Phase 2 Clinical Trials to Begin subject to FDA IND Approval
HOUSTON (Mar. 3, 2020) – 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, announces as of February 2020, a patient from the Phase 1 clinical trial for the treatment of glioblastoma multiforme (“GBM”), conducted by Reata Pharmaceuticals, Inc., remains cancer free. GBM is an aggressive type of brain cancer and, currently, there are no effective therapiesapproved to treat this disease.
In the Phase 1 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, which is defined by the National Cancer Institute as the disappearance of all signs of cancer in response to treatment. This initial trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years.
“We are delighted to provide this update on Berubicin’s potential capabilities given the unmet need for this aggressive disease,” commented John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals. “We are looking forward to initiating our Phase 2 clinical trial in the second half of this year with our partner, WPD Pharmaceuticals, Inc. In addition, we expect WPD Pharmaceuticals, Inc. to commence a first-ever Phase 1 trial in children later this year. As previously announced, the pediatric trial will be conducted at Children’s Memorial Health Institute, the largest pediatric hospital in Poland.” WPD Pharmaceuticals, Inc. was founded by Dr. Waldemar Priebe, the founder of the Company.
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, 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. 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 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 initiates its Phase 2 clinical trial in the second half of this year, and the ability of WPD Pharmaceuticals to commence a Phase 1 trial in children later this year. 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 the heading “Risk Factors” in the Form S-1 filed on October 7, 2019. 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.
Christopher S. Downs, CFO
LHA Investor Relations