WPD and CNS Pharmaceuticals Announce Positive Opinion of the Polish Central Ethics Committee for the WPD-201 Study and Central IRB Study Level Approval for the CNS-201 Study
WPD Pharmaceuticals plans to initiate a Berubicin Phase 2 adult GBM trial in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in
CNS Pharmaceuticals plans to initiate a Berubicin adult GBM trial in Q1 2021
HOUSTON, Feb. 18, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD") and CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), biopharmaceutical companies specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that WPD Pharmaceuticals received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming Berubicin clinical trial in adults with Glioblastoma Multiforme (GBM) under the WPD-201 Clinical Trial Protocol. CNS Pharmaceuticals has received study level Central IRB Approval from the Central IRB for the CNS-201 Clinical Trial Protocol.
Berubicin is the Company’s novel anthracycline candidate for the treatment of a number of serious oncology indications, currently in development for the treatment of GBM. CNS entered into a sublicense agreement with WPD in November 2019, which provided WPD the commercial rights in select territories in Europe and Asia to Berubicin.
Mariusz Olejniczak, CEO of WPD comments, “This is an important step for WPD from both a project and sublicense agreement point of view. After receiving the positive opinion from the Central Ethics Committee, we are planning to submit our application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA. We hope to receive approval within three months from submission, dependent on if we receive any questions or requests from the President of the Office. We are planning for our sites to start recruiting patients soon after approval is received. Information about our sites will be published both on clinicaltrials.gov and in the European database. During the review process, we will start preparing submissions to Ethic Committee and Competent Authority (equivalent of FDA) in one country outside of Poland.”