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Coronado Biosciences Announces Phase 2 Study Evaluating TSO in Ulcerative Colitis

BURLINGTON, Mass., Dec. 21, 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 signing of a Clinical Trial Agreement between the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and Coronado Biosciences to evaluate TSO (Trichuris suis ova or CNDO-201) for the treatment of ulcerative colitis (UC) in a phase 2 clinical trial. This multi-center study will be conducted by the NIAID-funded Autoimmunity Centers of Excellence (ACE).

"We are pleased that the ACE and NIAID have decided to fund a multi-million dollar study to evaluate TSO in UC patients, which shows further support for the hygiene hypothesis and TSO. Having this agreement in place advances the clinical development of TSO in ulcerative colitis into a phase 2 trial," said Dr. Bobby W. Sandage, Jr., President and CEO of Coronado. "This study further builds on our strategy of continuing support for investigator-initiated clinical trials evaluating TSO in a broad range of autoimmune diseases, while focusing our internal clinical development efforts and resources on our lead indication, Crohn's disease."

The phase 2 trial is a randomized, double-blind, placebo-controlled clinical study designed to examine the safety and efficacy of TSO treatment in active left-sided ulcerative colitis and its effects on mucosal immune state and microbiota. The trial will randomize 120 people in a 1:1 ratio to receive either TSO 7500 or placebo. Participants will receive six doses of TSO 7500 or placebo orally every other week over a 12-week treatment period. The trial will evaluate the effect of TSO on clinical response of UC, intestinal mucosal immunological response, and inflammatory markers. The primary endpoint will be the percentage of patients who achieve response (reduction of UCDAI of ≥ 3) by Week 12. The trial is planned to begin during the first quarter of 2013.

Stephen Hanauer, MD, the Principal Investigator of the study, is a Professor of Medicine and Clinical Pharmacology at the University of Chicago, where he is currently Chief of Gastroenterology, Hepatology and Nutrition and Director of The Logan Center for GI Clinical Research. Dr. Hanauer is a world leader in the treatment of inflammatory bowel diseases (IBD).

"We are very excited to work with the NIH and Coronado to evaluate the potential of TSO as a treatment for ulcerative colitis," stated Dr. Hanauer. "One of the exciting aspects of the Autoimmunity Centers of Excellence grants is the translational research component of the trial that should provide further insights into the mechanism of action of TSO with regards to genetics, the microbiome and the impact on chronic immune-mediated inflammation."

About Ulcerative Colitis

Inflammatory bowel disease (IBD) encompasses Crohn's disease (Crohn's) and ulcerative colitis (UC), chronic immune-mediated inflammatory diseases, in which the intestines (small and large intestines or bowels) become inflamed (red and swollen). This inflammation causes symptoms such as severe or chronic pain in the abdomen, diarrhea that may be bloody, weight loss, loss of appetite, bleeding from the rectum, joint pain, fever and skin problems. Symptoms can range from mild to severe and account for hundreds of thousands of physician visits and hospitalizations, annually, in the U.S. Treatments for IBD are aimed at inducing and maintaining symptomatic relief and healing of the inflammation (remissions). Once healed, therapies are directed to prevent recurrence (flare-ups) that are commonplace when acute treatments are stopped.

The most common forms of IBD are Crohn's disease and ulcerative colitis. In both Crohn's and UC, the mucosal inflammation generates large amounts of cytokines, immune messenger molecules  such as IFN-y and TNF-α, which is why drugs blocking these cytokines have been shown to be effective in controlling symptoms. The main difference between the two diseases is the parts of the digestive tract they affect.

Ulcerative colitis affects the superficial layer of the large intestine and causes swelling and tiny open sores, or ulcers, to form on the surface of the lining. The ulcers can bleed and produce pus. In severe cases of ulcerative colitis, ulcers may weaken the intestinal wall so much that ulcers develop. Ulcerative colitis can occur in people of any age, but it usually starts between the ages of 15 and 30. It affects men and women equally and appears to run in families, with reports of up to 20 percent of people with ulcerative colitis having a family member or relative with ulcerative colitis or Crohn's disease.

Standard therapy for the symptomatic treatment may include sulfasalazine, mesalazine, systemic and topical glucocorticoids, immunosuppressants like azathioprine or 6-mercaptopurine, and in severe cases also treatment with anti-TNF-α therapy, methotrexate, or cyclosporine as monotherapy or in combination with other agents. About 25-40 percent of patients are ultimately faced with surgery to remove sections of the diseased intestine. When the entire large intestine is removed, the patients can be completely cured. According to a 2012 Decision Resources report, in the U.S., the prevalence of ulcerative colitis in 2011 was 582,000 patients and there are about 1.1 million Americans living with IBD.

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 percent 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), multiple myeloma and solid tumors.  For more information, please visit www.coronadobiosciences.com.  

The Coronado Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13033

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.

CONTACT: Lucy Lu, MD Executive Vice President & Chief Financial Officer Coronado Biosciences, Inc. 781-652-4525; ir@coronadobio.com Tricia Swanson, Associate The Trout Group, LLC. 646-378-2953; tswanson@troutgroup.com Susan Forman Dian Griesel Inc. 212-825-3210; susan@dgicomm.com

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