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.
ABOUT PARKINSON'S DISEASE
Parkinson's disease is a progressive, neurodegenerative brain disorder that occurs when the neurons within the brain that are responsible for producing the chemical dopamine die. Primary symptoms of the disease include involuntary shaking of the arms or legs (tremors), difficulty with balance, slowness of movement, and stiffness.
According to the Parkinson's Disease Foundation, roughly 1.5 million Americans are affected by Parkinson's disease, making it the second most common neurodegenerative disease after Alzheimer's disease. Approximately 60,000 new cases are diagnosed each year in the United States. There presently is no known cure for Parkinson's disease.
Avicena Group, Inc. (OTCBB: AVGO) is a late stage biotechnology company focused on developing products based on its proprietary understanding of the regulation of cellular energy processes. The company's core technologies, supported by a robust IP portfolio, have broad applications in both pharmaceuticals and dermaceuticals. Avicena's pharmaceutical program centers on rare neurological disorders (orphan diseases). The company is currently analyzing data from its Phase IIb/III trial in ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease). Near term, Avicena intends to initiate a Phase III trial in Huntington's disease to accompany the NIH sponsored Phase III trial in Parkinson's disease described in this release. Avicena's science is well established and its products are safe and well tolerated. Unlike traditional biotechnology companies, Avicena's clinical programs are largely funded by government and non-profit organizations. Avicena presently derives revenue from the sale of proprietary ingredients to skin care.
This release may contain forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements reflect, among other things, management's current expectations, plans and strategies, and anticipated financial results, all of which are subject to known and unknown risks, uncertainties and factors that may cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict. See "Risk Factors" under "Item 6. Management's Discussion and Analysis of Financial Condition and Results of Operation" from our Annual Report on Form 10-KSB for the year ended December 31, 2005, and other descriptions in the company's public filings with the Securities and Exchange Commission for a discussion of such risks, including the company's need for additional funds, the company's dependence on a limited number of therapeutic compounds, the stage of the products the company is developing, uncertainties relating to clinical trials and regulatory reviews, competition and dependence on collaborative partners, the company's ability to avoid infringement of the patent rights of others, and the company's ability to obtain adequate patent protection and to enforce these rights. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. Avicena does not undertake any obligation to update or review any such forward-looking information, whether as a result of new information, future events or otherwise.
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