Onxeo expands Livatag® international phase III clinical trial “ReLive” to 3 new countries
Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that Livatag® phase III clinical trial “ReLive” is expanded to 3 new countries in the Middle-East and North Africa region (MENA).
The ReLive study is an international phase III trial designed to assess Livatag®’s (Doxorubicin Transdrug™) efficacy on survival in 400 patients with refractory hepatocellular carcinoma in progression following treatment with Sorafenib. The study is already implemented in about 65 clinical centers in 8 countries, in Europe and North America, with more than 40% of the patients having already been randomized. Preliminary data from the “ReLive” study are expected by early 2017.
Relive phase III trial expansion in line with strategic plan
In line with Onxeo’s strategic expansion plan for the Livatag® “ReLive” phase III trial, the company is opening up trial centers in three new countries: Lebanon, Egypt, and the Kingdom of Saudi Arabia (KSA). These new countries are in addition to the 8 countries where patients are currently being recruited. The decision to expand the number of countries in the study is based on the reassuring feedback that has been received from the data safety monitoring board (DSMB) and the additional funds that Onxeo has available post the recent successful capital raising. The addition of these 3 new countries is designed to optimize recruitment rate in the study.
MCT : Specialized CRO for MENA region
Onxeo has engaged MCT, a contract research organization (CRO) specialized in running clinical trials in the Middle East and North Africa (MENA region), to implement the trial in the Lebanon, Egypt, and KSA. MCT, which will be driven by Onxeo´s internal clinical development team, will be in charge of all administrative procedures as well as the opening and follow-up of new trial centers. Approximately 10 additional trial centers should be open and the first patient expected to be enrolled as soon as mid- 2015.
Data Safety and Monitoring Board (DSMB)
The next Data Safety and Monitoring Board (DSMB) session, at which the safety data from this Phase III trial are reviewed, is scheduled to take place in the coming weeks. Since the study started, the DSMB has met 5 times and concluded each time that the trial could be pursued with no modification, which reflects a good safety profile of Livatag® so far.
“Livatag® is a key program within Onxeo’s orphan oncology portfolio and the opening of the ReLive trial in an additional region is a critical element of our strategy to perform the study in a timely manner and as result creates significant value from this very attractive asset. The launch of the study in new regions such as MENA also helps to raise awareness about Livatag® ® with clinicians at a broader level, which will be extremely important for ensuring the product’s adoption at a later stage”, said Judith Greciet, CEO of Onxeo.