Positive pre-clinical results with PledOx published in Antioxidants

The article, titled Calmangafodipir Reduces Sensory Alterations and Prevents Intraepidermal Nerve Fibers Loss in a Mouse Model of Oxaliplatin Induced Peripheral Neurotoxicity, has been published in the peer-reviewed open access journal Antioxidants. The first-author Dr. Annalisa Canta, University of Milano-Bicocca, Monza, Italy, is part of the research team led by Professor Guido Cavaletti at the Experimental Neurology Unit and Milan Center for Neuroscience. Professor Cavaletti is one of PledPharma’s scientific advisors and collaborators.

The preclinical oxaliplatin study confirms a protective effect of PledOx (calmangafodipir) against oxaliplatin-induced small fiber neuropathy. The administration of PledOx at the dose of 5 mg/kg prevent oxaliplatin-induced mechanical allodynia, cold hyperalgesia and reduction in intraepidermal nerve fiber density.

“We are very encouraged by the publication of these results, which indicate a protective effect against oxaliplatin-induced peripheral neuropathy at the pathological level, and are in line with the behavioural results,” said Nicklas Westerholm, CEO, PledPharma.

PledOx is studied to reduce nerve damage associated with chemotherapy (CIPN) through its phase III program POLAR. The company announced on April 6 that is has decided to prematurely close the POLAR program, with a data cut-off targeted for the third quarter. The current status of the POLAR program is as follows: A total of 590 patients out of the planned 700 patients have been randomized, patients currently enrolled in the POLAR program will continue with their scheduled study procedures, while not receiving the study drug, until the data cut-off. The totality of data generated will enable a thorough efficacy and safety evaluation and an assessment of the benefit/risk of PledOx.

The article can be accessed through the journal’s website. Link