WPD and CNS Pharmaceuticals Announce Positive Opinion of Polish Central Ethics Committee for WPD-201 Study and Central IRB Study Level Approval for CNS-201 Study
HOUSTON, February 18, 2021 / PRNewswire / – WPD Pharmaceuticals (CSE: WBIO) (8SV1.F) (“WPD”) and CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), biopharmaceutical companies specializing in the development of new treatments for primary and metastatic cancers of the brain and central nervous system, today announced that WPD Pharmaceuticals has received a positive opinion from the Committee ethics of the Lower Silesian Medical Chamber in Wroclaw, Poland for its upcoming clinical trial of berubicin in adults with glioblastoma muliformis (GBM) under the WPD-201 clinical trial protocol. CNS Pharmaceuticals has received central IRB approval at the central IRB study level for the CNS-201 clinical trial protocol.
Berubicin is the Company’s new anthracycline candidate for the treatment of a number of serious oncological indications currently in development for the treatment of GBM. CNS has entered into a sublicense agreement with WPD in November 2019, which provided WPD with the commercial rights in certain territories by Europe and Asia with berubicin.
Mariusz Olejniczak, WPD CEO comments, “This is an important milestone for WPD, both from a project perspective and from a sublicense agreement. After receiving the positive opinion from the Central Ethics Committee, we plan to submit our application to the Registry of Medicines Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA. We hope to receive approval within three months of submission, depending on whether we receive questions or requests from the chair of the office. We are planning our sites to begin recruiting patients soon after receiving approval. Information on our sites will be published both on cliniclatrails.gov and in the European database. During the review process, we will begin to prepare submissions to the Ethics Committee and Competent Authority (FDA equivalent) in a country outside of Poland. ”
“We are delighted that WPD is taking this key milestone and are encouraged by their continued execution in the further development of Berubicin,” commented Jean Climaco, CEO of CNS Pharmaceuticals. “It is important to note that the WPD Ethics Board approval of the WPD-201 clinical trial protocol, coupled with our recent IND approval and IRB central study level approval, brings us one step closer to the joint launch of three berubicin clinical trials in 2021. We look forward to continuing our trial preparations, as well as the planned submissions from WPD to the Polish competent authority. “
Following the sublicence agreement, WPD subsequently obtained a reimbursement grant for the further development of Berubicin which was assessed at $ 6 million on the date of the grant from the Polish National Research and Development Center within the framework of the operational program Smart Growth 2014-2020 co-financed by the European Union. WPD plans to initiate both a multicenter phase 2 clinical trial for GBM in adults Berubicin in the first half of 2021 and a phase 1 multicenter clinical trial for pediatric malignant glioma in 2021. Approximately 60% of the budget of the program should be funded by the reimbursement grant.
CNS Pharmaceuticals has received approval from the United States Food and Drug Administration (FDA) to proceed with its previously submitted Investigational New Drug (IND) for berubicin in the treatment of GBM. The Company plans to initiate its Phase 2 trial evaluating the efficacy and safety of berubicin in the treatment of adults with GBM who have failed first-line treatment in the first quarter of 2021. The Company also received the Central IRB study-level approval for the United States. part of the adult GBM study.
Berubicin is an anthracycline, a class of drugs that is among the most potent chemotherapy drugs and effective against more types of cancer than any other class of chemotherapy drugs. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of topoisomerase II, an essential enzyme that enables cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research center. Berubicin appeared to demonstrate a long-lasting complete response in a phase I human clinical trial conducted by a previous developer.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing new treatments for primary and metastatic cancers of the brain and central nervous system. Its main drug candidate, berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds an exclusive worldwide license to the chemical compound Berubicin and has acquired all data and expertise from Reata Pharmaceuticals, Inc. relating to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall stable disease response rate or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient has shown a lasting complete response and remains cancer-free at February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, do not guarantee that similar results will be obtained in subsequent trials. By the end of 2020, CNS plans to begin a phase 2 clinical trial of berubicin for the treatment of GBM in the United States, while a sublicensed partner undertakes a phase 2 trial in adults and a very first phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
For more information, please visit www.CNSPharma.com.
About WPD Pharmaceuticals
WPD is a biotechnology research and development company focused on oncology and virology, namely the research and development of drugs involving biological compounds and small molecules. WPD has authorized 10 new drug candidates in certain countries, 4 of which are in the clinical development phase. These drug candidates have been researched in medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and the main hospitals and university centers in Poland.
WPD has entered into licensing agreements with Wake Forest University Health Sciences and Sublicence Agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grants WPD an exclusive and paid sublicence of certain compounds for approximately 30 countries, primarily in Europe. Such agreements give WPD certain rights and obligations in research, development, manufacture and sale, among others.
For more information, please visit wpdpharmaceuticals.com.
SOURCE CNS Pharmaceuticals, Inc.