VANCOUVER, BRITISH COLUMBIA -- (Marketwired) -- 05/30/13 -- Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs) that aim to "reboot" the body's innate immune system, is pleased to welcome internationally recognized gastroenterology experts Dr. Richard Fedorak and Dr. William Sandborn to the company's newly formed Inflammatory Bowel Disease (IBD) advisory team. Qu Biologics has developed the IBD advisory team to provide guidance and independent oversight of its new Phase 1/2 clinical trial of its investigational drug, QBECO Site Specific Immunomodulator (SSI) for Crohn's disease. The company launched the Crohn's disease clinical trial in March and is actively recruiting participants with moderate-to-severe Crohn's disease for this trial.
"We are very pleased to welcome Drs. Richard Fedorak and William Sandborn, two highly respected IBD experts, to our advisory team," commented Dr. Hal Gunn, CEO of Qu Biologics. "Crohn's disease affects an estimated half a million people in North America and our SSIs present a possible new treatment for people living with this disease. We are pleased with the safety data reported to date and we hope to affirm the safety profile in our current clinical trial. The preliminary data of sustained remission in a small number of patients is encouraging, although requires assessment in a larger study and we look forward to receiving ongoing guidance from our new IBD advisory team throughout our Crohn's disease clinical trial," Dr. Gunn added.
As reported to Health Canada in Qu Biologics' Clinical Trial Application, QBECO SSI has been administered to 121 patients, including 10 patients with Crohn's disease in compassionate use programs. The results were promising with all ten patients reporting improvement in symptoms while on SSI treatment. Seven of the ten patients reported full resolution of clinical symptoms with a course of SSI treatment of three months or more. Four of these patients have had sustained clinical remission after discontinuing all medication including SSI treatment. The longest case of clinical remission reported is still ongoing after almost three years. Three of the four patients reporting ongoing sustained remission after stopping all treatment have had follow-up colonoscopies or CT scan with confirmation of full remission. These patients were treated under a "compassionate" use program, not a controlled blinded clinical trial and therefore, these results do not provide proof of benefit.
QBECO SSI therapy was well-tolerated in the 121 compassionate use patients with no serious adverse events reported. A small number of patients reported increased redness or tenderness at the injection site or flu-like symptoms but these symptoms were transient and resolved within a few days with dose adjustment and without other treatment.
Qu Biologics received a no objection letter from Health Canada to conduct a Phase 1/2 clinical trial of its investigational new drug, QBECO SSI, for Crohn's disease. Qu Biologics is recruiting 60 adults with active moderate-to-severe Crohn's disease and will evaluate SSI efficacy in terms of clinical response and disease remission. The main purpose of this study will be to test whether this investigational treatment is safe and effective for the treatment of Crohn's disease.
Further information about this Crohn's disease clinical trial can be found at www.qucrohnstrial.com.
For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.
About Dr. Richard N. Fedorak, MD, FRCPC, FRCP (London), FRSC
A recipient of numerous awards, research fellowships and grants, Dr. Richard N. Fedorak is an internationally recognised expert in inflammatory bowel disease. He has an active basic gastrointestinal research laboratory in the area of mucosal immunology, inflammation, and membrane function and structure and leads a large gastrointestinal disease clinical research group. Dr. Fedorak serves on multiple national and international scientific advisory boards. He has published over 500 peer-reviewed manuscripts and book chapters, produced two patents on colonic-specific drug delivery, and has lectured around the world. He has multiple grant review committee memberships and editorial positions with front ranked gastrointestinal journals. Currently, Dr. Fedorak is Associate Vice President (Research) and Professor of Medicine in the Division of Gastroenterology at the University of Alberta and also serves as Director for both the Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR) and the Northern Alberta Clinical Trials and Research Centre (NACTRC). In addition, Dr. Fedorak is President of the Canadian Digestive Health Foundation (CDHF) and Chairman of the Research Committee, World Gastroenterology Organization. Dr. Fedorak received his medical degree with First Class Honours from the University of Alberta. His Gastroenterology Clinical and Research Fellowship training was carried out at the University of Chicago and Columbia University, New York.
About Dr. William J. Sandborn, MD
Dr. William Sandborn is an internationally recognized expert in the conduct of clinical trials in inflammatory bowel disease. Currently, Dr. Sandborn is a Professor of Medicine at the University of California San Diego and Director of the IBD Center and Chief of the Division of Gastroenterology for the UC San Diego Health System. He directs a large research unit where his supervises a multi-investigator team specializing in inflammatory bowel disease clinical trials. Dr. Sandborn has published over 447 peer reviewed articles including articles in the New England Journal of Medicine, the Lancet, JAMA, the Annals of Internal Medicine, and Gastroenterology. His research interests are clinical trials and clinical pharmacology related to inflammatory bowel disease. Dr. Sandborn completed a gastroenterology fellowship at the Mayo Clinic, where he also held positions of Professor of Medicine, Vice Chairman of the Division of Gastroenterology and Hepatology, and Associate Dean of Research for Intellectual Property and Industry Relations. He completed medical school and an internal medicine residency at Loma Linda University in Loma Linda California.
About Qu Biologics
Qu Biologics is a Vancouver-based private clinical stage biopharmaceutical company that develops Site Specific Immunomodulators (SSI), a novel class of immunotherapies that aim to reboot the body's innate immune system. SSIs are designed to stimulate an innate immune response in targeted organs or tissues to potentially reverse the chronic inflammation underlying many conditions including cancer, inflammatory bowel disease and arthritis.
Backed by a prestigious group of scientific advisors and board members, Qu Biologics is led by a management team that includes co-founder and CEO Dr. Hal Gunn, a physician and expert on the body's immune response to chronic disease; and Chief Medical Officer Dr. Simon Sutcliffe, former CEO of the BC Cancer Agency and a distinguished clinician, scientist and leader in cancer control in Canada and internationally.
Qu Biologics Inc. cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Qu Biologics' forward-looking statements due to the risks and uncertainties inherent in Qu Biologics' business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Qu Biologics does not assume any obligation to update any forward-looking statements except as required by law.
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