Quark diabetic macular edema drug advances in clinical trial

Quark Pharmaceuticals will receive a milestone payment of several million dollars from Pfizer.

RNA interference (RNAi)-based drug development company Quark Pharmaceuticals Ltd. has launched a Phase II clinical trial for its drug for the treatment diabetic macular edema (DME). Quark is developing the drug with Pfizer Inc. (NYSE; PFE; LSE: PFZ).

The trial, involving 160 DME patients worldwide, will evaluate the safety and efficacy of the drug compared laser therapy. The drug is designed to inhibit Quark’s proprietary target RTP801, a gene involved in abnormal blood vessel development and leakage in the eye. Under Quark's global licensing agreement with Pfizer, Quark will receive a milestone payment of several million dollars, and will in turn make small technology license milestone payments to Silence Therapeutics plc (AIM: SLN) and Alnylam Pharmaceuticals Inc. (Nasdaq: ALNY).

The drug previously underwent Phase I clinical trial for the treatment of wet age-related macular degeneration (wet-AMD) in patients who failed to respond to currently approved therapies. Based on data from this trial, Pfizer decided to pursue a Phase II trial of the drug for both DME and wet-AMD. The trial on wet-AMD is due to begin in a few months.

These trials will increase the number of clinical trials for Quark's drugs to four. Two products are undergoing Phase I clinical trials. These two products are not part of the company's contract with Pfizer, and Quark is pursuing and financing them independently. One product is for the treatment of acute renal failure, and the other is for dyslipidemia and metabolic syndrome to improve implant acceptance.

Quark's field of RNAi-based therapeutics has become a hot field in recent years. Merck & Co. Inc. (NYSE: MRK) acquired SiRNA Inc. for $1.1 billion and Alnylam Inc. has a market cap of $1.2 million.

Published by Globes [online], Israel business news - www.globes-online.com - on July 30, 2008

© Copyright of Globes Publisher Itonut (1983) Ltd. 2008

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