Mariusz Olejniczak reports
WPD PHARMACEUTICALS ANNOUNCES FIRST ADULT PATIENT DOSED IN PHASE 1B/2 CLINICAL TRIAL OF BERUBICIN IN THE TREATMENT OF RECURRENT GLIOBLASTOMA MULTIFORME AFTER FAILURE OF STANDARD FIRST LINE THERAPY
The first patient enrolled in
WPD Pharmaceuticals Inc.'s phase 1B/2 clinical trial of intravenously infused berubicin in the treatment of adult patients with recurrent glioblastoma multiforme (World Health Organization grade IV) 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 multicentre, open-label, phase 1B/2 efficacy and safety study of berubicin utilizing a Simon's two-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 studies (7.5 milligrams per square metre berubicin hydrochloride), on the endpoint of ORR (objective response rate) in up to approximately 61 patients.
Four Polish clinical sites have been contracted for purpose of these clinical trials. A central reader will determine the radiologic responses for each patient according to m-RANO (modified radiographic response assessment in neuro-oncology) criteria. The responder criteria for this Simon's design will be based on objective response criteria defined as individual patients achieving CR (complete response) or PR (partial response) per m-RANO criteria within six months from baseline. More data could be found on the U.S. National Library of Medicine's Clinical Trials website.
WPD has a sublicence for berubicin from CNS Pharmaceuticals Inc. The sublicence allows WPD geographic exclusivity for development and marketing in a region consisting of selected countries in Eastern Europe and Central Asia.
Berubicin is an anthracycline, a class of anti-cancer 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 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.
About WPD Pharmaceuticals Inc.
WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries nine novel drug candidates with four that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has continuing collaborations with Wake Forest University, and leading hospitals and academic centres in Poland.
WPD has entered into licence agreements with Wake Forest University Health Sciences, and sublicence agreements with Moleculin Biotech Inc. and CNS Pharmaceuticals Inc., respectively, each of which grant WPD an exclusive royalty-bearing sublicence to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things. The sublicence territory from CNS Pharmaceuticals and Moleculin Biotech includes about 29 countries in Europe and Asia, including Russia, depending on the compound.
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