- IND approval from the FDA has given CNS Pharmaceuticals the green light needed to continue with clinical research of Berubicin in patients suffering from GBM and other brain/nervous system cancers
- Company holds the exclusive worldwide license for Berubicin, the first anthracycline to cross the blood-brain barrier in the adult brain
- The GBM therapeutics market is expected to increase to an estimated $3.3 billion in 2024
- CNS Pharmaceuticals’ sublicensee will be conducting the first pediatric study using Berubicin
CNS Pharmaceuticals (NASDAQ: CNSP) is a clinical-stage biotechnology company that is currently specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, including the use of Berubicin for patients with glioblastoma multiforme (“GBM”), an aggressive form of brain cancer that is incurable. CNS is currently working on the development and clinical trials of Berubicin for GBM and the potential of addressing other central nervous system malignancies.
Berubicin appears to be the first anthracycline to cross the blood-brain barrier in the adult brain. Its development started over 15 years ago when Reata Pharmaceuticals, Inc. (NASDAQ: RETA) conducted the first Phase I trial, creating limited clinical data. Phase I trial results indicated that 44 percent of participants reported a significant improvement in the size of the tumor. The evidence concluded that there was a positive enough impact that CNS has continued with the development and the clinical-stage trials for the drug.
CNS holds the exclusive license for Berubicin worldwide. The company goes into the year 2021 determined to move forward with the development and distribution of Berubicin for GBM. The recent approval of the United States Food and Drug Administration (“FDA”) of Berubicin as an investigational new drug (“IND”) has only increased the opportunity for CNS to move forward with the three clinical trials currently in development.
“The company will transform within the next several months as Berubicin becomes the subject of up to three active clinical trials, which include our randomized, controlled Phase II trial in the U.S., and two trials planned by our sublicensee WPD in Poland,” CNS Pharmaceuticals CEO John Climaco said during a recent virtual presentation discussing the FDA IND approval and future company plans (https://ibn.fm/TP3oE).
The company’s sublicensee WPD Pharmaceuticals (CSE: WBIO) (FSE: 8SV1) will be conducting a Phase II trial in adults, as well as the first-ever Phase I trial in children who suffer from GBM and other cancers of the brain and central nervous system. This is the first pediatric trial of its kind.
According to Climaco, CNS aims to address the significant unmet medical need of GBM patients since the current treatment paradigm for the condition yields bleak results, and this aggressive and, as yet, 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 GBM and build on the promising results demonstrated by Berubicin in its Phase 1 clinical trial,” he added.
The GBM treatments market is anticipated to increase to an estimated $3.3 billion in 2014, marking a CAGR of 17.4% from 2014, when the market was $659. The growth is expected to be driven by seven major markets – the United States, Spain, the UK, France, Italy, Japan, and Germany, and is the direct result of the growing unmet needs of the current market (https://ibn.fm/ZAYjM).
Berubicin is currently being produced in two labs as a result of a dual-track manufacturing strategy implemented by CNS. To ensure that current conditions do not hinder the progress of Berubicin’s development and availability, CNS has turned to United States-based Pharmaceuticals International Inc. and Italy-based BSP Pharmaceuticals SpA for the production of Berubicin for the clinical trials. Both pharmaceutical companies have diversified the supply chain, and increased the availability of Berubicin, mitigating the risks of COVID-19 in clinical trial strategies.
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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