re: successful trial ann
IN PSORIASIS Summary: • Solbec’s Phase I/IIa trial of Coramsine™ for the treatment of psoriasis has finished treating patients with no adverse events reported by the investigators. • The data gathered during the final stage of the trial will be un-blinded and analysis of efficacy undertaken. Perth, Australia. 9th February 2005. Solbec Pharmaceuticals Ltd (ASX:SBP) today announced that its Phase I (safety) trial of Coramsine™ in the treatment of psoriasis has reached its primary endpoint successfully and ahead of schedule. Phase I trials are primarily intended to demonstrate the safety of the compound under test and in reports to date, the investigating physicians did not note treatment-related adverse events during any stage of the trial. This clinical trial was conducted in three stages, the first two of which were concerned only with investigation of safety, tolerability and pharmacokinetics (time required for absorption, duration of action, distribution in the body, and excretion) in healthy individuals. The third stage recruited ten psoriasis patients and looked additionally at efficacy for 56 days. The efficacy element of the trial was conducted as a double-blind, within-patients design in which Coramsine™ cream was compared to placebo and a standard topical treatment for psoriasis. Patients applied each of the three creams to different areas of psoriasis without knowing which cream was which (patient “blinding”). The investigators were also not informed of which cream was used on which rash when they assessed response (investigator “blinding”). Following completion of the patient treatment, the investigators can be “unblinded” and compare efficacy between the creams. This means analysis of the findings of the trial’s third stage and reporting on the results. Solbec expects to receive the report early in the second quarter of 2005. Further information: Stephen Carter Managing Director Solbec Pharmaceuticals Ltd Phone +61 (08) 944 67555 [email protected] Media: Rebecca Christie Phone: +61 (02) 9293 2836 / 0417 382 391 [email protected]
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