Adeona Pharmaceuticals, Inc., (AMEX: AEN) announced today that on July 6, 2010, it completed an equity financing of $1 million with a single institutional investor, Seaside 88, L.P. The financing involved the sale of 1,212,121 registered shares of common stock and no warrants. Enclave Capital served as placement agent and will receive a 7% cash commission and 5-year warrants to acquire 60,606 shares of Adeona at $1.32 per share. The use of proceeds is intended for general corporate purposes.
Separately, Adeona announced the completion of 75% enrollment in Part 2 of Adeona's 60 patient clinical study of oral Zinthionein ZC for Alzheimer's disease and mild cognitive impairment entitled, A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2). For further information see, http://clinicaltrials.gov/ct2/show/study/NCT01099332.
Adeona is also providing guidance today that it expects to complete the CopperProof-2 clinical study and announce results in the first quarter of 2011. If successful, Adeona and/or its marketing partner(s) should be eligible to immediately begin marketing Zinthionein ZC as a prescription medical food intended for the dietary management of Alzheimer's and mild cognitive impairment.
The CopperProof-2 study represents the first controlled clinical study of oral zinc therapy for 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 75% enrollment follows Adeona's announcement of completion of 50% enrollment less than one month ago as well as 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®.
"We are very pleased to have Seaside 88 as a new investor in Adeona. We also consider the rapid enrollment in our CopperProof-2 clinical trial as an excellent indication of the high clinical need for a potential disease modifying therapy in Alzheimer's disease and mild cognitive impairment, especially one that is convenient, tolerable and also having a substantial history of safety. Should our CopperProof-2 study prove successful, we believe that Zinthionein ZC is now well positioned to represent the first commercially available disease-modifying therapy for Alzheimer's disease and mild cognitive impairment, a multibillion dollar market opportunity," stated James S. Kuo, MD, MBA, Adeona's Chief Executive Officer.
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