Prima BioMed Initiates Phase IIb Study in Metastatic Breast Cancer
Prima BioMed Ltd (NASDAQ: PBMD) is pleased to announce the initiation of the first trial site for AIPAC, the Phase IIb clinical study of Prima's lead compound IMP321.
AIPAC (Active Immunotherapy PAClitaxel) is a multi-national, randomised, double-blind, placebo-controlled study of IMP321-plus-paclitaxel in metastatic breast cancer. Prima announced on 27 October 2015 that Belgium had become the first jurisdiction to clear the AIPAC clinical trial application by the competent regulatory authority. Today, four sites within Belgium have been approved by their Institutional Review Boards. The University Hospital Saint-Luc in Brussels will be the first AIPAC trial site ready for patient enrolment. The first patient is expected to be dosed in early 2016.
AIPAC, which has received Scientific Advice from the European Medicines Agency, is expected to recruit patients across 30 sites in 6 European countries once all approvals have been obtained. Work with the relevant pharmaceutical regulators and site administrators will continue for the remainder of 2015 and into 2016 to progress the study to its full recruitment capacity.
Prima's CSO & CMO, Dr. Frédéric Triebel, welcomed the news from Brussels. 'In a previous clinical trial, my colleagues and I were able to show that IMP321, acting as an Antigen Presenting Cell activator, generated about a doubling in response rate to paclitaxel in metastatic breast cancer over historic controls. It is gratifying to see the clinic at Saint-Luc collaborate with us to bring this potentially revolutionary new drug to market and thereby benefit patients for whom current treatment options are limited.'
Dr Duhoux of the King Albert II Cancer Institute (University Hospital Saint-Luc) commented, 'Favourable patient outcomes have been a hallmark of recent clinical research in the immuno-oncology field. While clinical success is not guaranteed for any investigational-stage compound, as an academic hospital, we at Saint Luc have sought to be at the forefront of new developments in the field and are therefore pleased to be associated with IMP321 and this carefully designed study.'
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