CNS Pharmaceuticals Featured in Syndicated Broadcast Covering Recent Announcements for Glioblastoma Multiforme (GBM) Therapy
CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company focused on brain cancer treatments, announces its recent feature in a NetworkNewsAudio broadcast. This highlights their submission of an Investigational New Drug (IND) application for Berubicin to the FDA and plans to initiate Phase 2 trials in Q1 2021. The trial aims to evaluate Berubicin's effectiveness against glioblastoma multiforme compared to Lomustine, with an expected interim analysis to optimize patient population size. The company aims to address significant unmet medical needs for GBM patients.
- Submission of IND application for Berubicin to FDA.
- Plans to commence Phase 2 trials in Q1 2021.
- Positive results from Phase 1 trial showing a 44% response rate.
- No assurance that FDA will expedite development or approval.
- Limited Phase 1 trial results based on a small sample size.
HOUSTON, Nov. 24, 2020 (GLOBE NEWSWIRE) -- via InvestorWire – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announces that it has been featured in a broadcast via NetworkNewsAudio (NNA), a solution that delivers additional visibility, recognition and brand awareness in the investment community via distribution to thousands of syndication points. The audio press release covers CNS Pharmaceuticals’ recent submission of an Investigational New Drug (“IND”) application to the U.S. Food & Drug Administration (“FDA”) for its brain cancer drug, Berubicin, as well as the Company’s plans to commence Phase 2 trials during the first quarter of 2021.
To hear the audio production, visit: https://www.nnw.fm/O2OcK
To read the original press release, visit: https://nnw.fm/1Qib1
"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," stated John Climaco, CEO of CNS Pharmaceuticals. "Our team has worked tirelessly for the past year, making several inroads on our manufacturing and clinical efforts to achieve this important milestone. We believe we are optimally positioned to continue to execute our plan and initiate our Phase 2 trial in the first quarter of 2021. We continue to build on the positive results Berubicin demonstrated in the Phase 1 study in high grade gliomas and look forward to advancing its clinical development in these patients, with the end goal of addressing the unmet medical need of better treatment for patients diagnosed with GBM."
The planned Phase 2 trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease, and results will be compared to the current standard of care, with 2 to 1 randomization of the 243 patients to Berubicin or Lomustine. The trial will include an interim analysis that will evaluate the comparative effectiveness of these treatments. The trial's adaptive design is intended to allow this interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. Based on this, the trial has the potential to provide data to the FDA that may allow an expedited pathway for development. However, there can be no assurance that the FDA will support any potential request for an expedited pathway to approval or further development.
Earlier this month, CNS Pharmaceuticals hosted a virtual presentation to discuss the clinical trial design for its upcoming Phase 2 U.S. trial for Berubicin. To view the recorded webinar, visit https://cnspharma.com/webcast-november-2020/.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was
For more information, visit: www.cnspharma.com
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Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to seek accelerated approval from the FDA of a New Drug Application (NDA) following the planned Berubicin trial. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
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