PALO ALTO, Calif., March 12 /PRNewswire-FirstCall/ -- Avicena Group, Inc. (OTC Bulletin Board: AVGO), 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 me
|SOURCE Avicena Group, Inc.|
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