CNS Pharmaceuticals Inc (NASDAQ:CNSP) Receives IND Application for Berubicin From the US FDA to Treat Glioblastoma Multiforme

The US FDA granted IND (Investigational New Drug) application for Berubicin of CNS Pharmaceuticals Inc (NASDAQ:CNSP) to cure GBM (Glioblastoma Multiforme).CNS will conduct clinical trials in adults, who suffer from GBM, in Q1 2021 to ascertain the efficacy of Berubicin in treating GBM.

CEO of CNS, John Climaco said the company’s main focus is to advance the development of Berubicin. It will quickly begin Phase 2 clinical trial of the new drug in patients with GBM. The company will recruit patients for the trial in Q1 2021.

Expects to commence clinical trials soon

CNS will conduct three clinical trials that comprise controlled and randomized phase 2 clinical trials involving Berubicin soon in the US. It will also engage Poland based WPD, its sub-licensee, to conduct two clinical trials. The company plans to develop treatments to address unmet medical needs for GBM. It already obtained promising results of Berubicin in Phase 1 clinical trial.

CNS plans to examine the efficacy of Berubicin in patients, who failed in the first primary treatment to treat GBM. It will use the data obtained in the trial to differentiate between the treatments and make adjustments in the program to enhance the efficacy of the drug. CNS will use the trial data to expedite the development and submit data to the FDA.

John features on the podcast

John featured on the podcast “Want Money Got Money” recently. He shared details about the recent research conducted by Waldemar Priebe, who studies the treatment for GBM. John also revealed few facts about Berubicin, the leading drug candidate for curing GBM, during the podcast.

The grade IV astrocytoma or GBM, the most invasive type of the glial tumor, spreads rapidly to the nearby tissues in the brain. It can evolve either from oligodendrogliomas or low-grade astrocytoma. GBM is the most dreaded brain cancer and causes death in the first one and a half-year after diagnosis. The market for brain tumor therapeutics worldwide expects to grow at a CAGR of 7.20% from $2.25 billion in the year 2019 to $3.4 billion in the year 2025.

CNS widened its net loss to $2.011 million in Q3 2020 when compared to a net loss of $706,655 in Q3 of the previous year.