CNS Pharmaceuticals (NASDAQ: CNSP), a clinical-stage biotechnology company specializing in the development of novel treatments with a focus on brain cancer, glioblastoma (“GBM”), and neuro-oncology, recently announced the presentation of updated safety results from its potentially pivotal clinical study on GBM treatment through its lead drug candidate, Berubicin. Most notably, this novel anthracycline demonstrated its capability to be a safe and innovative potential treatment option for GBM, having shown aspects integral to effective therapy for the disease (https://ibn.fm/yp5AC).
“Berubicin has demonstrated its capability to be an innovative treatment in GBM that is safe and well tolerated, which has the potential to be a novel and effective therapy for this disease,” noted Sandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals.
So far, 151 patients have been enrolled in the clinical study, with 105 set on Berubicin while the remaining 46 will be on Lomustine. This marks the data cutoff point for CNS Pharmaceuticals, a significant milestone toward reporting topline results before the end of the year.
“We are approaching the most important milestone to date since we launched CNS Pharma,” noted John Climaco, CNS Pharmaceuticals’ CEO.
“We are just a few months away from reporting topline results from our Berubicin potentially pivotal study interim analysis and, although we do not know what the data looks like at this time, we remain hopeful as we also approach full enrollment of the trial,” he added (https://ibn.fm/0Yy0n).
The primary endpoint of this study is Overall Survival (“OS”), a goal that the United States Food and Drug Administration (“FDA”) has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Approximately 50% of patients on both arms have completed the study, with each showing comparable demographics, including age, race, gender, KPS, and BSA. Based on the results seen preclinically and in the clinical study thus far, the company remains optimistic that Berubicin may provide a much-needed clinical benefit for GBM patients.
“Based on the results we’ve seen preclinically and in the clinic thus far, including these updated results from our ongoing potentially pivotal study, we remain optimistic that Berubicin may provide a much-needed clinical benefit for GBM patients,” noted Dr. Silberman.
The FDA has already granted CNS Pharmaceuticals Fast Track Designation for Berubicin, allowing it more frequent interactions with the agency, both for guidance and review. In addition, the company has received Orphan Drug Designation from the FDA, affording it seven years of marketing exclusivity upon approval of an NDA. Progress from its ongoing study is inching closer to enjoying these benefits and more, and its management is optimistic that it will offer a more viable treatment option for GBM than what is already in the market.
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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