Coronado Biosciences Announces Initiation of Investigator-Initiated Study Evaluating TSO in Autism Spectrum Disorders

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| Source: Coronado Biosciences

BURLINGTON, Mass., Nov. 12, 2012 (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 autism spectrum disorders (ASD). The study is being conducted by the Montefiore Medical Center, Albert Einstein College of Medicine. Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at the Albert Einstein College of Medicine and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and the Albert Einstein College of Medicine, is the Principal Investigator of the trial.

"Given the potential for TSO to be effective in treating a broad array of autoimmune disorders, we are eager to initiate a clinical trial in autism to explore the effects in additional indications. Recent research is pointing to a hyperactive immune system in people suffering from autism, as evidenced by increased levels of certain pro-inflammatory cytokines and the presence of autoantibodies," said Dr. Bobby W. Sandage, Jr., President and CEO of Coronado. "In addition to the TRUST-I trial, the company's phase 2 Crohn's study which was recently initiated, we plan to evaluate TSO in a number of other autoimmune diseases, including ulcerative colitis, multiple sclerosis, autism spectrum disorders, psoriasis, rheumatoid arthritis, psoriatic arthritis and Type 1 Diabetes."

This trial is a randomized, double-blind, placebo-controlled, cross-over study designed to enroll 10 patients who meet criteria for the diagnosis of autism spectrum disorders. Patients will receive placebo or TSO for 12 weeks, with a 4 week washout and then 12 weeks of the treatment not yet received. The goal of the pilot study is to test for early safety and efficacy of TSO compared to placebo on repetitive behaviors, irritability, global functioning and social cognition in adults with ASD. Additional study details can be found at www.clinicaltrials.gov

"This pilot study in young adults with autism spectrum disorders translates basic science findings on the role of inflammation in altering neurodevelopment in animals into a novel therapeutic strategy for targeting core and associated symptom domains of autism," stated Dr. Hollander. "It utilizes a biologic immunomodulator which has shown promise for the treatment of other immune-inflammatory illness to test for early safety and efficacy in adults with ASD."

About Autism Spectrum Disorders

Autism spectrum disorders (ASD) and autism are both general terms for a group of complex disorders of brain development. These disorders are characterized by three core symptoms: difficulties in social interaction, verbal and nonverbal communication and repetitive behaviors. Autism statistics from the U.S. Centers for Disease Control and Prevention (CDC) identify approximately 1 in 88 American children as on the autism spectrum. Studies also show that autism is four to five times more common among boys than girls. An estimated 1 out of 54 boys and 1 in 252 girls are diagnosed with autism in the United States. Autism Speaks, the world's leading autism science and advocacy organization, announced in March 2012 preliminary results of new research that estimates autism costs society $126 billion per year in the US – a number that has more than tripled since 2006.

About TSO

TSO (Trichuris suis ova or CNDO-201), 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.

In February 2012, the company 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. In August 2012, Coronado initiated TRUST- I (TRichUris Suis ova Trial), a phase 2 clinical trial of TSO in patients with Crohn's disease in the United States, which is expected to be completed in the second half of 2013.

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 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.

Lucy Lu, MD, Executive Vice President &
Chief Financial Officer
Coronado Biosciences, Inc.
781-652-4525; 

Tricia Swanson, Associate
The Trout Group, LLC.
646-378-2953; 

Susan Forman
Dian Griesel Inc.
212-825-3210;