Glenmark's Lead Candidate For Pain, GRC 6211, Enters Phase I In Europe

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Glenmark's Lead Candidate For Pain, GRC 6211, Enters Phase I In

Europe

(MENTIONS NEUROPATHIC PAIN)

http://www.medicalnewstoday.com/medicalnews.php?newsid=58934

Glenmark Pharmaceuticals S.A. [GPSA], the wholly owned Swiss

subsidiary of Glenmark Pharmaceuticals Ltd. [Glenmark], has applied

for Phase I clinical trials in Europe, for GRC 6211, its leading

vanniloid receptor [VR1] antagonist compound for a range of pain

indications like osteoarthritis, dental pain, neuropathic pain and

urinary incontinence. This study will be conducted by Kendle, a

leading global CRO. The Phase I study will be conducted using

single and multiple oral doses with the objective of assessing

safety and bioavailability of GRC 6211 in healthy human beings.

Glenmark would also be conducting, in parallel, a Proof of Concept

[Phase IIA] study on patients with dental pain. Glenmark hopes to

complete Phase 1 by June 2007 and the dental pain study by October

2007.

Glenn Saldanha, Managing Director and CEO of Glenmark

Pharmaceuticals Ltd., on this occasion commented, " GRC 6211 is

Glenmark's third and an exciting molecule to enter the clinics from

its pipeline of six NCEs. The pain market is amongst the largest

markets and this novel target presents an excellent opportunity. "

Dr. Swaroop Kumar V. V. S., President - Drug Discovery & Clinical

Development, Glenmark stated, " Pre-clinical studies have

demonstrated GRC 6211 to be highly potent with functional IC50 of

3.8 nM and good bioavailability across species tested. The molecule

also exhibited greater than 2600 selectivity over other TRP

channels. "

Glenmark is also in discussions for potential licensing partners for

this compound. Timing of the licensing would depend on the deal

terms and ability to get co-promotion rights in some of the

regulated markets. The Company targets launching the molecule in

2011 and aims to be an early launcher in this class. Other

molecules in the same category currently under development include:

Merck's lead molecule which is in-licensed from Neurogen and has

progressed to Phase II, GSK's molecule presently in Phase II and

Pfize's in-licensed compound from Renovis which is undergoing pre-

clinicals trials.