Coronado Initiates Phase 2 Clinical Trial of TSO for the Treatment of Crohn's Disease

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| Source: Coronado Biosciences

BURLINGTON, Mass., Aug. 14, 2012 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc., (Nasdaq:CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, announced today the initiation of TRUST- I (TRichUris Suis ova Trial), a Phase 2 clinical trial of TSO (Trichuris suis ova or CNDO-201) in patients with Crohn's disease. TSO, the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and inflammatory cytokines.

"Previous investigator-initiated trials have demonstrated TSO's therapeutic potential to induce response and remission rates in inflammatory bowel disease patients," said Dr. Bobby W. Sandage, Jr., Coronado's President and CEO. "This Phase 2 study will expand our understanding of TSO's clinical usefulness in patients with moderately to severely active Crohn's disease."

TRUST-I is a randomized, double-blind, placebo-controlled, U.S. multicenter study designed to evaluate the safety and efficacy of TSO. Approximately 220 patients with Crohn's disease will be enrolled and randomized to receive either 7500 ova or placebo once every 2 weeks, for 12 weeks. The primary endpoint for the study is induction of response, as measured by the Crohn's Disease Activity Index (CDAI), with induction of remission being the secondary endpoint. The study is expected to be completed in the second half of 2013. Additional study details can be found at www.clinicaltrials.gov.

Coronado's development partner for TSO in Crohn's disease, Dr. Falk Pharma GmbH, is also conducting a Phase 2 double-blind, randomized, placebo-controlled, multi-center study in Europe to evaluate the efficacy and safety of TSO in active Crohn's disease.

"The use of TSO in the treatment of Crohn's disease and other autoimmune disorders is based on the hygiene hypothesis, which suggests the immune systems of people living in developed countries with little or no exposure to parasites may not be able to properly regulate themselves. This hypothesis is further supported by epidemiologic findings of an inverse relationship between autoimmune diseases and helminthic colonization, as well as pre-clinical data in different disease models," said Dr. Karin Hehenberger, Coronado's Executive Vice President & Chief Medical Officer.

About TSO

TSO, the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and pro-inflammatory cytokines. The use of TSO as a therapeutic is based on the "hygiene hypothesis" and numerous animal and human studies. TSO was chosen as the biological agent of choice because it is not a human pathogen and is spontaneously eliminated from the body within several weeks after dosing.

The Company recently reported positive results from a Phase 1 clinical study of TSO in patients with Crohn's disease, where TSO was shown to be safe and well tolerated. The Phase 1 trial was a multi-center, sequential dose, dose-escalation, double-blind, placebo-controlled study of 36 patients with Crohn's disease.

Multiple investigator-sponsored clinical trials of TSO for the treatment of Crohn's disease, ulcerative colitis and multiple sclerosis have been completed in which TSO demonstrated benefit with regard to accepted outcome measurements of remission of disease and was shown to be well tolerated. In an open-label clinical trial with 29 patients reported in GUT in January 2005, TSO was shown to induce clinical remission in over 72% of patients with Crohn's disease after 24 weeks of treatment using the Crohn's Disease Activity Index as the primary outcome variable. As reported in the American Journal of Gastroenterology in April 2005, in a double-blind, randomized placebo-controlled trial in 54 patients with ulcerative colitis, TSO was shown to produce statistically significantly more responders than those treated with placebo (43.3% vs. 16.7%, p=.04).

About Coronado Biosciences

Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents.  The company's two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases, such as Crohn's disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML) and solid tumors. For more information, please visit www.coronadobiosciences.com.

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Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the company's product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to uncertainties relating to preclinical testing and clinical trials, the results of research and development activities, financing and strategic agreements and relationships, the early stage of products under development, our need for substantial additional funds, government regulation, patent and intellectual property matters; our dependence on third party suppliers and competition, as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

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