PledPharma (STO:PLED) has posted Phase IIb data linking its oxidative stress protector to a 43% drop in incidence of chemotherapy-induced peripheral neuropathy (CIPN). The data triggered a 20% jump in the stock price of the company as investors responded to the results and talk of a possible partnership.
|PledPharma CEO Jacques Näsström|
Stockholm, Sweden-based PledPharma trialed PledOx--which is designed to mimic the oxidative stress protecting endogenous enzyme MnSOD--in 173 patients with advanced colorectal cancer. Participants received FOLFOX6 chemotherapy plus either a placebo or one of two doses of PledOx. In one of the treatment arms, incidence of CIPN fell by 43%. CIPN involves damage to the peripheral nerves, can cause pain and was found by a meta analysis published in Pain last year to affect more than two thirds of patients in the month after chemotherapy. As it stands, there is no proven way to prevent CIPN.
PledPharma hailed the data as a milestone for the company. "The data are clear and robust. We believe this will form an excellent basis for to design registration studies in dialogue with FDA," PledPharma CEO Jacques Näsström told FierceBiotech. However, the CIPN data fell short of statistical significance. Näsström attributed the outcome to designing the study "not to find a statistically significant effect, but rather to find clear and clinically relevant signals." PledPharma changed its primary endpoint part way through the trial, a decision that is yet to be reflected on ClinicalTrials.gov.
"When the PLIANT trial was designed there was insufficient data to design the trial with [protection against CIPN] as the primary endpoint. However, after having received promising data from the open dose-escalation phase of the PLIANT study, this gave us confidence in changing the primary endpoint. This was done well ahead of the unblinding of the study," Näsström said. PledPharma has updated ClinicalTrials.gov with the revised endpoint, Näsström said, but the "process will take some time." The last visible update was made on March 10.
The top-line nature of the data means some questions are as yet unanswered. Data on the absolute neutrophil count--which was the primary endpoint in the original protocol--will not be available until PledPharma releases the full analysis. Neutrophils are a type of white blood cell, the number of which can drop in the weeks after chemotherapy. Similarly, data on side effects are limited for now. Näsström said PledOx was similarly well tolerated at both doses and didn't negatively affect the efficacy of the chemotherapy, but declined to say how its side effect profile differed from the placebo.
PledPharma is now preparing for an end of Phase II meeting with FDA and intensifying talks with potential partners as it plots how to design and finance the next stage of clinical development.
- read the release