Chevy Chase, MD, March 17, 2014
Metabiomics is pleased to announce the launch of a new IRB approved microbiome clinical research study titled “Metabiomics Neoplasia Clinical Research Study”, also referred to as MB-01. The ~200 patient study will be conducted in collaboration with our clinical partners at the Capital Digestive Care and Metropolitan Gastroenterology Group in Washington, D.C. and Chevy Chase, Maryland.
Metabiomics Chief Medical Officer Dr. Louis Korman reports that the MB-01 is now well underway as “Gastroenterologists at two endoscopy center sites are recruiting patients and collecting stool and rectal swab samples. Next, Metabiomics is characterizing each patient’s gut microbiome and comparing the results of the microbial DNA sequencing-based assay with the results of the patient’s colonoscopies to determine if the new testing approach can accurately associate changes in the gut microbiome with the presence or absence of colonic neoplasia, including colon polyps and colon cancer.”
Final results of the on-going study will not be available for several months, but a few of the early metrics have been very promising. So far, two investigators have recruited 51 patients and obtained 116 samples within 7 weeks of starting the protocol with a very high patient enrollment rate of over 85%.
Dr. Robert Hardi, a principal investigator and key Metabiomics advisory board member explains the high rate of recruitment. “Patient interest has been very high so far and the initial response to the study design and the ease-of-use of both of the potential sample types has been very positive.” Dr. Hardi is an experienced gastroenterologist and clinical researcher and currently the president elect of the Academy of Physicians in Clinical Research (APCR).
MB-01 is part of a series of studies designed to quantify the clinical evidence of safety, efficacy and clinical utility of the Metabiomics colon polyp and colon cancer test.
About Microbiome Links to Colon Cancer
Gut bacteria are thought to play a role in colorectal cancer carcinogenesis via production of genotoxins, DNA damaging superoxide radicals, and induction of immune dependent cell proliferation. Certain microbial taxa abundance patterns can reflect the changes in local microenvironment that occurs with cancer or adenomas. In addition, other patterns of colonization can identify an increased risk for colon cancer development.
About the Metabiomics Colon Cancer Test
The Metabiomics assay utilizes patented MultiTag™ Sequencing (MTS) technology to non-invasively characterize the fecal microbial ecology of individual patients. The technology may represent a major breakthrough in colon cancer detection because disruptions of the microbiome may provide the earliest warning signs of cancer and present opportunities for stratifying cancer risk and cancer interception.
Clinicaltrials.gov – Microbiome Test for the Detection of Colorectal Polyps and Cancer
ClinicalTrials.gov Identifier: NCT02141945
About Metabiomics
Metabiomics Corporation is an early-stage, colon cancer diagnostics company that is developing non-invasive screening tests for gastrointestinal and autoimmune diseases based on human microbiome biomarkers. The company has developed/licensed patented/patent-pending technology that integrates advances in microbial ecology, next-generation DNA sequencing, and computational systems biology. These innovations were developed over the past 10 years in collaboration with Dr. Patrick Gillevet, Vice President and Chief Scientific Officer of Metabiomics, at the Microbiome Analysis Center at George Mason University and many other clinical research partners at leading academic medical centers in the US and Canada. Metabiomics was formed in 2011 as a wholly owned subsidiary of BioSpherex LLC to focus on molecular diagnostic application of human microbiome research in translational medicine.
For More Information Visit: http://metabiomics.com
Metabiomics Safe Harbor Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential results and future outcomes our clinical research and business plan; ability to discover biomarkers and diagnostic tests; our beliefs regarding the need for and value of molecular diagnostics; and the focus and attributes of the company’s product pipeline, including the ability of the company’s tests to impact clinical practice. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the results of clinical and developmental studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and the timing thereof; unanticipated costs or delays in research and development efforts; the applicability of initial next generation sequencing studies to future results; the risk that we may not obtain or maintain reimbursement for diagnostic tests we may develop, both domestically and abroad; our ability to compete against third parties; the risks and uncertainties associated with the regulation of our tests by the FDA and other agencies abroad; and the other risks set forth in the company’s business plans and presentations. These forward- looking statements speak only as of the date hereof. Metabiomics disclaims any obligation to update these forward-looking statements.
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