Patient Enrollment On Target In National Institutes Of Health Phase III Parkinson's Disease Trial

Main Category: Parkinson's Disease
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 17 Jul 2007 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Avicena Group, Inc. (OTC Bulletin Board: AVGO), a late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, announced today that the Phase III efficacy trial of the Company's lead Parkinson's disease drug candidate, PD-02, has enrolled 288 patients in the first three months. This Phase III trial, which is sponsored by the National Institutes of Health's National Institute of Neurological Disorders and Stroke (NINDS), is evaluating PD-02's potential to slow the progression of Parkinson's disease.

This Phase III trial will enroll over 1,720 patients at more than 50 sites in the U.S. and Canada, making it one of the largest Parkinson's disease trials ever conducted. The lead investigators are 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.

"We are pleased that the rate of enrollment continues to be on target," stated Dr. Belinda Tsao-Nivaggioli, Avicena's Chief Executive Officer. "The rapid pace of enrollment underscores the unmet treatment need among 1 million Parkinson's disease sufferers in the U.S."

Avicena previously announced that the NINDS had awarded a grant for this Phase III trial to evaluate PD-02's potential to slow the progression of Parkinson's disease. As part of the Company's collaboration with the NINDS, Avicena will supply the drug PD-02 and placebo for use in the trial. In return, Avicena will have access to the study's data to file a New Drug Application with the Food and Drug Administration for the approval of PD-02 as a treatment for Parkinson's disease. Avicena also holds intellectual property rights for the use of PD-02 in Parkinson's disease.

ABOUT PD-02

PD-02 is a proprietary therapeutic for the treatment of Parkinson's disease. Data from Phase II efficacy trials conducted at the University of Rochester showed PD-02 to be safe and well tolerated. Furthermore, findings demonstrated PD-02's potential to slow the rate of disease progression as measured by the Unified Parkinson's Disease Rating Scale. Results were published in the journal Neurology. In preclinical studies of Parkinson's disease, PD-02 has demonstrated significant neuroprotective properties including protection of the dopaminergic cells which are affected in Parkinson's disease.

ABOUT PARKINSON'S DISEASE

Parkinson's disease is a progressive, neurodegenerative brain disorder that occurs when the neurons 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.

ABOUT AVICENA

Avicena Group, Inc. (OTC Bulletin Board: AVGO) is a Palo Alto, California based late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases. 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. Near term, Avicena intends to initiate a Phase III trial in Huntington's disease to accompany the ongoing NIH Phase III trial in Parkinson's disease. 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 dermaceutical ingredients to skin care manufacturers.

SAFE HARBOR

This release contains forward-looking statements that reflect, among other things, management's current expectations, plans and strategies, 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, 2006, 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.

Avicena Group, Inc.
http://www.avicenagroup.com