WPD Pharmaceuticals Inc. announced that first two sites have been initiated in multicenter, open-label, Phase 1B/2 efficacy and safety study of Berubicin utilizing a Simon's 2-stage design to confirm the efficacy (or futility) of a single arm of Berubicin treatment, administered at the recommended Phase 2 dose (RP2D) identified in Phase 1 study (7.5 mg/m2 Berubicin HCl), on the endpoint of ORR in up to approximately 61 patients. This is very important step in Berubicin clinical development. As per today these two Sites are ready to actively recruit patients into the study.

Four Polish clinical sites have been contracted for the purpose of this clinical trial. A central reader will determine the radiologic responses for each patient according to m-RANO criteria. The responder criteria for this Simon's design will be based on objective response criteria defined as individual patients achieving CR or PR per m-RANO criteria within 6 months from baseline.

WPD has a sublicense for Berubicin from CNS Pharmaceuticals Inc. Sublicense allows WPD geographic exclusivity for development and marketing in a region consisting of select countries in Eastern Europe and Central Asia. Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs, 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.

Phase 1 clinical trial previously conducted by Reata Pharmaceuticals Inc. demonstrated positive responses after Berubicin treatment of brain cancer patients with one durable complete response.