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In a Phase 2 Study PF-04523655 (RTP801I-14) Showed Improved Vision Over Standard of Care in Patients with Diabetic Macular Edema at 12 Months
Date:3/18/2011

FREMONT, Calif., March 18, 2011 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a pharmaceutical company engaged in the discovery and development of RNAi-based therapeutics, today announced that it has received results from a prospective randomized Phase 2 trial, the DEGAS study.  This study evaluated the safety and efficacy of PF-04523655 (RTP801I-14) in patients with diabetic macular edema (DME).  184 patients were randomly assigned to four treatment groups; three dose levels of PF-04523655 (RTP801I-14) (0.4mg, 1mg, and 3mg) or laser. The study was designed with a primary endpoint of mean visual acuity improvements over baseline at 24 months.  

Interim results at 12 months showed there were no drug related Serious Adverse Events (SAEs). Following 12 months of treatment with PF-04523655 (RTP801I-14), a dose dependent improvement in visual acuity was observed with the best results achieved at the 3mg dose level. At this dose, the mean improvement from baseline on a visual acuity test was 5.8 letters for all patients enrolled in this dose group while in patients treated with laser photocoagulation control (the current standard of care) visual acuity improved by only 2.4 letters on average (p=0.08).  Furthermore, in a separate secondary analysis of the 111 patients who completed the 12 month follow up visit, the mean improvement from baseline on a visual acuity test in the 3mg group was 9.1 letters while in patients treated with laser photocoagulation control visual acuity improved by only 3.2 letters on average (p<0.01).

The study was terminated at 12 months based upon this interim analysis suggesting that higher doses would be necessary to produce a therapeutic effect sufficiently superior to the current standard of care to benefit patients over the long term given emerging new therapeutic modalities.  Based upon these results, and in view of a dose related effect on vision, Quark and Pfizer have mutually agreed that a Pha
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SOURCE Quark Pharmaceuticals, Inc.
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