PALO ALTO, Calif., Nov. 19 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late-stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, announced today that Drs. Steven Hersch and Diana Rosas presented results regarding the Company's novel Huntington's disease treatment candidate HD-02 at the 2007 World Congress on Huntington's Disease in Dresden, Germany.
Drs. Hersch and Rosas, of Massachusetts General Hospital, led the open- label, dose escalation study, which evaluated daily administration of HD-02 in doses ranging from 10 to 40 grams. Results of the study showed that a 30-gram dose provided the optimal levels of efficacy, safety, and tolerability. The researchers also observed a slower cognitive decline and a sustained reduction in brain atrophy at the 30-gram dose level. These findings demonstrate the disease-modifying potential of HD-02 and provided the rationale for a Phase III study to further evaluate its efficacy at the 30-gram dose.
Based on these findings, Dr. Hersch and the Huntington Study Group have designed a double-blind, placebo-controlled Phase III clinical trial to evaluate the 30-gram dose and its ability to slow functional decline. The trial will be sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH). Enrollment is anticipated to begin in the second half of 2008.
"We are excited about the results of this HD-02 study in Huntington's disease and are pleased to have identified the optimal dose for further evaluation in next-year's Phase III trial," stated Belinda Tsao Nivaggioli, CEO and Chairman of Avicena. "We are also pleased to further strengthen our relationship with the NIH via their sponsorship of this trial and look forward to working with the NCCAM within this organization to advance HD-02."
HD-02 is a novel 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 reduced the Huntington's disease marker, which some researchers have linked to brain injury.
Earlier preclinical studies performed by Dr. Flint Beal of Cornell Medical Center and Dr. Robert Ferante of Boston University, showed that HD-02 has significant neuroprotective effects, such as improved motor movement and increased survival rate.
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 programmed 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 Huntington's disease and an additional 150,000 Americans are 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). 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 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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