PROTECT-1 Phase II/III Induction-Stage Results for ChemoCentryx's Traficet-EN(TM) Presented in Oral Session at DDW 2009 ...( Oral CCR9 Antagonist Demonstrates Cli...),Health

Oral CCR9 Antagonist Demonstrates Clinical Efficacy with Favorable Tolerability Profile

MOUNTAIN VIEW, Calif., June 1 /PRNewswire/ -- ChemoCentryx, Inc., announced that Phase II/III clinical data from the company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn's disease demonstrated evidence of clinical efficacy in the reduction of disease severity, as defined by a decrease from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points over the course of 12 weeks; the more stringent criterion of at least a 100 point decrease in the CDAI score was also met by week 12. In addition, Traficet-EN treatment resulted in colonoscopic evidence of improvement. These data, reported from the Induction Stage of the ongoing PROTECT-1 trial, were presented at Digestive Disease Week (DDW) 2009 in Chicago, IL, by Satish Keshav, M.D., Ph.D., Department of Gastroenterology, John Radcliffe Hospital, Oxford University, in an oral session today.

The study, "PROTECT-1 Study Demonstrated Efficacy of the Intestine-Specific Chemokine Receptor Antagonist CCX282-B (Traficet-EN) in Treatment of Patients with Moderate to Severe Crohn's Disease," showed that the 500 mg once-daily dose (QD) of Traficet-EN in patients with small bowel and/or colonic Crohn's disease was consistently superior to placebo across multiple efficacy endpoints. At week 12, the CDAI greater than or equal to 70-point response was 61 percent in the 500 mg QD group versus 47 percent for placebo (p=0.039). Similarly, the CDAI greater than or equal to 100-point response was 55 percent in this group versus 40 percent for placebo (p=0.029). In his oral presentation, Dr. Keshav further noted that colonoscopic evidence of improvement based on the Crohn's Disease Endoscopic Inde
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