Thrilling Phase III Cancer Immunotherapy Comeback and the Significance of the CEO's 3 Million Share Purchase
WEST HARRISON, NY / ACCESSWIRE / February 4, 2016 / A comeback management team has transformed CEL-SCI Corporation (NYSE MKT :CVM) into a classic special situation. That definition is a stock whose price should rise regardless of the overall stock market direction because of its intrinsic value and momentum.
During a recent presentation CEL-SCI CEO Geert Kersten quipped, "Among a class of college students in Economics 101 no one would ever believe the kind of stuff that happens to biotech companies. No one would ever invest if they knew, right? But the flip side is that no where can you make as much money as in small biotech companies which become successful!"
"Sheer persistence," is Kersten's explanation of CEL-SCI's almost miraculously survival. "My management team has been with me for 20 years. Where do you still find that? What holds us together is our data-driven belief that our Multikine drug treatment works."
After significant setbacks, CEL-SCI is approaching the finish line for its world's largest head and neck cancer immunotherapy Phase III study. Almost 700 patients are enrolled at 84 sites in 24 countries including in the U.S., Canada, Israel and parts of Europe and Asia. However, CEL-SCI's recent market cap of $62 million is a tiny fraction of the billions of some earlier stage Phase I or Phase II rivals. Last month to demonstrate his belief things are going well at last , the CEO made his biggest single personal purchase of 3 million shares valued about $1.1 million.
CEL-SCI's unique Phase III study is pioneering injecting its Multikine drug regime for three weeks into the four week window before traditional surgery, radiation and/or chemotherapy. In contrast, other cancer immunotherapy companies, which require much longer treatment times, must aim to boost the immune system after the tumor has recurred. Unfortunately that is also when the immune system may have been debilitated by the toxicity from the earlier surgery, radiation and chemotherapy.
Full enrollment of its trial 880 patients is expected in 2016 with possible study completion in late 2017. If a 10% improvement in patient survival versus the current standard of head and neck cancer care is achieved, CEL-SCI expects to submit a Biologics License Application to the FDA seeking approval of its Multikine drug regime. Success would offer the potential to become the fourth standard of care for head and neck cancer, preceding and joining surgery, chemotherapy and radiation. That would involve about 6% of the world's solid cancers.
