• Texas-based CNS Pharmaceuticals is a novel brain cancer drug developer that is building a series of global clinical trials for its lead drug candidate, Berubicin
• CNS began dosing patients in a global trial last September to evaluate Berubicin in treating glioblastoma multiforme (“GBM”), currently an incurable brain cancer
• CNS received FDA Fast Track designation for Berubicin in June 2021 and FDA Orphan Drug designation for Berubicin in June 2020
• Berubicin is a novel anthracycline capable of crossing the blood-brain barrier
• The company received approval from Switzerland’s swissethics organization for Berubicin trials there, boosting CNS’s efforts at a global response to GBM
• Interim evaluation of the first 30-50% of clinical trial participants is expected in early 2023
• A second anthracycline-based chemotherapy agent in development by CNS, WP1244, is progressing in development following synthesis of a new mesylate salt that has led to a new drug candidate named WP1874
• Following a common stock and warrants offering in January, the company’s planned operations are funded into early next year, according to the financial report

Rare cancer researchers at biopharmaceutical CNS Pharmaceuticals (NASDAQ: CNSP) reported advances in regulatory applications and clinical operations in a March 3 announcement that acknowledges expectations for further developments following completion of an $11.5 million private placement round of funding earlier this year. 

CNS Pharmaceuticals is developing its lead drug candidate Berubicin as a potential treatment for the aggressive and virtually incurable brain cancer glioblastoma multiforme (“GBM”). Key milestones last year led to the commencement of dosing for the first GBM clinical trial patients with Berubicin in September, and an interim analysis of the trial is expected early next year when 30 to 50 percent of the total expected patients have completed 6 months in the study, according to the company. 

“Operationally 2021 was a terrific year for the Company as we established the global framework for building and expanding our potentially pivotal clinical study,” CEO John Climaco stated (https://ibn.fm/0PlDo). “Our priority remains focused on advancing berubicin to bring a meaningful treatment to patients, families and clinicians, who currently have extremely limited and often ineffective treatment options. … I am very pleased with the progress we’ve made over the past year, but am even more so looking forward to what lays ahead for CNS Pharmaceuticals.”

The U.S. Food and Drug Administration (“FDA”) has granted CNS Fast Track designation for the Berubicin trial, and in December the company announced that swissethics, the umbrella organization of the cantonal Ethics Committees (“ECs”) in Switzerland, had also granted CNS approval for its Berubicin trial to proceed in Switzerland. The Swiss approval boosts CNS’s plans to advance its trials on a global basis. 

“Our stated goal is, and always has been, to see Berubicin approved for the treatment of glioblastoma, and this means globally. This terrible disease does not discriminate on the basis of geography or anything else: Patients in Europe are as desperate as patients in the United States,” Climaco stated (https://ibn.fm/F7zEj). “We have a number of additional clinical sites selected around the world that we anticipate coming online in the very near term. As we progress, my belief grows in the enormous potential of Berubicin to be a critical treatment option for this devastating disease.”

As an anthracycline chemotherapy agent used in the treatment of cancer, Berubicin is novel in that it has been designed to cross the blood-brain barrier — perhaps the first anthracycline to do so. 

During initial safety evaluation conducted by another company 16 years ago with a small group of patients, one trial-participant emerged cancer-free and has continued to survive during the intervening years — remarkable for a condition with an average life expectancy of no more than 15 months following diagnosis. Among the other 26 patients evaluated, 12 achieved some improvement or stabilization of their condition for a period of time (https://ibn.fm/VskUV).

CNS also continues to develop a second anthracycline and distamycin-based drug candidate known as WP1244 for stopping the expansion of tumor cells, but the update this month notes that a new mesylate salt of WP1244 has been produced, which is now identified as WP1874. The company states WP1874 will be the primary focus in development efforts of the WP1244 portfolio. Preclinical studies have shown WP1244 to be 500 times more potent than established chemotherapy drug daunorubicin. 

Regarding the company’s finances, the statement adds, “Our current expectation is that our cash on hand and the proceeds from the offering [of common stock and warrants] during January is sufficient to fund our operations into the first quarter of 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.” 

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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