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

July 11, 2022 10:20:00
  • 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…

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