Chennai: Orchid Chemicals & Pharmaceuticals, a city-based bulk drug major, has announced that its US drug discovery joint venture company, Bexel Pharmaceuticals, has received the approval from the Independent Ethics Committee for conducting phase-I human clinical trials for its novel anti-diabetic molecule (BLX-1002). The IEC is a designated body in Europe for reviewing protocols and results and approving molecules for going into further clinical tests.
BLX-1002 is an orally active small molecule for treatment of type-II diabetes. The molecule is distinctive in its class for not only its exceptional efficacy and safety, but also its unique anti-weight gain property. The molecule recently completed safety toxicity pre-clinical studies in the US both in small order animals like rodents and higher order animals like dogs. The phase-I human clinical study on the molecule, which will now be initiated in Europe from 15 December 2003, is scheduled to end by April 2004.
The molecule was also showcased with regard to its efficacy and safety at recent international conferences like International Diabetes Association (IDA) and American Diabetes Association (ADA) which evoked considerable interest. The phase-I clinical trial will be followed by phase-II (a) proof-of-concept studies in Europe.