News Details – Smallcapnetwork
CEL-SCI Delivers Positive Data
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February 2, 2024

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PDT

Dow Jones 11419.89 +0.00 6:00 am PDT, May 24, 2006 NASDAQ 2229.13 +0.00 For info, visit access.smallcapnetwork.com S & P 500 1292.08 +0.00 Change your subscription status here Russell 2000 737.47 +0.00 VOLUME 06: ISSUE 40 CEL-SCI Delivers Positive Data We've been covering CEL-SCI (AMEX: CVM) off and on now for almost four years. Both times we initiated coverage, first back in November of '02 and again in February of this year, the stock went on to reward our readers substantially for the year. Therefore, we like to think we have come to know this story as good as anyone, and let me tell you, this story is really starting to get good. If you don't own any CVM now, you best consider adding some to your portfolio on any pullbacks in the stock near-term, as the Company appears to be getting closer to its planned Phase III clinical trials. With recent data released and the changing tide in the Biotech arena, small companies such as CVM hold tremendous upside potential in our opinion, as the pipeline for new cancer drug studies is comparatively scarce. At 1:15 PM ET Tuesday, CEL-SCI announced the highly anticipated release of long-term survival data from its Phase II clinical trials in patients with head & neck cancer. The addition of Multikine as the first-line treatment prior to the standard of care treatment resulted in a 33-40% improvement in the median survival at 3 1/2 years post-surgery (release below). Multikine first-line treatment also resulted in a 2-year local regional control (LRC) rate of 79%, as compared to the median 2-year LRC of 73% reported in 39 scientific publications previously published. Local regional control (LRC) is the increased ability to delay the recurrence of the tumor. Bottom line is these results revealed substantial improvement in both the survival rate and the local regional control of tumors for cancer patients who received Multikine over 3 years ago. This is significant, as the data are thought to be directly applicable to CEL-SCI's planned global Phase III study. This clearly bodes well for the Company, which has already received the Phase III go-ahead from Canadian regulators.   Killing Cancer Worth Billions...and lives. Drug sales for cancer treatments are expected to more than double over the next five years, with cancer drugs replacing cholesterol-reducers as the number one pharmaceutical sector, according to a report from IMS Health. Right now, it's probably the fastest growing drug sector, with oncology drug sales projected to reach $55 billion in 2009. With its recent release of data and CEL-SCI's push toward a Phase III clinical trial, the future revenue prospects for the Company becomes mind boggling with potential. Cancer is America's second-biggest killer behind heart disease. Genentech (NYSE: DNA), one of the most prolific names in cancer treatment, is reaping the benefits of growing sales with its colorectal cancer drug, Avastin, posting record revenue in excess of $1 Billion in 2005 and is projected to achieve 6.9 billion a year in sales by 2009. To put it into perspective, Avastin is a treatment provided in conjunction with chemo, which received FDA approval based on data demonstrating a five-month improvement in the median survival of patients treated with Avastin plus the chemotherapy regimen compared to other patients. Sound familiar? Maybe Avastin and Multikine should be used together. We'll leave that up to the scientists and the FDA. Genentech's market cap currently fluctuates around $82 Billion. CEL-SCI's sits around $65 Million. Which appears to have more room for growth? It will likely take a 100-pound gorilla, a crane and a few missiles to launch shares of Genentech to new highs in the coming months ahead. If CEL-SCI can get an FDA go-ahead for its Phase III clinical trials, we believe the stock is at least an overnight double. Although we feel exposure to biotech is well warranted right now, regardless whom you choose to invest in, we can all find comfort in the fact that these companies are helping to save lives. Likely at one point or another throughout our lives, we've all had someone close to us diagnosed with cancer. When someone we know ends up having to battle this unbelievably ruthless disease, I think it becomes quite apparent why we tend to gravitate toward companies that develop cures or life extending drug treatments for those in need. Hence, just another reason why I'm always willing to bet a few bucks on the companies I believe are at the forefront of biotech research and development.     And, the Technical Picture Investing and Trading are two completely different animals. Within trading, we have various species. What are you? Predefine that and you are so far ahead of the game, it's not even funny. I'll do an edition on that soon. For now, shares of CVM are as good as it gets for traders, when you're on the right side of the trade. The stock has had huge run-ups on at least five separate occasions in the last five years. However, its most recent rocket move during the week of April 7th was on record volume. Blow away record volume to be more precise. Like I've said before, volume is your friend. It is one of the few leading indicators that one can use to identify buy or sell signals in stocks that simply aren't behaving with any sort of normalcy. The amount of volume displayed in CVM's latest move suggests much higher levels of interest in the stock than ever before. This is often the case prior to major moves in small stocks. This weekly chart shows shares of CVM violated the 5/8-retracement level from the run up that started back in February of this year, although the retracement was on fairly light volume, we would have preferred it hold the $.90 cent level. However, it's more interesting to note that prior to the big run-up in CVM recently, the move came off a higher trading base than its previous level. After the news hit the market yesterday, shares of CVM traded as high as $1.15 before backing up a bit at the close. We like the momentum in the stock right now. We believe yesterday's announcement will provide a new catalyst, we like the prospects of CVM shares making a move to the $1.30 - $1.40 level. From there, we'll reassess the chart. Use any short-term weakness in the stock as a potential entry point. A trading stop of $.85 cents is suggested. If you're an investor, I'd tuck some away for a rainy day. The market loves to reward investors when they least expect it.     Press Release CEL-SCI Presents Long-Term Survival Data With Its Anti-Cancer Drug Multikine(R) Tuesday May 23, 1:15 pm ET VIENNA, Va., May 23 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM - News) announces the presentation of long-term survival data from its Phase II clinical trial in patients with head & neck cancer (oral squamous cell carcinoma -- OSCC) treated with its anti-cancer drug Multikine®. The addition of Multikine as first-line treatment prior to the standard of care treatment resulted in a 33-40% improvement in the median survival at 3 1/2 years post-surgery, when compared to the results of 39 OSCC clinical trials published in the scientific literature between 1987 and 2004. The data were presented at the "Vaccine Discovery and Commercialization" conference in Philadelphia, PA. The long-term survival data were collected by the treating physicians in a follow-up study of 22 patients with advanced untreated primary tumors, who were enrolled in the Multikine Phase II clinical trial. The Multikine treatment regimen was administered to these patients prior to the standard of care treatment (i.e., surgery + radiation or surgery + chemo-radiation). Informed consent was obtained from all patients in the clinical trial and from 19 patients for the long-term follow-up study. Investigational Review Board / Ethics Committee approval was provided before the initiation of the clinical trial and again for the data collection in the follow-up study. The follow-up study questionnaire assessed the overall survival and the local regional control of the Multikine treated patients in this Phase II trial. Documented data were available for 19 of the 22 patients in the follow-up portion of this clinical trial. Of the three patients who could not be evaluated in the follow-up study, one patient was known to be alive, but failed to give informed consent, and the other two were lost to follow-up. One patient died the day after definitive surgery, unrelated to Multikine therapy. The median overall survival (calculated by including death from any cause of patients in the trial, even deaths not related to the disease) of the 19 evaluable patients in the follow-up portion of this clinical trial was 63% at a median follow-up of 40 months post-surgery. The results of the published scientific literature (39 OSCC clinical trials published between 1987 and 2004) document that survival at 3 1/2 years is approximately 47% following standard of care treatment. The addition of Multikine to the standard of care treatment resulted in a 33% increase in overall survival over the results published in the literature. The median survival of patients in this clinical trial was 67% at a median follow-up of 42 months post-surgery, excluding the one patient with immediate post-operative death. The same 39 scientific publications indicate that survival at 3 1/2 years is approximately 47% following standard of care treatment. The addition of Multikine to the standard of care treatment resulted in an increase in survival of 40% over the results published in the literature. Multikine first-line treatment also resulted in a 2-year local regional control (LRC) rate of 79%, as compared to the median 2-year LRC of 73% reported in the same 39 scientific publications. Multikine treatment resulted in an improvement over the published local regional control rate. It is clinically recognized that recurrence of disease in head & neck cancer is associated with a very poor prognosis. Multikine treatment did not result in any severe adverse events (SAE) in this Phase II clinical trial. No SAEs related to Multikine have been reported in other trials conducted with Multikine either. The data from CEL-SCI's Multikine Phase II clinical trial are thought to be directly applicable to CEL-SCI's planned global Phase III clinical trial, as the Multikine treatment regimen planned in the Phase III trial is identical to that of the Multikine treatment in the trial reported here. Furthermore, the planned endpoints of the Phase III trial are local regional control, disease-free survival and overall survival, all of which have shown improvement compared to historical controls, following Multikine first-line treatment over the current available treatments for these patients. Head & neck cancer is an aggressive cancer that affects 500,000 people per annum worldwide, and approximately 2/3 of patients present with advanced disease. Multikine is a patented immunotherapeutic agent consisting of a mixture of naturally-occurring human cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for the treatment of cancer. CEL-SCI Corporation, with operations in Vienna, VA and Baltimore, MD is developing new immune system based treatments for cancer and infectious diseases. CEL-SCI's other products are currently in the pre-clinical stage of development. Pre-clinical animal studies have received U.S. government support. The results of these studies indicate these products may offer protection against a number of diseases. The agents are being tested, among others, against diseases associated with bio-defense and avian (bird) flu. 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 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 hereof or to reflect the occurrence of unanticipated events.       ---------------------------- Source: CEL-SCI Corporation   We Value Your Feedback   Got comments, questions or suggestions? Send 'em on over: Editor@smallcapnetwork.com If you wish to send a written request or inquiry, please send it to our physical address: TGR Group, LLC 4653 Carmel Mtn Rd Suite 308 #402 San Diego, CA 92130 Biotech in Focus For those religious biotech followers who missed our SC Blog yesterday morning, one of the industry's biggest weeks of the year is just around the corner. And, if you don't think there's going to be a few biotech stocks that are going to make huge moves in the coming weeks after, think again. Look what happened to Amgen's stock, (NASDAQ: AMGN), last year in the few months following the big pow-wow. ASCO takes center stage in Atlanta this year June 2nd -- June 6th. Consider it the modern day Woodstock for cancer drugs, except everyone has grown up, dresses nicer and speaks much more eloquently. Maybe that's a bit of a stretch, but nevertheless, it's the most important event of the year for companies looking to gain recognition and tout their most recent advancements in the forever-coveted arena of cancer research and development. ASCO is a non-profit organization, founded in 1964, with overarching goals of improving cancer care and prevention and ensuring that all patients with cancer receive care of the highest quality. More than 23,000 oncology health care practitioners belong to ASCO, representing all oncology disciplines (medical, radiologic, and surgical oncology) and subspecialties. The ASCO Annual Meeting is considered the premier educational and scientific event in the oncology community. The Meeting attracts more than 29,000 attendees from all over the world, from street analysts to the most renowned cancer research and development scientists on the planet; ASCO is a who's who gathering of biotech big wigs. If you're interested in learning more about the industry, the ASCO web site is loaded with valuable and insightful information. What is this going to do for certain biotech stocks in the few months following ASCO? I think we're in for a short-term biotech rally. I say short, because we're talking about a trade here, not an investment. Whatever comes of ASCO, you'll likely have time to invest in the weeks after, if that's what you choose to do. For now, let's have a quick look at the BTK, which is the Amex Biotech Index, and the IBB, which is the NASDAQ ETF for Biotech stocks. In this weekly chart of the BTK, you can see the index has sold off of late in sympathy with the broader markets, we've circled its 3/8-retracement, where it currently is hovering, but point to the 5/8, which would be an even more ideal entry point, obviously. All of our favorite technical indicators are pointing to an oversold market for biotech right now, so I suspect we'll see a tradable rally leading into ASCO, and good follow through in the right stocks following the meeting. Inevitably, it would be no surprise to see the BTK clean up the 5/8 retracement level sometime this summer. If you agree with our thinking, some exposure to sector wide puts may be in order at the top of the short-term rally anticipate. Of the two, the IBB appears riper for a rally (you can't directly trade the BTK anyway). Keep in mind, the BTK and the IBB are made up of different stocks, so different price action makes clear sense. The IBB, as shown in this weekly chart, currently sits on a nice 5/8-retracement level (circled). We point out the volume of late in the chart, which has been fairly substantial, so we like that. A clean up of the $70 level would be no surprise at all, and would represent an excellent entry for a trade to the long side. Whatever you decide, pay attention to ASCO. It will tell many of us where the industry is going over the next couple of years, and likely who will be leading it there. Subscribe Information is power and timely information is profitable. Become informed and profit from SmallCapDigest Profiles and Trading Alerts by becoming a Preferred Member today. There is no cost associated with your email subscription. Add your email address below and make sure to check your email inbox and confirm your opt-in request to start receiving the SmallCapDigest Email Newsletter on a regular basis. 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Unsubscribe Here D I S C L A I M E R: The Small Cap Digest, the Small Cap Network, its website and email newsletter (hereafter, cumulatively referred to as "SCD") , is an independent electronic publication committed to providing its readers with factual information on select publicly traded companies. SCD is owned and operated by TGR Group, LLC ("TGR"). TGR is not a registered investment advisor or broker-dealer. All companies are chosen on the basis of certain financial analysis and other pertinent criteria with a view toward maximizing the upside potential for investors while minimizing the downside risk, whenever possible.  Moreover, as detailed below, TGR accepts compensation from third party consultants and/or companies, which it features in the publication and circulation of SCD. To the degrees enumerated herein, SCD should not be regarded as an independent publication.  Click Here or go to http://access.smallcapnetwork.com/compensation_disclosure.html to view our compensation on every company we have ever covered, or visit the following web address: http://www.smallnetwork.net/profile_disclosure.html for our full profiles and http://access.smallcapnetwork.com/short_term_alerts.html for Trading Alerts.  TGR Group LLC has been paid a fee of $25,000 and 150,000 shares of newly issued restricted stock by Cel-Sci for coverage of the Company. Additionally, back in November of 2002, TGR Group LLC was paid a fee of $25,000 and 250,000 shares of newly issued restricted stock of Cel-Sci for coverage of the company until November of 2003. The aforementioned 250,000 restricted shares became free trading under SEC rule 144 and were sold in the open market prior to the company entering into a new contract agreement with TGR Group in February of 2006. 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