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Cerimon Pharmaceuticals Initiates Phase I Clinical Study of Topical Diclofenac Sodium Patch
Date:10/2/2007

Diclofenac Patch is Second Cerimon Product Candidate to Enter Clinical

Studies in 2007

SOUTH SAN FRANCISCO, Oct. 2 /PRNewswire/ -- Cerimon Pharmaceuticals, Inc., announced today it has initiated a Phase I clinical study of a novel diclofenac sodium patch, the Company's lead pain asset. The study will evaluate safety, tolerability, and systemic pharmacokinetics of a topical patch formulation of diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID), in 16 healthy volunteers. The Phase I study is expected to be completed in the fourth quarter of 2007. Following the completion of this study, Cerimon plans to rapidly initiate late-stage efficacy and safety studies of its diclofenac sodium patch in patients with acute musculoskeletal pain.

"Topical diclofenac is the second therapeutic product Cerimon has advanced into clinical studies this year, following the initiation of Phase IIb testing for Simulect(R) (basiliximab) in the first quarter," stated Paul Sekhri, President and CEO of Cerimon Pharmaceuticals. "We are proud of this progress and believe the diclofenac patch will address the market need for safe and effective topical pain therapies. Currently, topical NSAIDs are marketed in Europe, Japan, and other parts of the world, but not in the U.S. Their advantage in treating musculoskeletal pain is the ability to deliver drug directly to the affected area with minimal systemic exposure. Given the systemic side effects of traditional non-topical NSAIDs, as well as the withdrawal of some COX-2 inhibitors, we believe developing a new treatment option is an important goal for the medical community."

Pain Market

Musculoskeletal pain is pain that affects the muscles, ligaments, and tendons. Acute musculoskeletal injuries are common and can occur during sports activities, exercise, or other physical activities. They often result in pain due to soft tissue injuries, such as sprains, strains, and minor co
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SOURCE Cerimon Pharmaceuticals, Inc.
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