Diversigen, Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ:OSUR), and Alimentiv Inc. (formerly Robarts Clinical Trials) today announced they have signed a collaboration agreement for a research study on patients with Acute Severe Ulcerative Colitis (ASUC).
The study, titled: “Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis (PROTOS Study),” is designed to provide new insights into the molecular determinants of response to infliximab (IFX) in patients with ASUC. Under the terms of the agreement, the companies will co-fund the study. ASUC is the most aggressive presentation of ulcerative colitis (UC), and occurs in 15 percent of adults and children with UC. Thirty patients with ASUC who are starting infliximab in an acute setting will be recruited for the study.
The results will be jointly owned by Diversigen and Alimentiv, and the data will be co-published upon completion of the study.
“This is an exciting collaboration whereby we can apply our full gamut of precision medicine tools to better understand the molecular factors influencing drug response, which may provide the potential to address an unmet medical need in patients with ASUC,” said Dr. Niels Vande Casteele, Director, Precision Medicine, Alimentiv Inc. and Assistant Professor of Medicine, University of California San Diego. “We believe that Diversigen is the best partner for this precision medicine study given their outstanding track record of studying the microbiome in clinical trials. Our team is thrilled about the prospect of working with such a successful partner.”
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“Alimentiv is recognized for their expertise in inflammatory bowel disease (IBD) and clinical trial design and are at the forefront of accelerating gastro-intestinal (GI) drug development with precision medicine,” said Joy Nassif, Vice President, Services at Diversigen Inc. “We are proud that they are utilizing Diversigen’s science-driven, high-quality CLIA-customized solutions for metagenomics sequencing, bioinformatics, and statistical analysis for the study of the microbiome and look forward to deriving new insights that could lead to improvements in the treatment of patients with ASUC.”
Together Diversigen and Alimentiv will deliver end-to-end support for this precision medicine study. Alimentiv will leverage Diversigen’s expertise in metagenomic sequencing and analysis of the cohort samples. As overall study sponsor, Alimentiv will provide full service clinical study management, imaging and precision medicine services.
Source: BioSpace
