SOUTH SAN FRANCISCO, July 9 Cerimon Pharmaceuticals, Inc.,announced today it has initiated a Phase II proof-of-concept study ofSimulect(R) (basiliximab) for the treatment of noninfectious uveitis, achronic and potentially sight-threatening inflammation of the eye. Therandomized, double-masked, placebo-controlled study will evaluate the safetyand efficacy of Simulect as maintenance therapy in 56 patients. During thestudy, patients will undergo tapering of concomitant immunosuppressivemedications, the mainstay of treatments for noninfectious uveitis. This isthe second mid-stage trial for basiliximab run by Cerimon, which began a PhaseIIb study for patients with moderate-to-severe, steroid-refractory ulcerativecolitis (UC) in April 2007.
"The initiation of this proof-of-concept study is part of our overallstrategy to seek additional indications for already marketed drugs in areaswith significant unmet medical needs," stated Paul Sekhri, President and CEOof Cerimon Pharmaceuticals. "In noninfectious uveitis, we believe Simulecthas the potential to significantly improve the quality of life for patients byreducing adverse events often associated with oral or topical corticosteroidswhile maintaining effective control of their inflammation."
Basiliximab is a monoclonal antibody that selectively blocks theinterleukin-2 (IL-2) receptor. This mechanism of action provides highlytargeted inhibition of the T-lymphocyte activation that is involved in seriousimmune-related diseases including noninfectious uveitis. In February 2006,the Company licensed basiliximab from Novartis Pharma AG for the treatment ofInflammatory Bowel Disease (IBD) and initiated a Phase IIb clinical study forthe treatment of moderate-to-severe, steroid-refractory ulcerative colitis thefollowing year. In December 2007, Cerimon entered into an agreement withNovartis to conduct a proof-of-concept study for basiliximab for the treatmentof noninfectious uveitis.
About Noninfectious Uveitis
Uveitis is an inflammation of the internal structures of the eye. Uveitiscan be described by the underlying condition that causes it: autoimmune(noninfectious), bacterial, viral, parasitic and eye trauma, and by the partof the eye that it affects: anterior, intermediate, posterior and panuveitis.Noninfectious uveitis affects approximately two hundred forty thousand peopleworldwide and can lead to complications, such as glaucoma, cataract and totalvision loss. Current treatments include topical and oral corticosteroids,steroidal implants and immunosuppressive drugs; however, these generally havelimited success and can lead to adverse events.
About Cerimon Pharmaceuticals
Cerimon Pharmaceuticals, Inc., is a biopharmaceutical company dedicated todeveloping and commercializing therapeutic products for autoimmune diseases,inflammation and pain. Cerimon believes these new treatment options willenable physicians to further improve the lives of their patients.
Cerimon currently has two drugs in clinical development. The Company'sautoimmune program has two development programs. The lead program is a PhaseIIb study in which Simulect(R) (basiliximab) is being assessed as a treatmentfor moderate-to-severe, steroid-refractory ulcerative colitis (UC). Thesecond program is studying Simulect as a treatment for noninfectious uveitisin a Phase II study. Cerimon's lead asset in its pain portfolio is theCompany's topical formulations of diclofenac. The Company is in mid-stageclinical testing with its topical diclofenac products.
The Company continues to seek additional assets to add to its developmentpipeline and is financed by the premier investors MPM, Nomura Phase4 Venturesand OrbiMed Advisors.
For more information on Cerimon, please visit the Company's website athttp://www.cerimon.com .
SOURCE Cerimon Pharmaceuticals, Inc.