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PledPharma reports issue by FDA of clinical hold in US on phase III POLAR programme.

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Global Banking News-January 24, 2020-PledPharma reports issue by FDA of clinical hold in US on phase III POLAR programme

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PledPharma AB (STO: PLED), an integrated pharmaceutical drug development company, announced on Thursday that the US Food and Drug Administration (FDA) has issued a clinical hold in the US of the phase III POLAR programme for its lead candidate PledOx.

As a result of this, the recruitment and dosing of patients in the POLAR-M study is halted in the US. Reportedly, this decision by the FDA is due to safety reasons based on a few numbers of observed adverse events.

According to the company, based on the evaluation of the independent Drug Safety Monitoring Board (DSMB), the overall safety profile for PledOx supports the continuation of the POLAR programme and both studies will continue as planned in Europe and Asia.

The global phase III POLAR programme for PledOx consists of two double blinded randomised placebo-controlled trials, POLAR-A and POLAR-M. POLAR-A is conducted in Europe and Asia in patients undergoing adjuvant chemotherapy treatment...

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