Celgene Corp (SUMMIT, New Jersey), an integrated global biopharmaceutical company engaged in the discovery, development, and commercialization of novel therapies for the treatment of inflammatory diseases and cancer, announced plans to advance its leading oral anti-inflammatory candidates to address a broad range of inflammatory diseases.

CC-10004 (apremilast), an orally bioavailable small molecule TNF-alpha antagonist and anti-inflammatory agent, showed positive clinical efficacy and safety data in a 260-patient, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison, phase II study in psoriasis. CC-10004 achieved its primary endpoint after 12 weeks of treatment, with 24% of patients with moderate-to-severe plaque-type psoriasis receiving the oral treatment twice daily achieving PASI-75 (Psoriasis Area and Severity Index -75) score, compared with 10% receiving placebo; 57% of patients receiving CC-10004 twice daily achieved PASI-50, compared with 23% receiving placebo. In addition, patients receiving CC-10004 twice daily, 14% of whom were achieving PASI-90, is comparable to etanercept (EnbrelR, Amgen/Wyeth Pharmaceuticals) dosed at 25 mg by subcutaneous injection twice weekly. Patients treated with CC-10004 continued to improve throughout the 12-week treatment regimen.

On the basis of these results, Celgene is accelerating clinical and regulatory strategies for CC-10004 in psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA), and other inflammatory diseases. The company also plans to advance CC-11050, an oral TNF-α inhibitor, and other compounds from this class as potential novel oral therapies for chronic inflammatory diseases.

Adverse side effects in patients receiving CC-10004 were mild and well tolerated. Overall, the percentage of patients who reported at least one adverse event in the CC-10004 twice daily arm (54%) was equivalent to that experienced with the placebo arm of the study (60%).

In addition to TNF-alpha, CC-10004 inhibits the production of multiple pro-inflammatory mediators including interleukin-2 (IL-2), IL-12, interferon-gamma, leukotrienes, phosphodiesterase-4, and nitric oxide synthase.

—A. Techman

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