Never looked at this program before. Might have to check out the event (headache and nausea) rate.
SAN FRANCISCO, March 6 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG - News) 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.
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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 |
