CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Leading the Charge toward Advancing Research on Treatments for Primary and Metastatic Central Nervous System Cancers

• CNS Pharmaceuticals is a clinical stage biotechnology company focused on the development of novel treatments for brain tumors
• The company’s lead product candidate, Berubicin, is a novel anthracycline that is designed to cross the blood-brain barrier
• The blood-brain barrier ordinarily hinders the vascular delivery of therapeutic substances to brain tumors
• By crossing this protective barrier, Berubicin holds promise for the thousands of adult Americans diagnosed with malignant central nervous system cancers annually

This year, about 25,050 adults (14,170 men and 10,880 women) will be diagnosed with malignant central nervous system (“CNS”) tumors – cancerous tumors that start in the spinal cord or brain. The figure represents an increase from an estimated 24,530 cases documented last year. Of these statistics, the American Society of Clinical Oncology (“ASCO”) notes that brain tumors account for 85-90% of all primary CNS tumors (https://ibn.fm/c9ThB). But despite this prevalence, the treatment of brain tumors has long been complicated by the brain’s internal workings.

A healthy human brain has a mechanism known as the blood-brain barrier that protects the active functions of the CNS and blocks toxins and microorganisms from passing through the highly picky semipermeable border. While this barrier promotes stability of the sensitive internal environment of the brain, it complicates the treatment of brain tumors. Most notably, it hinders the vascular delivery of various therapeutic substances, including anthracyclines, to the cancerous growths within the brain’s internal environment (https://ibn.fm/YZGPK).

“[Anthracycline] is a classic drug that’s been around for 60 years. It’s the first line therapeutic for all sorts of difficult-to-treat cancers. But no one has been able to get a drug like this across the blood-brain barrier until our Founder modified the classic anthracycline molecule to be more effective in crossing the blood-brain barrier,” CNS Pharmaceuticals (NASDAQ: CNSP) President & CEO John Climaco told Proactive last fall (https://ibn.fm/em55b).

Following the modifications, now woven into the company’s lead product candidate, Berubicin – a novel anthracycline designed to concentrate in tumor tissue within the brain – CNS Pharmaceuticals is targeting the treatment of glioblastoma multiforme (“GBM”). GBM, also known as a grade IV astrocytoma, is the most malignant, aggressive, and common form of astrocytoma – a type of brain cancer – and is one of the most treatment-resistant cancers that form in the brain (https://ibn.fm/fed4R). Historically, a GBM diagnosis often led to a prognosis of months or less to live. But this narrative is changing, with research and clinicians’ work helping prolong patients’ lives. 

Founded in 2017, CNS Pharmaceuticals is leading the charge toward advancing research on the treatment for GBM as well as other primary and metastatic brain and CNS cancers. Last year, the company commenced a potentially pivotal clinical trial of Berubicin for the treatment of GBM, dosing its first patients in September (https://ibn.fm/cE5xu). The company expects to report an interim analysis of the trial when 30-50% of the planned subjects reach six months in-study, potentially in the first half of 2023. 

The adaptive, multicenter, open-label, randomized, and controlled study will involve about 243 adult patients with recurrent GBM after failure of standard first-line therapy. The subjects will be randomized in a 2:1 ratio to receive Berubicin or lomustine, a compound used in chemotherapy, to evaluate Overall Survival, the study’s primary endpoint. The study is expected to potentially build on the Phase 1 trial and pharmacokinetic study of Berubicin, whose results revealed that 44% of the patients showed clinical response of stable disease or better, with one patient demonstrating a lack of detectable cancer cells and two patients with partial tumor reduction of up to 80%. 

In a recent update, CNS Pharmaceuticals also celebrated the production of a new mesylate salt of its WP1244 drug technology, now known as WP1874, whose improved solubility may enhance its ability to be formulated for use in an IV infusion. WP1874 is believed to retain the potency and toxicity attributes of WP1244, which, in turn, was shown to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation.

Moving forward, CNS Pharmaceuticals expects to primarily focus its development efforts of the WP1244 portfolio on the newly minted WP1874. The company is also investigating the use of WP1244/WP1874 in treating other primary CNS cancers as well as brain metastases such as pancreatic, ovarian, and lymphoma (https://ibn.fm/CLVDb).

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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