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Ception Therapeutics Initiates Phase II/III Clinical Trial for Its Lead Product Reslizumab in Eosinophilic Esophagitis (EE) in Children
Date:3/5/2008

FDA Also Grants Orphan Drug Status to Reslizumab for Pediatric EE

MALVERN, Pa., March 5 /PRNewswire/ -- Ception Therapeutics, Inc. announced today the initiation of a multi-center, Phase II/III clinical trial to evaluate reslizumab, a humanized monoclonal antibody (mAb) against interleukin-5 (IL-5), for the treatment of eosinophilic esophagitis (EE) in pediatric patients. EE is a chronic inflammatory disease characterized by difficulty swallowing, vomiting, stomach or chest pain, and a failure to thrive. IL-5 is the major cytokine responsible for the eosinophilic inflammation of the esophagus seen in this condition.

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to reslizumab for the treatment of pediatric EE. This designation is part of a well-established program designed to support the development of drugs for rare diseases which affect fewer than 200,000 people in the United States. Depending upon the study results, Ception expects to file a Biological License Application (BLA) with the FDA for reslizumab based on this study.

"The initiation of this study marks a major corporate milestone for Ception," said Steve Tullman, co-founder, President and CEO of Ception Therapeutics, Inc. "Over the last decade, awareness of EE has dramatically increased, but currently, there is no approved treatment. Children with this disease may suffer significant morbidity and it can be a challenge for them to maintain proper nutrition."

The study (Res-05-0002) is a randomized, double-blind trial of reslizumab versus placebo in the treatment of pediatric patients between 5 and 18 years of age with poorly-controlled EE. Subjects will be randomized to one of three active dose groups or placebo, administered at monthly intervals for four months. The co-primary endpoints of the study are changes in clinical symptoms and esophageal eosinophil levels at the end of therapy. The clinical study is being conducted at multiple cente
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SOURCE Ception Therapeutics, Inc.
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