- Pivotal Phase 2 Berubicin trial expected to commence in Q1 2021 following planned IND submission in Q4 2020
- CNS Pharmaceuticals also plans to begin pre-clinical work on Berubicin in connection with treatment for lymphomas, pancreatic, and ovarian cancers
- Brain tumor drug therapeutics market expected to reach $3.4 billion by 2025
CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, has expanded its Scientific Advisory Board by welcoming new member Dr. Patrick Wen, M.D., a leading neurology and neuro-oncology expert (https://ibn.fm/VJ6e9). Dr. Wen joins current Board members, Dr. Waldemar Priebe, Ph.D., and Dr. Sigmund Hsu, M.D., both of whom were involved in the Phase 1 trial of Berubicin, CNS Pharmaceuticals’ lead drug candidate.
Dr. Wen is a Neurology professor at Harvard Medical School and the Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute. Dr. Wen is a member of the Board of Directors of The Society for Neuro-Oncology and is also its immediate past President. An accomplished neuro-oncologist with a proven track record treating brain tumors and related neurologic complications, Dr. Wen is a graduate of University of London’s Medical College of St. Bartholomew’s Hospital. He continued his postgraduate internal medicine training with the University of London and completed his neurology residency with the Harvard-Longwood Neurology Training Program.
According to CNS Pharmaceuticals CEO John Climaco, Dr. Wen’s extensive experience in neuro-oncology will be invaluable to the company as it prepares for its upcoming Berubicin clinical trials. “The addition of Dr. Wen strongly complements our strategy to further drive the development of Berubicin as we look forward to initiating our pivotal Phase II trial in the U.S. and to working with our partner WPD Pharmaceuticals on the Phase I pediatric and Phase II adult studies in Poland,” Climaco added.
Dr. Wen’s appointment was included among the latest company updates furnished to the Securities and Exchange Commission on September 21, 2020. The investor presentation in the Form 8-K/A also announced that the company’s pivotal Phase 2 clinical trial for Berubicin in the United States is expected to begin in Q1 2021 (https://ibn.fm/MRaIq). In addition, Berubicin clinical trials in Poland (Phase 2 for adults and the first-ever Phase 1 trial for pediatric patients) are also due to begin on a similar timeline.
CNS Pharmaceuticals’ lead drug candidate is proposed for the treatment of glioblastoma multiforme (“GBM”), an aggressive and incurable form of brain cancer. It is an organ targeted therapeutic that belongs to a class of cancer drugs called anthracyclines. CNS Pharmaceuticals has stated that it believes, based on limited clinical data, that Berubicin is the first drug in this class to cross the blood-brain barrier in adults, reaching the tumor cells of a patient with brain cancer.
Berubicin was developed by CNS Founder and Scientific Advisory Board member Dr. Waldemar Priebe, Ph.D., Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center. The development of Berubicin has been ongoing for over 15 years. The drug was granted Orphan Drug designation by the FDA for malignant gliomas in June 2020. CNS Pharmaceuticals is currently expected to make an Investigational New Drug (“IND”) submission to the FDA in Q4 2020.
In Phase 1 trials of Berubicin, conducted by Reata Pharmaceuticals (NASDAQ: RETA), 44% of GBM patients showed clinically significant response to Berubicin. A patient from the Phase 1 trial remains cancer-free following the trial treatment of Berubicin approximately 14 years ago.
CNS Pharmaceuticals plans for the Phase 2 adult trial in the United States to be adaptive, randomized, and controlled. These criteria for Phase 2 are intended to provide the data required for accelerated approval by the FDA. Additionally, the company plans to use the Phase 2 adult trial in Poland, conducted by sub-licensee WPD Pharmaceuticals, Inc. (CSE: WBIO) (FSE: 8SV1), to provide additional statistical support for the U.S. trial.
Plans are also in motion to begin Berubicin clinical trials for lymphomas, pancreatic, and ovarian cancers in 2021, which speaks to the high level of confidence CNS Pharmaceuticals has in Berubicin trials and its potential impact on the brain tumor therapeutics market. It is estimated that the global brain tumor therapeutics market will reach $3.4 billion by 2025, growing at a CAGR of 7.2 percent (https://ibn.fm/qJSuy).
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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