CellGate Inc has announced positive results from a randomized Phase IIa clinical trial for psoriasis with the company's topical cyclosporine conjugate, PsorBan (CGC1072) ointment.

The double-blind placebo controlled trial evaluated safety and preliminary efficacy of two dose formulations (0.4% and 4.0%) of CellGate's proprietary topical cyclosporine conjugate ointment in 24 patients with mild to moderate plaque psoriasis. Subjects were randomized to receive one of the two strengths of the PsorBan ointment and an internal control vehicle in self-applied treatments over six weeks. The study lesions were evaluated using the psoriasis severity score (PSS), color photograph and the physician treatment preference. High dose CGC1072 exhibited benefits over placebo in both PSS and physician preferences scores. In side-by-side comparisons of two concentrations of CGC1072 with a vehicle control, blinded investigators preferred the actively treated side over the control 80 percent of the time. Higher concentration of CGC1072 resulted in an improvement in psoriasis severity scores as early as day fourteen. In addition, cyclosporine levels in the skin and blood were measured periodically, and, importantly, PsorBan ointment was able to show active drug tissue level in the same therapeutic range as oral cyclosporine in the skin, but blood levels of the drug were undetectable among the participants in the study. There were no serious adverse events.

"Data from this small pilot study suggests that CellGate's topically applied cyclosporine conjugate product, PsorBan, may improve psoriasis," said Dr. Kimball, a lead investigator on the study. "This novel topical treatment appears to be well tolerated, not absorbed systemically, and offers potential benefit in treating mild to moderate psoriatic patients without the associated systemic adverse effects typically associated with cyclosporine."