- In June 2020, CNS’ lead drug candidate, Berubicin, received Orphan Drug designation from the FDA. In June 2021, it received Fast Track designation following positive results from an extensive clinical study that saw 44% of the patients post a clinical response, with one Durable Complete Response
- With GBM having a survival rate of only 6.8% and an average length of survival of only eight months, Berubicin is showing tremendous potential, and CNS is leading the charge to find a potential treatment option for the disease
- CNS’ management is optimistic about its lead drug candidate and continues to explore the potential treatment of other conditions such as lymphomas, lung and breast cancers
CNS Pharmaceuticals (NASDAQ: CNSP), a clinical stage biotechnology company, recognizes the growing problem of metastatic cancers of the brain and central nervous system. More importantly, it recognizes how few and largely ineffective current solutions are available, ultimately contributing to higher mortality rates and a poor quality of life for victims with such conditions.
This understanding led to the introduction of Berubicin, the company’s lead drug candidate aimed at treating Glioblastoma Multiforme (“GBM”), with the potential to also deal with other central nervous system malignancies.
In June 2020, Berubicin received Orphan Drug designation from the United States Food and Drug Administration (“FDA”) and Fast Track designation in June 2021. These designations came in the wake of positive results following an extensive clinical study in which 44% of patients showed a clinical response of stable disease or better, with one Durable Complete Response.
This was a huge milestone for the industry, particularly since over 10,000 individuals with GBM succumb to the disease annually, given its five-year survival rate of only 6.8%. In addition, the condition has an average length of survival for patients of only eight months (https://ibn.fm/mzJy3).
“Against the backdrop of statistics that show the aggressiveness of GBM, CNS is leading the charge to find a potential treatment option for the disease,” notes a recent article (https://ibn.fm/zzzf1).
CNS’ Berubicin, an anthracycline chemotherapy agent, has appeared to demonstrate, based on limited clinical data, the ability to cross the blood-brain barrier to target tumors directly. This has set it apart from other more mainstream anthracyclines, allowing it to achieve more significant outcomes and a potential solution for patients with GBM and other brain tumors.
According to the American Cancer Society, about 25,050 malignant tumors of the brain and spinal code will be diagnosed in the United States in 2022 alone. In addition, the society projects that about 18,280 people will die from brain and spinal cord tumors this year (https://ibn.fm/ldQYJ). Cancer.net further projects that about 4,170 children under the age of 15 will also be diagnosed with a brain or CNS tumor this year in the United States (https://ibn.fm/GYQ57).
With such numbers, one would understand why CNS received its Fast Track designation from the FDA. Its research so far is the most promising in treating such conditions. Berubicin could potentially help save thousands of people every year and reduce such conditions as GBM to treatable and manageable ailments.
CNS’ management is optimistic about prospects for its lead drug candidate. It continues to explore the potential treatment of other conditions such as lymphomas, lung and breast cancers. The company is also expanding its global presence, having already received clinical approvals in Switzerland, France, and Spain. It expects to utilize the Fast Track designation to build on the studies conducted so far to achieve its organizational goals and offer a viable treatment for patients with GBM.
“Our focus and priorities remain on advancing our clinical development program for Berubicin to ultimately bring meaningful treatment to GBM patients, families and clinicians, who currently have extremely limited and often ineffective treatment options,” notes John Climaco, CNS’ Chief Executive officer (“CEO”) (https://ibn.fm/kZ8PN).
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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