Berubicin Phase 2 Clinical Trial
Trials in Poland to be funded by a $6 million grant previously awarded to WPD Pharmaceuticals
HOUSTON, April 30, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system in collaboration with WPD Pharmaceuticals Inc. (CSE:WBIO) (8SV1.F) ("WPD") a clinical stage pharmaceutical company, today announced it has identified several leading medical institutions in Poland to conduct its Berubicin Phase 2 clinical trial in adults with glioblastoma multiforme ("GBM"), an aggressive and incurable form of brain cancer.
The US Phase 2 trial Sponsor will be CNS and the Polish Phase 2 trial Sponsor will be WPD, a Polish corporation founded by Professor Waldemar Priebe, founder of CNS Pharmaceuticals. The Company expects to initiate both its Phase 2 US and Polish trial of Berubicin in adults with GBM during the second half of 2020.
As previously announced, CNS entered into a sublicense agreement with WPD providing WPD commercial rights in selected territories in Europe and Asia to Berubicin. WPD was subsequently awarded a reimbursement grant that was valued at $6 million upon the date of the grant from the EU/Polish National Center for the research and development of Berubicin. Proceeds from this grant will be used to support the Company's upcoming Phase 2 clinical trial of Berubicin in adults with GBM in Poland.
Mariusz Olejniczak, CEO of WPD Pharmaceuticals commented, "We are honored to have the leading cancer research and treatment facilities in Poland interested in further development of Berubicin." He continued, "We are doing our best to assure that Phase 2 trial in adults and Phase I pediatric trial will start during the second half of 2020. The continued enthusiasm remains a key driver in our development pipeline."
"The grant awarded to WPD by the National Centre for Research and Development is a testament to the unmet medical need facing patients with GBM," commented John M. Climaco, CEO of CNS Pharmaceuticals. "We look forward to initiating this investigation of a unique topoisomerase II inhibitor that appears to cross the blood-brain barrier, with the goal of bringing a much-needed new treatment to GBM patients around the world."
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 treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever 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.
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to receive orphan drug designation for Berubicin and to commence Phase II trials of Berubicin this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
SOURCE CNS Pharmaceuticals, Inc.