By IANS,
Mumbai : Piramal Life Sciences Ltd, part of the Piramal Group of companies, has commenced the clinical study of its P1736, a drug meant for the treatment of diabetes (type II), in the Netherlands.
Announcing this here Tuesday, the company said the oral drug would be tested on 72 normal, healthy volunteers to determine the safety and tolerance of the glucose lowering compound, P1736.
Piramal earlier submitted the clinical trial application (CTA) for P1736 to the Netherlands regulatory agency, the Central Commission on Medical Research Involving Human Subjects (CCMO) and the Independent Ethics Committee of the Foundation Evaluation of Ethics in Biomedical Research (BEBO).
Both these panls have approved the company’s application to initiate the phase I study of P1736.
The company also said that an oral presentation of the pre-clinical data pertaining to this compound will be made at the forthcoming congress of the American Diabetes Association (ADA), to be convened in June this year at San Francisco in the US.
Piramal managing director Somesh Sharma said the company was the sixth entity to enter the clinical trials for the diseases wherein there is a dearth of proper medicine.