WPD Pharmaceuticals Inc. announced that the first patient enrolled in the Phase 1B/2 clinical trial of intravenously infused Berubicin in the treatment of adult patients with recurrent glioblastoma multiforme after failure of standard first line therapy, has received the first dosing of Berubicin. This is a very important step in Berubicin clinical development. WPD Pharmaceuticals has initiated multicenter, open-label, Phase 1B/2 efficacy and safety
study of Berubicin utilizing a Simon's 2-stage design to confirm the efficacy of a single arm of Berubicin treatment, administered at the recommended Phase 2 dose identified in Phase 1 studies, on the endpoint of ORR in up to
approximately 61 patients. Four polish clinical sites have been contracted for purpose of this clinical trials. 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. 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 damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin, was developed by Dr. Waldemar Priebe. 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.