- Brain cancer drug developer CNS Pharmaceuticals is actively enrolling patients for a potentially pivotal Phase 2 trial of the company’s lead drug candidate, Berubicin, a promising candidate for treating a devastating condition
- CNS’s focus has been on developing a means of combating glioblastoma, a fatal, generally incurable class of brain cancers that are aggressive and recurrent amid current surgical and chemotherapy interventions
- One patient from the Phase 1 trial of Berubicin 15 years ago remains cancer-free, as assessed in November, despite glioblastoma’s reputation for proving fatal generally within about 15 months of diagnosis
- CNS recently announced it will be included in the Russell 2000 Index of small-cap companies for the coming year, effective June 25, which it expects to boost its visibility among investors
As novel biopharmaceutical CNS Pharmaceuticals (NASDAQ: CNSP) approaches its annual meeting of stockholders scheduled for June 28, the company is enthusiastically pursuing enrollment of about 243 brain cancer patients in a clinical trial designed to analyze the efficacy and safety of the company’s lead drug candidate.
The Phase 2 trial will compare the drug Berubicin’s response to established chemotherapy drug lomustine in treating glioblastoma (“GBM”), a fatal class of brain cancers generally considered incurable which usually only leaves patients about 15 months to live on average once they are diagnosed. Patient enrollment began last month across 35 clinical sites in the United States and CNS expects to expand the trial into western Europe during the coming year (https://ibn.fm/KEVIq).
Once about 30 to 50 percent of the patients have reached the six-month point in the trial, CNS will conduct an interim non-binding futility analysis to obtain a snapshot of safety and secondary efficacy outcomes while enrollment otherwise continues.
Berubicin, an anthracycline chemotherapy agent believed to be the first to successfully cross the blood-brain barrier to improve treatment capability, was the subject of a Phase 1 trial 15 years ago that resulted in the long-term survivability of one patient who achieved cancer-free status and continued in that condition during the most recent evaluation conducted in November. Among the other small pool of patients participating at that time, 44 percent saw their disease stabilize or improve, generating optimism for the drug’s potential (https://ibn.fm/gQBzo).
CNS’s efforts have generated interest in the investment community that resulted in the company’s selection to be added to the Russell 2000 Index effective June 25, when the index undergoes its annual reconstitution, according to a news release announcement June 17 (https://ibn.fm/Pj9pQ).
The reconstitution draws in the largest U.S. stocks each year and provides a benchmark measure consulted by investment managers and institutional investors for active investment strategies. The Russell 2000 Index is a measure of the performance of the small-cap segment of the U.S. equity market, a subset of the Russell 3000 Index that represents about 10 percent of the total market capitalization of that index, according to the announcement.
“We are pleased to meet this noteworthy milestone and be included in the Russell 2000 Index. As our team continues to drive our clinical program forward for the treatment of glioblastoma multiforme (GBM), we believe this inclusion well-positions us to drive market awareness,” CNS Pharmaceuticals CEO John Climaco stated. “We are honored to be listed among our industry peers on what is considered to be a widely respected performance benchmark for small-cap companies. We look forward to leveraging the access and positioning this inclusion brings to unlock additional value.”
CNS has sublicensed Berubicin to Polish company WPD Pharmaceuticals, which will commence a similar Phase 2 clinical trial in Europe during 2H 2021. WPD also plans to conduct a clinical trial examining Berubicin’s safety for pediatric malignant glioma patients later in the year, which would be the first significant investigation of the therapy in these brain cancers in children (https://ibn.fm/VEY0J).
WPD is also helping to advance GBM research by participating in an international consortium of industry experts researching the potential of nanoparticles in maximizing the efficiency of radiotherapy in X-ray dosing to end the recurrence of these high-grade tumors while preserving the adjacent healthy tissue (https://ibn.fm/p7Ydz).
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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