Profil Institute for Clinical Research, Inc. provides early phase clinical research services in diabetes and obesity. It guides the developmental planning, design, and actual performance of early phase clinical studies, and helps its clients in the determination of whether a new compound should be carried forward into the later phases of clinical development. Profil Institute for Clinical Research, Inc. has a strategic alliance with Rosa & Co. LLC; and a strategic collaboration with DiaVacs, Inc. The company was founded in 2004 and is based in Chula Vista, California.
855 3rd Avenue
Chula Vista, CA 91911
Founded in 2004
DiaVacs Announces Strategic Collaboration with Profil Institute to Conduct Phase IB/IIA Randomized Clinical Trial of New Cell-Based Therapy for Type 1 Diabetes
Feb 12 14
DiaVacs, Inc. and Profil Institute for Clinical Research, Inc. announced a strategic collaboration to conduct DiaVacs' phase Ib/IIa clinical trial. This clinical trial will study the safety and preliminary efficacy of DiaVacs' novel dendritic cell therapy for treatment of type 1 diabetes in patients who are newly diagnosed. DiaVacs' proprietary technology is based on dendritic cell therapy. DiaVacs has perfected the immunology and technology to take a patient's own dendritic cells from their blood, modify them through the use of small interfering oligonucleotides, and then vaccinate the patient by simple injection of these modified cells under the skin using a small needle. The cells are taken up and trafficked to the pancreatic lymph nodes where they take up residence and induce tolerance. This cell-based therapy has been shown to be safe in phase I human trials and effective at halting disease progression in preclinical models of disease. The double-blind, placebo-controlled study will begin by first enrolling 10 subjects who are at least 18 years of age with newly diagnosed type 1 diabetes (< 6 months from diagnosis). A fifteen month commitment will be required of all study participants, including multiple visits to Profil Institute's San Diego clinical facility. Thereafter, the study will expand the inclusion criteria to include younger participants who are newly diagnosed. The primary efficacy endpoint of the study is evidence of the return of insulin secretion by the pancreas. Additionally, various immune markers will be assessed for evidence that the autoimmune process responsible for type 1 diabetes has been altered.
Profil Institute Announces Board Appointments
Nov 4 13
Profil Institute for Clinical Research, Inc. announced the appointment of Dan Bradbury, Managing Member of BioBrit, LLC and former Amylin Pharmaceutical CEO, to its Board of Directors. Mr. Bradbury joins Profil Institute's current Board Directors Dr. John Amatruda, a pharmaceutical research executive and former Senior Vice President and Head of Diabetes and Obesity at Merck Research Laboratories; Dr. Jerrold Olefsky, Professor of Medicine at the University of California, San Diego (UCSD) Division of Endocrinology and Metabolism and the Associate Dean of Scientific Affairs for the UCSD School of Medicine; Dr. Linda Morrow, Profil Institute's COO; and Dr. Marcus Hompesch, Profil Institute's President and CEO. Mr. Bradbury is a life sciences executive with over 30 years of experience creating and implementing strategies that transform businesses and bring novel medicines to market. He is currently Managing Member of BioBrit, LLC, a life sciences consulting and investment firm. Prior to that, Mr. Bradbury served as Amylin Pharmaceuticals' President, Chief Executive Officer and Director from 2007 until its acquisition by Bristol-Myers Squibb Company in 2012. Mr. Bradbury serves on the Board of Directors of Corcept Therapeutics, Geron Corporation, Illumina, Inc., BioMed Realty, Biocon Limited, Castle Biosciences, Inc. (Private), DiaVacs (Private) and Microdermis, Inc. (Private). He also serves on the Board of Trustees of the Keck Graduate Institute, the Investor Growth Capital Advisory Board, and the BioMed Ventures Advisory Committee. In addition to his Board positions, Mr. Bradbury serves on the University of California San Diego's Rady School of Management's Advisory Council and the University of Miami's Innovation Corporate Advisory Council.