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12:00 AM
 | 
Dec 22, 2008
 |  BioCentury  |  Product Development

Taking homework seriously

Despite having top-line Phase IIa data in hand showing efficacy for its NSAID in osteoarthritis, CrystalGenomics Inc.'s CG Pharmaceuticals Inc. unit is not rushing to get to Phase III. Instead, it is fleshing out its early stage development program, including an additional Phase I study against active comparators, with the aim of proving to FDA that the compound will avoid the cardiovascular risks associated with COX-2 inhibition.

FDA's Arthritis Advisory Committee made clear in its review of Merck & Co. Inc.'s Arcoxia COX-2 inhibitor that new NSAIDs should be superior in some way to approved NSAIDs(see BioCentury, April 16, 2007).

CG says its discussions with former regulators lead it to believe a robust early stage safety program including head-to-head studies and tests in high-risk patients may avoid a requirement for large outcomes studies prior to approval.

"We need to show we're at least as safe on GI and superior on cardiovascular in 'provocative' trials now, and in Phase III trials that include appropriate doses of comparator drugs," William Schmidt, CG's clinical and scientific consultant, told BioCentury. Provocative trials would test the compound's effects on safety in high-risk patients, for example, measuring effects on blood pressure in patients with hypertension.

Last week, CG reported a double-blind, European Phase IIa study (CG100649-2-01) in 248 patients with osteoarthritis (OA). It showed the high dose of CG100649 produced a clinically and statistically significant change in the WOMAC...

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