CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Expands Patient Eligibility for Brain Cancer Drug Trial, Receives Approval from U.S. FDA for Protocol Amendment

• Novel brain cancer drug developer CNS Pharmaceuticals, Inc. has received approval from the U.S. FDA for a Protocol Amendment that expands patient eligibility for participation in its potentially pivotal Phase 2 clinical trial for a novel drug candidate that targets the nearly 100 percent fatal cancer glioblastoma (“GBM”)
• CNS is developing the drug candidate Berubicin as an alternative to the standard-of-care chemotherapy agent, Lomustine, with the hope that Berubicin will prove itself at least as effective and potentially more so 
• Berubicin has demonstrated the capacity to cross the blood-brain barrier in order to attack central nervous system tumors directly, which grants it a novel position since anthracyclines are known for their inability to cross the blood-brain barrier
• The drug trial is enrolling GBM patients worldwide who have failed to see improvement from the standard of care anthracycline as part of first-line therapy
• The expansion of the trial allows patients who have perhaps undergone multiple procedures qualified as first-line therapy to participate as well as those who have not undergone the additional procedures
• The company expects interim results from the study in 2023, primary completion by the end of 2024 and ultimate resolution in the first half of 2025

CNS Pharmaceuticals (NASDAQ: CNSP) is reporting that its global clinical trial for a potentially pivotal brain cancer treatment will expand its patient eligibility following an amendment to its protocol for the study. 

The protocol is a document that describes how the clinical trial will be conducted and ensures the safety of the trial subjects and integrity of the data collected (https://ibn.fm/q6Czx). CNS has been enrolling patients in its potentially pivotal Phase 2 clinical trial for novel drug candidate Berubicin, which has shown promise in fighting the aggressive brain cancer glioblastoma (“GBM”). 

The trial participants include GBM patients who have received the standard-of-care treatments (surgical resection, radiation, and temozolomide) and have seen a recurrence of progression. The newly announced change to patient eligibility standards under the clinical trial’s protocols opens the doors to GBM patients who have received additional treatments that may constitute “multiple procedures” as part of the first line therapy for their disease.

“The change was made due to the complexity of new agents introduced as a component of first line therapy,” a company statement explained June 23 (https://ibn.fm/0MCyW).

The U.S. Food and Drug Administration (“FDA”) has granted “fast-track” status to Berubicin, which provides CNS Pharmaceuticals a channel to obtain developmental guidance and reviews from the FDA on a prioritized basis. The FDA has also granted Berubicin “orphan drug” status, which means that if Berubicin obtains approval as a new drug (“NDA”) it can obtain marketing exclusivity for seven years. 

The trial will compare Berubicin’s performance to the standard of care chemotherapy agent Lomustine, aiming to establish that Berubicin is at least as effective as Lomustine and potentially better because of Berubicin’s reported capacity to cross the blood-brain barrier to attack brain tumors directly. 

Crossing the blood-brain barrier gives Berubicin novel status, because other anthracycline chemotherapy agents have thus far been unable to accomplish that feat, resulting in an average life expectancy of just over a year for GBM patients once they are diagnosed with the nearly always fatal illness. The ultimate goal of the clinical trial is to establish potential improvements in overall survivability for the patients using Berubicin. 

Enrollment is ongoing at 19 sites thus far, with 42 more anticipated across the United States, Italy, France, Spain and Switzerland now that European regulatory approvals have been granted. 

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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