Vancouver, British Columbia - October 29, 2014 - Qu Biologics Inc., a biotechnology company developing Site Specific Immunomodulators (SSIs) that aim to restore the body’s immune system, announced that an independent Data Safety Monitoring Committee (DSMC) has reviewed the safety data generated from 30 patients (50% enrollment) from Qu Biologics’ current Crohn’s disease clinical trial and has recommended that the trial continue as planned with continued safety monitoring.
The DSMC is an independent group of experts who monitor patient safety and treatment efficacy data while the Crohn’s clinical trial is ongoing. The Board provides an “arms length” review to act on behalf of patients enrolled in the clinical trial to ensure their safety and freedom from harm.
Qu Biologics’ Crohn’s disease clinical trial is a Phase 1/2, randomized, double-blinded, placebo-controlled trial recruiting 60 participants with moderate-to-severe Crohn’s disease from Canada and the U.S. The trial takes place in Vancouver, BC, and is now 60% enrolled. More information about the trial can be found at www.qucrohnstrial.com.
Qu Biologics’ CEO Dr. Hal Gunn stated, “We are pleased to learn that safety data collected to date in our clinical trial has passed independent DSMC review.” He added, “SSIs represent a new treatment approach by aiming to restore innate immune function in chronic conditions like Crohn’s disease and cancer. We believe that harnessing the body’s own immune response rather than blocking or disrupting a process may lead to safer and potentially more effective treatments.”
Qu Crohn’s trial involves the use of investigational treatment QBECO SSI, derived from components of inactivated bacteria, which aims to stimulate a normal immune response to reverse the chronic inflammation underlying Crohn’s disease.
Prior to this clinical trial, QBECO SSI was used to treat 10 patients with Crohn’s disease in a compassionate use program. In the program, all 10 patients reported clinical improvement while on SSI treatment, 7 went into clinical remission while on treatment and 4 patients have achieved ongoing sustained clinical remission off all medications including SSI treatment; the longest continues after more than four years. It’s important to note that data collected from the compassionate use program were neither placebo-controlled nor blinded to the physician or patient and therefore they represent a prospectively-acquired, cumulative, preliminary experience from which proof of benefit cannot be established.
Primary endpoint results from Qu’s Phase 1/2 Crohn’s disease clinical trial are expected in Q2 2015. Qu Biologics is also preparing to initiate a Phase 2a clinical trial of QBKPN SSI in lung cancer later this year and a Phase 2a clinical trial of QBECO SSI in ulcerative colitis in the first half of 2015.
About Qu Biologics
Qu Biologics develops Site Specific Immunomodulators (SSI), a novel class of immunotherapies that aim to reboot the body’s immune system. SSIs are designed to stimulate an immune response in targeted organs or tissues to potentially reverse the chronic inflammation underlying many conditions including cancer and immune-related disease. The company is currently recruiting participants for a Phase 1/2 clinical trial to research SSI therapy for the treatment of Crohn’s disease.
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 and www.qucrohnstrial.com.
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