Adeona Pharmaceuticals, www.adeonapharma.com – the pharmaceutical company with particular emphasis on central nervous system diseases – whose primary strategy is licensing clinical-stage drugs that have demonstrated efficacy and then developing them further – reported today obtaining 100% enrollment in Part 2 of the CopperProof-2 clinical study of a new oral zinc cysteine preparation for Alzheimer’s called Zinthionein.
Zinthionein is AEN’s proprietary, single-dose oral formulation of zinc cysteine, which is characterized by notable sustained release and gastro-retentive advantages, as well as vastly superior bioavailability of zinc, compared to the extant FDA-approved inorganic zinc acetate.
Part 2 of this prospective, randomized and double-blind trial was designed as a comparator study involving 60 subjects with Alzheimer’s and mild cognitive impairment.
A randomized 50:50 split for either Zinthionein or the matching placebo is implemented over a 3-6 month interval, after which time standard clinical testing for Alzheimer’s via serum measurements of zinc/copper is performed to validate efficacy.
Senior VP of R&D for AEN, David A. Newsome, M.D., F.A.R.V.O., buzzed with excitement at the progress being made in this clinical study, noting in particular how Zinthionein is a vehicle with the potential to drive massive revenues for the Company and its shareholders.
Newsome projected March 2011 results for Part 2 of the CopperProof-2 study, noting the absence of a single case of adverse side effects or dropouts in the study thus far, and indicating that Zinthionein could soon be readily available as a prescription medical food.
Newsome characterized the enrollment report as a “milestone” which would allow for a greater quantum of energy and resources to be applied to GMP production, product packaging and pre-commercialization work in order to get the product ready for an extremely eager market.
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