- When CNS went public in 2019, the funds went primarily into pre-clinical preparation, trial design approval, and drug manufacturing for its potentially pivotal global clinical trial of Berubicin for recurrent glioblastoma multiforme (“GBM”)
- So far, CNS has received FDA Fast Track Designation on its Berubicin clinical study, inching the company closer to offering a viable solution to the millions of people dealing with GBM, a devastating malignant brain cancer
- It remains committed to pushing the envelope in terms of research and development of potential GBM treatment, as we ll as brain cancers in general, to offer a viable solution to patients and address a huge worldwide market
When CNS Pharmaceuticals (NASDAQ: CNSP) decided to go public in November 2019, its Chief Executive Officer (“CEO”), John Climaco, expressed his optimism about the next chapter in both the company’s operations and performance. Since its inception in 2017, he noted, the company had been working “under the radar and within its capital means,” and the Initial Public Offering (“IPO”) would offer an opportunity for it to scale up its operations (https://nnw.fm/lePTm).
“This company has been built slowly and carefully, laser-focused on a single mission- trying to really move the needle in [glioblastoma] and brain cancers in general,” noted Mr. Climaco.
“I think we’ve got all the pieces in place now,” he added.
After the 2019 IPO the company’s management noted that the proceeds would fund its clinical trials and pre-clinical programs for other research and development activities and general corporate purposes. In addition, it would form the foundation for the company’s pivotal glioblastoma (“GBM”) study, which has since earned Fast Track Designation from the U.S. Food and Drug Administration (“FDA”).
As a pre-clinical stage biotechnology company specializing in developing novel treatments for brain tumors, CNS has focused on its lead drug candidate, Berubicin, to potentially treat GBM. However, this candidate has also shown tremendous potential in treating other central nervous system malignancies, appearing to be the first anthracycline to cross the blood-brain barrier in the adult brain.
Before the IPO, CNS estimated that over $25 million in private capital and grants were invested in Berubicin in what could be described as the company’s confidence in the product’s potential and what it could do should it receive FDA approval. The initial objective was to submit an Investigational New Drug (“IND”) application during the fourth quarter of 2020, with the commencement of Phase II clinical trial in the first quarter of 2021.
CNS has since made significant headway, even receiving FDA Fast Track Designation, which now offers it an accelerated path to approval for Berubicin.
“With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease,” noted Mr. Climaco (https://nnw.fm/eqhnj).
GBM’s median survival from initial diagnosis is less than 15 months, with a 2-year survival rate of 26-44%. Globally, it affects 5 out of every 100,000 people, making it the most common and devastating primary malignant brain tumor affecting adults. CNS hopes its research will offer a solution to the millions of people currently dealing with GBM globally. Given how much promise Berubicin has shown, its management is optimistic that with additional studies, it will get to offer a much-needed treatment option for the condition.
“With the recent regulatory authority approvals received in Europe, we are currently on the cusp of opening clinical sites globally, including France, Italy, Spain, and Switzerland, to expand the scope and outreach to patients for this trial,” noted Sandra L. Silberman, the Chief Medical Officer (“CMO”) of CNS.
“We remain dedicated to driving this study forward and ultimately hope to provide a much-needed option for treatment in GBM as a safe and effective therapy,” she added.
CNS remains committed to pushing the envelope in terms of research and development of potential GBM treatment. Through this, it hopes to take advantage of the growing brain tumor therapeutics market, projected to hit $2.74 billion by 2023, posting a CAGR of 11% over the forecast period (2018-2023). But, more importantly, through its efforts, CNS looks to offer relief and a viable solution to millions of people globally who are dealing with GBM. Doing so will not only offer a unique solution unlike any currently in the market but also will create tremendous value for its shareholders as it pushes the GBM conversation forward.
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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