PALO ALTO, Calif., Feb. 5 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today the completion of the dose-escalating portion of a chronic toxicology study of PD- 02, its lead Parkinson's disease drug candidate. Results, which demonstrated that PD-02 is safe and well-tolerated, will allow Avicena to proceed with patient enrollment in a Phase III Parkinson's disease study.
"We are encouraged by the results to date, and our next step is to initiate patient enrollment for the Phase III trial," stated Belinda Tsao- Nivaggioli, Avicena's chief executive officer. "We are eager to pursue our clinical program to evaluate the potential of PD-02 as a treatment option for patients with Parkinson's disease."
The Food and Drug Administration (FDA) approved a Phase III study design for PD-02 in April 2006, and requested a dose-escalating chronic toxicology study of PD-02 prior to patient enrollment. This Phase III study is designed to evaluate PD-02's potential to slow the progression of Parkinson's disease and will be funded by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institute of Health. The trial's 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.
ABOUT PD-02
PD-02 is Avicena's proprietary therapeutic that has demonstrated the potential to improve neurological function in patients with 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 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.
It is estimated that 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. 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, in addition to the Phase III trial in Parkinson's disease discussed in this press 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 manufacturers.
SAFE HARBOR
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 early 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.CONTACT: Investors: Sara Ephraim, +1-646-536-7002, orsephraim@theruthgroup.com, or John Quirk, +1-646-536-7029, orjquirk@theruthgroup.com; media: Janine McCargo, +1-646-536-7033, orjmccargo@theruthgroup.com, all of The Ruth Group, for Avicena Group, Inc.)
