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.
Our complete in depth sponsored CEL-SCI Corporation February profile can be found archived on our Flaherty Financial News website at http://www.flahertyfinancialnews.com/.
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Flaherty Financial News Inc. ("FFN") is the publisher of totally-electronic coverage of interesting public companies. FFN was launched in 2007 by the "legendary financial editor" Bob Flaherty, Editor and Chairman of Flaherty Financial News Inc., and his son Brian, President and Publisher. While previously serving as Chairman and Editor of Equities Magazine for twenty-five years and also Editor-in-Chief of Equities Special Situations, Bob had one of the most consistent and highest ranked long-run performance records measured by Hulbert Financial Digest. He is also an award-winning retired Senior Editor of Forbes Magazine, where he wrote 33 cover stories, two shy of the all-time Forbes record. He was also Chairman of The Over-The-Counter Securities Fund. Bob Flaherty is a Magna Cum Laude graduate of Harvard College in economics and also has an MBA with a Distinction in Finance from Harvard Business School. A former president of the New York Financial Writers' Association, Bob is a co-founder of their annual student scholarship program and their annual award for significant long-term achievement in financial journalism.
About CEL-SCI Corporation.
CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy Multikine (Leukocyte Interleukin, injection) is currently being studied in a pivotal Phase III clinical trial as a potential neo-adjuvant treatment for patients with squamous cell carcinoma of the head and neck. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care as compared to subjects treated with the current standard of care only is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Naval Medical Center, San Diego, under a CRADA (Cooperative Research and Development Agreement) and at the University of California, San Francisco.
CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia and in and near Baltimore, Maryland.
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This news release contains "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of l995) regarding the Flaherty Financial News Newsletter profile on CEL-SCI Corporation and its future business plans. These statements involve known and unknown risks and uncertainties, which may cause actual results and future achievements to be materially different than those implied by these forward-looking statements. Flaherty Financial News Inc. and CEL-SCI Corporation have and undertake no obligation to provide public updates and revisions to these forward-looking statements to reflect any changes in their expectations of future events. Our full disclaimer and safe harbor statement appears in our Flaherty Financial News Newsletter.
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