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www.fdanews.com/articles/69857-study-of-psoraxine-for-psoriasis-does-not-meet-primary-study-endpoint

Study of Psoraxine for Psoriasis Does Not Meet Primary Study Endpoint

March 15, 2005

Astralis has announced that the Phase II study of its novel immunostimulatory product for the treatment of psoriasis did not meet the primary study endpoint upon completion of the treatment phase of the study.

In the study, Psoraxine was found to be safe and well-tolerated. The Phase II randomized, double-blind, placebo-controlled study involved 120 patients with moderate-to-severe psoriasis who received intramuscular injections of Psoraxine.

The primary endpoint of the study was a specified level of improvement of symptoms as measured in accordance with the Psoriasis Area and Severity Index, a measurement scale that ranks the severity of symptoms of patients suffering from psoriasis. Initial analysis of the preliminary data showed no statistically significant clinical improvement compared to placebo following six injections over twelve weeks of treatment.