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2020-07-09

Positive pre-clinical results with PledOx published in Antioxidants

PledPharma AB (STO: PLED) today announced that positive pre-clinical results with PledOx® are published in the peer-reviewed journal Antioxidants. The results confirm the protective effect of PledOx® against oxaliplatin-induced peripheral neuropathy.

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

contact


Nicklas Westerholm, CEO, phone: +46 73 354 20 62
nicklas.westerholm@pledpharma.se

About Us


PledPharma is an innovative, unique and integrated pharmaceutical drug development company, focusing on improving treatments for diseases with substantial unmet medical need. The company's most advanced project PledOx® is being developed to reduce nerve damage associated with chemotherapy. The phase III program was recently stopped with a data cut-off targeted for the third quarter 2020. The drug candidate Aladote® is being developed to reduce the risk of acute liver injury associated with acetaminophen/paracetamol poisoning. A proof of principle study has been successfully completed and the design of the next study is being finalised. Aladote® has been granted Orphan Drug Designation in the US. PledPharma (STO: PLED) is listed on the Nasdaq Stockholm main market since October 31, 2019. For more information, see http://www.pledpharma.com/

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