Coronado Biosciences Announces Phase 1 Clinical Trial Results for TSO in Crohn's Disease

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| Source: Coronado Biosciences

BURLINGTON, Mass., Feb. 28, 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, today announced positive results from the Phase 1 clinical trial of TSO (Trichuris suis ova or CNDO-201) in patients with Crohn's disease. The study showed that TSO is safe and well tolerated. TSO, the microscopic eggs of the pig whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and inflammatory cytokines. 

The Phase 1 clinical trial was a multi-center, sequential dose-escalation, double-blind, placebo-controlled study of TSO in patients with Crohn's disease. The primary objective of the study was to evaluate the safety and tolerability of TSO. The trial enrolled 36 patients with Crohn's disease ranging in age from 20 to 54 with an equal distribution of male and female patients in three single dose cohorts of orally administered 500, 2500 and 7500 ova. Each cohort had twelve patients, with nine patients receiving TSO and three receiving placebo. Primary safety assessments were determined at day 14 post dose.

Overall, TSO was found to be safe and well tolerated across all three dose levels tested. There were only two adverse events (metallic taste and sour taste) that were considered to be study drug related as assessed by the Investigators, one which was reported in the 7500 ova dose group and the other in a patient receiving placebo, respectively. All other reported events were assessed as unrelated to study drug and were self-limiting. Mild gastrointestinal side effects such as nausea (in one placebo treated patient and two TSO treated patients) and diarrhea and/or abdominal pain (in two TSO treated patients) were reported. Safety laboratory values were assessed throughout the study and no clinically significant adverse trends were observed and no laboratory-related adverse events were reported. There were no serious adverse events reported and no patient discontinued the study prematurely.

"We are very pleased with the study results," said Dr. Bobby W. Sandage, Jr., Coronado's President and CEO. "These data are consistent with the numerous investigator sponsored trials and are supportive to our ongoing development program. We are on track to initiate our Phase 2 dose ranging study in the second quarter of this year."

About TSO

TSO, the microscopic eggs of the pig whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and 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.

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.

TSO has demonstrated efficacy in two clinical trials for inflammatory bowel disease, one in Crohn's disease and a second trial in ulcerative colitis. In an open-label clinical trial 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

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 risks relating to the results of research and development activities, uncertainties relating to preclinical and clinical testing, 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.

Investor Relations
Lucy Lu, MD
Executive Vice President & Chief Financial Officer
Coronado Biosciences, Inc.
781-238-6619; 

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The Trout Group, LLC.
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