Financial Daily from THE HINDU group of publications Saturday, Feb 25, 2006 |
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Announcements Glenmark trials on diabetes drug Our Bureau
Mumbai , Feb. 24 A prospective diabetes drug from Glenmark Pharmaceuticals Ltd has completed its first phase of trials on human beings. The drug molecule has entered the second phase of targeted human trials that will commence in South Africa. Glenmark's wholly-owned subsidiary Glenmark Pharmaceuticals SA said its lead DPP-IV inhibitor candidate for diabetes (GRC 8200) had successfully completed its Phase I study. The objective of the Phase I study was to assess the safety and bio-availability of GRC 8200 in humans and was conducted using single and multiple oral doses on 88 healthy volunteers. The study was filed with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and was conducted by clinical research organisation Parexel UK. The prospective drug molecule has now entered Phase II trials. These trials involve testing the drug on about 100-500 people suffering from the indications that the prospective medicine is targeting. Glenmark expects to file an Investigational New Drug application in the US for the drug molecule by May 2006 for further Phase II clinical testing. It expects to complete all Phase II trials by March 2007.
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