Trial Enrollment Growth Supports Plans of CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) to Complete Enrollment for Important Brain Cancer Drug Study

• CNS Pharmaceuticals is conducting a global clinical trial to evaluate its flagship drug candidate for treating glioblastoma, a deadly brain cancer
• CNS has enrolled 200 of its planned 243 patients for its clinical trial roster, and anticipates filling out the remainder of patients by year’s end
• The company is also preparing the interim study analysis for release by year’s end, now that more than 50 percent of the planned patient roster has reached a point necessary for effective comparison of performance of the flagship drug, Berubicin, to that of a standard of care chemotherapy agent
• The company has stated that it took longer than anticipated to launch the interim analysis because many patients were living longer than historical expectations, and CNS hopes to show that Berubicin has helped patients achieve a longer Overall Survival (“OS”), driving eventual commercialization and improved treatments

Cancer drug developer CNS Pharmaceuticals (NASDAQ: CNSP) is closer to reporting the results of its drive toward a new treatment for the effectively incurable brain cancer glioblastoma (“GBM”), with 200 of the expected 243 patients now enrolled in the company’s potentially pivotal study involving its flagship drug candidate Berubicin, according to a company news release (https://ibn.fm/OqKzk).

The Texas-based company has clinical trial sites operating in the U.S., Italy, France, Spain, and Switzerland, to evaluate Berubicin’s performance against standard of care alkylating chemotherapy agent Lomustine for treating recurrent GBM.

GBM has been generally untreatable by anthracyclines because of their inability to cross the blood-brain barrier, but Berubicin is believed to be able to cross the barrier and directly target central nervous system tumors.

CNS Pharmaceuticals’ progress in enrolling patients for its potentially pivotal, global clinical trial indicate the company is on track to not only complete enrollment by the end of the year, but also to issue its planned futility interim analysis by the end of the year.

The interim analysis was triggered when at least 50 percent of the enrolled patients had reached the pre-planned primary efficacy endpoint, allowing an independent Data Safety Monitoring Board (“DSMB”) to review the number of deaths in each arm of the trial to ensure that the overall survival of patients receiving Berubicin shows at least a statistically significant comparison to those receiving Lomustine.

The news release notes that Overall Survival (“OS”) is a rigorous endpoint that the U.S. Food and Drug Administration (“FDA”) has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm, and the DSMB’s review will consider making recommendations on whether to continue the study as planned or to modify it based on patient outcomes thus far.

CNS announced last month that it has taken longer than planned to reach the endpoint for launching the interim analysis because “many patients in this study are living longer than the historical data would suggest they should,” which means it took longer to reach the number of mortality events required to conduct the interim analysis (https://ibn.fm/5G4tw).

“As we have noted previously, patient volunteers and their treating clinicians are the backbone of our Berubicin development program. We are deeply sensitive to the fact that these brave patients are facing the battle of their lives and we are forever in their debt for the trust and confidence they and their treating clinicians have in Berubicin and the company,” CNS CEO John Climaco stated in the most recent company statement on enrollment. “We are pleased to achieve this landmark milestone. Importantly, this takes us one step closer to bringing the study across the finish line and potentially offering an effective treatment in GBM that is safe and well tolerated.”

Berubicin was originally produced by Reata Pharmaceuticals, Inc., in 2006, and a small-scale clinical trial testing Berubicin’s safety at the time produced statistically significant improvements in the two dozen patients, including one who has remained cancer-free during the ensuing years. CNS reached an agreement with Reata in more recent years to advance development of the drug, and launched the global trial in 2021.

For more information, visit the company’s website at www.CNSPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP

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