Klein,aber fein: Adeona Pharmaceuticals

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

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

Written by Michael Vlaicu    
Friday, 04 September 2009 01:25
http://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 Acquires Access to Clinical Data Supporting Oral Zinc for Prevention of Infections in the Elderly
-- Zinc Therapy Demonstrates 67% Reduction in Incidence of Infections --
-- Zinc Research Pioneer, Ananda S. Prasad, M.D., Ph.D., Joins Adeona Scientific Advisory Board --

Press Release Source: Adeona Pharmaceuticals, Inc. On Thursday December 16, 2010, 6:00 am EST

ANN ARBOR, Mich., Dec. 16, 2010 /PRNewswire-FirstCall/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that it has acquired access to clinical data supporting a zinc-based therapy for the prevention of infections in the elderly. This acquisition expands and enhances Adeona's zinc-based product candidate portfolio that already includes its proprietary zinc-based tablets for use in the dietary management of mild to moderate Alzheimer's disease and mild cognitive impairment patients, and age-related macular degeneration. In addition, Adeona also announced the appointment of the zinc research pioneer, Ananda S. Prasad, M.D., Ph.D., to the Company's Scientific Advisory Board.

"I am pleased to join the Scientific Advisory Board of Adeona, a company leading the development of zinc-based therapies addressing diseases in the elderly," said Ananda S. Prasad, M.D., Ph.D. "I look forward to providing guidance as Adeona moves their promising zinc-based product candidates through development."

Zinc for Prevention of Infection in the Elderly

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 :-)))  

Adeona to Raise $4 Million in Registered Direct Offering
.
(Amex:AEN - News), a developer of innovative medicines for serious central nervous system diseases, announced today that it has executed an agreement for the sale of approximately 2.85 million shares of its common stock at $1.40 per share to two new institutional investors in a registered direct offering for $4 million in gross proceeds. The investors will also receive warrants to purchase approximately 1.42 million shares of common stock at an exercise price of $2.00 per share. The warrants are exercisable upon issuance for a period of 13 months from the closing date.  If exercised for cash, the warrants are expected to generate up to an additional $2.85 million in proceeds to Adeona.

"This financing will allow us to continue developing our zinc-based therapy currently in a clinical study and, if clinical results are positive, will allow us to further our commercialization efforts as a prescription medical food for Alzheimer's disease," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO.

The offering is expected to close on or before February 2, 2011, subject to customary closing conditions, including approval by the NYSE AMEX. The net proceeds of approximately $3.7 million will be used for general corporate purposes, including conducting operations and advancing our clinical development programs.

Chardan Capital Markets acted as the sole placement agent for this transaction.

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...

http://www.crainsdetroit.com/article/201...

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

ANN ARBOR, Mich., Feb. 8, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (Amex:AEN - News), a developer of innovative medicines for serious central nervous system diseases, announced today that an abstract on the Company's pivotal clinical trial of its zinc and cysteine-based product candidate being evaluated in patients with Alzheimer's disease and mild cognitive impairment has been accepted for presentation at the 2011 American Academy of Neurology Annual Meeting in April. The abstract will provide top line clinical trial results, as well as the rationale and design of the pivotal study.

Diana Pollock, M.D., Lead Principal Investigator of the trial at Morton Plant Neuroscience Institute on the campus of Morton Plant Hospital, is the first author on the abstract titled "Clinical Trial Results of the First Controlled Clinical Trial of Zinc-Based Therapy for Alzheimer's Disease and Mild Cognitive Impairment." The poster presentation will be held from 2:00 to 6:30 p.m. on April 14, 2011 at the Hawaii Convention Center in Honolulu, Hawaii. Due to conference restrictions with regard to the embargo policy relating to clinical trial results, Adeona plans to present the results of its pivotal clinical trial during this conference and distribute a concurrent press release.

Adeona also announced that "reaZin™" has been adopted as the new trademark for its zinc and cysteine-based oral tablet currently under development as a prescription medical food for the dietary management of Alzheimer's disease and mild cognitive impairment. Previously, Adeona's zinc and cysteine-based product candidate was called Zinthionein.

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 http://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 http://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:

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