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Investing.com -- 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.
The results have raised questions about the future of Berubicin, as investors react to the mixed outcomes of the trial. The continuation of patient treatment and follow-up for overall survival is proceeding, with final data expected to be included in future analyses. The study has enrolled 252 patients across North America and Europe, with a 2:1 randomization of Berubicin to Lomustine.
The significant drop in CNS Pharmaceuticals’ stock price reflects investor concerns over the commercial viability of Berubicin following these trial results. The company’s next steps will likely be closely monitored by the market as it determines the path forward for its treatment portfolio.
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