PledPharma and Solasia enter a second license agreement for the development and commercialisation of PledOx® in Asia, targeting neuropathy caused by taxanes and any other chemotherapy

About PledOx®

PledOx® is a “first in class” drug candidate developed to provide patients, that are treated adjuvantly or for metastatic colorectal cancer, prevention against the nerve damage that can occur in conjunction with chemotherapy treatment. The results from a completed Phase IIb trial (PLIANT), where patients with metastatic colorectal cancer were treated with the chemotherapy combination FOLFOX and PledOx®, indicates that the patients who received PledOx® had a lower risk than the placebo group to suffer from nerve damage during the chemotherapy. PledOx® showed 38% effect (odds ratio=0.62; p=0.16) on investigator reported sensory nerve damage, the primary endpoint, compared with the placebo group. This was not statistically significant, but a difference of this magnitude is considered clinically relevant. After completion of chemotherapy, PledOx® showed 77% effect (odds ratio=0.23; exploratory analysis: p=0.014) on patient-reported moderate and severe neuropathy compared to the placebo group. This is considered valuable for the success of the forthcoming POLAR studies, where patient-reported symptoms after completion of treatment will be the primary efficacy parameter. No apparent negative effect on the efficacy of the cancer treatment was observed. The phase III program for PledOx® consists of two double blinded randomized placebo-controlled trials, POLAR-M and POLAR-A. POLAR-M includes 420 patients undergoing chemotherapy treatment for metastatic colorectal cancer and is being conducted in Asia, Europe and the US. The study compares PledOx® at doses of 2 µmol/kg and 5 µmol/kg with placebo. POLAR-A includes 280 patients undergoing adjuvant chemotherapy treatment for colorectal cancer and is being conducted in Asia and Europe. The study compares PledOx® at a dose of 5 µmol/kg with placebo.

About chemotherapy induced peripheral neuropathy (CIPN)

Peripheral neuropathy symptoms are caused by damages to sensory nerves, most commonly in hands and feet. Certain chemotherapies, including oxaliplatin, can cause such damages, which is then called chemotherapy induced peripheral neuropathy (CIPN). This can be a debilitating adverse reaction of the cancer treatment and may occur at any time after the initiation of chemotherapy. The symptoms often increase as the chemotherapy treatment continues and may often causes discontinuation of the chemotherapy. In many patients, the symptoms are resolved after discontinuing the chemotherapy, but up to 20-30% of the patients have sustained symptoms such as numbness, tingling and pain in hands and feet. Patients with CIPN may have difficulties with fine motor skill, such as buttoning buttons, challenges using a computer keyboard and become hypersensitive to cold. The sensory loss in the feet may increase the risk of falls. There is currently no approved drug to prevent or treat CIPN.