Adeona expands and enhances zinc-based product candidate portfolio

Dec 16 2010

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).

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. 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.

"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."

SOURCE Adeona Pharmaceuticals, Inc.