Mainz Biomed Enrolls First Patient in ColoFuture Study Evaluating Integration of Novel mRNA Biomarkers into ColoAlert
BERKELEY, Calif. and MAINZ, Germany, June 28, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it has enrolled the first patient in ColoFuture, an international clinical study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) which is being commercialized across Europe.
The mRNA biomarkers were acquired from the Université de Sherbrooke in January 2022 and are the result of the institution’s pioneering work in the field, where researchers tested multiple novel transcriptional biomarkers using colon cancer samples and precancerous lesions. The results from these studies demonstrated that the mRNA targets chosen by Mainz provided the greatest sensitivity and specificity of detection. (Herring et al 2021). The ColoFuture study is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.
“The first patient in milestone marks the conclusion of several months of intensive preparatory work to ensure the trial is optimally managed and signifies the formal commencement of the study,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This is a particularly exciting clinical trial for the Company and of course, the patient and medical communities as the outcome could potentially position ColoAlert as the gold standard at home screening test for this deadly form of cancer.”
Mainz is currently marketing ColoAlert as a top-tier discretionary diagnostic option in Europe through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. In addition, the Company is preparing for ColoAlert’s U.S. pivotal trial, and Mainz’s clinical team is in the process of preparing the protocols for this multi-center study which is on track to commence in late 2022. If the ColoFuture study reports positive results, ColoAlert’s technical profile will be upgraded to include the novel mRNA biomarkers and the U.S. trial will be amended to enable the updated ColoAlert product to be utilized in the study.
The ColoFuture study is an international clinical trial evaluating over 600 patients (women or men) in the age range of 40-85 at two participating centers in Norway and two in Germany. Subjects are invited to potentially participate in the trial when referred for a colonoscopy (pre-inclusion) to screen for CRC or an overall diagnostic analysis. Those who agree to provide a stool sample in advance of the procedure will be eligible for participation. Inclusion criteria are based on one of the following diagnostic outcomes: CRC, advanced precancerous lesions in colon, or normal colon. Then, each patient outcome will compare the observations recorded from the colonoscopy to the results from the ColoAlert test that incorporates the novel biomarker. The primary endpoints of the study are to determine sensitivity and specificity rates for CRC with ColoAlert plus the new mRNA biomarkers. There are multiple secondary endpoints for evaluating the modified ColoAlert test, including, determining sensitivity for AA lesions in colon, specificity for advanced precancerous lesions in colon and, specificity for no colorectal finding (normal colon). The Company is expecting to complete enrollment during the second half of 2022 and is targeting reporting study results in early 2023.
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