oxidant properties. Adeona is developing this product candidate for the dietary management of Alzheimer's disease and mild cognitive impairment as a prescription medical food. All 60 patients are enrolled in the clinical study evaluating reaZin. In this randomized, double-blind, placebo-controlled study, patients are assessed 3 and 6 months after they begin the once-daily oral treatment or matching placebo. These 60 patients should complete their 6 month treatment by the end of March 2011. If successful, Adeona expects to make its reaZin product commercially available as a prescription medical food for patients suffering from Alzheimer's disease and mild cognitive impairment.

MFG
Chali

Zitat:

>>Müssen wir aufpassen und vorsichtig sein ?

die bereits verpartnerte Studie mit Flupirtin (EFFIRMA) zur Therapie bei Fibromyalgie.

Mir ist zu Ohren gekommen,dass das Medikament  bereits bei Rückenschmerzen sehr erfolgreich angewendet wird. Bei Fibromyalgie "off label" soll es aber  deutlich weniger Erfolg haben höre ich aus persönlichen Erfahrungen von anwendern/Betroffenen.<<

Weiß jemand etwas darüber?

Nun ist es März und wieder hoffen alle, daß die News über die Studie zum Alzheimer Mittelchen erstens kommen und dann natürlich zweitens positiv sind. Nach den beiden Ausbrüchen im Januar ging es ja leider stetig bergab. Leider hat sich unser Fachmann Chalifmann3 lange nicht mehr zu Wort gemeldet.

Denken wir an Human Genom Siences und drücken Adeona die Daumen.

Jo, er hat´s mal wieder geschafft! Gesperrt bis 19.03., und dann wahrscheinlich auch nur kurze Zeit wieder frei. 

Ich hoffe, dass es endlich wieder aufwärts geht, denn eigentlich gibt´s doch keinen Grund für den Absturz - außer der Tod des Senior Vice Presi Newsome kann´s doch nicht sein. 

 

www.nasdaq.com/aspxcontent/...;selected=AEN&SourceCode=PMZ

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.

Die zulassung von Flupirtin soll zur debatte stehen,höre ich,aber ich habe im FDA Kalender nichts gefunden ....

Grummel

da bist. Und wollen wir das Beste hoffen. Vielleicht haben die 10% Plus schon was damit zu tun.

Es kommt wieder Leben in unser Baby,bierro berichtet mir von einer positiven Studie zu Zinthionein,vielleicht gehts jetzt mal so richtig los,hm ?

MFG
Chali

Lauf heute. Wie könnte jetzt das Kursziel sein?

Bärenstark:

Hohes Vol. und z.Zt.  1,55

Bei dem heutigen Kurs, der wohl durch die guten News herrührt, hätte man, wenn man in die Zukunft schauen könnte, Anfang März schön nachkaufen können. Na mal sehen, wie es weitergeht. Auch ohne wenn und aber und hätte und könnte.

mal eine interessante Einschätzung aus dem W:O von Dottore:
Zitat:

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. Zitat Ende.

Im Moment gerade am Tageshoch bei 1,81!!!!!!!

Leute,es sieht verdammt gut aus,wobei ich mich momentan frage ob wir wegen Flupirtin oder wegen zinthionein explodieren ? Mann könnte aber mutmassen,dass Phase-3 Results der Studie ,die jetzt im März endet,bereits intern durchgesickert sind,bei dem Kursverlauf brauch man sich wohl nicht mehr fragen ob negativ oder positiv .....

MFG
Chali

Einige im Yahoo-Board sehen eine ähnlich Rallye kommen wie bei Prana die letzten zwei Tage. Die hatten eine erfolgreiche Studie eines Parkinson-Medikaments veröffentlicht.

Kurs 1. Tag + 80 %, 2. Tag + 35 %

Na super, das Teil heute schön auf 1,54 runtergebolzt. Minus 12 %. Grrr...

Adeona Pharmaceuticals, Inc. announced today that Ashley I. Bush, M.D., Ph.D., has joined the Company's Scientific Advisory Board.

"Given my research in the area, I believe Adeona's product candidate for the dietary management of Alzheimer's disease, reaZin(TM), 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."

Ich kenne zwar Herrn Bush nicht persönlich, aber der Kurs mag ihn.

www.finanznachrichten.de/...e-involvement-of-met-008.htm 

 

 

ist der Mitbegründer von Prana!

Stimmen vom begeisterten Yahoo-Board:

This is big. It's almost validation we're on the right track. This bodes very well for the development of reaZin.
 
  To have the co-founder of Prana jump to our side speaks volumes about the path we're on.
 
  We are so close to success people.

Much more! If the chief scientific and cofounder of Prana joins Adeona`s board just 3 weeks before pivotal results will be published,
results should yet be unblinded ( as it`s end of March )...........Rocket leaves the station!!!!
 

messages.finance.yahoo.com/Stocks_(A_to_Z)/...rt=1#26035 

für den Beitrag. Sollte uns Mut machen weiter zu investieren.

Immer dasselbe, genau wie gestern: Hoch bis 1,95 und dann wieder runter. Öde!

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 www.clinicaltrials.gov/ct2/show/NCT00451204.

MFG
Chali

sollten doch Vertrauen erwecken. Denn entgegen anderer, nur Sprechblasen produzierender Firmen, stehen hier Fakten im Vordergrund, die uns hoffen lassen, daß Adeona auf dem richtigen Weg ist.

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 prescription 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." 

 

momentan.
Es zeigt sich,wie richtig es war und ist,an der Aktie festzuhalten!

   * 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.

SOURCE Adeona Pharmaceuticals, Inc.

Read more: www.nasdaq.com/aspx/...ear-end-financial-results#ixzz1ImOKjPHH

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.

www.finanznachrichten.de/...secondary-outcome-of-reazi-008.htm

So, also die Prognosen wurden bestätigt, der Kurs hat sich allerdings im Vorfeld wenig bewegt. Was sagen die Biotech-Spezialisten dazu?

Ist überhaupt noch jemand hier?

Adeona Zinc Tab Fails to Aid Alzheimer's Patients 

Unter diesem reißerischen Aufmacher hat der berüchtigte Kolumnist Adam Feuerstein von TheStreet die Wirksamkeit von reaZin in Abrede gestellt.

Und was der Kurs machte, wissen nun. Ich denke, sie kommt wieder.

www.thestreet.com/story/11083931/1/...mers-patients.html 

 

 

ich mag nicht glauben, dass ein "berüchtigter Kolumnist" einen Kusrsturz von ca. 50% verursachen kann....
Da muss doch mehr dahinterstecken...

www.finanznachrichten.de/...ter-2011-financial-results-008.htm

Jetzt muß nur noch einer erklären, wieso Adeona fällt nach diesen Nachrichten. Nichts Negatives, alles im grünen Bereich.

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

Kurz zusammengefasst: Bei einer Untergruppe der bisherigen Studie wurden signifikant positive Ergebnisse festgestellt, sodass AEN jetzt eine weitere Studie in Auftrag gibt.

20 % PLUS. Ist doch mal was nach der Watschn von Fred Feinbein, oder? 

www.finanznachrichten.de/...rietary-zinc-based-therapy-008.htm

ist, ist jedem klar. Da die Studie nun wieder Hoffnung macht, sollten nicht gleich wieder alle schmeißen, falls in den nächsten zwei Tagen ein Dödelanalyst kommt und alles schlecht redet.

Ich habe mir mal die Kommentare zu Human Genome Siences durchgelesen. Da kam im März 09 eine positive Analyse, trotzdem schmierte die Aktie um 40% ab. Dann waren da noch 1 Mrd Schulden und unser Chalifmann3 fragte sogar, ob die Firma überleben wird. Fast verständlich, wenn man den Kurs von Mai 08 zu 4 Euro mit dem von März 09 zu 39 Cent vergleicht. Doch was passierte dann? Bis August 09 stand der Kurs bei 10 Euro und stieg auf über 20 Euro. Natürlich kein Trost für den Kurs von 2001 bei 75 Euro.

Ob wir bei Adeona die Bodenbildung zwischen 50 und 60 Cent gesehen haben weiß keiner. Die Studie wird noch lange laufen. Doch die Aussicht auf Erfolg sollte uns bei der Stange halten.

Da die Studie nun wieder Hoffnung macht, sollten nicht gleich wieder alle schmeißen 

Tja, haben sie aber am Freitag, diese A... Kurs steht wieder bei 0,85 USD.

 

 

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.

SOURCE Adeona Pharmaceuticals, Inc.

Read more: www.nasdaq.com/aspx/...ary-arterial-hypertension#ixzz1eOIIO1nW

Hab den Crash im April mitgemacht(s.o.) und bin dringeblieben. Hooray......

Manchmal zahlt sich Geduld aus.

die Steigerung scheint wirklich nachhaltig zu sein.Trotz der schlechten Börse ist es schon der dritte Tag mit Plus.
Hoffe die Tendenz bleibt.Nach der Meldung könnte noch  E I N I G E S  drinsitzen!

ohne substanz und nur hochgezockt !!!  nun kommt / ist abverkauf .... super!  

@bierro auch diesmal wird es ein crash werden werden! jedoch TOI...TOI...TOI... alles gute

nur meine meinung, jeder soll sich sein eigenes bild machen

dich vielleicht mal etwas mehr mit dem Unternehmen beschäftigen und die Meldungen genauer lesen. Das was momentan läuft,sieht sehr interessant aus,vor allem langfristig.

Ohne Substanz ist absoluter Quatsch!

@Heiko T, deine angesprochene " NACHHALTIGKEIT " ist doch ein witz, denn der kurs zeigt uns etwas ganz anderes. meldungen sind nichts wert, denn nur zahlen ... fakten sind ausschlaggebend! die zukunft wird in der heutigen zeit nicht gehandelt, sondern nur der moment.

na dann, wie sagt die merkel  " ALLES WIRD GUT " ... warten wir es mal ab.

wieder aufwärts,plus 8 %
Nix Abverkauf,sondern normale Gewinnmitnahmen.

Ist ja auch völlig normal!

Nach dem Debakel mit zinthionein war ich enttäuscht von Adeona und bin raus ! Aber gibt es hier jetzt neues Potential ? Interessante Frage ,aber ich bin nicht mehr investiert,habe in Galena Biopharma umgeschichtet und erfreue mich da an 25% Kursplus seit gestern ! Galena ist aktuell übrigens genauso viel (wenig) wert wie Adeona,es gibt sogar einen Galena Thread hier auf Ariva,wenn ihr mal lesen wollt,aber eigentlich gehört das hier ja nicht hin,aber ich denke einfach die Aktie ist auf jeden Fall mal erwähnenswert,und wer sie noch nicht kennt ..... bitteschön!

MFG
Chali

Wow, und heute geht´s wieder mal rund, wheeeeeeeeee!!!!!!

Chali, wo hast Du die ganze Zeit gesteckt, lange nix mehr gehört.

Und die alte Ostsemmel aus dem Harz hat mich bis hierhin verfolgt, lol.. So sieht ein Anstieg aus, Ostharzer, nicht wie bei Eurer PAK, die sich seit Monaten im Seitwärtstrend befindet.

Substanzlos, so so...

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. The study was conducted under an Investigational New Drug application (IND) and was registered at 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. At baseline, the average ALSFRS-R score of these patients was 33 and the average time from symptom onset was one year.

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. Eight out of the ten patients enrolled completed three months of zinc therapy. Two patients dropped out within the first month for reasons unrelated to the zinc therapy. 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).

On average, the eight patients who completed the study lost 0.37 ALSFRS-R points per month during the three months of therapy. 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.[i] 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.

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. 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. 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. They will receive clinical trial medications for at least six months with periodic monitoring. A small Phase I pharmacokinetic clinical trial of AEN-100 is planned for completion prior to initiating the multi-center clinical trial. 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.

"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, M.D., 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. "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."

"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, M.D., M.B.A., Chief Executive Officer of 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."

About 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. 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. Gastrointestinal tolerability (namely, nausea and vomiting) represents a major dose limiting factor of oral high dose zinc therapy. Adeona also intends to file for orphan drug protection with the Food & Drug Administration (FDA) in the U.S. and European Medicines Agency (EMEA) in the E.U, which may provide for marketing exclusivity for a period of seven and ten years, respectively, following approval. 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]

About Amyotrophic Lateral Sclerosis (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. It is estimated that as many as 30,000 Americans may have the disease at any given time. The progressive degeneration of the motor neurons in ALS eventually leads to the death of the patient. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. When motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.

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. Currently, RILUTEK is the only FDA-approved drug for ALS. RILUTEK is an NMDA receptor antagonist and has been shown to prolong life in patients with ALS by 3 months. Presently, there is no cure for ALS, nor is there a known cause. For more information on ALS, please visit the ALS Association website at www.alsa.org.

About PNA Center for Neurological Research

PNA Center for Neurological Research (PNA) is an independent, not-for-profit organization based 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'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 hopes to optimize proper treatments in order to improve outcomes for patients with neurological diseases. For more information about PNA, please visit its website at www.pnaresearch.org. For more information about Phoenix Neurological Associates, Ltd., please visit its website at www.phoenixneurology.com.

SOURCE Adeona Pharmaceuticals, Inc.


Read more: www.nasdaq.com/aspx/...zinc-for-als-collaborator#ixzz1fIkhdI4K

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 editorial@rttnews.com

Read more: www.nasdaq.com/aspx/...al-in-lou-gehrigs-disease#ixzz1fInGWuu3

Adeona wird mit ihrer Zink-therapie diese Krankheiten wie ALS,Alzheimer etc. nicht heilen können,deshalb hab ich einen Thread zu einer anderen Aktie aufgemacht,die das in ferner Zukunft mit neuronalen Stammzellen vielleicht doch heilen können,die aktie bleibt bei mir vorerst auf Watchlist: International Stem Cell Corp (ISCO.OB)

MFG
Chali

P.S. Hi bierro ,altes Haus,was ist mal wieder mit YRCW los..... ,hahaha ?

Alzheimer 100% zu heilen,ist ja auch nicht unbedingt der Anspruch.

Danke,hab ISCO mal auf WL

...ob sie damit Alzheimer heilen können oder nicht, der Anstieg scheint nachhaltig.

Wir stehen heute bereits bei 1,15 USD.

Wahnsinn!

Hier gehts ja wirklich mal wieder gut ab,ob hier tatsächlich neues Potential entfacht ist ? Aber die Rakete Pacific Ethanol geht derzeit mindestens genaau so gut,hmhmm .... Grummel .....

MFG
Chali

im Moment wirklich super.
Heute schon mal im Hoch bis 1,41.Das deutet die Richtung an.
Momentan 20% plus!

Mit Gewinnmitnahmen wird man in Zukunft immer mal rechnen müssen,aber Haupsache die Richtung bleibt.

Was haltet ihr von dem Medarex spin-off Celldex Therapeutics ? (Nasdaq:CLDX) Bin noch unsicher,aber mit einem einstieg am liebäugeln ! Celldex hat eine vielzahl von Antikörperimpfstoffen,von denen gestern einer in Phase-3 gestartet ist gegen glioblastoma! Der witz an der Sache: Celldex ist im Peer-Group Vergleich absolut günstig: Seattle Genetics (1,8 Mrd.-$) Immunogen (900 Mio.-$) Celldex (130 Mio.-$)

Gebt es Meinungen ? Die aktie ein Kauf ?!!

MFG
Chali

Was Adeona einfach nocht fehlt,sind starke finanzkräftige Partner,die die Pipeline vorantreiben ....

MFG
Chali

CLDX find ich auch ganz interessant.Hatte die mal Anfang 2010 und ca. 20% gemacht.
Sind sicherlich etwas unberechtigt abgestraft worden auch i.Z. mit dem Dendreon Verfall im August.Für 3,60 sind sie m.M. nach erst mal gut.Dann mal schauen.

wieder  b l e n d e n d aus.Hat sich die letzten Tage auch eigentlich super gehalten nach dem famosen Anstieg.

Charttechnisch auch sehr gut.

gestern Kaufempfehlung für Adeona in THE STREET von Stockpickr

Das Ding ist im Moment der Hit!

www.thestreet.com/_nasdaq/story/11338224/1/...ee&cm_ite=na

für AEN gewesen.
Sogar jetzt im Plus,obwohl alles andere,vor allem auch Pharma, runtergeht.
Sehr gutes Zeichen!

Anfang bis Mitte Dez. hat ca.1,10 gehalten und somit wurde SKS verhindert.
Könnte jetzt wieder Ri. 1,45 laufen.
Good Luck

1,57 

Hoch 1,60

mit durchschnittlichem Gewinn von 70 % bei 1,69 raus.
Good Luck an alle noch investierten.

Glückwunsch zu Adeona euch beiden und allen anderen,läuft im moment echt perfekt,und keiner weiss warum,es gibt ja bald eine Namens und fokussierungsänderung ! Was ich euch sagen wollte,speziell dir Heiko,wo du jetzt investieren kannst ist Schaut euch mal Lpath inc. (LPTN.OB) an,Hammerteil ! alles weitere zu Lpath in meinem neuen Thread .....

Bis bald !

MFG
Chali

Tach Ihr zwei,

wir sind ja scheinbar die einzigen hier. Der Aufwärtstrend scheint mir ok, deswegen hab ich gestern auch die 1,88 mitgenommen und hoffe auf weiterhin Gutes.

Danke Chali,
werd mir das mit LPTN mal überlegen.
CLDX gehen ja auch ganz gut,wie ich vermutete.

Grüße

Leute

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."

For comments and feedback: contact editorial@rttnews.com

www.rttnews.com




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 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 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 (734) 332-7800, 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.

...schmeißt einer 15.300 Shares. F...ck! After Hours 2,04. Aber ich denke, AEN macht ihren Weg.

Among SA authors, I am a small minority who see the value in former SuperGen, now Astex. But it doesn't matter. Astex is on fire because the share price has jumped from $1.51/share on 30 November 2011 to Friday's close at $2.72/share. That is a monstrous jump in a very short two months.

As my #2 Top 3 Biotech picks, Astex is still under-valued at $2.72/share. I realize few biotechs go straight up, and retracing and accumulation may occur, but I wouldn't be surprised if Astex goes over $3/share as it hit $3.27/share on 2 June 2011. I will be more surprised if Astex doesn't go over $4/share in the coming months.

With a supplementary new drug application FDA decision ahead for Dacogen, investors are probably seeing the pps recovery and run-up going into the news. There will always be day-traders who will claim their lion's-share, but back in 2011, I observed that Astex may be a great trading stock with its variable ups and downs. Or for long-traders, sitting tight, and holding. Clearly, when it hit $1.51/share, that was a gift and congratulations to anyone who jumped in at a fabulous moment.

Still, the Market is hard to interpret and what happens after Friday's run won't be know until Monday. Yet it goes without saying that Astex is cash-flush, so I'm inclined to think the Market is returning the value to Astex that it should have been all along.

MFG
Chali