Cerimon Pharmaceuticals Initiates Phase II Study to Evaluate Simulect(R) (Basiliximab) for Noninfectio...( SOUTH SAN FRANCISCO July 9 /- Cer...),Health

SOUTH SAN FRANCISCO, July 9 /PRNewswire/ -- Cerimon Pharmaceuticals, Inc., announced today it has initiated a Phase II proof-of-concept study of Simulect(R) (basiliximab) for the treatment of noninfectious uveitis, a chronic and potentially sight-threatening inflammation of the eye. The randomized, double-masked, placebo-controlled study will evaluate the safety and efficacy of Simulect as maintenance therapy in 56 patients. During the study, patients will undergo tapering of concomitant immunosuppressive medications, the mainstay of treatments for noninfectious uveitis. This is the second mid-stage trial for basiliximab run by Cerimon, which began a Phase IIb study for patients with moderate-to-severe, steroid-refractory ulcerative colitis (UC) in April 2007.

"The initiation of this proof-of-concept study is part of our overall strategy to seek additional indications for already marketed drugs in areas with significant unmet medical needs," stated Paul Sekhri, President and CEO of Cerimon Pharmaceuticals. "In noninfectious uveitis, we believe Simulect has the potential to significantly improve the quality of life for patients by reducing adverse events often associated with oral or topical corticosteroids while maintaining effective control of their inflammation."

Basiliximab is a monoclonal antibody that selectively blocks the interleukin-2 (IL-2) receptor. This mechanism of action provides highly targeted inhibition of the T-lymphocyte activation that is involved in serious immune-related diseases including noninfectious uveitis. In February 2006, the Company licensed basiliximab from Novartis Pharma AG for the treatment of Inflammatory Bowel Disease (IBD) and initiated a Phase IIb clinical study for the treatment of moderate-to-severe, steroid-refractory ulcerative colitis the following year. In December 2007, Cerimon entered into an agreement with Novartis to conduct a proof-of-concept study for basiliximab for the treatment of noninfectiou
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