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.
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