Adeona Pharmaceuticals, Inc. (Amex: AEN) announced the completion of 50% enrollment in Part 2 of its clinical study, A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2).
The CopperProof-2 study represents the first controlled clinical study of oral zinc cysteine for the dietary management of Alzheimer's disease and mild cognitive impairment. Part 2 of the CopperProof-2 study is designed as a 60-subject comparator study. Subjects are randomized on a 50:50 basis to receive either Zinthionein ZC or matching placebo. After 3 and 6 months on clinical trial material, serum measurements of zinc and copper are taken, and any changes in cognitive function using standard clinical tests used in Alzheimer's disease and mild cognitive impairment are recorded.
The completion of 50% enrollment follows Adeona's April 14th announcement of positive results from Part 1 of the CopperProof-2 study. Part 1 demonstrated a substantially lower incidence of adverse effects in Alzheimer's disease and mild cognitive impairment subjects (33% versus 100%) in favor of Zinthionein ZC (containing 150 mg of elemental zinc acetate and 100 mg of cysteine) compared to Galzin® (containing either 50 mg or 100 mg of elemental zinc as zinc acetate). Zinthionein ZC also demonstrated superior serum zinc bioavailability in Alzheimer's disease and mild cognitive impairment subjects compared to both the 50 mg and 100 mg dose levels of Galzin®.
"Since first enrolling subjects, we are pleased to have reached this 50% enrollment milestone so quickly," commented Diana Pollock, MD, principal investigator of the CopperProof-2 study and Associate Director, Memory Disorder Center, Clearwater, Florida. "Our recent addition of two other institutional review board approved clinical sites has succeeded in moving the study along the desired trajectory towards full enrollment," she observed.
David Newsome, MD, FARVO, Adeona's Senior Vice-President for Research and Development remarked, "Having pioneered the use of oral zinc therapy in dry age-related macular degeneration, which has now become the standard of care, I believe that Adeona's once-daily, high bioavailability, well-tolerated oral zinc cysteine formulation has the potential to ameliorate the sub-clinical zinc deficiency in Alzheimer's and mild cognitive impairment subjects and substantially grow current markets for oral zinc-based therapies."
"We are pleased to have reached this enrollment milestone on a timely basis and within budget. Along with the recently announced Meda collaboration for flupirtine's development and completion of 50% enrollment in the Trimesta multiple sclerosis clinical trial, it represents one of several major transformational changes taking place at the company in the past few months," stated James S. Kuo, MD, MBA, Adeona's Chief Executive Officer.
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