One of Largest Parkinson's Disease Trials Ever Conducted
PALO ALTO, Calif., March 22 /-/ -- Avicena Group, Inc. (OTC Bulletin Board: AVGO), a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today that its National Institutes of Health (NIH) collaborator and sponsor, the National Institute of Neurological Disorders and Stroke (NINDS), initiated patient enrollment in a Phase III efficacy trial of PD-02, Avicena Group's lead Parkinson's disease (PD) drug candidate. PD-02 is an ultra-pure form of creatine made under strictly controlled drug manufacturing guidelines to not contain harmful neurotoxins that may be present in common types of creatine.
This will be one of the largest trials in the history of the NINDS. The NINDS has agreed to provide complete funding for the five-year trial to evaluate PD-02's potential to slow the progression of Parkinson's disease. Designed as a double-blinded and placebo-controlled protocol, the trial is expected to enroll more than 1,720 Parkinson's patients at over 50 trial sites across the US and Canada. 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.
As part of its ongoing collaboration with the NINDS, Avicena will supply the drug candidate, PD-02, and placebo for this trial. Under terms of the collaboration, Avicena will have rights to the study's findings for NDA (New Drug Application) submission to the FDA (Food and Drug Administration) for the approval of PD-02.
"The support from NINDS funds a critically important trial of a potentially neuroprotective agent for Parkinson's disease and further validates our technology platform," stated Dr. Belinda Tsao-Nivaggioli, Avicena's Chief Executive Officer. "The trial represents the world's largest clinical study in Parkinson's disease in terms of patient enrollment and is also one of the largest studies of Parkinson's disease undertaken by the NINDS We are eager to proceed with this excellent collaborative relationship with the NINDS and the lead investigators."
Recently, Avicena met a necessary precondition for patient enrollment in the NINDS-sponsored Phase III Parkinson's disease trial by completing the dose-escalation portion of a self-funded chronic toxicology study of PD-02. The journal Neurology has also published results from a Phase II study where PD-02 demonstrated a rate of disease progression that was lower than the threshold for futility. The Phase II futility study was also led by Dr. Kieburtz and Dr. Tilley and sponsored by the NINDS.
Conference Call to Be Held Monday, March 26
Chief Executive Officer Dr. Belinda Tsao-Nivaggioli will host a live webcast and conference call on Monday, March 26, 2007, at 11:00 a.m. Eastern Time, to discuss this announcement. The live webcast can be accessed at Avicena's corporate website at http://www.avicenagroup.com. Interested parties without Internet access or wishing to ask questions may dial the domestic U.S./Canada number (877) 407-0789, or the international number (201) 689-8562. Telephonic and audio webcast replays of the call will be available for one week and six months, respectively. Callers may access the telephonic replay archive through April 2, 2007, by dialing (877) 660-6853 in the U.S./Canada or (201) 612-7415 internationally (Account Number 3055 and Conference ID 235697). The audio webcast will be archived at http://www.avicenagroup.com through September 25, 2007.
PD-02 is a proprietary therapeutic that incorporates an ultra-pure, toxin-free, clinical form of creatine. This ultra-pure, clinical form of creatine has demonstrated the potential to improve neurological function in certain patient populations. 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 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. (OTC Bulletin Board: 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 in addition to the 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 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" 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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