SEOUL, South Korea, May 31, 2011 /PRNewswire/ -- CrystalGenomics, Inc. (Seoul, Korea) and CG Pharmaceuticals, Inc. (Emeryville, California), a biopharmaceutical company with 3 clinical stage candidates, has announced that the first patient has been enrolled for a Phase 2b clinical study of CG100649, CrystalGenomics' clinical stage novel NSAID candidate, in patients with knee or hip osteoarthritis (OA).
CG100649 is a first-in-class NSAID drug candidate that is a dual inhibitor of COX-2 and carbonic anhydrase (CA). CG100649's interaction with carbonic anhydrase in red blood cells provides it with a novel "tissue-specific" transport mechanism that is designed to deliver sustained levels of drug to inflamed tissues, while maintaining low systemic exposure. Its unique dual COX-2 and CA binding properties are designed to provide potentially superior safety to cardiovascular, renal, and gastrointestinal tissues compared to traditional NSAIDs or COX-2 inhibitor drugs.
An earlier placebo-controlled Phase 2a efficacy study in hip and knee in 248 OA patients in Europe showed that a 1.2 mg daily dose provided a highly significant efficacy profile vs. the three major OA symptoms of pain, stiffness, and physical disability. Although this was not an active-comparator trial, the efficacy profile of CG100649 appeared to be at least as favorable as other COX-2 drugs. This prompted CrystalGenomics to conduct a supra-threshold Phase 1 Multiple Ascending Dose (MAD) study in healthy subjects last year that showed that higher doses of CG100649 (2, 4, or 8 mg per day) are likely to provide even higher levels of efficacy while maintaining CG100649's favorable safety profile.
The current Phase 2b study is a double-blind, randomized, multicenter, non-inferiority, repeat dose study of CG100649 versus celecoxib (Celebrex®) in OA patients. This is the first time that the OA efficacy of CG100649 is being tested directly against celecoxib in the same clin
|SOURCE CrystalGenomics, Inc.|
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