BioWorld International Correspondent
PARIS - NicOx SA is moving its lead compound, HCT 3012, into Phase III trials in osteoarthritis, following a "successful end-of-Phase II meeting" with the FDA.
HCT 3012 is one of a number of CINOD (Cox-Inhibiting, Nitric Oxide-Donating) compounds that NicOx, of Sophia-Antipolis, France, is developing for the treatment of pain and inflammation.
The company's CEO, Michele Garufi, said HCT 3012 offers "the potential to bring to osteoarthritis sufferers an effective new pain treatment with an improved cardiovascular and gastrointestinal safety profile."
The company said the Phase III trial will start in the U.S. in the second half of 2005, "subject to a further meeting on manufacturing and formulation with the FDA planned in the first quarter of next year."
An extensive program of Phase II trials, involving more than 2,700 patients, demonstrated that HCT 3012 is a "potent and safe anti-inflammatory" and that it has the potential to afford improved cardiovascular safety relative to NSAIDs (non-steroid anti-inflammatory drugs) and COX-2-selective NSAIDs.
NicOx pointed out that the profile is particularly relevant given the heightened awareness of the potential risks of COX-2-selective NSAIDS following the withdrawal of Vioxx (rofecoxib) from the market at the end of September.