- Glioblastoma multiforme (“GBM”) is one of the most aggressive, deadly, and treatment-resistant forms of cancer within the brain, with an average life expectancy of 12-18 months and more than 50,000 new cases each year
- The current standard of care for GBM is ineffective for approximately 60% of patients
- Initial Phase 1 trial information for Berubicin (approximately 14 years ago) resulted in one patient surviving cancer-free to present and two experiencing significant tumor reduction of up to 80%
CNS Pharmaceuticals (NASDAQ: CNSP), a clinical stage biotechnology company specializing in the development of novel treatments for brain tumors, recently participated in the H.C. Wainwright 24th Annual Global Investment Conference held on September 12-14, 2022, in New York and online in a hybrid virtual conference.
During the event, CEO John Climaco presented the company’s investor presentation and participated in one-on-one investor meetings. An audio recording of Climaco’s presentation is currently available on the company’s News & Events page, through December 11, 2022 (https://nnw.fm/DiT9g).
The company’s presentation includes key investor highlights on the efforts being pursued by CNS Pharmaceuticals to develop anti-cancer drug candidates for the treatment of primary and metastatic brain and central nervous system cancer. Berubicin, the company’s lead drug candidate, is a novel anthracycline in an ongoing, potentially pivotal international trial in glioblastoma treatment. The interim analysis data from this potentially pivotal trial is expected in mid-2023.
Glioblastoma multiforme (“GBM”) is one of the most aggressive, deadly, and treatment-resistant cancers forming within the brain. Per the company presentation, GBM has an average life expectancy of 12-18 months, with more than 50,000 new cases each year (includes US, France Germany, Italy, Spain, UK, Japan and urban China), accounting for approximately 48% of all primary malignant brain tumors in the US. Unfortunately, the current standard of care for GBM is ineffective for approximately 60% of patients.
Anthracyclines are among the most effective anti-cancer treatments. Berubicin was the first to provide scientific data which appears to demonstrate its ability to cross the blood-brain barrier and was designed with a molecular target of topoisomerase II enzymes responsible for cleaving and recombining double-stranded DNA during cellular replication. As tumors are rapidly growing compared to healthy tissues, the anthracycline effects tumor tissues much more than healthy neurons within the brain. The Phase 1 safety trials of Berubicin were conducted around 2006-2007 by Reata Pharmaceuticals, Inc., with one person surviving cancer-free to present and two others showing significant reduction in tumor size by up to 80%.
CNS Pharmaceuticals, founded in 2017, entered a collaboration agreement with Reata and has used the initial Phase 1 trial information as the foundation for subsequent trials and to receive FDA Orphan Drug Designation in 2020 and FDA Fast Track Designation in 2021 for Berubicin. The current U.S. Orphan Drug Designation provides CNS Pharmaceuticals with U.S. marketing exclusivity for 7 years post-NDA approval. The company is pursuing Orphan Drug Designation in the EU, which will provide 10 years of protection following European approval.
Since the beginning of 2022, CNS Pharmaceuticals has completed pivotal milestones with Berubicin, receiving approval from Switzerland Ethics Committee (“EC”) and Competent Authority (“CA”), France EC, and CA, and Spain EC and CA to open sites. The company’s next steps include pivotal trial expansions into additional countries, expected completion of enrollment, interim analysis/data, and target topline results from the potentially pivotal study. The company offers a strong balance sheet to execute its strategy with cash to progress toward key clinical and regulatory milestones within its development goals.
CNS Pharmaceuticals is leveraging its ongoing clinical trial for Berubicin, and the novel anthracycline remains the only competitor to cross the blood-brain barrier to drive value for shareholders. “We are at the point where the finish line is within sight, and that is: ‘Is this drug performing in a clinical setting the way we want it to?’ And if it is, there is nothing to compete with it,” Climaco commented. “We believe this will be an absolute knock-it-out-of-the-park opportunity for neuro-oncology, but we have to prove that carefully, and that’s what we do on a day-to-day basis. That’s how we continue to build that [shareholder] value over time.”
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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