- Investors Act On News That CNSP’s Phase II Trails Get The Green Light.
- That’s because CNSP’s drug produced a complete response, which is very rare with brain cancer and even more rare in Phase I trials.
- Now, FDA Considers Awarding Accelerated Status To CNSP’s Breakthrough Drug.
One more day. One more week. One more month.
For tens of thousands of people with a common but aggressive brain cancer, life is about hope for a winning treatment.
It’s that kind of hope some brain cancer patients are looking for from a young biotech, CNS Pharmaceuticals (NASDAQ:CNSP), which made its successful Initial Public Offering on Friday November 8. CNSP shares closed at $4.57, up just under 15%.
The positive investor response is because the brain cancer CNS is targeting is Glioblastoma Multiforme, also known as GBM.
It’s the highly invasive, malignant, and virtually incurable, cancer that killed Sens. Ted Kennedy and John McCain, exactly nine years apart to the day.
CNS’s Brain Cancer Drug
– Berubicin –
Has Shown Awesome Potential
But, CNS has a drug called Berubicin that shows great potential for offering the GMB suffers a glimmer of hope.
A potentially huge breakthrough, Berubicin was developed by researchers at the world-renowned M.D. Anderson Cancer Center in Houston, Texas. It’s the world’s largest cancer research center.
CNS’s Berubicin has such potential that CNS was able to forge a collaboration agreement with Reata Pharmaceuticals (NASDAQ:RETA), which sports a $1.5 billion market cap. Berubicin also attracted more than $25 million in private capital and grants.
Today, CNS is led by three world-class cancer doctors. They are set to begin Phase II clinical trials with Berubicin.
There Is No Question CNS Pharmaceuticals (NASDAQ:CNSP) Is Led By Brilliant Doctors
Admittedly, the term “world-class” is overused and often undeserved. But that is not the case with CNS Pharmaceuticals. Its three preeminent cancer researchers include:
Dr. Sandra L. Silberman, a Hematologist/Oncologist who, while at Boston’s Dana Farber Cancer Institute, played key roles in the development of many drugs including Gleevec™, for which she led the global clinical development at Novartis.
Gleevec is a landmark drug that turned some cancers of the blood, such as forms of leukemia, into chronic illnesses instead of death sentences. The hope is similar for CNS Pharmaceutical’s Berubicin
That’s because, Dr. Silberman has led drug trials from Phases I through III during her work with leading biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, ImClone and Roche.
Another member of the CNS team is Dr. Waldemar Priebe, Ph.D. He’s a world-renowned medicinal chemist, and entrepreneur. Dr. Priebe is also a professor in the Department of Bioimmunotherapy at MD Anderson.
He’s the founding scientist of six pharmaceutical companies, including three listed on NASDAQ. And, it was Dr. Priebe’s research that formed basis for the development of the potent agents that make Berubicin one of the leading drugs in cancer research.
Finally, there’s Dr. Donald Picker, who joined the CNS team in November 2017. His 35 years of drug development experience includes the development of Carboplatin, one of the world’s leading cancer drugs, acquired by Bristol-Myers Squibb and with annual sales of over $500 million.
A Young Biotech Getting To Phase II, With What Could Be A Miracle Drug, Is A Notable Investment Event
And, to be frank about, the team at CNS Pharmaceuticals (NASDAQ:CNSP) could be offering investors hope as well… though solving brain cancer is the ultimate hope.
To that end, investors should be aware that CNS received positive guidance from FDA.
So, now Berubicin is poised for a Phase II clinical trial for treatment, with a potentially accelerated approval pathway due to desperate unmet clinical need.
That rush could be on because the team that developed Berubicin solved one of brain cancer’s most baffling puzzles. The research found away deliver a powerful anticancer drug directly to the brain tumor.
The drug is of a class known as anthracyclines. They are among the most effective anticancer treatments ever developed and are effective against more types of cancer than any other class of chemotherapeutic agents.
Until now, however, the problem with anthracyclines was they could not cross what’s known as the Blood Brain Barrier. The barrier is semipermeable, but highly selective in what it allows from the circulating blood into the brain.
In simple terms, the BBB allows Berubicin access to the brain where it can make contact with, and destroy, cancer cells.
Here is why the FDA could fast track Berubicin.
First, Berubicin has been studied in depth because it was in pre-clinical and human clinical development for more than 15 years. That’s not a long time in drug development as researchers fine tune how the drug works.
Then, the GBM in Berubicin’s Phase 1 trial showed what’s called a clinically significant response to the drug.
One GBM patient from Phase 1 remains cancer-free 10 years after treatment with Berubicin.
Its Drug Could Defeat Other Cancers, So The Long-Term Outlook Is Bright For CNS Pharmaceuticals (NASDAQ:CNSP)
In all, to date, the evidence finds that Berubicin lets GBM sufferers live beyond the median survival rate of only 14.6 months from diagnosis.
That’s hope. And, it means Berubicin could be one day closer to widespread use.
Moreover, pre-clinical research found that Berubicin shows promise in defeating pancreatic and ovarian cancer, as well as lymphomas.
This would amount to a major breakthrough as well because ovarian and pancreatic cancers are difficult to detect until they have really taken hold. That makes them just as deadly a GBMs.
Defeating one cancer – GBM – would make CNS Pharmaceuticals a notable biotech. Tackling pancreatic and ovarian cancer, too, could make CNS Pharmaceuticals one of the world’s most important biotech.
From its solid November 8, IPO, this is the shared hope of patients and investors for CNS Pharmaceuticals (NASDAQ:CNSP).
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