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BURLINGTON, Mass., Feb. 25, 2013 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc. (Nasdaq:CNDO), a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, announced today the initiation of an Investigator-Initiated Study (IIS) evaluating TSO (
Trichuris suis ova or CNDO-201) for the treatment of psoriasis. The first site initiated in the multicenter study is the Icahn School of Medicine at Mount Sinai (ISMMS). Dr. Mark G. Lebwohl, Sol and Clara Kest Professor and Chairman of the Department of Dermatology, is the Principal Investigator of the trial at ISMMS.
"We are excited to be working with Mount Sinai and Professor Lebwohl, a renowned thought leader, in our pursuit of potential treatments of diseases for our lead program, TSO, where the hygiene hypothesis and immunology are important for their basic epidemiology," said Dr. Karin Hehenberger, Executive Vice President & Chief Medical Officer of Coronado. "Psoriasis is one of these diseases with critical medical need and we believe the objective nature of the assessment of progression or worsening of this disease lends itself well to this type of pilot trial."
This trial is an open-label study designed to enroll 20 patients with moderate to severe plaque psoriasis. ISMMS is the first of three sites which the company anticipates being involved in this study. Participants will receive eight doses of either TSO 2500 or TSO 7500 orally every other week over a 16-week treatment period. The trial will evaluate the effect of TSO on clinical response of psoriasis. The primary endpoint will be the average improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 16. The goal of the pilot study is to test for early safety and efficacy of TSO at two different doses.
Psoriasis (psoriasis vulgaris) is a chronic inflammatory skin disease characterized by red, scaly, raised plaques. The disease process is driven by T-cell infiltration and associated elevation in cytokine levels leading to increased cell division and aberrant differentiation, resulting in the psoriatic phenotype. Plaque psoriasis has a worldwide prevalence of 2-3%, and is a chronic, recurrent skin condition with varying degrees of severity. It is the most common autoimmune disease in the U.S. As many as 7.5 million Americans have psoriasis.