NetworkNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) to Release Interim Data by Year End for Lead Treatment Candidate Berubicin
CNS Pharmaceuticals (NASDAQ: CNSP) is a biopharmaceutical company focused on developing innovative therapies for central nervous system disorders, specifically aggressive brain cancers. The company today announced its confidence in sharing the results from an interim analysis on one of its lead treatment candidates, Berubicin, with the public before the end of the year. Berubicin is a chemotherapy drug that interferes with the DNA of cancer cells to inhibit their growth and potentially shrink tumors. Distinct from other anthracyclines, a clinically trusted class of drugs in use for 60 years against dozens of common cancers, and other traditional chemotherapy drugs, CNS Pharmaceuticals reports that Berubicin has the ability to penetrate the blood-brain barrier and directly target cancer cells in the brain, increasing its potential effectiveness.
In October, the company announced that 229 out of 243 expected patients had already been enrolled in its ongoing study evaluating the effectiveness of Berubicin for recurrent glioblastoma (“GBM”), a highly aggressive and incurable form of brain cancer. The global critical and adaptive trial involves multiple centers and is open-label, randomized and controlled, comparing Berubicin to Lomustine – a drug unapproved for this indication but still used as the standard of care – in adult patients with recurrent GBM (WHO Grade IV) after standard first-line therapy has failed. CNS Pharmaceuticals had set a specific goal to analyze the efficacy data after more than half of the patients enrolled in the study reached the primary endpoint. During this analysis, an independent data safety monitoring board (“DSMB”) closely examines the number of deaths in each treatment group to ensure that Berubicin patients show a significant improvement in overall survival compared to those receiving Lomustine. In addition, other important factors are considered, such as how long patients live without the cancer progressing, response rates and safety. The interim analysis will conclude if Berubicin is at least as effective as Lomustine, in which case the DSMB will make a recommendation that the trial continue.