CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin for Phase 2 Clinical Trial

Rhea-AI Summary

CNS Pharmaceuticals (NASDAQ: CNSP) announced the completion of the manufacturing process for its lead drug candidate, Berubicin, aimed at treating glioblastoma multiforme (GBM). This milestone is crucial for filing an Investigational New Drug (IND) application in Q4 2020 and initiating a Phase 2 trial in the U.S. in Q1 2021. The company has engaged various partners for trial preparations and received Orphan Drug Designation from the FDA, potentially leading to market exclusivity. The dual-track manufacturing strategy also aims to mitigate COVID-19-related delays.

Positive

• Completion of Berubicin manufacturing process.
• Preparation to file IND application in Q4 2020.
• Engagement of Worldwide Clinical Trials and other partners for Phase 2 trial.
• FDA granted Orphan Drug Designation for Berubicin.

Negative

• None.

HOUSTON, Oct. 20, 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 U.S. manufacturer, Pharmaceutics International, Inc. ("Pii"), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.

"Completing the manufacturing process for Berubicin in the United States is an essential step in our preparations to file an IND during the fourth quarter of this year," stated John Climaco, CEO of CNS Pharmaceuticals. "We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021."

The Company implemented a dual-track drug product manufacturing strategy to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Under this strategy, it engaged two separate manufacturers for Berubicin on different continents. In the United States, the Company engaged Pii, who has now completed manufacturing, and in Italy it engaged BSP Pharmaceuticals S.p.A. ("BSP"). BSP has begun the manufacturing process, which is expected to be completed early in the fourth quarter this year.

In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations. CNS recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group ("IAG") as the imaging partner, and Berry Consultants as a biostatistical advisor for its Phase 2 trial design. The Company has also added Dr. Patrick Wen, a renowned neuro-oncologist, to its Scientific Advisory Board. The FDA granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product's development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug's approval for that use.

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 file an IND in the fourth quarter of this year and to initiate its Phase 2 trial for Berubicin in the first quarter of 2021. 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 under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its 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.

 

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SOURCE CNS Pharmaceuticals, Inc.

FAQ

What is Berubicin used for in CNSP's clinical trials?

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

What milestone has CNS Pharmaceuticals achieved regarding Berubicin?

CNS Pharmaceuticals has completed the U.S. manufacturing process for Berubicin, essential for their upcoming clinical trials.

When does CNS Pharmaceuticals plan to initiate its Phase 2 trial for Berubicin?

CNS Pharmaceuticals plans to initiate the Phase 2 trial for Berubicin in the U.S. during the first quarter of 2021.

What is the significance of FDA's Orphan Drug Designation for Berubicin?

The Orphan Drug Designation provides certain benefits during the product's development and may grant market exclusivity upon approval.

What manufacturing strategy did CNS Pharmaceuticals implement for Berubicin?

CNS employed a dual-track manufacturing strategy to mitigate COVID-19-related risks by engaging two manufacturers on different continents.