VIENNA, Va., Feb. 5 /PRNewswire-FirstCall/ -- The following letter is being released by CEL-SCI Corporation to its shareholders:
Dear Fellow Shareholders:
We are elated!!! After announcing last year that the head & neck cancer patients enrolled in our key Phase II clinical trial with our cancer drug Multikine(R) showed a 33% increase in overall survival 3.5 years after surgery, we now have great news again. In January of 2007 we received the go- ahead from the U.S. Food and Drug Administration (FDA) to commence our Phase III clinical trial with Multikine in patients with advanced primary head & neck cancer. Very few drugs ever make it to Phase III clinical testing. Our success is even more incredible because Multikine is a "first in a new class of anti-cancer drugs".
We can still remember the long list of objections that potential investors threw at us in the past. This list has now become very short. The only remaining objection to our Multikine in some parts of the investment community is the fact that Multikine is an immunotherapy treatment. Immunotherapy, while ultimately expected to be very successful in the treatment of cancer, has not been successful in studies conducted by other companies so far. When we mentioned this issue to an oncologist friend of ours he responded, "But that should not be an issue for Multikine because you have the data to show that your drug works." He is right, but we still have to go out of our way to explain why Multikine works when other immunotherapy drugs have not delivered the expected results.
1) As you know our cancer drug Multikine is a defined and consistent mixture of human cytokines, substances that coordinate an immune response. Cytokines as a therapy have been very successful when used in a situation where there is a clear and simple cause and effect relationship, such as in the case of Amgen's multi-billion dollar drug, EPO. If you need more red blood cells, you take EPO and the problem is "fixed". However, in the treatment of cancer using the single cytokine approach has not worked well because there is no single cause and effect. You need a comprehensive anti-tumor immune response to be successful in the fight against cancer. Our Multikine, as we have published in the "Journal of Clinical Oncology", empowers the patient's own immune system to mount a comprehensive and effective anti-tumor immune response. 2) Historical cancer drug development placed the emphasis on developing drugs for patients who have failed prior therapy. This same thought pattern was extended to immunotherapy and immunotherapy was given to late-stage cancer patients. We now know that this makes no sense -- and in fact, it is starting to make no sense to many oncologists with whom we have consulted. Why would one want to try to stimulate the immune system after it has been ravaged by surgery, radiation and chemotherapy? There is not much left to be stimulated. We give our Multikine to cancer patients with advanced tumors that have not yet been treated because they still have an immune system that can be stimulated and is able to respond! 3) You may be the best at your job, but you will most likely fail if you are tasked with everybody else's job which you know little to nothing about. That is what was requested of immunotherapy by others until now. It has been asked to clean up the "mess" of all prior failed cancer therapies pretty much on its own. No wonder it did not succeed!
We give our Multikine to cancer patients in supra-physiological doses, the way the body does, we give it to patients who have not yet been treated and still have an intact immune system that can be stimulated, and we give it as an adjunct (enhancement) to the existing first-line cancer therapy for advanced primary head & neck cancer patients.
The primary goal of Multikine is to "clean" the tumor margins and to kill the tumor cells that have migrated to the local lymph nodes. This is crucial because the tumor cells around the tumor and those in the local lymph nodes are the primary reason for recurrence in these patients. By eliminating these tumor cells, we can reduce recurrence of the tumor and hopefully increase the overall survival of these patients in a meaningful way.
Multikine does other things as well. All of them can be viewed as wonderful additional bonuses. Multikine has been shown to be non-toxic, eliminate the tumor in 12% of the patients after only a 3 week treatment, on average reduce the number of tumor cells by about 50% before the scheduled surgery even begins, and enhance the likely effectiveness of the radiation/chemotherapy treatment given after surgery (Laryngoscope. 2003 Dec; 113(12): 2206-17).
Now that we have FDA go-ahead for our Phase III study with Multikine, we have a clear path to approval. We were told that we will only need one clinical trial, as long as the data is robust enough. The Phase III study essentially is a comparison between the current standard of care for advanced primary head & neck cancer patients (surgery plus radiation or concurrent radiation and chemotherapy) on the one hand and our Multikine for 3 weeks prior to the standard of care on the other hand. This global study will enroll about 800 patients. To be successful, the group of patients receiving Multikine plus the standard of care treatment will need to show a 10% increase in overall survival when compared to the group of patients receiving standard of care treatment alone.
Historically about 66% of Phase III studies are successful. Of the failure rate of about 34%, about 1/3 can be attributed to serious safety issues. Since we have not seen any serious safety issues with Multikine, we presume that we will not run afoul of that problem and that therefore our chance of success in the Multikine Phase III should be about 78%. In addition, we have built several "risk mitigation factors" into our Phase III study that we hope will give us an even greater chance of success:
1) The Phase III study will use the same Multikine treatment regimen as did the key Phase II study which showed a great increase in overall survival. 2) We have powered the study to show an increase in overall survival which is much less than the one we already observed in our Phase II study. 3) With the help of BioProperties, Inc, a real estate developer specializing in the construction of biotechnology facilities, we are building our own Multikine manufacturing facility which will supply the drug for both the Phase III clinical trial and future sales. Since manufacturing control is essential to our type of drug (a Biologic), this approach removes a great deal of risk from the regulatory approval process.
I hope that by now you understand that we really are at a point of inflection and that we are developing Multikine in a well-thought-out and methodical manner. The next question is, "How big is the market?"
Head & neck cancer accounts for about 5-6 % of all cancers, which translates to about 500,000 cases world-wide annually. Since our Phase III study is a comparison between the standard of care for first-line therapy on the one hand and Multikine plus standard of care on the other hand, a win for Multikine would mean that we would establish a new first-line standard of care -- one that would require the use of Multikine in addition to the current standard of care.
In theory, having a drug that is first-line standard of care should translate into every patient receiving the drug. To be more realistic, let us assume a 20% market penetration for Multikine, a very low level for a first- line treatment of a serious life-threatening disease -- such as head & neck cancer. This would still results in sales of about $2.5 billion annually, assuming a sales price of $25,000 for the treatment, which is much less than the cost of many of the new cancer drugs and/or treatments. In other words, a first-line indication is very significant to patients and investors alike.
We believe that Multikine is a drug that will change the way we currently treat cancer.
We will continue to work hard for the success of this new and promising anti-cancer drug. We thank you for your support.
Sincerely, Geert Kersten Chief Executive Officer
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, 2006. 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.
CEL-SCI CorporationCONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460
Web site: http://www.cel-sci.com/
