CNS Pharmaceuticals Achieves Critical Manufacturing Milestone

Rhea-AI Summary

CNS Pharmaceuticals (NASDAQ: CNSP) announced a critical achievement in the manufacturing of Berubicin, its lead cancer treatment. Partner NCK A/S has received a Certificate of Analysis for the Active Pharma Ingredient, which allows for large-scale production. This development is expected to ensure drug availability for upcoming Phase 2 clinical trials for glioblastoma, anticipated to start in Q1 2021. CNS holds exclusive rights to Berubicin and aims to advance treatment options for aggressive brain cancers, following promising earlier trial results.

Positive

• NCK A/S received a Certificate of Analysis for the Active Pharma Ingredient, allowing Berubicin production.
• Manufacturing milestone expected to ensure drug availability through Phase 2 trials.

Negative

• Forward-looking statements indicate uncertainty regarding the initiation of the Phase 2 trial.
• Past trial results from a limited sample size may not guarantee future success.

HOUSTON, Oct. 1, 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 that the Company's GMP manufacturer partner NCK A/S, received a Certificate of Analysis (CoA) for its Active Pharma Ingredient (API), clearing it for use in the production of Berubicin.

As previously announced, CNS signed a contract with NCK A/S for the large-scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors. NCK A/S is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals. NCK A/S production of Berubicin should ensure drug availability through the end of Phase 2 clinical trials for glioblastoma.

"We believe the execution of this critical manufacturing milestone positions the company advantageously ahead of our expected U.S. Phase 2 trial," stated John Climaco, CEO of CNS Pharmaceuticals. "Our partnerships have proven instrumental in further progressing the manufacturing process necessary to continue the clinical development of our lead candidate. We look forward to continuing the work underway and to initiating our U.S. Phase 2 trial in Q1 of 2021."

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 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. 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. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. 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.

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.

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SOURCE CNS Pharmaceuticals, Inc.

FAQ

What recent milestone did CNS Pharmaceuticals achieve regarding Berubicin?

CNS Pharmaceuticals' partner NCK A/S received a Certificate of Analysis for the Active Pharma Ingredient, enabling large-scale production of Berubicin.

When does CNS Pharmaceuticals expect to start the Phase 2 trial for Berubicin?

CNS Pharmaceuticals expects to initiate the Phase 2 clinical trial for Berubicin in the U.S. in Q1 2021.

What is Berubicin used to treat?

Berubicin is being developed for the treatment of glioblastoma multiforme, an aggressive brain cancer.

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

In the Phase 1 trial, 44% of patients experienced significant clinical benefit, although results were based on a small sample size.

What risks are associated with CNS Pharmaceuticals' forward-looking statements?

Forward-looking statements involve risks and uncertainties that may affect the company's ability to initiate Phase 2 trials as planned.