Positive Clinical Data on CC-10004 Confirms Potential as Novel Oral Approach to Treating Inflammatory DiseasesCelgene to Advance Clinical and Regulatory Development of Oral Anti-Inflammatory Franchise
SUMMIT, N.J., May 22, 2007 /PRNewswire-FirstCall/ -- Celgene Corporation announced its plans to advance the development of leading oral anti-inflammatory candidates across a broad range of inflammatory diseases. CC-10004 (apremilast), an oral TNF antagonist and anti-inflammatory agent has demonstrated significant activity and an excellent side effect profile in a placebo controlled proof-of-mechanism trial in psoriasis.
The multicenter, randomized, double blind, placebo-controlled Phase II study achieved the primary endpoint after 12 weeks of treatment with 24% of patients receiving CC-10004 twice daily achieving a PASI-75 score compared to 10% of those receiving placebo. The Psoriasis Area and Severity Index (PASI) is a standard measurement of response utilized to assess improvement in patients with moderate to severe psoriasis. In addition, 57% of patients receiving CC-10004 twice daily achieved a PASI-50 compared to 23% of those receiving placebo. Most importantly, patients receiving CC-10004 continued to improve over time.
"The data from the Phase II study in patients with moderate-to-severe psoriasis are clinically and statistically significant compared with placebo. In addition, patients continued to improve throughout the 12 week treatment regimen with an oral therapy that has a good side effect profile addressing an unmet medical need," said Alice Gottlieb, M.D., Ph.D., Dermatologist in Chief and Chair, Department of Dermatology of Tufts-New England Medical Center. "The PASI-90 response of 14% for CC-10004 is comparable to Enbrel dosed at 25 mg twice weekly."
Based on these results, Celgene is accelerating clinical and regulatory strategies for CC-10004 in psoriasis, psoriatic arthritis, rheumatoid arthritis and other inflammatory diseases. The Company is also initiating development plans to advance CC-11050 and other compounds from this class of oral TNF alpha inhibitors, as potential novel oral therapies for chronic inflammatory diseases.
"CC-10004 is a unique oral therapy that demonstrates reasonable efficacy and favorable safety profile in a moderate to severe psoriasis setting. The drug is clearly working," said Kim Papp, M.D., Ph.D., Assistant Clinical Professor of Medicine at the University of Western Ontario, Canada and a principle investigator of the Phase II study.
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%).
"These positive results validate the potential of our oral class of anti- inflammatory compounds," said Sol J. Barer, Ph.D., Chairman and Chief Executive Officer of Celgene Corporation. "We plan to evaluate multiple opportunities across a broad range of debilitating inflammatory diseases where there are limited effective oral treatment options for these devastating conditions."
About the Phase II Study
This Phase II study was a multicenter, randomized, double blind, placebo- controlled, parallel-group, dose comparison efficacy study in 260 patients with moderate-to-severe plaque-type psoriasis who were candidates for systemic therapy. Patients who participated in this study were required to have a minimum of a 6-month history of moderate-to-severe plaque-type psoriasis prior to enrollment.
About Chronic Inflammatory Diseases
Chronic inflammatory diseases are caused by persistent stimulus to tissues in the body over a prolonged period of time resulting in inflammation. This class of diseases includes immune-mediated conditions, such as rheumatoid arthritis and psoriasis, where a person's immune system attacks their own body tissues trying to heal and repair them, but ultimately causing inflammation. Chronic inflammatory diseases afflict millions of people worldwide and are a physical, social and economic burden to patients and their families. Despite the burden and prevalence of inflammatory diseases, there have been relatively few innovative breakthroughs in identifying their cause, treatment or cure.
CC-10004 is a member of a proprietary pipeline of novel small molecules with anti-inflammatory activities that inhibit the production of multiple proinflammatory mediators including, PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. CC-10004 is our lead investigational drug in this class of anti-inflammatory compounds. Based on promising results from proof-of-mechanism studies, Celgene is accelerating the evaluation of clinical and regulatory strategies around the development of CC-10004 and other anti-inflammatory agents into clinical trials designed to determine their potential across a broad range of debilitating inflammatory diseases.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.
CONTACT: David Gryska, Sr. Vice President and Chief Financial Officer,+1-908-673-9059, or Brian P. Gill, Vice President, CorporateCommunications, +1-908-673-9530, both of Celgene Corporation
Posted: May 2007