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Prometheus Announces New Method for Real-Time Monitoring of Patients Treated With Biologic Therapy

Friday, May 14, 2010 Press Release
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Data Presented at International Meeting, Awarded Poster of Distinction

SAN DIEGO, May 13 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced a new method for detecting antibody levels in individual patients treated with infliximab, a biologic therapy that has been used to treat more than a million patients across a number of autoimmune diseases, including rheumatoid arthritis, Crohn's disease and ulcerative colitis.
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Human anti-chimeric antibody (HACA) levels have been associated with decreased duration of response and increased side effects in infliximab-treated patients (1). Current methods for detecting HACA are limited by the presence of infliximab and therefore require a minimum of 8 weeks following therapy for accurate measurement. To overcome these limitations, Prometheus has developed a proprietary highly sensitive method to measure HACA and infliximab levels in patient serum in real time. The Company believes this method can also be applied to detect other biologic drugs and their antibodies.
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"Early and accurate detection of antibody levels during the course of biologic therapy may enhance our ability to assess reasons for loss of response," said David Rubin, M.D., Associate Professor of Medicine, Co-Director, University of Chicago Inflammatory Bowel Disease Center. "In addition, we anticipate that therapeutic monitoring of biologic therapy may become routine in our approach to individualizing therapies to maximize effectiveness and minimize adverse events."

Data from a preliminary study of this novel method for early detection of HACA during infliximab treatment were recently presented by Prometheus scientists at Digestive Disease Week (DDW), the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. The presentation, entitled "Measurement of Human Anti-Chimeric Antibodies (HACA) and Infliximab Levels in Patient Serum Using a Novel Homogeneous Assay," was awarded Poster of Distinction by the DDW sponsoring societies.

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with a comprehensive solution to treat chronic diseases. Prometheus' corporate offices are located in San Diego, California.

(1)Afif W et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 May;105(5):1133-9.

SOURCE Prometheus Laboratories Inc.

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