Immuno-oncology company Prima BioMed (ASX:PRR) has announced initial safety data from the first cohort of patients in its Phase IIb AIPAC chemo-immunotherapy clinical study of its lead compound, IMP321.
AIPAC (Active Immunotherapy PAClitaxel) is a multi-national, randomised, double-blind, placebo-controlled study of IMP321 plus paclitaxel in hormone receptor-positive metastatic breast cancer.
The trial is currently being conducted out of Belgium, The Netherlands and now also Hungary, with further European sites to be initiated in the future.
The first six patients have received 6 mg doses of IMP321 in combination with paclitaxel.
"This dose has proved to be safe and well tolerated with no drug related serious adverse events," said the company. "The data also demonstrated activation of blood monocytes/dendritic cells and CD8 T cells."
Prima’s Chief Medical Officer, Dr Frederic Triebel, said: “The data from this initial open-label run-in cohort of six patients confirms the safety, pharmacokinetics and pharmacodynamics of IMP321 and we are encouraged to have met our anticipated timelines for recruitment. We will now start enrolling nine additional patients in the second cohort with 30 mg of IMP321, with the results of both cohorts to be presented and compared in the fourth quarter of 2016. Then the randomisation phase with the recommended phase IIb dose will begin enrolling approximately 196 patients.”
Prima’s CEO, Marc Voigt, added: “We are pleased to have confirmed previous results at the 6 mg dose in metastatic breast cancer. We believe that the interim results obtained at 6 mg significantly de-risk the remainder of the trial as the previous phase I/IIa trials provided very encouraging results with that dose level.”
The company said the primary purpose of the AIPAC trial is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival as the primary clinical endpoint.