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The Phase II prospective, randomized, multi-center, dose ranging study is designed to evaluate the efficacy and safety of PF-04523655 versus laser therapy in 160 patients with DME. Eligible patients will be randomized to receive intravitreal injections of one of three dose levels of PF-04523655 or laser. Therapeutic effect will be evaluated through visual acuity and retina morphological examinations conducted over a 36-month follow up period.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc. is a development-stage pharmaceutical company engaged in discovering and developing novel therapeutic RNAi drug candidates. Quark has a fully integrated drug development platform that spans therapeutic target identification to drug development. Quark's RNAi technology includes novel siRNA structures and chemistry that the Company believes provide Quark with freedom to operate in the siRNA intellectual property arena, as well as the ability to deliver siRNA locally and systemically to organs including the eye, ear, kidney, lung, spinal cord and bone marrow.
PF-4523655 (RTP801i-14), currently in Phase II clinical trials, is a synthetic, chemically modified, siRNA molecule to inhibit the expression of the gene RTP801. In addition, Quark's current clinical pipeline includes AKIi-5, developed by Quark for the prevention of acute kidney injury (AKI) following major cardiac surgery, currently in Phase I/IIa clinical trials via systemic delivery. Based on publicly available information, Quark believes this was the first siRNA delivered systemically in a human clinical trial. The Company has structure related technology licenses from Silence Therapeutics and from Alnylam.
In addition, Quark has a broad pipeline of siRNA drug candidates based
a novel structure developed internally. The Company expects to utilize the
structure to develop add
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