- CNS Pharmaceuticals is conducting a potentially pivotal clinical trial in the United States and Europe to establish the effectiveness of a drug candidate for combating incurable glioblastoma (“GBM”) brain cancers
- CNS’s flagship drug candidate is called Berubicin, a product initially developed by another company with encouraging small-population results in 2006, and CNS is expanding the testing with expectations of eventually delivering an innovative new GBM treatment to market
- The company aims to enroll more than 200 patients in its global Berubicin trial on a 2:1 randomization schema comparing Berubicin-treated patients to those receiving second-line standard of care chemotherapy agent lomustine
- The company recently reported that patient enrollment has risen to 67 across its varied sites, with plans to provide an interim analysis of the trials’ progress in mid-2023
A Phase 2, globally sited clinical trial evaluating the potential efficacy of a promising brain cancer drug candidate against deadly glioblastoma (“GBM”) tumors is proceeding apace with a variety of patient profiles, affirming the drug developer’s confidence in its product.
In a Dec. 8 news release, CNS Pharmaceuticals (NASDAQ: CNSP) reported that 67 patients have enrolled in the potentially pivotal study comparing drug candidate Berubicin’s effectiveness to second-line standard of care chemotherapy drug lomustine.
GBM tumors are aggressive, with most patients dying within about a year of diagnosis and only 10 percent or less surviving to five years. First-line treatment generally involves surgical removal of as much of the tumor as possible, followed by targeted radiation therapy. But because of the difficulty in removing the entire tumor from critical function brain cells, the cancer usually regrows, making it practically 100 percent fatal.
Second-line chemotherapy treatment tends to have limited effectiveness, in large part because scientists have been unable to demonstrate that anthracyclines used in chemotherapy can cross the blood-brain barrier and achieve significant levels of activity in the brain. But Berubicin has demonstrated a unique ability to cross the blood-brain barrier.
“Although data are still early, we are pleased with these results in terms of recruiting a balanced patient population to compare Berubicin to Lomustine in the treatment of GBM, which may highlight Berubicin’s potential to provide a better therapeutic option for patients after first-line therapy for their disease,” CNS Pharmaceuticals CEO John Climaco stated in the news release (https://ibn.fm/ZbgT2). “We remain steadfast in our efforts to drive patient enrollment across the U.S. and Europe and are making significant progress toward our planned interim analysis, which we expect to occur in mid-2023.”
The company’s recent report notes that between the Berubicin and lomustine arms of the ongoing trial, demographics including age, gender and race are comparable and that the percentage of patients continuing on study or having withdrawn is also comparable.
The company plans to have more than 200 patients participate in the clinical trial on a 2:1 randomization schema between those receiving Berubicin and those receiving lomustine. Prior stages of the clinical study have examined Berubicin’s safety in human patients and potential effectiveness against lab cells.
Berubicin’s performance in an initial safety trial conducted by another company in 2006 resulted in apparent life extension for some patients and complete remission for one patient who, unusually, survives nearly 17 years later.
The ongoing study now seeks to demonstrate overall survivability of GBM patients using Berubicin, established by a decrease in the size of the tumor, arrested development of the tumor’s size once the patient is put on study, and / or a favorable change in the time to progression of the tumors.
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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