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Pharma & Bio Ingredients
This study is the next step in the steady development program for HD-02, which has been granted orphan drug designation by the FDA. Results from a previous Phase I/II clinical study of HD-02, published in the January 24, 2006, issue of Neurology, demonstrated that the drug was safe and well- tolerated at a dose of 8 g/day in HD patients. HD-02 patients also showed reduced levels of an oxidative marker, serum 8-hydroxy-2'-deoxyguanosine, which some researchers have linked to reduced oxidative injury in patients with Huntington's disease. Earlier preclinical trials examining the effects of HD-02 in a model of Huntington's disease showed significantly improved survival and slowed the rate of brain atrophy.
"We are continuing to move our HD program forward, and I am very encouraged by the Phase I/II results as well as by our previous clinical and pre-clinical data," stated Belinda Tsao-Nivaggioli, Avicena's chief executive officer. "To date, HD-02 has shown significant potential in Huntington's disease, and based on the results of this toxicology study, we expect to initiate a Phase III trial for HD-02 in 2007."
