SAN DIEGO, May 24 /PRNewswire/ -- Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases announced today that it has initiated its first North American and European pivotal Phase 3 clinical trial evaluating the efficacy and safety of AST-120 in patients with fistulizing Crohn’s disease.
“We are pleased to study a new alternative oral therapy for the treatment of Crohn’s disease patients who suffer from draining fistulas, a debilitating condition that affects 20-40 percent of Crohn’s patients,” stated Dr. Laurent Fischer, President and CEO, Ocera Therapeutics.
Data from a double blind, placebo controlled Japanese study of AST-120 in patients with Crohn’s disease suffering from anal fistulas will be presented today at the annual Digestive Disease Week conference in Los Angeles. The study entitled, “The Treatment with an Oral Spherical Adsorptive Carbon (AST-120) improves anal fistula, PDAI and CDAI scores - A Randomized Double-Blind Placebo-Controlled Trial” will be presented by Dr. Fukuda of Hyogo College of Medicine, Nishinomiya, Japan. The presentation will take place on Wednesday, May 24th at the Los Angeles Convention Center at 8:45 a.m. in the Petree C Room.
“The results of our study demonstrate a significant reduction in the number of draining fistulas in patients receiving AST-120 compared to placebo,” commented Dr. Fukuda, Associate Professor, Hyogo College of Medicine. “We are encouraged by these findings which show that AST-120 has the potential to be used as first-line therapy for the treatment of anal fistulizing Crohn’s disease.”
“Recent clinical data published last week in the Journal of the American Medical Association, show that some TNF alpha inhibitors seem to be associated with an increased risk of developing serious infections and malignancies,” commented Dr. Xavier Frapaise, Chief Medical Officer, Ocera Therapeutics. “Therefore, we are happy to have the opportunity to assess AST-120 in our clinical program as a new therapeutic alternative with a potentially significantly improved therapeutic risk benefit profile.”
About Ocera Therapeutics, Inc.
Ocera Therapeutics, Inc. is a privately-held biopharmaceutical company focused on the licensing, development and commercialization of proprietary clinical candidates to treat a broad range of gastrointestinal and liver diseases. Ocera Therapeutics was founded in 2005 by Laurent Fischer, M.D., Eckard Weber, M.D. and Domain Associates, LLC and is financed by Domain Associates and Thomas McNerney & Partners. Ocera in-licensed AST-120 from Kureha Corporation in Japan in 2005, and is engaged in the development of the compound in Crohn’s disease.
For more information on Ocera Therapeutics’ clinical trials, please visit: www.clinicaltrials.gov, keyword: AST-120.
Additional information on the Company can be found at www.oceratherapeutics.com.
Ocera Therapeutics, Inc.
CONTACT: Melissa Hill of Porter Novelli Life Sciences, +1-858-527-3482,mhill@pnlifesciences.com, for Ocera Therapeutics, Inc.; or Xavier FrapaiseM.D. of Ocera Therapeutics, Inc., +1-858-436-3900, xfrapaise@ocerainc.com
