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MDxHealth, Inc., Merck KGaA (MKGAF.PK) Ink Diagnostic Pact


7/5/2012 7:55:30 AM

IRVINE, Calif. & LIEGE, Belgium, Jul 05, 2012 (BUSINESS WIRE) -- Regulatory News: MDxHealth SA (nyse euronext:MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, announced today that it has expanded its collaboration with Merck KGaA, Darmstadt, Germany. This expanded collaboration covers the development and worldwide commercialization of MDxHealth's MGMT (methylguanine-DNA methyltransferase) diagnostic test (PredictMDx(TM) for Glioblastoma), which might help to identify those glioblastoma patients who might be more likely to benefit from cilengitide-based therapies that are currently under investigation, in combination with temozolomide and radiotherapy.

Cilengitide is Merck's cancer drug candidate currently in Phase III development for newly diagnosed glioblastoma, an aggressive form of brain cancer. As part of the expanded collaboration, Merck has agreed to support MDxHealth's development and regulatory activities for the MGMT test and, after regulatory approval, the coordinated launch together with cilengitide in glioblastoma. Financial details of the agreement have not been disclosed.

MDxHealth's PredictMDx for Glioblastoma test has already been used for the identification and stratification of newly diagnosed glioblastoma patients enrolled in cilengitide clinical studies who may benefit from combination treatment with temozolomide, radiotherapy and cilengitide. The test assesses the methylation status of the methylguanine-DNA methyltransferase (MGMT) gene promoter. The MGMT gene is thought to contribute to cellular DNA repair; and, when the gene is methylated, it is no longer expressed in normal amounts leading to a proposed increased responsiveness of tumor cells to some chemotherapeutic regimens.

"With this agreement, MDxHealth and Merck are collaborating to bring PredictMDx for Glioblastoma to the clinical community -- as a companion diagnostic in the US if approved by FDA, and as a validated assay in other regions of the world -- enabling personalized treatment of newly diagnosed glioblastoma patients. Today, we are excited to be partnering with Merck, one of the most advanced pharmaceutical companies in the field of personalized medicine," said Dr. Jan Groen, CEO of MDxHealth.

"Our collaboration with MDxHealth reflects the importance of diagnostics in the field of personalizing cancer care, an approach that Merck Serono is actively investing in with the ultimate goal to identify those patients who are most likely to benefit from a certain treatment through the use of a biomarker-guided approach," said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for Merck Serono. "We are hoping that this will help to improve the future treatment of patients with glioblastoma, a disease which today has high unmet medical needs."

"We are proud to expand our existing partnership with MDxHealth, sharing complementary skills and capabilities in the field of personalized medicine with the common passion to get new therapies to patients who need them," added Dr. Susan Jane Herbert, Head of Global Business Development and Strategy for Merck Serono.

About the MGMT assay: PredictMDx(TM) for Glioblastoma

PredictMDx for Glioblastoma, MDxHealth's most advanced product, is a test to identify patients with different prognosis when treated with current standard of care (temozolomide plus radiotherapy) for newly diagnosed glioblastoma patients. The test assesses the methylation status of the MGMT gene, which is a crucial DNA repair gene. The PredictMDx for Glioblastoma test determines the methylation status of the MGMT gene promoter in tumor tissue, and it can be used as a prognostic assay for the treatment of newly diagnosed brain cancer that utilizes standard of care. The patented epigenetic gene test PredictMDx is attractive for brain cancer drug developers since this could provide an opportunity to better target their new drugs in the interest of the patients.

About Cilengitide in glioblastoma

Cilengitide is currently being developed by Merck Serono, a division of Merck, Darmstadt, Germany. Cilengitide is the first in a new class of investigational anti-cancer therapies called integrin inhibitors to reach Phase III development; it is currently being investigated for the treatment of newly diagnosed glioblastoma (Phase III and Phase I/II) and non-small cell lung cancer (PhaseI/ II).

About MDxHealth

MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. By applying patented DNA methylation platform and biomarkers, MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. For more information visit http://www.mdxhealth.com .

Important information about forward-looking statements

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.

SOURCE: MDxHealth




   

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