WEST HARRISON, NY / ACCESSWIRE / March 10, 2016 / New patient enrollment is continuing to progress very smoothly in CEL-SCI Corporation's (NYSE MKT: CVM) pivotal world's largest global head and neck cancer Phase III study. As of February 29, 2016 724 patients are enrolled. Only 156 new patients are needed for CEL-SCI to reach the current study full enrollment goal of 880 patients sometime this summer.
A hearing (trial) of the $50 million arbitration suit with an extra $100 million in consequential damages sought from its former CRO nears. Expected in about 2 years when the 300th enrolled patient in the two main comparison groups dies survival results will be measured. A 10% improvement in the overall patient survival versus the current standard of cancer care could increase the stock valuation by $ billions.
"Immunotherapy drug development so far has been mostly with sick patients who have already received surgery, radiation and/or chemotherapy," CEL-SCI CEO Geert Kersten said at a recent conference.
"But that is when the immune system is already severely weakened from those treatments. To help the greatest number of patients, should we not boost the immune system of patients before they receive surgery, radiation and chemotherapy? We believe that an immune system drug ought to work better in newly diagnosed patients who have not yet had those treatments. Yet, as far as we know, we are the only one in the world to be doing that in our Phase III trial."
Boosting the immune system upfront while it is still healthy is such a logical idea. How is it possible that CEL-SCI is the only company in the world doing so in its Phase III trial? "The first rule as a doctor is to do no harm," Kersten continues. "Therefore you cannot delay the patient's surgery which must take place within four weeks or you will increase the odds of the cancer spreading. Unless an experimental drug can be given within that four week window, it cannot be given. We can think of no other cancer immunotherapy besides our three week Multikine treatment that fits into the four week window between initial cancer diagnosis and surgery."
Our complete in depth sponsored CEL-SCI Corporation March update 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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