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Positive pre-clinical results with PledOx to be presented at Peripheral Nerve Society’s annual meeting

June 26, 2020

PledPharma AB (STO: PLED) today announced that positive pre-clinical results with PledOx® will be presented as a poster at 2020 Annual Meeting of Peripheral Nerve Society (PNS) on June 27, which this year is kept completely virtual due to the Covid-19 pandemic. The results confirm the protective effect of PledOx® against oxaliplatin-induced peripheral neuropathy.

The poster, titled Neuroprotective Effect of PledOx in Oxaliplatin-Induced Peripheral Neurotoxicity in Mouse Models, will be published in an abstract supplement of the Journal of the Peripheral Nervous System (JPNS). There will also be a virtual poster forum with possibility to interact with the co-author Dr. Alessia Chiorazzi, University of Milano-Bicocca, Monza, Italy, who 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 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.

2020 Annual Meeting of Peripheral Nerve Society (PNS) virtual poster forum starts on Saturday June 27, 2020 at 10.00 EDT, 15.00 BST, 16.00 CEST, and will remain active for participant engagement for a 30-day period. On July 27, all abstracts will be archived on the PNS website for member viewing only. Link: (https://www.pnsociety.com/i4a/pages/index.cfm?pageid=3431)
Abstract number: 1221 poster 0148_Chiorazzi

Professor Cavaletti’s research team has also run a preclinical study with paclitaxel which is a part of PledPharma’s evaluation of potential indication expansions for PledOx. The initial results from this study are mixed and further evaluation is ongoing.

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