CNS Pharmaceuticals, Inc. (NASDAQ: NASDAQ:CNSP) stock fell sharply by 50% following the announcement that its flagship cancer drug, Berubicin, did not show a statistically significant difference in overall survival compared to Lomustine in a key clinical trial. The company, which specializes in developing treatments for brain and central nervous system cancers, revealed that while Berubicin demonstrated clinically relevant outcomes across multiple endpoints, it failed to meet the primary endpoint of improved overall survival.
The clinical trial pitted Berubicin, an anthracycline known for its ability to cross the blood-brain barrier, against Lomustine, a standard care treatment for recurrent or progressive Glioblastoma Multiforme (GBM), an aggressive brain cancer. Despite the lack of statistical significance in overall survival rates, the trial did highlight some positive aspects of Berubicin, including a favorable safety profile and the absence of cardiotoxicity, which is a common risk associated with other anthracyclines.
Further analysis of the trial data is ongoing, with the company evaluating advanced imaging review, pharmacokinetics, and clinical endpoints to gain additional insights. CNS Pharmaceuticals’ Chief Medical (TASE:BLWV) Officer, Sandra Silberman, MD, PhD, stated that the overall survival was comparable between Berubicin and Lomustine and that the results warrant further investigation of the drug.
The company also emphasized Berubicin’s potential benefits over Lomustine, such as the lack of pulmonary toxicity and thrombocytopenia, along with its broader mechanism of action that could make it a more generalizable therapy for cancer treatment. CNS Pharmaceuticals CEO John Climaco expressed gratitude to patients, caregivers, and investigators for their support and mentioned that the company is considering further development of Berubicin and applying the trial’s methodology to other drugs for CNS malignancies.
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