LOS ANGELES, July 23, 2014 (GLOBE NEWSWIRE) -- Yesterday morning, CEL-SCI Corporation (NYSE MKT:CVM) announced that Turkey's Ministry of Health had cleared the company to begin patient enrollment in CEL-SCI's global pivotal Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine.
The news that Turkey has the 16th country to participate in the world's largest Phase III head and neck cancer trial of the firm's Leukocyte Interleukin, Injection follows last week's news that Sri Lanka's Ministry of Health had also cleared the Company to commence patient enrollment in Sri Lanka.
Similar clearances to conduct the Phase III study in the UK and Austria were announced in previous weeks and though it has becoming increasingly clear that CEL-SCI's expansion of the trial is finally going as planned (with the goal of having 880 patients enrolled through 100 clinical centers in 20 countries by the end of 2015), the valuation and share prices have yet to see a real impact.
Even with last week's news that CEL-SCI had just been awarded a Small Business Innovation Research (SBIR) grant in the amount of $225,000 to fund the further development of CEL-SCI's LEAPS technology as a potential treatment for rheumatoid arthritis (an autoimmune disease of the joints whose drug market will generate revenues of $38.5 billion by 2017), company shares continue to be an example of undervaluation and market irrationality at its best.
The Vienna, VA based firm, which had been criticized and punished by investors for showing extremely slow enrollment in their late stage clinical trial, terminated inVentiv Clinical, LLC in April 2013 announcing that it had replaced the poorly executing CRO, with two new clinical research organizations, Aptiv Solutions, Inc. and Ergomed Clinical Research Ltd. Ergomed even entered a co-development agreement, which calls for them to contribute up to $10 million towards the study in exchange for milestone and single digit % royalty payments up to a specified maximum amount.
The more patients the new CRO's continue to enroll, the more speculators may bet that Cel-Sci's shares might suddenly get a massive boost thanks to a their open arbitration claim which seeks at least $50 million in damages from inVentiv. Public information and filings point to that original CRO having only enrolled 117 patients at 39 sites in 8 countries, including three centers in Israel where CEL-SCI's partner Teva Pharmaceuticals has the marketing rights, and nine centers in Taiwan where the company's partner Orient Europhama has the marketing rights.
Some Wall Street analysts believe that despite an ongoing Phase III trial with a potentially strong platform technology, safety data, and a cGMP compliant manufacturing plant, CEL-SCI shares remain undervalued to this day.
That the firm has simply taken far too long in getting investors to the Promised Land is one common theory for the low priced shares, but given the clear increase in enrollment and positive news flow, investors have been left to wonder why stock prices can't seem to gain positive traction.
A more likely answer involves simple consolidation, in which levels of resistance and support within the consolidation are created through the upper and lower bounds of the stock's price. The basic concept is that as markets move from periods of high directional activity and volatility (trend), to periods of rest (consolidation) the cycle repeats over and over again in almost every active market.
Once the price of the asset breaks through the identified areas of support or resistance, volatility quickly increases and so does the opportunity for short-term traders to generate a profit.
The chart here shows that Cel-Sci's shares have actually been rising slowly since early June, despite the fact that the stock's Williams %R momentum indicator is pointing to the stock being "oversold."
Today's CEL-SCI shares continue to trade well below the 12 month $7.00 price target issued by Laidlaw & Co. analysts in October of 2013.
While everyone knows that there will be no new data out from the Phase III Multikine trial in head and neck cancer, analysts who cover the stock are expecting nearer-term news flow from the new potential indications for the drug: HIV/HPV co-infected patients with peri-anal warts and HIV/HPV co-infected women with cervical dysplasia.
As of the most recent filing, for the quarterly period ended March 31, 2014 the company stated that believes that it has enough capital to support its operations for more than the next twelve months and believes that it has ready access to new equity capital should the need arise.
During the six months ended March 31, 2014, CEL-SCI raised approximately $21.8 million in net proceeds through the sale of common stock and warrants in two public offerings and from the exercise of previously issued warrants. Then, in April 2014, the Company raised approximately $9.84 million in net proceeds through the sale of common stock and warrants in a public offering and from the exercise of previously issued warrants.
Since the Company launched its Phase III trial for Multikine, the Company has spent approximately $12,800,000 as of March 31, 2014 on direct costs for the Phase III clinical trial.
With a market cap of $77.1 million, an estimated over $30 million in cash, a $25 million manufacturing facility, a product in a large Phase III trial and having now entered two new indications with faster paths to approval, shares may be poised to head higher, but an unexpected injection of many tens of millions of dollars via the arbitration claim against inVentiv Clinical, LLC could become the real surprise story and a strong trade catalyst here.
CEL-SCI's market cap could be greatly impacted if they are awarded even part of the $50 million+ they seek in damages has the attention of traders and speculators who like to buy into litigation catalyst plays.
In 2012's Vringo, Inc. – saw shares soar after that firm won a November 2012 trial against Google for violations of patents. Google, denies infringing the patents, and is challenging their validity and the value set by the jury, but investors who were able to get shares at low prices walked away with plenty of profits.
Patient investors should be rewarded whether a surprise announcement comes or not. Cel-Sci still possesses positive data from its successful Phase II showing a robust 33% survival rate at 3 ½ years for Multikine; a biological blend of human cytokines long suspected to exert a destructive effect on solid tumors when delivered through the skin, via the lymphatic system or around the tumor itself.
Those human study results convey a solid measure of confidence in the current trials' results, but they also reminds us that firms like Peregrine Pharmaceuticals, which is not as far along in their own Phase III study of their immunotherapy drug Bavituximab, already has a market cap valuation many times higher than CEl-SCI's ($291M versus roughly $77M). If Multikine goes on to prove successful in Phase III trials, management intends to apply to the FDA for use of Multikine plus the current standard of care as a first-line treatment for head and neck cancer; an estimated $3.6 billion market in the U.S. alone. In fact, 6% of all cancers are head and neck cancer with an estimated 650,000 new cases globally and about 150,000 in the U.S. and Europe.
Keep a close watch on CEL-SCI shares as the company continues to execute their game plan and know that the "Buy" recommendation and 12-month price target for CEL-SCI ($7.00) included a risk adjusted value for Multikine in all three potential indications, yet it attributed no value for the firm's LEAPS (Ligand Epitope Antigen Presentation System) program due to its preclinical status. Given last week's news about LEAPS as a potential treatment for rheumatoid arthritis, however, potentially changes things and adds tremendous value in the future, as longs as at least one drug candidate enters Phase I studies by the end of 2016.
Some believe CEL-SCI share prices will continue to see a gradual appreciation from now until Phase III testing results are unveiled. There may be the occasional sell-off but overall, long-term investors should be handsomely rewarded.
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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 therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include 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. Navy under a CRADA (Cooperative Research and Development Agreement).
CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
When used in this report, the words "intends," "believes," "anticipated", "plans" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2013. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. CONTACT: M. Davila, Assistant Editor, BioMedReports.Com; e-mail: firstname.lastname@example.org
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