SAN FRANCISCO, March 6 /PRNewswire-FirstCall/ -- Celgene Corporation announced that phase II data, evaluating CC-10004 - a novel compound with anti-inflammatory activities - as a potential oral-therapy for patients with severe plaque-type psoriasis, were reported at the 64th Annual American Academy of Dermatology meeting in San Francisco, Calif on Sunday, March 5, 2006.
Psoriasis is a lifelong skin disease that has been diagnosed in 4.5 million adults in the United States, according to the National Psoriasis Foundation, with up to 260,000 new cases diagnosed annually. The severity of psoriasis is measured by the percentage of psoriasis covering the body, and by the impact that psoriasis has on a patient's quality of life. More than 1.5 million Americans have moderate to severe psoriasis.
At the American Academy of Dermatology meeting, Dr. Alice Bendix Gottlieb M.D., Ph.D., Professor of Medicine, Tufts-New England Medical Center presented data from a Phase II trial evaluating the clinical response in patients with severe plaque psoriasis treated for 29 days with CC-10004. Dr. Gottlieb reported that that 73.7 percent of enrolled patients demonstrated improvement in their psoriasis symptoms with 15.8 percent of these patients showing a greater than 50 percent reduction in their PASI score. Eight (53.3 percent) of the evaluable 15 patients demonstrated greater than 20 percent reduction in epidermal skin thickness, the protocol-defined definition of pharmacodynamic response. The mean reduction of epidermal thickness among the 15 evaluable patients was 20.5 percent. Furthermore, 52.9 percent of enrolled patients showed an improvement in their physician's global assessment scores and 58.8 percent showed a reduction in their psoriasis body surface area scores.
About the Phase II Study
This pilot, open-label, single arm phase II study enrolled 19 patients with 15 patients having complete sets of evaluable biopsies and 17 patients evaluable for complete efficacy assessments. CC-10004 at 20mg was administered daily for 29 days with an additional 28-day observational follow-up period to monitor safety. Skin punch biopsy specimens of 6mm were obtained at baseline, day 15 and day 29 of the study. A nonlesional skin biopsy was also taken at baseline. The primary objective of the study was to assess the pharmacodynamic activity of CC-10004 by measuring the percent change from baseline in epidermal thickness at day 29. Psoriasis area and severity index (PASI), physician's global assessment (PGA) and body surface area measurements (BSA) were performed to assess clinical efficacy during the 29-day treatment phase of the study. Additional assessments for immunohistochemical changes were performed. No deaths were reported nor did any patient prematurely discontinue due to an adverse event. Adverse events observed were headache and nausea, and no clinically significant changes were noted in laboratory values.
"We are very encouraged with the results of the psoriasis trials as they exceeded the predetermined guidelines we had established," said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer of Celgene Corporation. "Based on these results, we are accelerating our clinical program and are moving forward with an adequate and well-controlled multi-center study. Additionally, due to the novel mechanism of action, we will be continuing to evaluate CC-1004 in other chronic inflammatory and rheumatologic indications."
About CC-10004
CC-10004 is a novel, orally available small molecule with anti- inflammatory activities that inhibits 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 the lead investigational drug in this class of anti-inflammatory compounds, and is being studied in Phase II proof of principle clinical trials for the treatment of psoriasis and other chronic inflammatory diseases. Based on promising results from these proof-of-principle studies, Celgene is advancing the clinical development of CC-10004 in moderate to severe plaque-type psoriasis. Early stage studies in healthy human volunteers found CC-10004 to be safe and well tolerated with good bioavailability and pharmacokenetics.
About Psoriasis
Psoriasis is a lifelong skin disease that has been diagnosed in 4.5 million adults in the United States, according to the National Psoriasis Foundation, with up to 260,000 new cases diagnosed annually. The most common form, plaque psoriasis, appears as raised, red patches or lesions covered with a silvery white buildup of dead skin cells, called scale. Psoriasis often appears between the ages of 15 and 35, but can develop at any age. The severity of psoriasis is measured by the percentage of psoriasis covering the body, but also measured by how psoriasis affects a person's quality of life. Psoriasis can have a serious impact even if it involves a small area, such as the face, palms of the hands or soles of the feet. About 30 percent of people with psoriasis have cases that are considered moderate to severe (generally meaning it covers more than three percent of their body). More than 1.5 million Americans have moderate to severe psoriasis. Severe types of psoriasis can compromise the skin's ability to control body temperature and prevent infections. Overall costs of treating psoriasis are estimated to exceed $3 billion annually.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at http://www.celgene.com.
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 10K, 10Q and 8K reports.
Celgene CorporationCONTACT: Robert J. Hugin Senior VP and CFO +1-908-673-9102, or Brian P.Gill, Director, PR/IR, +1-908-673-9530, both of Celgene Corporation
Web site: http://www.celgene.com//
