Global phase III study POLAR-A fully recruited
December 16, 2019
Stockholm, December 16, 2019. PledPharma AB (STO: PLED) and Solasia Pharma K.K. (“Solasia”) (TSE: 4597) today jointly announced that the global Phase III study POLAR-A with PledPharma’s lead candidate PledOx® is now fully recruited and top line results expected approximately one year later.
The now fully recruited POLAR-A study is the first study of the Global Phase III POLAR program for PledOx, which is developed to prevent nerve damage associated with chemotherapy. It is a double-blind, randomized, placebo-controlled trial involving 280 patients with colorectal cancer undergoing adjuvant chemotherapy and conducted in Asia and Europe.
“We are excited to have successfully completed the recruitment in the POLAR-A study and to be able to do it within the intended time plan. This year we started screening the first patient in the study and what better way to end the year than screening the last one. Top line results are expected approximately one year later. I want to thank everybody who has been and still is involved in this important study, which takes us one step closer to a treatment that can truly help the patients optimize their cancer treatment and improve their quality of life,” said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.
“We are extremely excited to achieve this great milestone in the POLAR-A study. As we continue to work together with our partner, PledPharma, advancing our enrollment in the POLAR-M study, we will move another step closer to the completion of the Global Phase III program “ said Yoshihiro Arai, President and Chief Executive Officer, Solasia.
As was communicated in each report, for the third quarter 2019, the second study in the POLAR program, POLAR-M, conducted in 420 patients with metastatic colorectal cancer, is expected to be fully recruited in Q2 2020, and it is anticipated that PledPharma and Solasia will have top line results approximately a year later.