Sep. 23, 2009 (Baystreet.ca) --
Hype versus substance. Perception versus reality. During the past week, there has been much debate regarding the work being done by CEL-SCI (NYSE AMEX:CVM).
In June, the company filed a provisional U.S. patent application covering its L.E.A.P.S.(TM) immune therapy drugs for the prevention and treatment of H1N1, swine, bird flu, Influenza A and/or evolving mutants or variants of these viruses. At the time, few people took notice. Company shares could be had for about $0.47 per share on average daily trading volume of about 1.6 million shares.
As we know now, experimental work had been initiated on these various methods of use and applications for the A influenza vaccines and government officials took special notice when they learned that these L.E.A.P.S. vaccines, when used individually or together, induced antigen specific immune responses.
Last week, in swift order, the company was granted FDA approval to proceed with human clinical trials of its H1N1 flu treatment candidate. Shares soared after rising steadily on rumors and reports during the weeks leading up to the surprise announcement.
Some published reports attributed genuine concerns about the H1N1 pandemic by the Obama administration as a catalyst for the fast moving developments and closed-door secret meetings between government agencies and company officials. The company still can't reveal many specifics about this new treatment option, but one recent presentation by an outside investigator from the University of Hawaii at the Annual American Society for Microbiology in Philadelphia may help shed some light. His presentation dealt with new L.E.A.P.S. Tuberculosis data and interestingly, this TB data demonstrated that vaccines utilizing the L.E.A.P.S. technology, with specificity for particular Mycobacterium tuberculosis (TB) antigens, could not only elicit immune responses that could be protective against tuberculosis, it also showed evidence that the platform had potential to treat swine and other H1N1 influenzas.
The TB data showed that blood and spleen cells from immunized mice produced gamma interferon in responses when injected while the cells from mice in the various control groups did not. Other recent L.E.A.P.S. data, presented by Dr. Kenneth S. Rosenthal, Professor of Microbiology, Immunology and Biochemistry at Northeastern Ohio Universities Colleges of Medicine and Pharmacy along with colleagues at the 12th NFID meeting in Baltimore showed that CEL-SCI's L.E.A.P.S. technology can activate and cause human blood monocyte cells to become dendritic cells that secrete the IL-12 cytokine. The dendritic cells that result initiate a protective cell mediated and antibody immune response. These results were obtained for L.E.A.P.S. vaccines against herpes simplex and HIV.
"In the short term, either investors and speculators are going to buy into the idea that Cel-Sci is on to something with substance here or they're not," said one industry expert who knows the company and has worked with them on various issues, including the development of internal regulatory standards. "It doesn't really matter at this point if lay people get it or not. This is happening either way and it's good to know that those who matter do understand what's going on here and have put things in motion.
"The company has been calculating every move very carefully.
