Cerimon Pharmaceuticals Initiates ARREST UC-1, A Global Phase 2b Study Of Basiliximab In Patients With Steroid-Refractory Ulcerative Colitis

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Acid Reflux / GERD;  Clinical Trials / Drug Trials
Article Date: 05 Apr 2007 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Cerimon Pharmaceuticals, Inc., announced today it has begun enrolling patients in a Phase 2b clinical study, for its lead product candidate basiliximab (Simulect(R)), titled ARREST UC-1 (Achieve Remission & Reduce or Eliminate Steroid Therapy in Ulcerative Colitis) for the treatment of ulcerative colitis, a common type of Inflammatory Bowel Disease (IBD). This randomized, double-blind, placebo-controlled study will enroll a total of 135 patients and will study the safety, efficacy, and pharmacokinetics of a 3-dose induction regimen of basiliximab in patients with moderate to severe ulcerative colitis who are not responding to a standard course of oral corticosteroids.

Basiliximab is a monoclonal antibody that selectively blocks the interleukin-2 (IL-2) receptor. Cerimon believes basiliximab's highly targeted inhibition of T-lymphocyte activation will result in a safe and effective treatment for IBD. In February 2006, Cerimon licensed the exclusive worldwide rights to develop and commercialize basiliximab for the treatment of IBD, including ulcerative colitis, from Novartis Pharma AG, who continues to market the compound as Simulect(R) in transplantation indications.

"There is a significant need for improved therapies in ulcerative colitis, and we believe basiliximab's proven ability to target and block the IL-2 receptor makes it an ideal candidate for the treatment of this serious form of IBD," commented Paul Sekhri, President and CEO of Cerimon Pharmaceuticals. "The initiation of the ARREST UC-1 Phase 2b study is a watershed event for Cerimon, as it represents the tremendous progress we have made in a very short time. In just over a year, we have secured significant capital through our successful Series A financing and we have in-licensed a promising pipeline with which to establish our pharmaceutical business focusing on autoimmune disease and associated conditions."

About Inflammatory Bowel Disease

Ulcerative colitis (UC) and Crohn's disease (CD), collectively referred to as Inflammatory Bowel Disease, are chronic recurrent autoimmune diseases affecting the gut. UC and CD are characterized by the inflammation of the lining and, in the case of CD, other layers of the lower digestive tract and involve a dysregulation of the body's immune system. IBD is thought to be caused by the influence of several factors, including genetic predisposition and environmental precipitants that influence the gastrointestinal tract's response to the presence of normal and pathogenic bacteria in the gut. The result is an abnormal immune response, causing chronic inflammation of the intestinal wall.

About Cerimon Pharmaceuticals

Cerimon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to developing and commercializing therapeutic products for the physician who specializes in treating autoimmune diseases and associated conditions. The Company also has an asset in pain management. Cerimon employs a corporate strategy of in-licensing late-stage or marketed drugs to reduce the development and regulatory risk, decrease time to market, and expand the commercial potential of known drugs.

Cerimon currently has two drugs in development, basiliximab, which entered Phase 2b studies in early 2007 for moderate-to-severe steroid-refractory ulcerative colitis and a topical formulation of diclofenac sodium for the treatment of osteoarthritis and musculoskeletal pain that will enter clinical testing in the US in 2007. The Company is well financed, having closed a $70 million Series A financing in late 2005 with the premier investors MPM, Nomura Phase 4 Ventures, and OrbiMed Advisors.

Simulect(R) is a registered product of Novartis Pharma AG.

Cerimon Pharmaceuticals, Inc.
http://www.cerimon.com