PledOx enters Phase III trials to treat neuropathy consequent upon chemotherapy.

PledPharma AB announced that the company, following interactions with the European Medicines Agency EMA, has finalized the design of the global Phase III program for the drug candidate PledOx. The Phase III studies are expected to be initiated before year end 2017. The company’s current funds are expected to cover costs up to the planned read out of top line results in 2020.

The design of the Phase III program for PledOx: The Phase III program has been designed based on interactions with the European Medicines Agency (EMA), the FDA and PledPharma’s Scientific Advisory Board. It consists of two double-blind, randomized, placebo-controlled studies, POLAR-M and POLAR-A: POLAR-M includes 300 patients undergoing chemotherapy for metastatic colorectal cancer and is planned to be conducted in Europe and the US. In the study, 2 μmol/kg and 5 μmol/kg of PledOx are compared to placebo. POLAR-A includes 200 patients undergoing adjuvant chemotherapy for colorectal cancer and is planned to be conducted in Europe. In the study, 2 μmol/kg and 5 μmol/kg of PledOx are compared to placebo. In both studies, patients will receive PledOx or placebo as add-on to the chemotherapy FOLFOX. The primary efficacy parameter is patient-reported symptoms of CIPN nine (9) months after initiation of chemotherapy.

Evaluation of symptoms is performed using the validated FACT/GOG-NTx instrument. Secondary efficacy parameters evaluate other aspects of CIPN, functional loss, the need for dose adjustments of chemotherapy, pain and quality of life. Patients are followed in the studies for two years after initiation of chemotherapy, focusing on progression free survival and overall survival (POLAR-M) and disease-free survival (POLAR-A). In the POLAR-M study, an additional follow-up of overall survival is performed after three years.