Paris (France), may 23, 2017 – 18: 00 CEST – Onxeo SA (Euronext Paris, Nasdaq Copenhagen: ONXEO), a biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, especially in oncology, today announced that the company has received the 10th unanimous recommendation of the Data Safety Monitoring Board (DSMB), for the continuation without modification of the study of phase III of Livatag®, ReLive, and for patients still under treatment. The DSMB is a committee of independent experts european in charge of the submission of blind tolerance data of the test.
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ReLive is an international trial a randomized, phase III study to demonstrate the efficacy of Livatag® in patients with hepatocellular carcinoma (hcc (advanced HCC, also called primary liver cancer) after failure or intolerance to sorafenib.
The study protocol ReLive included the recruitment of approximately 400 patients, divided into three arms : two arms of treatment with Livatag® at 20 and 30 mg /m2 every 4 weeks intravenously for 6 hours, until progression or intolerance, and one arm with the comparator of patients receiving the best available treatment, at the discretion of their physicians. Since the end of January 2017, all of the patients specified in the protocol was randomized.
“Now that we are approaching in large steps of the key step of the preliminary results of ReLive, we are, again, very encouraged by the positive recommendations of the DSMB, which confirm the profile of acceptable tolerance of Livatag® in terms of safety and side effects. Livatag® has the objective of treating a pathology difficult, advanced hepatocellular carcinoma (HCC). This candidate product could become a new therapeutic option innovative for patients with cancer and orphan-resistant, and thereby generate a powerful catalyst for value to the Company, ” comments Judith Greciet, ceo of Onxeo.
According to the study protocol, the DSMB reviews twice a year, in the blind, the tolerance data from the test ReLive. The DSMB receives, however, no data which would enable him to pronounce on the efficacy of Livatag®.
The preliminary results of effectiveness to ReLive should be available mid-2017.
About Onxeo
Onxeo is a company of biotechnology with the clinical stage, specializing in the development of innovative medicines for the treatment of orphan diseases in particular in the field of oncology, in response to a strong demand therapy in one of the segments with the strongest growth of the pharmaceutical industry.
Onxeo has the ambition of becoming a global leader and a pioneer in the field of cancer is an orphan, or rare. The strategy of Onxeo is based on the development of therapies for advanced, effective and safe, designed to improve the lives of patients with rare cancers or resistant to making a true difference compared to current therapies.
The portfolio of Onxeo in cancers orphans includes 3 major products in a number of programs in preclinical and clinical courses, alone or in combination for multiple indications of cancer.
The Company is based in Paris, France, with offices in Copenhagen and New York, and has approximately 60 employees. Onxeo is listed on Euronext Paris, France (Mnémo : ONXEO, ISIN Code : FR0010095596) and Nasdaq Copenhagen, Denmark (Mnémo : ONXEO).
For more information : www.onxeo.com
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