- CNS Pharmaceuticals wants to obtain FDA authorization for an Investigational New Drug application for drug candidate Berubicin, a novel treatment for Glioblastoma Multiforme
- Company believes it’s on track to start in Q1 2021 a potentially pivotal Phase II Berubicin trial with adult GBM patients who have failed their primary treatment for the disease
- Separately, a Phase II adult trial and a first-ever Phase I pediatric trial are slated to begin in 2021 in Poland in collaboration with sub-licensee partner, WPD Pharmaceuticals
- Members of CNS’s management team attended A.G.P.’s Virtual Health Symposium, meeting 1-on-1 with investors
CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, recently announced that it has filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its lead drug candidate Berubicin. This application has been accepted for review (https://nnw.fm/KiXLc).
Berubicin is proposed for the treatment of Glioblastoma Multiforme (“GBM”), an aggressive form of brain cancer currently considered incurable, and may prove beneficial in treating other central nervous system malignancies. Since gaining the rights to Berubicin, and securing from Reata Pharmaceuticals, Inc. (NASDAQ: RETA) the Phase 1 trial data and assets, CNS has worked diligently to complete the requirements to bring the drug to trial.
John Climaco, CEO of CNS Pharmaceuticals, Inc., made a statement about the IND filing and how the tireless efforts of the team during the last year have helped reach this important milestone. “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,” he added.
The company believes it is well positioned to execute its plan and initiate a potentially pivotal Phase II trial for Berubicin in Q1 2021 beginning in the United States and expanding to a global trial. The Phase II Berubicin trial that is currently planned in Q1 2021 will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for the disease. Results will be compared with the current second-line standard of care. The trial will be executed with a 2 to 1 randomization of the participating 243 patients to Berubicin or Lomustine (as standard of care). This trial could potentially provide data to the FDA needed for approval of an expedited pathway for further development or approval.
CNS Phamaceuticals, in collaboration with sublicensee partner WPD Pharmaceuticals (CSE: WBIO) (FSE: 8SV1), is preparing two other clinical trials for Berubicin in Poland. The two studies include a Phase II trial in adults (set to begin in February 2021) and the first-ever Phase I trial for pediatric patients (scheduled to start later in 2021) (https://nnw.fm/Q9yQK).
The IND announcement came a few days before CNS management members attended A.G.P.’s Virtual Healthcare Symposium that took place Thursday, November 19, 2020. The virtual event brought together numerous healthcare and biotech companies for one-on-one meetings with investors, engaging panels and discussions with leading healthcare executives and a keynote speaker address (https://nnw.fm/eZN2e).
The IND filing and the upcoming clinical trials make Berubicin an interesting opportunity for investors, as CNS believes its novel treatment can fill the current gap in available GBM treatments and help position the company as a market leader in this fast-growing sector. The overall global brain tumor therapeutics market is targeted to reach an estimated $3.4 billion by 2025, from $2.25 billion in 2019, reflecting a CAGR of 7.20% during the forecast period of 2019 to 2025, Market Study Report research shows (https://nnw.fm/VToM1). Another report estimated that this market would reach $2.74 billion in 2023, registering a CAGR of 11% during the forecast period of 2018 to 2023 (https://nnw.fm/7Zlk4).
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://nnw.fm/CNSP
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