PALO ALTO, Calif., March 12 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, announced today that it met with the Food and Drug Administration (FDA) and will proceed with a Phase III trial of its lead drug candidate, HD-02, for the treatment of Huntington's disease, pending final analysis of completed animal toxicology studies.
A double-blind, placebo-controlled Phase III clinical trial which will be led by Dr. Steven Hersch and Dr. Diana Rosas of Massachusetts General Hospital, Dr. Bernard Ravina of University of Rochester and the Huntington Study Group will evaluate the ability of HD-02 to slow functional decline in Huntington's disease patients as measured by the Total Functional Capacity (TFC) score. A Special Protocol Assessment will be submitted which will expedite FDA review. The trial will be sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH) and the Orphan Product Division of the FDA. Enrollment is anticipated to begin in Q3 2008.
In previous studies, HD-02 has shown potential neuroprotective properties in Huntington's disease patients. Results from a Phase II clinical trial of HD-02, led by Dr. Steven Hersch, were published in the January 24, 2006 issue of Neurology and showed that HD-02 suppressed an oxidative damage marker, 8OH2DG, which is a measure of cellular injury. Also, in a dose escalation 2 year open-label study led by Dr. Steven Hersch and Dr. Diana Rosas of Massachusetts General Hospital, higher doses of HD-02 were observed to normalize 8OH2DG and stabilize clinical and radiological hallmarks of HD. These findings demonstrate the disease-modifying potential of HD-02 and provided the rationale for a Phase III study to further evaluate its efficacy.
"We are extremely pleased with the outcome of the FDA meeting and look forward to this pivotal assessment of HD-02 as a treatment for slowing Huntington's disease for which there currently is no approved treatment," stated Belinda Tsao Nivaggioli, CEO and Chairman of Avicena. "We are also pleased to further strengthen our on-going relationship with Dr. Steven Hersch, Dr. Diana Rosas, and Dr. Bernard Ravina. We look forward to working with the NCCAM, a Division of NIH, and the Orphan Products Division through their sponsorship of this trial."
"We are very enthusiastic about the study results of HD-02 to date and excited to be advancing it into a Phase III trial," stated lead investigator Dr. Steven Hersch. "This Phase III study will evaluate whether HD-02 can slow the progression of Huntington's disease, and pending positive results, may provide a much needed treatment option to Huntington's patients."
HD-02 is a novel and proprietary drug candidate for the treatment of Huntington's disease (HD). HD-02 has been granted orphan drug designation in the U.S. Results from a Phase II clinical trial of HD-02, led by Dr. Steven Hersch of Massachusetts General Hospital, were published in the January 24, 2006 issue of Neurology and showed that HD-02 suppressed a Huntington's disease marker. Some researchers have linked this oxidative marker as a measure of cellular injury. Earlier preclinical studies performed by Dr. Flint Beal of Cornell Medical Center and Dr. Robert Ferrante of Boston University, showed that HD-02 has significant neuroprotective effects, such as improved movement, reduced neuropathology, and prolonged survival.
ABOUT HUNTINGTON'S DISEASE
Huntington's disease is a progressive neurodegenerative disease caused by a defective gene that is often inherited from parent to child. This genetic defect causes a widespread deterioration of neurons in those parts of the brain that are responsible for controlling cognitive, emotional and motor functions. This progressive deterioration results in a variety of symptoms including uncontrolled muscle movement, loss of intellectual capacity, and severe emotional disturbances.
Approximately 35,000 people in the US suffer from the symptoms of Huntington's disease and an additional 150,000 Americans are at risk to be carriers of the Huntington's gene. Carriers of the Huntington's gene will develop this deadly disease during their lifetime.
Avicena Group, Inc. 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). Near term, the Company plans to initiate a Phase III trial in Huntington's disease as discussed above and a confirmatory Phase III trial in ALS 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.
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.
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