Dow Jones 12568.97 +12.89 7:01 am PST, January 16, 2007 NASDAQ 2506.21 +3.39 For info, visit access.smallcapnetwork.com S & P 500 1432.73 +2.00 Change your subscription status here Russell 2000 798.88 +4.62 VOLUME 07: ISSUE 6 FDA Grants Phase III Approval for CEL-SCI's Multikine  Company Name: CEL-SCI Corporation Stock Symbol : CVM Coverage Initiated: November 8, 2002 Current Price: $.60 Average Volume: 177,654 52 Week Range: $.49 - $1.78 Suggested Target: $1.48 Suggested Stop: $.54 Remember a couple of weeks ago when we discussed how CEL-SCI Corporation (AMEX: CVM) had been unusually quiet of late? Knowing what we know about the company, we just figured something big was brewing and the news would be released seemingly out of nowhere, like a bolt of lightning.  Well, it seems we were right. In fact, the news CEL-SCI just announced - in our opinion - might just be the biggest news the company has had in years. Their primary head and neck cancer treatment, called Multikine, has just been approved by the FDA to enter Phase III studies in the United States. Phase III testing is the last research step required by the FDA before they can decide on any final approval, which is when a drug therapy or treatment can actually be commercialized.  Needless to say, we think this is huge - just huge. Back on the 5th, we felt the stock may be at a short-term bottom. Now with this good news to support the stock, we don't see what could possibly prevent a rally. As a result, we're issuing an official trade alert - more on that below.    Getting Specific Long-time readers will probably recall the details about Multikine, but if you're relatively new, let's catch you up.  Initial testing of Multikine, which is CEL-SCI's lead cancer treatment, has shown effectiveness at not only beating head and neck cancer, but also at increasing the survival rates of these cancer patients after their first illness. See, cancer can be (and often is) a chronic condition. The advantage Multikine may have over other forms of cancer treatment is how the results could be more permanent than alternative treatments are.  In fact, CEL-SCI says Phase I and Phase II studies have already indicated Multikine has superior results when used to treat head and neck cancer. Specifically, 12% of patients had no tumor remaining after only a three week treatment. And, 3.5 years after the whole cancer treatment was finished, survival with Multikine appeared to be much higher. In Phase II testing CEL-SCI saw a 65% - 70% chance of survival with Multikine, versus only a 50% chance without it.  Phase III will look to verify these early results in a larger number of patients.    That's Good Medicine We've talked about the results and effectiveness, but maybe we should at least explain the basics behind why this cancer treatment holds so much promise as well as monetary potential.  See, Multikine is a combination, or "cocktail", of natural human interleukin-2 (IL-2) and certain lymphokines and cytokines (regulators of the immune system). In human testing Multikine has been shown to induce both an anti-cancer immune response and to significantly increase the susceptibility of the tumor cells to radiation therapy. Or in plain English, it's an immune system booster, but uses another type of immune cell in the attack on the tumor.  The patient treatment process is a combination of the Multikine cocktail and more traditional therapies. The global Phase III study will test the hypothesis that the Multikine treatment regimen will indeed extend overall survival in head and neck cancer patients, while increasing disease-free survival in these patients.  Better still, it's a non-toxic way to help beat cancer. What does that mean? It doesn't cause the all the same negative side effects that radiation and chemotherapy can when those treatments are used alone.  See the attraction? Imagine a very effective cancer treatment, and one that doesn't create a ton of other medical problems as part of the cancer-beating process. Do you think there could be enormous potential demand for such a therapy? We do - and that's why we think CVM shares could pay off big in the near as well as distant future.    A Trade, or an Investment? Maybe Both. As we said above, we're issuing an official trading alert based on the news. While our trading ideas are typically shared using a straight-forward 'buy low/sell high' framework with a relatively short timeframe in mind, we'd be the first to acknowledge there's a short-term as well as a long-term opportunity here. The longer-term 'investment' idea is based on the kinds of dollars CEL-SCI is looking at. If Multikine is used only by 10% of the 500,000 newly-diagnosed head and neck cancer patients each year, that means 50,000 patients per annum. At the estimated cost of approximately $25,000 for each patient, that's $1.25 billion in revenues each year. Yes, it could be years until Multikine actually hits the market, but we'd say forward-thinking investors may be well rewarded now for what the stock could be worth in the future.  In the meantime, we've seen CVM make huge short-term runs on fantastic news. Shares rallied 137% in just two days last April when it was announced one of CEL-SCI's therapies could help prolong the supply of bird flu vaccines. Between February 10th and April 4th of 2006, the stock shot up 232% on a combination of bird flu, new patent, and Multikine news.  For short-term traders, we expect this news to drive the stock higher in a hurry. Our suggested target is $1.48, which roughly mirrors the size of the last news-based, short-term gain we saw for CVM shares. Our suggested stop is 54 cents - just a hair below the lows we hit in December. Of course, by the time you get this, the news will have been out at least a short while...which means the stock may already be running wild. If indeed it is, we'd suggest being wise about an entry point. Perhaps an entry level of no greater than 80 cents? Maybe - it just depends. It could be hard to really find a reasonable entry area until we see how the market responds, and we can actually define 'reasonable'. We might see a one-day surge, or this may be the beginning of a very long uptrend...we've seen both before. If it's the latter, it may be worth shopping for an advantageous break in any buying spree.  Our bigger picture (longer term) opinion is also a very optimistic one - we think owning shares in CEL-SCI is easily worth the risk when looking at the possible reward down the road. From our point of view, there's a light at the end of the tunnel, and shareholders could be very well rewarded as the company works its way from here to there. We'd say the Phase III approval is a giant victory for the company, and an important step to investors looking for great opportunities.    CEL-SCI RECEIVES GREEN LIGHT FROM FDA TO PROCEED WITH PHASE III CANCER STUDY  VIENNA, VA, USA, JANUARY 16, 2007 -- CEL-SCI Corporation (AMEX: CVM, Germany: LSR.F) today announced that the U.S. Food and Drug Administration (FDA) has stated in a letter to the Company that, "... the proposed Phase III study may proceed at any time". CEL-SCI's Phase III clinical study is designed to prove that its cancer drug Multikine? increases the survival of head and neck cancer patients.  The study is expected to be conducted in numerous countries around the world. It is designed to develop conclusive evidence of the efficacy of the Multikine treatment regimen in advanced primary squamous cell carcinoma of the oral cavity (head and neck cancer). Upon successful completion of this study, the data will be included in CEL-SCI's worldwide Marketing Applications to make Multikine commercially available for the treatment of this patient population. Head and neck cancer is an aggressive disease affecting about 500,000 people per annum worldwide.  Geert Kersten, Chief Executive Officer of CEL-SCI, said, "So far Multikine has been shown to be non-toxic, which is very unusual for a cancer drug. In Phase II clinical studies with head and neck cancer patients it also markedly increased survival. Now we will get the chance to prove that Multikine can extend the survival of these cancer patients."  The global Phase III study will test the hypothesis that the Multikine treatment regimen, administered locally prior to the current standard therapy given to patients with advanced primary squamous cell carcinoma of the oral cavity, will extend the overall survival and enhance the local/regional control of the disease, while increasing disease free survival in these patients.  Multikine is a patented immunotherapeutic agent consisting of a defined mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors.  CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has operations in Vienna, Virginia and Baltimore, Maryland.  When used in this report, the words "intends," "believes," "anticipated" 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, inability to get American Stock exchange approval for any transaction 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, 2005. 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 thereof or to reflect the occurrence of unanticipated events.    We Value Your Feedback   Got comments, questions or suggestions? 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