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MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced that the publication in the New England Journal of Medicine of a phase III randomized trial of bevacizumab, brand name Avastin®, for newly diagnosed glioblastoma patients, confirms the clinical utility of its PredictMDx® for Glioblastoma test.
MDxHealth's PredictMDx for Glioblastoma (MGMT) test, included in the 2013 National Comprehensive Cancer Network (NCCN) Senior Adult Oncology Guidelines, provides actionable information to oncologists seeking to provide personalized treatment of elderly patients with glioblastoma (GBM), the most common and most aggressive malignant primary brain tumor in humans. The test assesses the methylation status of the MGMT gene, which is a key DNA repair component. If the MGMT gene is methylated, cancer patients have shown improved response to alkylating drug therapy. Studies on thousands of clinical trial patients have demonstrated that PredictMDx for Glioblastoma can help oncologists identify newly diagnosed glioblastoma patients that are likely to respond to the most commonly used class of brain cancer drugs (alkylating agents).
Dr Gilbert et al describe the results of the phase III study,"A Randomized Trial of Bevacizumab for Newly Diagnosed Glioblastoma" (N Engl J Med 2014; 370:699-708, February 20, 2014) in which patients were prospectively randomized into the treatment arms based on MDxHealth's MGMT (O6-methylguanine-DNA methyl transferase) methylation test results. MGMT methylation status was shown to be prognostic for progression-free survival (PFS) and overall survival (OS), regardless of therapies investigated in this study. The median PFS for patients with unmethylated tumors was 8.2 months vs. 14.1 months in the patients with MGMT methylated tumors, with a hazard ratio of 1.67 (95% CI of 1.36 to 2.05, p<0.001). The median OS for patients with MGMT unmethylated tumors was 14.3 months compared with 23.2 months in patients with MGMT methylated tumors. The hazard ratio for death in patients with unmethylated tumors was reported as 2.10 (95% CI of 1.65 to 2.68, p<0.001).
"As shown in previous published studies these results again confirm the prognostic value of our PredictMDx test in glioblastoma. These results demonstrate the clinical importance of using molecular biomarkers, like MGMT, to improve patient stratification and the current standard of care," stated Prof. Dr. Wim van Criekinge, Chief Scientific Officer of MDxHealth.
About MDxHealth®
MDxHealth (formerly OncoMethylome Sciences) is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. The company's first commercial product, ConfirmMDx® for Prostate Cancer, has been validated to help distinguish patients who have a true-negative biopsy from those who may have undetected cancer, thereby aiding in the reduction of unnecessary repeat biopsies. MDxHealth (mdxhealth.com) helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for prostate, brain, bladder and lung cancers.
Contacts
Mike Sinclair (media) - Halsin Partners
UK: +44(0)20 7318 2955 / C: +44(0)79 6802 2075
E: msinclair[.]halsin.com.
Len Hall (investors) - Allen & Caron, Inc
US: +1 949 474 4300 - E: len[.]allencaron.com.
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
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