Celgene Corporation has reported better than expected phase II data evaluating CC-10004 as a potential oral therapy for patients with severe plaque-type psoriasis.
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.
At the 64th American Academy of Dermatology meeting, Dr Alice Bendix Gottlieb, professor of medicine at 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% of enrolled patients demonstrated improvement in their psoriasis symptoms with 15.8% of these patients showing a greater than 50% reduction in their psoriasis area and severity index (PASI) score.
In addition, 53.3% of the evaluable 15 patients demonstrated greater than 20% reduction in epidermal skin thickness, the protocol-defined definition of pharmacodynamic response. The mean reduction of epidermal thickness among the evaluable patients was 20.5%.
Furthermore, 52.9% of enrolled patients showed an improvement in their physician's global assessment scores and 58.8% showed a reduction in their psoriasis body surface area scores.
"We are very encouraged with the results of the psoriasis trials as they exceeded the predetermined guidelines we had established," said Dr Jerome Zeldis, Celgene's chief medical officer. "Based on these results, we are accelerating our clinical program and are moving forward with an adequate and well-controlled multi-center study."
