dm+d

Unassigned

New Medicines

PledOx Neuropathic pain secondary to chemotherapy treatment

Information

PledOx
New molecular entity
Egetis Therapeutics
Egetis Therapeutics

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Oct 21PledOx is no longer being developed by Egetis (formerly known as PledPharma) [10].

Category

Antioxidant, Iron chelating agent
The prevalence of neuropathic pain has been estimated to be between 6-9%. [2]
Neuropathic pain secondary to chemotherapy treatment
Intravenous

Trial or other data

Apr 20Solasia Pharma and PledPharma announce that an early data cut-off for the POLAR programme will be made in Q3 2020, following which the study will be closed. A detailed and robust evaluation of safety and efficacy will be conducted by the companies, focusing on the information obtained after the termination of this study. The decision was based on recommendation from the independent DSMB to stop new patient enrolment and dosing in the studies due to a number of severe allergic reactions and hypersensitivity, observed post repeated dosing of calmangafodipir in combination with oxaliplatin, in eight patients. As of Apr 20, 590 patients have been enrolled in the two studies (POLAR-A and POLAR-M) vs. the initially planned 700 cases. Despite the POLAR programme being put on hold, the patients enrolled in programme will continue with their scheduled study procedures, while not receiving the study drug, until the data cut-off targeted for the third quarter [9].