Qu Biologics

Qu Biologics

July 28, 2015 19:33 ET

Qu Biologics Begins Phase 2 Clinical Trial in Ulcerative Colitis

VANCOUVER, BRITISH COLUMBIA--(Marketwired - July 28, 2015) - Qu Biologics Inc., a biotechnology company developing Site Specific Immunomodulators (SSIs) that aim to restore normal immune function in the targeted organ, announced that it has initiated a Phase 2 clinical trial to study QBECO SSI for the treatment of ulcerative colitis.

Qu Biologics' clinical trial in ulcerative colitis has been initiated at the GI Research Institute in Vancouver, the first of at least four clinical trial sites in Canada. In the coming weeks, three additional sites will open in Edmonton, Calgary and Hamilton. All participants in the study will receive QBECO SSI treatment.

Qu Biologics' CEO Dr. Hal Gunn stated, "SSIs represent a promising new treatment option for inflammatory bowel disease designed to restore normal immune function rather than suppressing immune response." He added, "In combination with results from our Phase 2 trial in Crohn's disease expected in the first half of 2016, it is our hope that results from this ulcerative colitis clinical trial could provide further evidence supporting QBECO SSI as a potentially important new therapy for patients with inflammatory bowel disease."

Qu Biologics received a No Objection Letter (NOL) from Health Canada to proceed with the Phase 2 open-label, dose-ranging, proof-of-concept study to evaluate the safety, tolerability and efficacy of QBECO SSI for the treatment of patients with moderate-to-severe ulcerative colitis.

To learn more about this clinical trial, visit www.quibd.com or email ulcerativecolitis@quibd.com or call 1-855-209-9680.

Prior to this clinical trial, Qu Biologics' QBECO SSI was used in a compassionate use program to treat 12 patients living with inflammatory bowel disease (2 ulcerative colitis, 10 Crohn's disease). All 12 patients had a therapeutic response to treatment, with improvement in symptoms. Nine of the 12 patients went into clinical remission during SSI treatment. Of those patients, four remain in remission today, having continued in sustained remission after discontinuing all medications, including SSI treatment, more than three years ago. These patients have all had a follow-up colonoscopy and/or imaging confirming their remission. It is important to note that data collected in the compassionate use program were neither placebo-controlled nor blinded to the physician or patient. Accordingly, they represent a retrospectively-acquired, cumulative, preliminary experience from which proof of benefit of QBECO SSI treatment cannot be established. However, these observations are promising and are the precedent for the current Health Canada approved clinical studies of QBECO SSI treatment in patients with active, moderate to severe ulcerative colitis and Crohn's disease.

About Qu Biologics

Qu Biologics develops Site Specific Immunomodulators (SSIs), a novel class of immunotherapies that aim to restore the body's normal immune response. SSIs are designed to stimulate an innate immune response in targeted organs or tissues to reverse the chronic inflammation underlying many illnesses, including cancer and other immune-related diseases. The company is currently recruiting participants for clinical trials in Crohn's disease, ulcerative colitis and recurrent non-small cell lung cancer to study SSI treatment.

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, Chief Medical Officer Dr. Simon Sutcliffe, former CEO of the BC Cancer Agency and a distinguished clinician, scientist and leader in cancer control internationally, and Chief Scientific Officer Dr. David Mullins, Assistant Professor of Microbiology and Immunology in the Norris Cotton Cancer Center at the Geisel School of Medicine at Dartmouth, and recognized expert in immune cell trafficking to tumours. For more information, visit www.qubiologics.com or www.quibd.com.

Qu Biologics Inc. cautions you that statements included in this release that are not a description of historical facts may contain forward-looking statements. These forward-looking statements are only predictions and may involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements. Qu Biologics does not assume any obligation to update any forward-looking statements except as required by law.

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