Coronado Biosciences Announces Initiation of Investigator-Initiated Study Evaluating TSO in Ulcerative Colitis
- Category: DNA RNA and Cells
- Published on Tuesday, 07 August 2012 17:18
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BURLINGTON, MA, USA I August 7, 2012 I 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 ulcerative colitis (UC). The Study is being conducted by the NYU School of Medicine. Dr. Michael A. Poles, Associate Professor of Medicine, Gastroenterology, Microbiology and Pathology and Dr. P'ng Loke, Assistant Professor, Microbiology, from the NYU School of Medicine, are the Principal Investigators of the trial. Dr. Loke has acted as a scientific advisor to the company and in this role has received minimal compensation for his services.
"Coronado's clinical development strategy includes supporting investigator-initiated research 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," said Dr. Bobby W. Sandage, Jr., President and CEO of Coronado. "In addition to UC, we expect to support IISs evaluating TSO in numerous other autoimmune indications, including multiple sclerosis, psoriasis, rheumatoid arthritis, psoriatic arthritis, type-1 diabetes, and autism."
This UC trial is a randomized, double-blind, placebo-controlled, cross-over study designed to enroll 18 patients with active UC (Mayo score 6-10). Patients will receive either TSO (2500 ova) or placebo every other week for 12 weeks, and then cross-over to receive the other treatment for an additional 12 weeks for a total study period of 24 weeks. The primary outcome measure of the trial is change from baseline of mucus production at 12 and 24 weeks as assessed by histopathology. Additional outcome measures include change from baseline of effector lymphocyte populations (Th1, Th2, Th17, and T-regulatory cells), bacterial composition and attachment, gene expression, Mayo score and simple clinical colitis activity index. Additional study details can be found at www.clinicaltrials.gov
"The concept of helminthic therapy for ulcerative colitis is supported by experiments in mouse models as well as several clinical studies," stated Dr. Poles. "Dr. Loke and I hypothesize that treatment with TSO may lead to an anti-inflammatory immune response in some individuals with UC through an increase in intestinal mucus production and modulation of Th1, Th2, Th17, and T-regulatory effector lymphocyte populations."
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.
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.
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.
SOURCE: Coronado Biosciences