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Glenmark files for Phase I trials on asthma drug in UK

Our Bureau

Mumbai , Aug. 23

GLENMARK Pharmaceuticals S.A. (Switzerland) has filed for Phase I clinical trials of GRC 3886, its novel drug candidate for asthma and chronic obstructive pulmonary disease , in the UK. The trials are likely to be completed by March 2005, a company communication said.

The company, a wholly owned subsidiary of the Mumbai-based Glenmark Pharmaceuticals Ltd, made the filing with the Medicines and Healthcare Products Regulatory Agency in the UK.

The Phase I study will be conducted in the UK by Quintiles, a global contract research organisation, and is expected to commence in September. It will be conducted using single and multiple oral doses on healthy volunteers. The objective of this study is to assess the safety and bioavailability of GRC 3886 in humans, the company informed the BSE.

According to Mr Glenn Saldanha, Managing Director and Chief Executive Officer of the company, the demonstration of proof of concept in Phase I would instil confidence in potential licensing partners. The company would be studying doses from 1 mg to 25 mg in these trials.

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