Qu Biologics Release: Positive Feedback From FDA Reviewers In Response To Pre-IND Meeting Package
VANCOUVER, British Columbia, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a unique platform of immunotherapies designed to restore the body’s innate immune system, reports positive and informative feedback from the US Food and Drug Administration (FDA) in response to Qu’s first Pre-IND meeting package submission. The FDA provided informative feedback on important product development questions related to manufacturing, clinical trials and non-clinical testing that will guide Qu in its QBECO SSI development program for inflammatory bowel disease.
Dr. Hal Gunn, CEO of Qu Biologics, commented, “We are pleased with the feedback received from the FDA reviewers, which was consistent with our expectations and our development plans to initiate follow-on studies in Crohn’s disease and ulcerative colitis, and will inform our development program as we continue to move QBECO SSI for the treatment of patients with inflammatory bowel disease forward.”
Jim Pankovich, Qu Biologics’ VP Clinical Operations and Drug Development, stated, “Our three clinical trials to date have been conducted in Canada and we are pleased with our initial interactions with the US FDA and the potential to expand our future trials into the US. This initial positive interaction with the FDA is an important milestone for the company, providing a clear pathway forward to the initiation of clinical trials within the US."
For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.
About Qu Biologics
Qu Biologics is a Vancouver-based private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSI), a novel class of immunotherapies. SSIs are designed to stimulate an innate immune response in targeted organs or tissues to reverse the chronic inflammation underlying many conditions including cancer, inflammatory bowel disease, inflammatory lung disease and arthritis. SSIs are a broad platform technology being tested in multiple disease indications, including Health Canada approved clinical trials in lung cancer, Crohn’s disease and Ulcerative Colitis.
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.
For more information regarding this press release, contact: Hal Gunn, MD CEO Qu Biologics Inc. Phone: 604.734.1450 Email: email@example.com