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 evaluate whether HD-02 can slow the progression of Huntington's disease and translate into real-world clinical benefits for patients," stated lead investigator Dr. Steven Hersch.
HD-02 is a novel drug candidate for the treatment of Huntington's disease (HD) with orphan drug designation in the U.S. Avicena has recently completed a Phase II clinical study of HD-02 led by Dr. Steven Hersch of Massachusetts General Hospital.
Results from this study, which were published in the January 24, 2006 issue of Neurology, showed that HD-02 reduced the Huntington's disease marker, which some researchers have linked to brain injury. Further studies by Dr. Hersch and Dr. Rosas have optimized the dosing of HD-02 and provided further evidence supporting its potential to slow HD.
Earlier preclinical studies performed by Dr. Flint Beal of Cornell Medical Center and Dr. Robert Ferante of Boston University, HD-02 have shown significant neuroprotective effects such as improved motor movement and increased survival rate.
Avicena intends to collaborate with Dr. Hersch and the Huntington Study Group to initiate a Phase III trial in early 2008 following completion of a chronic toxicology study that is currently underway.