Cerimon Pharmaceuticals Initiates Phase II Study To Evaluate Simulect(R) (Basiliximab) For Noninfectious Uveitis

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 10 Jul 2008 - 1:00 PDT

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Cerimon Pharmaceuticals, Inc., announced 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 noninfectious uveitis.

About Noninfectious Uveitis

Uveitis is an inflammation of the internal structures of the eye. Uveitis can be described by the underlying condition that causes it: autoimmune (noninfectious), bacterial, viral, parasitic and eye trauma, and by the part of the eye that it affects: anterior, intermediate, posterior and panuveitis. Noninfectious uveitis affects approximately two hundred forty thousand people worldwide and can lead to complications, such as glaucoma, cataract and total vision loss. Current treatments include topical and oral corticosteroids, steroidal implants and immunosuppressive drugs; however, these generally have limited success and can lead to adverse events.

About Cerimon Pharmaceuticals

Cerimon Pharmaceuticals, Inc., is a biopharmaceutical company dedicated to developing and commercializing therapeutic products for autoimmune diseases, inflammation and pain. Cerimon believes these new treatment options will enable physicians to further improve the lives of their patients.

Cerimon currently has two drugs in clinical development. The Company's autoimmune program has two development programs. The lead program is a Phase IIb study in which Simulect(R) (basiliximab) is being assessed as a treatment for moderate-to-severe, steroid-refractory ulcerative colitis (UC). The second program is studying Simulect as a treatment for noninfectious uveitis in a Phase II study. Cerimon's lead asset in its pain portfolio is the Company's topical formulations of diclofenac. The Company is in mid-stage clinical testing with its topical diclofenac products.

The Company continues to seek additional assets to add to its development pipeline and is financed by the premier investors MPM, Nomura Phase4 Ventures and OrbiMed Advisors.

For more information on Cerimon, please visit the Company's website at http://www.cerimon.com.

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

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