January 10, 2005 10:15:35 (ET)
VIENNA, Va., Jan 10, 2005 /PRNewswire-FirstCall via COMTEX/ -- The following letter is being released by CEL-SCI CORPORATION (CVM, Trade) to its shareholders:
Dear Fellow Shareholders:
Imagine that you come across a company with a unique cancer drug which, following just a few weeks of non-toxic treatment, kills a large number of cancer cells, renders the remaining cancer cells more susceptible to follow-on radiation and chemotherapy, appears to reduce the cancer recurrence and even appears to lower cholesterol levels in the blood. On top of this you learn that the company has just submitted to FDA a Phase III head & neck cancer clinical trial protocol designed to produce the data required for approval to market the drug. If this company were private and ready to go public, its valuation might be a few hundred million dollars. But, since it has been public for years, the initial excitement has worn off and the company's valuation is much lower.
The company I just described is our company, CEL-SCI. I believe that there are times when investors shun biotech stocks or, vice-a-versa, fall in love with them for no apparent reason, and that these emotional investment "waves" represent opportunities for investors willing to take risks. I further believe that the stage of entering Phase III clinical trials is a very important one for CEL-SCI, for the investment community as well as for partnering negotiations. During the many years I have been in this business, I have seen a number of biotech companies, now very successful, in a similar position. Based upon the fact that biotech stocks are currently not "in fashion," but most likely will be at some point in the future, the fact that we are entering such an important stage and my own personal belief in our team and science, I once again have added significantly to my CEL-SCI stock position in the past year.
Robert Collier, the well-known author, said that, "Success is the sum of small efforts, repeated day in and out ... ." I want to tell you how I, as the Chief Executive Officer of the Company, see the rapid accumulation of small efforts at CEL-SCI starting to pay off. It has been a long road. During the past 10+ years we spent close to $40 million on the development of a validated manufacturing process for our immunotherapy drug Multikine(R). Also during the past 10 years we conducted multiple clinical studies with Multikine to determine how to best administer it. The studies were designed to determine the optimal dose to administer, the best route of administration, how frequently to give Multikine and for how long. They took a long time to complete because answers to one question needed to be found before the next question could be addressed. Based on this work we have determined how to best administer Multikine, its effects, its mechanism of action and even that it appears to reduce cholesterol levels in the blood. Our initial findings were published in December 2003 in The Laryngoscope and in June 2004 at the very prestigious American Society of Clinical Society (ASCO) conference. This, along with a lot of other work, culminated in the year-end submission to FDA of our Phase III protocol for advanced primary squamous cell carcinoma of the oral cavity. What may look like an old story to many investors has changed substantially in the past year.
The question naturally arises as to the expected key events with regard to Multikine in 2005. I am hopeful that we will be cleared to enter a pivotal clinical study with Multikine by the second quarter of 2005. This approximately 500 patient study may be conducted in conjunction with our Asian partner Orient EuroPharma in the U.S. and internationally. The final details are all dependent on the regulators' requirements. I am further hopeful that we will receive one or more patents on Multikine. These patents will serve to enhance our most important protection from competitors, namely the unique manufacturing process. I also expect to see one or more important publications on Multikine during the year. My experience in the industry tells me that most data is not considered to be real until published. With regard to the L.E.A.P.S.(TM) technology, our other project that is funded mostly by government grants, I am hopeful that it may hold a few surprises as well.
Our vision for Multikine is that it will some day be used as an addition to many different cancer treatments and for many different types of cancer to increase the survival rate of patients. We believe that Multikine contributes unique attributes to a combined cancer therapy that surgery, radiation or chemotherapy alone or in combination with one another cannot provide. While some patients seem to have no tumor remaining after Multikine treatment (ASCO June 2004), it is unreasonable to presume that any single cancer treatment modality alone will defeat a disease as insidious as cancer.
It is for this reason that the proposed Phase III clinical trial was designed to add Multikine to a regimen of surgery followed by radiation or surgery followed by concurrent radiation and chemotherapy (standard therapy), with the control group receiving the standard therapy. Once this concept of using Multikine to enhance standard therapy has been proven in squamous cell carcinoma of the oral cavity (head & neck cancer), it can be tested in many other types of cancer since Multikine is not tumor specific.
We have shown by pathology that Multikine by itself can reduce the number of, or in some cases, eliminate the cancer cells. This finding alone suggests that the combined treatment should be more successful. However, it has been discovered that in addition Multikine also appears to render remaining cancer cells more susceptible to follow-on radiation and chemotherapy (The Laryngoscope, December 2003). This additional effect should be particularly valuable to patients receiving combined treatment with radiation or concurrent radiation and chemotherapy. Preliminary follow-up data collected by one doctor outside of the Phase II protocol suggests that Multikine reduced the cancer recurrence rate in patients treated at one center. The controlled Phase III clinical trial we plan to initiate is designed to develop the statistically meaningful data to confirm this finding. If our initial findings are confirmed and the addition of Multikine to the existing cancer therapies gives substantial benefit to the patients, we expect Multikine to become a very important drug.
During 2004 we also discovered that Multikine may have important uses beyond cancer. I was not surprised because I believe that the immune system is central to our health and therefore a drug like Multikine may be able to influence diseases in ways we cannot even imagine, yet. Multikine was shown in a meta-analysis to lower total cholesterol in clinical studies involving 120 head & neck cancer patients. This reduction in total cholesterol was considered to be highly statistically significant (p<0.0001). Most of the patients were treated with Multikine for 2 or 3 weeks, but some of them were treated for up to 24 weeks.
A meta-analysis is a statistical procedure to combine a number of existing studies. Through such a procedure, effects which are hard or impossible to discern in the original smaller studies can be made visible as the meta- analysis is, in the ideal case, equivalent to a single study with the combined size of all the original studies.
We are very interested in testing this new application for Multikine further, but we will only do so after we have entered pivotal clinical trials in head & neck cancer.
In closing, I invested more money in CEL-SCI last year because I believe in the need for an immune system component of cancer therapy to enhance the success rate of the current cancer treatments and I believe that we may have the answer. I also believe that the fact that we have been around for a long time works against us because the "story is old". This means that we have a harder time being noticed on Wall Street, but it also creates more opportunity. The world is full of 10 or 20 year "overnight successes" and I can assure you that our great team is working hard to make us one of those. We wish you much health and happiness in 2005.
Sincerely,
Geert Kersten
Chief Executive Officer
AI
