Healthcare Industry News: PD-02
News Release - December 6, 2006
Avicena Signs Agreement with the National Institute of Neurological Disorders and Stroke for Phase III Trial for Novel Parkinson's Disease CandidatePD-02 Study to be Initiated in Q1, 2007
PALO ALTO, Calif., Dec. 6 (HSMN NewsFeed) -- Avicena Group, Inc. (OTC Bulletin Board: AVGO ), a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today that the company has signed an agreement with the National Institute of Neurological Disorders and Stroke (NINDS) to supply PD-02, the Company's lead Parkinson's disease (PD) drug candidate, for a Phase III trial that is being planned by the Institute. The trial is to 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. The trial is designed to evaluate PD-02's potential to slow the progression of Parkinson's disease.
As part of its ongoing collaboration with NINDS, Avicena will provide PD- 02 and placebo for the trial and fund a related chronic toxicology study. In turn, Avicena has the right to utilize the study's findings for the NDA (New Drug Application) submission to the FDA for the approval of PD-02 as a treatment for Parkinson's disease.
"This agreement is an important milestone in advancing our Parkinson's disease program," stated Belinda Tsao-Nivaggioli, Avicena's chief executive officer. "We look forward to continuing our partnership with the NINDS and Dr. Kieburtz who also was the lead investigator for the Phase II study of PD-02."
PD-02 is Avicena's proprietary therapeutic that has demonstrated the potential to improve neurological function in patients with ALS, Huntington's disease, and Parkinson's disease. In preclinical studies, 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 (PD) is a progressive, neurodegenerative brain disorder that occurs when the neurons that produce 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.
It is estimated that roughly 1.5 million Americans are affected by PD making it the second most common neurodegenerative disorder after Alzheimer's disease. Approximately 60,000 new cases are diagnosed each year in the United States. There presently is no known cure.
ABOUT THE AVICENA GROUP
The Avicena Group, Inc. (OTC Bulletin Board: AVGO ) is a late stage, revenue generating 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 Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig's disease. Near term, Avicena intends to initiate both a Phase III trial in Huntington's disease and a Phase III trial in Parkinson's disease. Avicena's science is well established and its products are safe and well tolerated. Avicena's clinical programs are largely funded by government and non-profit organizations. Based on its cellular energy technology, Avicena also develops and sells proprietary ingredients to skin care manufacturers.
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" in the company's prospectus 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 early state 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.
Source: Avicena Group
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