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 --
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."
About Ananda S. Prasad, M.D., Ph.D.
Ananda S. Prasad, M.D., Ph.D., a Distinguished Professor of Internal Medicine at Wayne State University School of Medicine and renowned zinc expert, recently received the 2010 Mahidol Award in the Field of Public Health for his groundbreaking research. Among his many achievements, he is credited for identifying zinc deficiency as the underlying cause of growth retardation and hypogonadism that has afflicted millions of children in the developing world. Dr. Prasad estimates that over 2 billion people worldwide currently suffer from zinc deficiency. For over five decades, he has been a vocal advocate of zinc supplementation for diseases characterized by zinc deficiency. Dr. Prasad is the 2007 recipient of the American College of Physicians Award for Outstanding Work in Science as Related to Medicine and has over 200 peer-reviewed publications.
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company developing innovative medicines for the treatment of serious central nervous system diseases. The Company's 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. Currently, Adeona is developing the following product candidates: a prescription medical food for Alzheimer's disease, and drugs for multiple sclerosis, fibromyalgia, rheumatoid arthritis and age-related macular degeneration.
This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the timing and results of our clinical study and our ability to successfully develop products with superior benefits. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure of our clinical trials to be completed on time or to achieve desired results, a failure of our clinical reference laboratory to continue to grow and achieve revenue or a failure by us or our strategic partners to successfully commercialize products and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2009 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
(1)Prasad AS, Beck FWJ, Bao B, Fitzgerald JT, Snell DC, Steinberg JD, Cardozo LJ, Zinc supplementation decreases incidence of infections in the elderly: effect of zinc on generation of cytokines and oxidative stress, Am J Clin Nutr, 85; 837-44 (2007)
(2) Cakman I, Kirchner H, Rink LJ, Zinc supplementation reconstitutes the production of interferon-alpha by leukocytes from elderly persons, Interferon Cytokine Res. 1997 Aug;17(8):469-72.
(3) CDC, National Vital Statistics Report, Vol. 50, No. 15 (2002)
SOURCE Adeona Pharmaceuticals, Inc.
CONTACT: James S.
Kuo, M.D., M.B.A., Chief Executive Officer, +1-734-332-7800
Posted: December 2010