Benzinga | Jul 12, 2021 07:33AM EDT

WPD Pharmaceuticals' Licensor CNS Pharmaceuticals Receives FDA Fast Track Designation For Berubicin For The Treatment Of Recurrent Glioblastoma Multiforme; WPD Poland Arranges Loans

WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical-stage pharmaceutical company, is pleased to announce that CNS Pharmaceuticals Inc. ("CNS") (NASDAQ:CNSP), the company that licenses the drug candidate Berubicin to WPD for 29 countries mainly in Europe, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM). As previously reported, CNS had also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.



Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need. Receiving Fast Track Designation from the U.S. FDA is a significant achievement in the advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain. Many patients have almost no meaningful options and thousands lose the fight against this cancer every year. With this designation, CNS now has an accelerated pathway to approval for Berubicin and a clear opportunity to bring this potentially impactful investigational therapy more expediently.

CNS recently announced the start of patient enrollment in its study of Berubicin for the treatment of recurrent glioblastoma multiforme. WPD would significantly benefit from advancement of Berubicin as a treatment for GBM as it has the rights to produce and sell the drug candidate in 29 countries.

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.