CNS Pharmaceuticals Engages Berry Consultants to Advise Phase 2 Trial Design

Rhea-AI Summary

CNS Pharmaceuticals announced the engagement of Berry Consultants to assist in designing its Phase 2 trial for the lead drug candidate, Berubicin. The CEO, John Climaco, expressed confidence in Berry Consultants' expertise, emphasizing the importance of their innovative approach. Berubicin aims to treat glioblastoma multiforme (GBM), an aggressive brain cancer, following a Phase 1 trial that showed a 44% disease control rate. The Phase 2 trial is expected to commence in Q4 2020, alongside a partner's trials in Poland for pediatric GBM patients.

Positive

• Engagement of Berry Consultants enhances trial design expertise.
• Phase 1 trial of Berubicin demonstrated a 44% disease control rate.
• Initiation of Phase 2 trial expected in Q4 2020.

Negative

• Risks associated with the timeline for initiating the Phase 2 trial.

HOUSTON, June 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, today announced it has engaged Berry Consultants, a leading clinical statistical consulting group, to advise the Company ahead of its Phase 2 trial regarding its lead drug candidate Berubicin.

"We are extremely excited to have Berry Consultants, a renowned clinical statistical consulting company, advise on our Phase 2 trial design," commented John Climaco, Chief Executive Officer of CNS. "We believe the company's unparalleled expertise and innovative approach to clinical trial design will prove invaluable in the construction of our Phase 2 trial for Berubicin. With the support of Dr. Berry and his team's deep experience and advice, we look forward to further driving the development of our lead candidate, Berubicin, and initiating our Phase 2 trial in the fourth quarter of this year."

Berry Consultants is a statistical consulting company specializing in the Bayesian approach to medical statistics, an approach that is radically changing the way research is done throughout the medical industry in both device and drug development.  Berry Consultants employs world renowned experts in Bayesian statistics and strives to set the standard for innovative clinical trial design and analysis in the statistical and medical communities. Founder Dr. Don Berry is a professor in the Department of Biostatistics of The University of Texas MD Anderson Cancer Center and has designed and supervised the conduct of hundreds of clinical trials, including in glioblastoma, GBM-AGILE, and pancreatic cancer. As a result of his prolific experience in clinical design, he is a Thomson Reuters Highly Cited Researcher, a distinction he received for ranking in top 1% of most cited researchers in Clinical Medicine. Dr. Berry received his Ph.D. in statistics from Yale University, and has served on the faculty at the University of Minnesota and Duke University.

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. 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 shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

Forward-Looking Statements
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 in the fourth quarter of 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.

 

View original content to download multimedia:http://www.prnewswire.com/news-releases/cns-pharmaceuticals-engages-berry-consultants-to-advise-phase-2-trial-design-301085581.html

SOURCE CNS Pharmaceuticals, Inc.

FAQ

What is the purpose of CNS Pharmaceuticals' Phase 2 trial?

The Phase 2 trial aims to evaluate the efficacy of Berubicin in treating glioblastoma multiforme.

When will CNS Pharmaceuticals begin its Phase 2 trial?

CNS Pharmaceuticals expects to begin the Phase 2 trial in the fourth quarter of 2020.

What were the results of the previous Phase 1 trial for Berubicin?

The Phase 1 trial showed a 44% disease control rate among evaluable patients.

Who is advising CNS Pharmaceuticals on the Phase 2 trial?

CNS Pharmaceuticals has engaged Berry Consultants for expert advice on the Phase 2 trial design.

What type of cancer is Berubicin targeting?

Berubicin targets glioblastoma multiforme, an aggressive and currently incurable brain cancer.