HOUSTON, July 22, 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, today recognizes Glioblastoma (GBM) Awareness Day.
GBM is a highly aggressive and virtually incurable form of brain cancer. Every year, roughly 10,000 individuals in the United States are expected to succumb to glioblastoma. Accounting for more than 60% of all brain tumors in adults, it is estimated that more than 13,000 Americans will be diagnosed with GBM in 2020. For the past several decades, the survival outcomes and mortality rates for patients with GBM have improved only slightly. Patients diagnosed with GBM currently have a median survival time of 14-16 months, and a five-year survival rate of just 6.8%.
CNS Pharmaceuticals is continuing to drive the development of Berubicin, a novel therapy for the treatment of glioblastoma. Berubicin is an anthracycline, a class of anticancer agents among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Berubicin has demonstrated the potential to be one of the first anthracyclines to cross over the blood brain barrier and kill tumor cells in humans. In a Phase 1 human clinical trial under a prior developer, 44% of patients treated with Berubicin experienced a statistically significant improvement in progression-free survival and one patient experienced a durable complete response.
As part of the Company's efforts to initiate a Phase II trial in GBM by the end of the year, CNS Pharmaceuticals successfully engaged USA-based Pharmaceutics International, Inc., (Pii) and Italian BSP Pharmaceuticals S.p.A., (BSP) to produce Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy to mitigate COVID-19 related risks, diversify its supply chain, and reduce the risk that inefficiencies could impact the Company's clinical timeline. Through contracting both a European and United States manufacturer, the Company also provided for localized availability of Berubicin for the upcoming Phase I Pediatric and Phase II adult studies in Poland, and the U.S. Phase II trial. CNS has completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and has shipped API to both Pii and BSP to prepare an injectable form of Berubicin ready for clinical use. CNS believes these are pivotal steps in allowing the Company to initiate clinical studies in GBM patients.
"Among brain tumors, GBM remains an unmet need for patients, with bleak survival outcomes and mortality rates," commented John Climaco, CEO of CNS Pharmaceuticals. "We would like to take the time today to recognize GBM Awareness Day, and draw attention to providing solutions to this very aggressive form of brain tumor which claims numerous lives every single year. Treating GBM and driving the clinical development of Berubicin remains a key priority for CNS Pharmaceuticals and we are extremely pleased to be making tremendous progress towards our upcoming trials to help these patients. We look forward to further investigating Berubicin's potential to treat this deadly cancer in our upcoming Phase I Pediatric and Phase II adult studies in Poland and initiating our U.S. Phase II trial."
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.
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 glioblastoma multiforme (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, Inc. 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. By the end 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 shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
Some of the statements in this press 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 initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes 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 in the Company's 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 press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
SOURCE CNS Pharmaceuticals, Inc.