WPD Pharmaceuticals Announces Berubicin Supply Agreement for the Upcoming Clinical Trials
VANCOUVER, British Columbia, Feb. 24, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD" or the “Company”) today announced that it has signed an agreement with CNS
Pharmaceuticals, Inc. (NASDAQ:CNSP) (“CNS”) to obtain Investigational Medicinal Product (“IMP”) for use in the planned clinical trials of Berubicin. WPD will purchase half of the batch previously
manufactured for CNS by BSP Pharmaceuticals for the WPD-201 and WPD-201P studies which are planned to begin in the first half of 2021. This IMP will be QP certified by Clinigen Clinical Supplies
Management on behalf of WPD under European current Good Manufacture Practice (“cGMP”) requirements.
Berubicin is a novel anthracycline candidate for the treatment of a number of serious oncology indications including Glioblastoma Multiforme (GBM). WPD sublicensed Berubicin from CNS in November 2019, which provided WPD with the commercial rights to Berubicin in select territories primarily in eastern Europe and Asia.
Mariusz Olejniczak, CEO of WPD comments, “This agreement will allow us to submit a complete application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA, to initiate the studies without any delay. We hope to receive approval within three months from submission, dependent on if we receive any questions or requests from the President of the Office.”
Shortly after the sublicense agreement, WPD was awarded a reimbursement grant for further development of Berubicin valued at $6 million from the Polish National Center for Research and Development under Smart Growth Operational Program 2014-2020 co-financed by the European Union. WPD plans to initiate both a multicenter Berubicin Phase 2 trial in adult GBM in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021.
CNS Pharmaceuticals has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with their planned randomized and controlled Phase 2 trial of Berubicin in the treatment of adults with GBM who have failed first-line therapy, which is expected to commence in the first quarter of 2021. The FDA has also designated Berubicin an Orphan Drug. CNS has received Central IRB study-level approval for its GBM study.