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This clinical trial is about to change the Crohn's community as we know it. Learn what it is, how it works, and if you qualify to be apart of it.
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One Canadian biotech company hopes to provide a new way to treat patients living with Crohn’s disease. Qu Biologics Inc. is developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies intended to restore — instead of suppress — particular elements of innate immune function.
“While we are hopeful that our novel treatment approach may achieve long-term remission and reduce treatment burden for patients, we need to carry out the clinical studies that will show the treatment is safe and effective” says Dr. Hal Gunn, CEO and Co-Founder of Qu Biologics.
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Qu Biologics is currently conducting a phase 2 clinical trial for Canadians with moderate to severe Crohn’s disease. The company anticipates this trial will provide part of the evidence needed to establish QBECO safety and efficacy and support eventual marketing approval.
The company is actively recruiting patients in sites across Canada, including Hamilton, ON, New Westminster, BC and Vancouver, BC. If eligible, participants in the first study stage will receive the treatment for one year, via self-administered injections every other day. In the second stage QBECO will be compared to a placebo treatment.
“We will be assessing the clinical symptoms for each patient during the treatment period,” Dr. Gunn says. “Part of the assessment includes endoscopic examination to track any changes in the gastrointestinal tract, in addition to other tests for safety and effectiveness.”
For many Canadians suffering from Crohn’s, a lifetime of medication is a cumbersome course of treatment. Qu Biologics is encouraging patients who are interested and have moderate to severe Crohn’s symptom to visit restoretrial.ca to learn more and see if you are eligible by filling out the pre-screening questionnaire.
http://www.personalhealthnews.ca/pr...-investigational-treatment-for-crohns-disease
https://clinicaltrials.gov/ct2/show/NCT03472690 QBECO SSI for Clinical and Endoscopic remission in Moderate to Severe Crohn's Disease
Gastroenterol Res Pract. 2015;2015:231243. doi: 10.1155/2015/231243. Epub 2015 May 12.
Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease.
Bressler B1, Bethel KP2, Kleef R3, Reynolds SL4, Sutcliffe S4, Mullins DW5, Gunn H4.
Abstract
We investigated the mechanism of action, safety, and efficacy of the Site-Specific Immunomodulator (SSI) QBECO, a novel immunotherapy for Crohn's disease (CD). Using human monocytic THP-1 cells, we demonstrate that SSI QBECO (derived from the common colon bacteria E. coli) activates macrophages to an M1 phenotype (associated with enhanced capacity to eliminate bacteria and activate innate immune responses). We assessed SSI QBECO in a compassionate use protocol of ten adult patients with active CD. Patients with moderate to severe clinical symptoms receiving conventional CD treatments and/or complementary therapies were included, except patients receiving anti-TNF medications. SSI QBECO was self-administered subcutaneously every second day, for a minimum of 2.5 months and a maximum of 11 months. All 10 patients reported improvement of symptoms while on the SSI QBECO treatment. Seven patients reported full resolution of clinical symptoms during a course of SSI QBECO of at least three months. Three patients have experienced ongoing sustained clinical remission after discontinuing all medications, including SSI treatment. The longest case of clinical remission is still ongoing (>4 years). No serious severe adverse clinical events were reported. Collectively, we conclude that treatment with the immunoactive SSI QBECO was well tolerated and effective for treatment of Crohn's disease in this case series.
https://www.ncbi.nlm.nih.gov/pubmed/26064087
...
One Canadian biotech company hopes to provide a new way to treat patients living with Crohn’s disease. Qu Biologics Inc. is developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies intended to restore — instead of suppress — particular elements of innate immune function.
“While we are hopeful that our novel treatment approach may achieve long-term remission and reduce treatment burden for patients, we need to carry out the clinical studies that will show the treatment is safe and effective” says Dr. Hal Gunn, CEO and Co-Founder of Qu Biologics.
...
Qu Biologics is currently conducting a phase 2 clinical trial for Canadians with moderate to severe Crohn’s disease. The company anticipates this trial will provide part of the evidence needed to establish QBECO safety and efficacy and support eventual marketing approval.
The company is actively recruiting patients in sites across Canada, including Hamilton, ON, New Westminster, BC and Vancouver, BC. If eligible, participants in the first study stage will receive the treatment for one year, via self-administered injections every other day. In the second stage QBECO will be compared to a placebo treatment.
“We will be assessing the clinical symptoms for each patient during the treatment period,” Dr. Gunn says. “Part of the assessment includes endoscopic examination to track any changes in the gastrointestinal tract, in addition to other tests for safety and effectiveness.”
For many Canadians suffering from Crohn’s, a lifetime of medication is a cumbersome course of treatment. Qu Biologics is encouraging patients who are interested and have moderate to severe Crohn’s symptom to visit restoretrial.ca to learn more and see if you are eligible by filling out the pre-screening questionnaire.
http://www.personalhealthnews.ca/pr...-investigational-treatment-for-crohns-disease
https://clinicaltrials.gov/ct2/show/NCT03472690 QBECO SSI for Clinical and Endoscopic remission in Moderate to Severe Crohn's Disease
Gastroenterol Res Pract. 2015;2015:231243. doi: 10.1155/2015/231243. Epub 2015 May 12.
Site-Specific Immunomodulator: A Novel Treatment for Crohn's Disease.
Bressler B1, Bethel KP2, Kleef R3, Reynolds SL4, Sutcliffe S4, Mullins DW5, Gunn H4.
Abstract
We investigated the mechanism of action, safety, and efficacy of the Site-Specific Immunomodulator (SSI) QBECO, a novel immunotherapy for Crohn's disease (CD). Using human monocytic THP-1 cells, we demonstrate that SSI QBECO (derived from the common colon bacteria E. coli) activates macrophages to an M1 phenotype (associated with enhanced capacity to eliminate bacteria and activate innate immune responses). We assessed SSI QBECO in a compassionate use protocol of ten adult patients with active CD. Patients with moderate to severe clinical symptoms receiving conventional CD treatments and/or complementary therapies were included, except patients receiving anti-TNF medications. SSI QBECO was self-administered subcutaneously every second day, for a minimum of 2.5 months and a maximum of 11 months. All 10 patients reported improvement of symptoms while on the SSI QBECO treatment. Seven patients reported full resolution of clinical symptoms during a course of SSI QBECO of at least three months. Three patients have experienced ongoing sustained clinical remission after discontinuing all medications, including SSI treatment. The longest case of clinical remission is still ongoing (>4 years). No serious severe adverse clinical events were reported. Collectively, we conclude that treatment with the immunoactive SSI QBECO was well tolerated and effective for treatment of Crohn's disease in this case series.
https://www.ncbi.nlm.nih.gov/pubmed/26064087
