WPD Pharmaceuticals Inc. provided an update on its Berubicin drug candidate clinical development program for the treatment of glioblastoma multiforme (GBM). 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’s Phase I clinical trial in adults, the first time it was tested in humans, yielded promising results with 44% of the patients with glioblastoma multiforme (GBM) showing a clinical response of stable disease or better based on limited clinical data. This response rate rises to 49% in Avastin-naive patients. Importantly, Berubicin has shown evidence of improved overall survival in a patient population that currently has a dismal median survival rate of only 14.6 months from diagnosis. The compant expects final approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products shortly and anticipates starting a Phase II Trial in the second half of 2021. Based on the promising Phase I results, WPD plans to commence a multicenter, open-label, Phase Ib/II 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 II dose (RP2D) identified in the Phase I study (7.5 mg/m2 Berubicin HCl), on the endpoint of Overall Response Rate in up to approximately 61 patients with GBM. The trials will include an interim analysis of the first 18 patients in the first half of 2022 for efficacy and safety as well as an extensive pharmacokinetic profile for these patients. The company is planning the Phase I clinical trial for malignant gliomas at two clinical sites in Poland. The study includes a multicenter, open-label, dose escalation Phase I study of intravenous Berubicin in pediatric patients. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and pharmacokinetics of Berubicin and to estimate its MTD and/or RP2D when administered to pediatric patients with progressive, refractory, or recurrent HGG who have completed at least 1 standard line of therapy. This study will also make a preliminary assessment of the antitumor activity of Berubicin in this patient population in up to approximately 35 patients. This Phase I trial of Berubicin represents the first ever investigation of Berubicin in pediatric brain tumors. The company has already received Ethical Committee approval for Phase I clinical trial and has submitted its request for approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Information on approval and study number in European clinical trials database will be provided within 60 days. The company expects to commence the Phase I clinical trial in third or fourth quarter of 2021.