- U.S.-based drug innovator CNS Pharmaceuticals is enrolling patients in a global clinic trial to evaluate the performance of the company’s lead drug candidate, Berubicin, in fighting glioblastomas
- Glioblastoma is an incurable brain cancer that is aggressive in its progression and recurrence, leaving most patients with a life expectancy of less than a year after diagnosis
- CNS’s efforts to fill an unmet medical need arise from promise shown during Berubicin’s initial development by another company over 15 years ago, which included a small-scale human safety trial that produced a patient with no detectable cancer and others that saw tumor shrinkage and stable disease
- The FDA has granted Berubicin Fast Track and Orphan Drug status and enrollment for the current potentially pivotal global Phase 2 clinical trial is taking place in the United States, France, Spain and Switzerland
An incurable brain cancer known as glioblastoma multiforme (“GBM”) has drawn the attention of researchers throughout the world as the medical science industry races to fill an unmet need for an effective treatment.
While surgery is a standard procedure for removing cancerous GBM tumors, the tumors tend to regrow within a narrow margin of time because of the cancer’s capacity to infiltrate the surrounding tissues, preventing the surgeon from clearly identifying the boundaries between the tumor and the normal tissue.
And because of the vital importance of the brain, overly aggressive tissue removal is out of the question.
“So the tumor will come back again, and that sharply decreases the survival rate after treatment,” University of Wisconsin–Madison School of Pharmacy’s Pharmaceutical Sciences Division assistant professor Quanyin Hu stated in a report on the school’s work to develop a GB treatment for improving GBM survival rates in lab animals (https://ibn.fm/CRwdr).
Biopharmaceutical innovator CNS Pharmaceuticals (NASDAQ: CNSP) is staking out its own position within the competitive field of research, having already progressed to human trials of the company’s novel GBM solution, known as Berubicin (or WP744).
Berubicin is a patented doxorubicin (“Dox”) analog — an anthracycline chemotherapy agent novel in its ability to cross the blood-brain barrier to target tumors directly.
Tested against Dox in cancer cells, Berubicin showed a greater capacity to destroy or damage the cancers. In models evaluating intracranial gliomas, Berubicin showed a greater capacity to prolong life than temozolomide, another standard of care in GBM (https://ibn.fm/QdfUa).
Other anthracyclines have been limited in their ability to fight brain cancers by their inability to cross the blood-brain barrier, but Berubicin’s unique capacity potentially led to significant outcomes in its earliest safety trial conducted by the drug’s initial developer, Reata Pharmaceuticals.
In that small-scale Phase I clinical trial in 2006, one of the two dozen evaluated patients emerged cancer-free and has remained so over the subsequent years up to today. Nearly half of the trial’s other patients experienced a statistically significant improvement in clinical benefit of stable disease or better (https://ibn.fm/mA0KA).
For a trial participant patient to survive cancer-free for well over a decade is a remarkable outcome given the disease’s statistics — approximately 13,000 patients receive new GBM diagnosis each year in the United States and have an average survival time of less than a year after diagnosis. Only 10 percent or less survive to five years (https://ibn.fm/H3vyJ).
CNS Pharmaceuticals’ ongoing development of Berubicin includes two dozen trial enrollment sites that are already open, with up to 54 planned at selected locations in the United States, Italy, France, Spain and Switzerland, the most recent approvals in Europe being granted in April with additional countries being considered.
This global trial is comparing Berubicin responses to yet another GBM standard of care, Lomustine.
By next summer, the company expects to have gathered enough data for an interim analysis (https://ibn.fm/l0Jf9). Berubicin has already been granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (“FDA”), which may further boost its development as the company reports its results.
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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