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Qu Biologics Enrolls First Patient in Phase 1/2 Clinical Trial of QBECO SSI for the Treatment of Crohn's Disease

Jun 11 2013 12:00AM

Marketwire

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VANCOUVER, BRITISH COLUMBIA -- (Marketwired) -- 06/11/13 -- Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs) that aim to "reboot" the body's immune system, announced it has enrolled its first patient in a Phase 1/2 clinical trial of QBECO SSI for the treatment of Crohn's disease. The company recently launched the Crohn's disease clinical trial and is actively recruiting participants with moderate-to severe Crohn's disease.

"We are encouraged by the preliminary results of sustained remission of Crohn's disease in some patients that were treated with QBECO SSI in a small compassionate use program and hope to achieve the same level of efficacy in this larger, controlled study," said Dr. Hal Gunn, CEO of Qu Biologics. "QBECO SSI aims to stimulate the innate immune system to remove the underlying trigger for this disease and therefore, presents a possible new treatment option for people living with Crohn's disease," added Dr. Gunn.

Ten patients with Crohn's disease have been treated with QBECO SSI in a compassionate use program. All ten patients reported 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 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.

A total of 121 patients with cancer and autoimmune disease have been treated with QBECO SSI therapy. QBECO SSI was well-tolerated with no serious adverse events reported.

Qu Biologics received a no objection letter from Health Canada to conduct a Phase 1/2 clinical trial of its investigational new drug, QBECO SSI, for Crohn's disease. Qu Biologics is recruiting 60 adults with active moderate-to-severe Crohn's disease and will evaluate SSI efficacy in terms of clinical response and disease remission. The main purpose of this study will be to test whether this investigational treatment is safe and effective for the treatment of Crohn's disease.

For information about this Crohn's disease clinical trial, visit www.qucrohnstrial.com.

For information about Qu Biologics and the science behind SSIs, visit www.qubiologics.com.

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 autoimmune 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; 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.



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Contacts:
Qu Biologics Inc.
Julie Jang
Director, Communications
604.734.1450 ext.41491
julie@qubiologics.com
www.qubiologics.com





Source: Marketwire


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