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MDxHealth's PredictMDx for Glioblastoma Identifies Newly Diagnose
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Buy and Hold Published: 08:00 CET 04-03-2014 /GlobeNewswire /Source: MDxHealth (TM) /XBRU: MDXH /ISIN: BE0003844611 MDxHealth's PredictMDx for Glioblastoma Identifies Newly Diagnosed Patients with Improved Progression Free and Overall Survival Results of Phase III Trial for Bevacizumab (Avastin®) Published in the New England Journal of Medicine IRVINE, California, and HERSTAL, BELGIUM - March 4, 2014 - MDxHealth SA (NYSE Euronext: MDXH), 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 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. For more information visit www.mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth. For more information: Dr. Jan Groen, CEO Mike Sinclair (media) Len Hall (investors) MDxHealth Halsin Partners Allen & Caron, Inc US: +1 949 812 6979 UK: +44 20 7318 2955 US: +1 949 474 4300 BE: +32 4 364 20 70 Cell:+44 7968 022075 len@allencaron.com info@mdxhealth.com msinclair@halsin.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. NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners. To access the PDF version, please click here This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients. Source: MDxHealth (TM), Tour 5 GIGA niveau +3 Av. de l’Hopital 11, Liège 4000, Belgique If you would like to unsubscribe and stop receiving these e-mails click here.
Mooi! Alleen maar goed nieuws de laatste tijd, nu de koers nog... :-)
Inderdaad, ook niet onbelangrijk ;-)
Wat mij opvalt is dat er veel kt denkers zitten in MDx . Dit is volgens mij een aandeel voor de LT met zeer grote mogelijkheden . Nu kopen en een aantal jaren vasthouden . Zodra er meer LT beleggers ingaan , wordt het aandeel ook een stuk stabieler .Kwestie van tijd . B.A.H.
Hij gaat omhoog, koers rammelt aan de € 5 grens en wil er doorheen..
bioscience schreef op 4 maart 2014 09:26 :
Wat mij opvalt is dat er veel kt denkers zitten in MDx .
Dit is volgens mij een aandeel voor de LT met zeer grote mogelijkheden . Nu kopen en een aantal jaren vasthouden .
Zodra er meer LT beleggers ingaan , wordt het aandeel ook een stuk stabieler .Kwestie van tijd .
B.A.H.
Wat is het uithoudingsvermogen van een LT belegger 3,5,7 of 10 of 30 jaar:-)? 10 jaar vanaf nu vind ik mooi zat. Liever 5.
Wederom een mooie mededeling. Vasthouden blijft het antwoord, al word het de laatste tijd wel moeilijk gemaakt. Het word tijd dat het aandeel eens de waardering krijgt die het verdiend.
Bank Analyst Kempen & Co Mark Pospisilik Petercam Roderick Verhelst KBC Securities Jan de Kerpel Koersdoel KBC is €6,50 Koersdoel Petercam €5,30 Kempen ????
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