BioAlliance obtains positive DSMB recommendation for Phase III study of liver drug

14th April 2014 (Last Updated April 14th, 2014 18:30)

The European Independent Board of Experts (Data Safety and Monitoring Board, DSMB) has unanimously recommended BioAlliance Pharma to continue the ReLive Phase III trial without any modifications.

liver

The European Independent Board of Experts (Data Safety and Monitoring Board, DSMB) has unanimously recommended BioAlliance Pharma to continue the ReLive Phase III trial without any modifications.

DSMB is in charge of the safety profile of the trial, which is designed to evaluate Livatag in patients with primary liver cancer.

The company said that DSMB meets every six months or after reaching 75 treated patients to assess the tolerance of the drug and ensure patient safety.

For the fourth time since November 2012, DSMB has unanimously recommended to continue the trial without modification, based on its positive evaluation of all safety data of Livatag.

The international, randomised ReLive Phase III trial is aimed at showing the efficacy of Livatag on survival in 400 patients with advanced hepatocellular Carcinoma (primary liver cancer) after failure or intolerance to Sorafenib.

"This positive evaluation is a major step forward in the overall assessment of this drug being developed for a rare cancer with no or few therapeutic alternatives, and representing sales potential estimated at nearly €800m."

So far, around 40 centres have opened in Europe and more than 25% of patients are enrolled in accordance with the plan.

The company said that the trial is still expanding in Europe and implementation of investigator centres is ongoing in the US further to the approval obtained from the FDA in December 2013.

Patient enrolment in the trial is scheduled to be complete by the end of 2015 for expected data for the end of 2016.

BioAlliance Pharma CEO Judith Greciet said each new positive recommendation from our DSMB, now covering over 25% of enrolled patients, strengthens the tolerance evaluation of Livatag.

"This positive evaluation is a major step forward in the overall assessment of this drug being developed for a rare cancer with no or few therapeutic alternatives, and representing sales potential estimated at nearly €800m," Greciet said.

Livatag uses Transdrug technology since the technology allows bypassing the mechanisms of multi-drug resistance developed by tumour cells.


Image: Livatag is developed for the treatment of primary liver cancer. Photo: courtesy of Filip em.