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news.Swedish pharmaceutical company PledPharma has reported top-line results from a Phase IIb trial (PLIANT) of its drug candidate PledOx in patients with advanced colorectal cancer.
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FOLFOX is a combination of the drugs folinic acid, 5-fluorouracil and oxaliplatin.
A total of 173 patients were included in the trial, which was conducted at about 30 centres in Europe and the US. In the trial, patients were treated with PledOx to reduce the risk of side effects associated with FOLFOX chemotherapy for advanced colorectal cancer.
The randomized double-blinded placebo-controlled Phase IIb trial had three parallel groups in which patients were given FOLFOX chemotherapy for up to eight treatment cycles and either PledOx at a dose of 2 umol/kg, 5 umol/kg or placebo.
The trial showed a clinically relevant reduction in the incidence of sensory nerve damage of 43% compared to placebo. Additionally, the anti-cancer effect of the chemotherapy was not negatively affected by the PledOx treatment.
PledPharma CEO Jacques Nasstrom said: "The clear reduction in neuropathy observed in this study has the potential to improve the quality of life and outcomes for a large number of cancer patients.
"There is currently no preventative treatment against this type of damage. We now look forward to, based on the promising results of the study, intensifying discussions with potential partners and to continue preparations for the next step in the clinical development of PledOx."
The company said that neuropathy in conjunction with chemotherapy can cause debilitating problems, such as hypersensitivity to cold, disruption of fine motor skills and severe pain especially in the hands and feet.
Based on these positive data, the company plans to intensify discussions with potential partners.