VIENNA, Va., March 08 /PRNewswire-FirstCall/ -- The following letter is being released by CEL-SCI CORPORATION to its shareholders:
Dear Fellow Shareholders:
CEL-SCI set out to create a cancer therapy that would work with the body, not against it; a cancer therapy that would help patients conquer their cancer with the first cancer treatment so that the cancer will not recur. We are pleased to report that recently analyzed follow-up data from the key Phase II clinical trial with our cancer drug Multikine(R) indicate that the drug had a substantial effect on the survival of the patients treated with it.
The long-term follow-up study of the head & neck cancer patients who received Multikine over 3 years ago showed a substantial improvement in both the survival rate and the local regional control of their tumors. The detailed results of this follow-up study are currently being prepared for publication in a scientific journal. These data, if confirmed in our planned Phase III clinical trial, would represent a huge step forward in the treatment of head & neck cancer patients.
The benefit of survival to the patient is obvious and survival is the gold standard of cancer drug development. Increased local regional control refers to the increased ability to delay the recurrence of the tumor in the head & neck area. If a drug can delay the recurrence of the tumor, the patient will have much improved life for the period during which there is no recurrence of disease. Clearly this is a meaningful benefit to the every-day life of a cancer patient, and in particular to a head & neck cancer patient, where local control often means preserving the ability to swallow, breathe and talk without assistance.
In our October 2005 letter to the shareholders we highlighted the three major contributions Multikine makes in fighting cancer and postulated that these contributions should lead to an increase in the success rate of the cancer treatment. We now have Phase II data that shows improved local regional control of the tumor as well as increased survival and we are therefore able to support our original hypothesis. Our next goal is to repeat these results in the planned Phase III clinical trial where the endpoints are the same as those that we measured in the follow-up study: local regional control of the tumor and survival.
The planned Phase III study already has been cleared for go-ahead by the Canadian regulators and CEL-SCI is currently awaiting word from the U.S. FDA. Since most of the head & neck cancer patients are outside of the U.S., we hope to conduct one worldwide Phase III study, including the countries of our Asian partner Orient EuroPharma, for drug approval.
We proceed on one simple assumption. If we can show clinical benefit by demonstrating increased survival or improved local regional control, or better yet, both, Multikine should end up being used as first-line therapy in head & neck cancer, 5% of all cancers worldwide. Ultimately it may even be useful in treating many other cancers as well. And, it cannot be stated often enough, Multikine has been essentially non-toxic. If we can achieve this, meeting worldwide demand for Multikine would likely become our challenge.
Let us again state the obvious: “If the cancer does not recur, you will have a much greater chance of survival.” That is our goal and the reason for adding Multikine to the standard first-line cancer therapy.
On a different note, we reported late last year that CEL-SCI had signed an agreement with the National Institute for Allergy and Infectious Diseases (NIAID), whereby NIAID agreed to test our CEL-1000 drug against the avian flu virus in animal models, which are very hard to come by. CEL-1000 is very interesting because it has protected against different viruses and parasites in animal models. Such broad based protection by CEL-1000 would be very helpful against the avian flu virus, as it undergoes constant mutation.
After discussions with avian flu virus experts we have decided that more research in the area of the avian flu virus infection and treatment with CEL- SCI products can and should be done. In conjunction with these experts we have developed a plan to test CEL-SCI products against the avian flu virus. The testing performed under this plan will be in addition to the testing of CEL-1000 that is currently being done by the NIAID. Some of what we are doing and plan to be doing will be obvious, but a lot of it focuses on areas that have not yet been highlighted in the popular press as areas in need of help. We will update you in the future on this program as it progresses.
We thank you for your support. Sincerely, Geert Kersten Maximilian de Clara Chief Executive Officer President
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/A for the year ended September 30, 2004. 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 Corporation
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460; orINVESTOR RELATIONS: Michael Lucci, Jr. of Lucci Financial Group, LLC,+1-248-723-3330, for CEL-SCI Corporation
Web site: http://www.cel-sci.com/
