|Adeona's clinical study met expectations and more|
|Friday, 15 April 2011 07:36|
You may recall that Adeona Pharmaceuticals is developing innovative medicines for the treatment of serious Central Nervous System (CNS) diseases. Their primary 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 – basically this means they develop their product candidates to attract large pharmaceutical partners with deep pockets. As we reported in December, AEN has demonstrated success with corporate partnering, they have started actively promoting the progress and potential of the clinical programs. They have expanded current revenue potential with their own clinical lab and we see them diligently trying to preserve cash. With several potential product candidates in the pipeline – it not only seems likely they should attract additional partners, they are actively working on it.
Two scientific observations support Adeona's hypothesis that correcting zinc and free copper abnormalities could benefit AD patients as measured by cognitive scores. The first observation is derived from studies conducted by Dr. Squitti and her group that have shown the following: 1) AD patients have elevated levels of serum free copper(2) and 2) the elevated levels of free copper correlate with lower cognitive function(3) and, over time, a decline in cognitive function(4). The second observation is the finding that AD patients are zinc deficient compared to age-matched control patients(5). These findings suggest that elevated free copper is toxic to the brain of AD patients. Therefore, based on these scientific observations, Adeona's therapeutic strategy for the reaZin clinical study is to correct zinc deficiency and to lower serum free copper in AD patients. Based on findings in Wilson's disease (a disease characterized by toxic levels of free copper), oral zinc is known to lower serum free copper.
The prospective, randomized, double-blind, placebo-controlled clinical study represents the first controlled clinical study evaluating the safety and efficacy of a zinc and cysteine-based therapy (reaZin) for Alzheimer's disease. Study subjects were randomized into the active treatment group or the placebo group and were assessed at baseline, 3 months and 6 months. Primary outcome measures include serum zinc and serum free copper. Secondary outcomes include cognitive measures using ADAS-Cog, CDR-SOB and MMSE.
"We are highly encouraged by the results from this clinical study, especially achieving the primary outcome with the statistically significant change in the free copper to zinc ratio in the treatment group over the placebo group," stated George J. Brewer, M.D., Adeona's Senior Vice President of Research & Development. "Also, of ultimate importance with respect to a potential treatment for Alzheimer's disease patients, the composite score supports cognitive benefit in the treatment group versus the placebo group."
Dr. Pollock also commented on the clinical study, "In my clinical experience, this zinc therapy appears to have been extremely well tolerated and may represent a new mechanism of action to address the cognitive deficits in Alzheimer's patients. This potential treatment deserves further study in larger clinical trials."
The poster titled "Clinical Trial Results of the First Controlled Clinical Trial of Zinc-Based Therapy for Alzheimer's Disease and Mild Cognitive Impairment" included findings from 42 of 57 subjects evaluable at the end of the study. The results are as follows:
A copy of the poster presented at the AAN meeting is available using the following URL: www.adeonapharma.com/AANposter.pdf.
Adeona will hold a conference call/audio webcast to discuss the results from the clinical study evaluating reaZin for the dietary management of Alzheimer's disease and mild cognitive impairment on Friday, April 15, 2011, at 2:00 p.m. (EDT). James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer and Diana Pollock, M.D., Lead Principal Investigator of the study at Morton Plant Neuroscience Institute on the campus of Morton Plant Hospital, will host the call. Interested parties should call toll free 1-800-860-2442 (U.S.) or 1-866-605-3852 (Canada), or from outside North America +1 412-858-4600, fifteen minutes before the start of the call to register and identify themselves as registrants of the 'Adeona' Conference Call. Any registered caller on the toll free line may ask to be placed in the queue for the Question & Answer session. The call will be simulcast on the web at http://www.videonewswire.com/event.asp?id=78671. If you are unable to participate during the live call, the webcast will be available for replay at www.adeonapharma.com for 30 days after the call.