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Quark Pharmaceuticals Announces First Patient Dosing by Pfizer in Phase II Trial of RNAi Therapy in Diabetic Macular Edema
Date:7/30/2008

Clinical Program Leverages Quark's RNAi Technology

FREMONT, Calif., July 30 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company discovering and developing novel RNA interference (RNAi)-based therapeutics, today announced that its partner, Pfizer Inc, initiated patient dosing in a Phase II trial evaluating

PF-4523655 (RTP801i-14) in patients with diabetic macular edema (DME).

PF-4523655 is a novel siRNA drug candidate being co-developed by Quark and Pfizer. As part of the companies' Global Licensing Agreement, the successful commencement of the trial triggers a milestone payment to Quark from Pfizer, a small percentage of which is payable by Quark to Silence Therapeutics and Alnylam as technology license milestone payments.

The Phase II prospective, randomized, dose-ranging study is evaluating the safety and efficacy of PF-4523655 versus laser therapy in 160 DME patients at multiple centers worldwide. PF-4523655 was designed to inhibit Quark's proprietary target RTP801, a gene involved in abnormal blood vessel development and leakage in the eye. Under the companies' Global Licensing Agreement, Pfizer has exclusive development rights to siRNA-mediated therapies that inhibit RTP801 for ophthalmic and non-ophthalmic indications, while Quark is eligible for development and sales based milestone payments.

Elena Feinstein, Chief Scientific Officer of Quark, commented, "By targeting the RTP801 gene, PF-4523655 is differentiated from other therapeutics for the same ophthalmic indications. While many competitors target VEGF and its receptors, PF-4523655 inhibits abnormal blood vessel growth and leakage independently of the VEGF pathway, reduces inflammation and suppresses apoptosis. Therefore,

PF-4523655 is a siRNA therapeutic candidate with the potential to be efficacious when used as a monotherapy and in combination with existing VEGF-based therapies."

Shai Erlich, Chief Development
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SOURCE Quark Pharmaceuticals, Inc.
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