Avicena Clarifies Description of Creatine Versus PD-02, Company's Lead Drug Compound Used in NIH Phase III Clinical Trial in Parkinson's Disease

(posted on 23/03/2007)

PALO ALTO, Calif., March 23 /PRNewswire-FirstCall/ — Avicena Group, Inc. (OTC Bulletin Board: AVGO), a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, wishes to clarify the difference between its compound, PD-02, being used in the Phase III Parkinson’s disease trial announced on March 22, 2007, versus a common (nutritional supplement) form of creatine.

PD-02, the Parkinson’s disease drug candidate being used in this Phase III clinical trial, is a unique creatine-based formulation that has been manufactured to strict FDA drug GMP guidelines. PD-02 is produced using a patented process that ensures a highly purified form of creatine without the harmful neurotoxins, such as cyanamide, which may be dangerous to patients with neurodegenerative diseases like Parkinson’s.

In addition, only this GMP drug formulation has been shown to be safe and well tolerated in high doses in previous clinical studies conducted by Karl Kieburtz, M.D., M.P.H., of the University of Rochester in New York, the lead investigator of this NINDS sponsored Parkinson’s trial.

Dr. Kieburtz pointed out, “There is a critical distinction between the pharmaceutical grade creatine formulation that is being used in this Parkinson’s disease trial and the creatine that may be sold over-the-counter in retail stores. It is unwise for Parkinson’s patients to conclude that the common form of creatine has any clinical benefits, and I recommend against using it.”

“We go to great lengths to ensure that Avicena’s Parkinson’s disease drug candidate, PD-02, is manufactured under the tightest FDA standards,” stated Belinda Tsao-Nivaggioli, Avicena’s Chief Executive Officer. “Only as a result of these efforts, can the drug’s purity as well as safety and efficacy profile be guaranteed.”

About the Trial

The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. It will enroll 1,720 people with early- stage Parkinson’s disease at fifty-one medical centers in the United States and Canada. Participants in the phase III study will be evaluated on an ongoing basis for five to seven years. The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson’s Disease). NINDS has organized this large network of sites to allow researchers to work with Parkinson’s patients over a long period of time, with a goal of finding effective and lasting treatments. The effort will be led by Karl Kieburtz, M.D., M.P.H., of the University of Rochester in New York, and Barbara C. Tilley, Ph.D., of the Medical University of South Carolina in Charleston, and the patients will be seen by movement disorders specialists at the NET-PD sites across the United States and Canada.