CEL-SCI Corporation Releases Letter to Shareholders

VIENNA, Va., Feb. 5 -- 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® 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.

(Amex: CVM---closed Friday's trading at 81 cents a share. Today's letter saw a slight increase in stock price, up 4 cents to 85 cents a share. Clearly, investors are not impressed by the data, IMO wrongly, that immunotherapies don't work, when indeed they do. I will watch this stock and I think my in may be at 95 cents a share.