Avicena Group, Inc. (OTC Bulletin Board: AVGO), a late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, announced today the selection of the optimal dose of HD-02, its novel drug candidate for the treatment of Huntington's Disease.
This dose was determined in an open-label dose escalation study, led by Dr. Steven Hersch and Dr. Diana Rosas of Massachusetts General Hospital (MGH), and will be further evaluated in a Phase III clinical trial.
The dose escalation study evaluated HD-02 in a range of doses from 10 to 40 grams per day and successfully determined the optimal dose that provided the maximum efficacy, safety and tolerability. The full scope of the data will be disseminated upon the results being peer reviewed.
Based on these findings, Avicena and its collaborators Dr. Hersch and the Huntington Study Group have developed a double-blind, placebo-controlled Phase III clinical trial anticipated to commence in early 2008. The Phase III trial will be one of the single largest trials for Huntington's patients, with external funding to be announced.
Upon commencement of this clinical trial, Avicena will have advanced three different indications into phase III trials that include some of the largest trial to date in both Parkinson's and Huntington's.
"We are very encouraged by the results of our HD-02 trial and we believe that in conjunction with our collaborators at MGH, we have identified the optimal dose as we move forward to validate HD-02 as a potential treatment for Huntington's disease, for which there is no current approved drug by the FDA.
We are committed to developing therapeutics that we hope can slow the progression of neurodegenerative diseases," stated Belinda Tsao-Nivaggioli, CEO of Avicena.
"We are excited by the results of our studies with HD-02 to date. This Phase III study will evaluat
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