- National awareness of glioblastoma tumors (“GBM”) sustained by Congressional leaders aim to improve efforts to treat brain cancers and ultimately improve patient survival
- GBM is a widely occurring, aggressive and effectively incurable brain cancer that few patients survive beyond three years
- U.S.-based drug developer CNS Pharmaceuticals is in the midst of a global potentially pivotal clinical trial for its lead pharmaceutical candidate, Berubicin, which it aims to show improves on standard of care chemotherapy agent Lomustine’s approach to treating GBM
- Berubicin is a novel anthracycline that is practically unique in its ability to cross the blood-brain barrier to directly target tumors, and a Phase I trial of the drug in 2006 produced a surviving patient with over 15 years cancer-free
- An interim futility analysis of the current trial is anticipated later this year
A simple search of the Internet shows a number of clinical trials attempting to improve treatment options for glioblastoma (“GBM”) brain cancers, and Congress will recognize a National Glioblastoma Awareness Day next month to further support development of effective brain cancer responses.
That’s because, as the U.S. Social Security Administration acknowledges in its protocols for speeding disability applications through “compassionate allowances,” GBM tumors are “the most malignant of the primary brain cancers” and they respond “poorly to all currently available treatments.”
The protocols for compassionate allowance in GBM cases further note that “prognosis is grim, as most patients die within 2 years and few survive longer than three years” (https://ibn.fm/GhhSL).
Texas-based cancer drug innovator CNS Pharmaceuticals (NASDAQ: CNSP) is nearing the release of its interim analysis for its potentially pivotal clinical trial tracking the effectiveness of drug candidate Berubicin, which has already produced one patient with over 15 years of GBM survival.
Berubicin distinguishes itself by being virtually unique in its status as a cancer-fighting anthracycline that crosses the blood-brain barrier to attack central nervous system tumors directly.
Berubicin also distinguished itself by presenting statistically significant improvement in nearly half of the two dozen patients evaluated in a Phase I trial in 2006, including one patient whose last-known status remained cancer free as the current trial process began ahead of the COVID-19 pandemic.
The American Association for Cancer Research recently highlighted the case of GBM patient Adam Hayden, who has survived his diagnosis since 2016 — a decade less than the Berubicin trial patient but highly noteworthy nonetheless at seven years.
Hayden’s role as a patient advocate led to an audience with Congressional leaders in May in which he and his family lobbied the lawmakers for increased funding for cancer research, as well as his participation in President Joe Biden’s Cancer Moonshot initiative at the White House (https://ibn.fm/iPbfm).
A bipartisan Congressional resolution designated last month as Brain Tumor Awareness Month in support of efforts to find better brain cancer treatments, and Arizona senior Sen. Kyrsten Sinema co-introduced bipartisan legislation designating July 9 as National Glioblastoma Awareness Day in honor of the late Arizona Sen. John McCain, who died of GBM in 2018.
Sinema’s resolution “calls for treatments of glioblastoma and related brain cancers to slow its progression, improve quality of life, and recognize the importance of molecular biomarker testing to improve diagnosis and treatment” (https://ibn.fm/gRvBo).
CNS Pharmaceutical has raised sufficient capital to enable the company to secure its trial beyond the interim analysis at least into the fourth quarter (https://ibn.fm/aWCfQ).
Primary completion of the trial is expected next year, with final results in late 2024 or early 2025. The trial has achieved global status, recruiting patients in the United States, Spain, France, Switzerland and Italy. The trial’s ultimate aim is to show Berubicin offers a better rate of overall survival compared to Lomustine, but there are also several secondary measurements that will be evaluated, including improved survival without tumor progression or adverse treatment events, and improvement in the overall proportion of patients responding to treatment.
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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