Cour Pharmaceutical Development Company today announced new data from a preclinical live animal study demonstrating a breakthrough approach for celiac disease treatment. The data shows a reversal of the effects of dietary gluten exposure, and is being presented during the 16th Annual International Coeliac (Celiac) Disease Symposium being held June 21-24, 2015 in Prague, Czech Republic.
The third-party study conducted at the Haartman Institute of the University of Helsinki, tested Cour's novel bioengineered nanoparticles, COUR-NP-GLI, in an animal model of celiac disease. COUR-NP-GLI targets a broad set of gliadin proteins found in wheat gluten, the class of antigenic proteins generally accepted as the dominant cause of celiac disease. Treatment with COUR-NP-GLI ameliorated symptoms of celiac disease even during gluten consumption. Investigators in the study concluded:
- Cour-NP-GLI were safely administered via intravenous infusion.
- Cour-NP-GLI treated animals previously sensitized to gluten maintained normal body weight even during continued exposure to gluten containing diet.
- Cour-NP-GLI treated animals showed duodenal biopsies that were significantly improved over non-treated animals.
- Cour-NP-GLI treated animals showed significantly lower inflammatory cytokines compared to non-treated animals.
- Overall, treatment with Cour-NP-GLI was comparable to or better than animals maintained on a gluten free diet.
"This robust antigen specific nanoparticle therapy is a significant breakthrough in celiac treatment and has the potential to cure celiac patients rather than relying on gluten avoidance, immune suppressive regimens or dietary supplements," said Dr. Daniel Getts, Chief Science Officer at Cour, and Visiting Professor at Northwestern University.
Dr. Getts continued, "Along with Steve Miller at Northwestern University and Lonnie Shea at the University of Michigan, we've combined discoveries on immune tolerance and immune system modulation with novel bioengineered nanoparticles creating a broad platform of antigen specific nanoparticle therapies we believe will be transformational for celiac and other immune diseases."
The COUR-NP-GLI are Toleragenic Immune Modifying nanoParticles (TIMP) consisting of a safe proprietary polymer and antigenic proteins (gliadins). The antigens are fully encapsulated for safety and dosing is administered intravenously. Once processed, the TIMPs control and regulate the auto-reactive T-cells, the primary driver of disease. Cour's targeted antigen-specific therapy has been successfully studied across multiple disease models including multiple sclerosis, type 1 diabetes, food allergies and now celiac disease.
"For millions of patients and families who suffer from the debilitating effects of celiac disease, a restricted gluten-free diet is the only solution doctors can offer today. While there have been other claims made about potential cures, we have now demonstrated in animal models that we have a solution – a revolutionary breakthrough - that can change lives. With this confirmatory data in hand, we are assessing our partnering and financing alternatives and plan to begin human clinical trials as soon as we possibly can," said John J. Puisis, President and CEO of Cour Pharmaceuticals.
For more information and to see an overview of the data, visit www.courpharma.com.
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