FDA Approves Investigational New Drug Application of Novel Therapy for Brain Cancer, Allowing the Treatment to Be Studied in Humans


The approval of an investigational new drug application will allow Berubicin’s manufacturer to begin studying the investigational drug in adults with glioblastoma who have previously failed their first treatment.

The Food and Drug Administration (FDA) has approved an investigational new drug application for Berubicin for the treatment of adult patients with glioblastoma, a rare and aggressive brain cancer, who have previously failed previous firstline therapy, according to the agent’s manufacturer, CNS Pharmaceuticals.

“Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin. We will now rapidly move to initiate our phase 2 trial of Berubicin for adults with (glioblastoma) and expect to begin enrolling patients in the first quarter of next year,” said John Climaco, CEO of CNS Pharmaceuticals, in a company-issued press release. “We are entering an area with significant unmet medical need since the current treatment paradigm for (glioblastoma) remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. We have a tremendous opportunity ahead of us as we continue our mission to improve patient outcomes for (glioblastoma) and build on the promising results demonstrated by Berubicin in its phase 1 clinical trial.”

Prior to testing therapeutics in humans, many treatments are tested in non-human subjects to assess the pharmacological activity of, and potential toxicities associated with, the drug. The approval of an investigational new drug application allows the manufacturer to begin administering the drug or product to humans.

The manufacturer, according to the release, plans to begin a trial to evaluate the efficacy of Berubicin in patients with glioblastoma who have failed initial treatment for their cancer. The study is expected to compare Berubicin to the standard-of-care chemotherapy Gleostine (lomustine). The trial, according to the release, will be designed to assess efficacy results at an interim analysis which could allow for an adjustment to the size of the patient population in the trial.

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