Qu Biologics, Inc., a biotech company that specializes in formulating Site Specific Immunomodulators (SSI) for the restoration of normal immune system function, has just announced that a Data Safety Monitoring Committee (DSMC) has completed a review of one of their pipeline product’s safety data from a 30-patient (50% enrollment) clinical trial. The product, QBECO SSI, is indicated for the treatment of Crohn’s disease and has received clearance to proceed with further clinical research, which the committee will continue to monitor.
The company’s ongoing trial plans to recruit a total of 60 US- and Canada-based participants diagnosed with moderate to severe Crohn’s disease. The testing site will be situated in Vancouver, British Columbia, Canada, and is currently 60% enrolled. The DSMC is tasked with setting standards of safety, monitoring these standards’ implementation for the trial participants and treatment efficacy data, and acting on behalf of patients whenever necessary.
“We are pleased to learn that safety data collected to date in our clinical trial has passed independent DSMC review,” said Hall Gunn, Chief Executive Officer, Qu Biologics, Inc. “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.”
QBECO SSI employs elements of inactive bacteria, modified to induce a normal response from the body’s immune system, thereby reducing or inhibiting chronic inflammation in various diseases such as cancer, autoimmune conditions, and inflammatory bowel diseases like Crohn’s disease.
The ongoing Phase 1/2 clinical trial was preceded by a 10-patient compassionate use program, which revealed all participants experienced improvement of symptoms while receiving the experimental SSI. Additionally, 7 participants achieved remission while on the medication, while 4 of this program’s participants achieved sustained remission even without treatment. The record for the longest remission stands at 4 years.
While these are impressive findings, the company would like to clarify that the compassionate use program was not placebo-controlled, nor was it blinded. These findings are therefore inconclusive, and only serves as a preview of what one can expect upon proceeding with further, more substantial research.
The company also announced they are targeting the 2nd quarter of 2015 for this clinical trial’s completion and publication of findings. In the meantime, Qu Biologics is working on launching a Phase 2a clinical research of QBKPN SSI, indicated for lung cancer; and another Phase 2a trial of QBECO SSI for use in ulcerative colitis.
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