- Brain cancer drug developer CNS Pharmaceuticals is celebrating recent news that the U.S. Food and Drug Administration (“FDA”) granted investigational new drug (“IND”) status to CNS Pharmaceuticals’ leading candidate for fighting glioblastomas
- Glioblastomas are a class of aggressive brain cancers with no known cure and a median life expectancy of 14 to 16 months following diagnosis
- The FDA’s decision to grant CNSP’s request for IND status clears the way for the company to begin human clinical trials within the next couple of months
- The company’s sublicensee partner, WPD Pharmaceuticals, will also prepare a first-ever Phase I trial for drug safety in children, planned later this year in Poland
During the last year the COVID-19 pandemic has occupied large headlines worldwide while small neuro-oncology biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP) has been quietly building a newsworthy effort of its own to improve a select group of individuals’ lives, preparing to launch medical trials that could help end the unrelenting and ultimately fatal advance of glioblastoma brain cancers.
CNSP acquired the worldwide exclusive licensing to its leading drug candidate Berubicin, an anthracycline that has demonstrated its potential in fighting off glioblastomas and a stand-out drug among other anthracyclines because of its apparent ability to effectively cross the blood-brain barrier and target central nervous system malignancies.
In a January podcast interview, company CEO John Climaco showed his excitement at news the U.S. Food and Drug Administration (“FDA”) had granted Berubicin investigational new drug (“IND”) status, clearing the way for the company to start human clinical trials and to ship the experimental drug across state lines to clinical investigators.
“This is the biggest news we’ve announced since our IPO back in November 2019,” Climaco said. “Based on that IND approval, we expect, in the next 90 to 120 days, we will go from zero active clinical trials today to three active clinical trials. … We have five employees at this company, so we are a tiny little shop. But we have an absolute powerhouse compound.”
The podcast, co-hosted by Sid Vaidya and Eric Gershey, is available for on-demand listening at https://anchor.fm/c3chat.
Berubicin’s “powerhouse” potential was demonstrated in an initial Phase 1 trial completed by another company well over a decade ago. Within the very limited pool of participants in the trial, 44 percent saw their disease stabilize or even begin to improve. One patient emerged cancer-free and as of the most recent medical assessment last year was still alive and still in remission 14 years after the Phase 1 trial — a remarkable exception to the rule that the vast majority of glioblastoma patients will be dead within 14 to 16 months of diagnosis.
CNSP’s planned Phase 2 trials will use a much larger pool of 243 patients for its real-time comparison of Berubicin’s performance against the “standard of care” chemotherapy drug lomustine in side-by-side brackets that compare the 162 Berubicin users with 81 lomustine users. The trials will take place in about 60 research centers scattered across North America, Europe and the Asia-Pacific region to help deliver a diverse representation of individuals (https://ibn.fm/4sWQi).
While the adult trials are taking place, CNSP’s sublicensee partner for testing will also be preparing a first-ever Phase I trial for drug safety in children who have glioblastomas and have already failed to see a significant turnaround with standard-of-care medications. The pediatric trial is slated to begin later in the year in Poland.
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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