CNS Pharmaceuticals Announces FDA Filing for Investigational New Drug to Treat Glioblastoma

CNS Pharmaceuticals announced this week that it has submitted for review an Investigational New Drug (ING) application, which has been accepted by the US Food and Drug Administration (FDA), for Berubicin, a drug that treats Glioblastoma Multiforme (GBM), the most aggressive type of brain tumor.

The current standard of care for glioblastoma is largely ineffective, and the average survival of a person diagnosed with glioblastoma is only 15 months; without treatment, people only live a dismal 3-6 months, on average, according to the Glioblastoma Foundation.

CNS will now conduct a Phase 2 trial to assess the efficacy of Berubicin in patients with GBM who have failed to respond to primary treatment. In the trial, 243 patients will be randomized 2 to 1 to receive Berubicin or Lomustine. An interim analysis will then compare the effectiveness of these treatments.


“Our laser focus from the beginning has been to start the next phase of the investigation of Berubicin for the treatment of this deadly disease as quickly as possible,” commented John Climaco, CEO of CNS Pharmaceuticals via a press release.

“Our team has worked tirelessly for the past year, making several inroads on our manufacturing and clinical efforts to achieve this important milestone. We believe we are optimally positioned to continue to execute our plan and initiate our Phase 2 trial in the first quarter of 2021. We continue to build on the positive results Berubicin demonstrated in the Phase 1 study in high grade gliomas and look forward to advancing its clinical development in these patients, with the end goal of addressing the unmet medical need of better treatment for patients diagnosed with GBM.”