VIENNA, Va., June 13 /PRNewswire-FirstCall/ -- The following letter is being released by CEL-SCI CORPORATION to its shareholders:
Dear Fellow Shareholders:
So far 2007 has been an excellent year for CEL-SCI and its cancer product Multikine(R). In January we received the US FDA go-ahead for the Phase III clinical trial with Multikine, a huge achievement for any drug, yet an even bigger achievement for a completely new type of drug such as our Multikine. We followed this up with a $15 million commitment to finance the Multikine manufacturing facility in Baltimore, Maryland and another $15 million in equity financing in April. In June we announced that we received orphan drug status from the FDA for Multikine. This designation brings many substantial benefits to the Company. I believe that the opportunity ahead for CEL-SCI is so compelling that I have continued to purchase CEL-SCI stock in the open market.
In talking to investors it has become clear to me that few investors understand the enormous impact that our Multikine will have on the treatment of cancer if we can confirm in our Phase III study the impressive survival results we have seen in our Phase II trial. I believe that a background summary on Multikine is helpful for that reason.
Background Summary on Multikine: -- The science: The science behind Multikine is based on the premise that a healthy immune system can cure cancer. When the immune system is imbalanced or weakened, diseases like cancer occur. Balancing and strengthening the immune system is thought to be an effective strategy in fighting cancer. -- What is Multikine? Multikine is a mixture of naturally occurring cytokines, substances that regulate the immune system. The patented Multikine mixture is representative of the mixture of cytokines produced by a healthy immune system. CEL-SCI scientists have published in the highly regarded “Journal of Clinical Oncology” that many different cytokines working together are needed to put in motion the comprehensive immune response needed to fight cancer. Most other immunotherapies being developed are based upon the use of only one cytokine. -- How is it used? Multikine is the first cancer immunotherapy being developed as a first line treatment. This means it is administered prior to any other cancer therapy (e.g. surgery, radiation and/or chemotherapy) because that is the time when the immune system can still be fully activated. Once the patient has had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and less able to mount an effective immune response. We believe that most of the failures of immunotherapy drugs up to now have been the result of giving immunotherapy after the patient’s immune system was damaged by other cancer therapies. -- How does it work? Multikine works in two ways: 1. It signals the immune system to mount an effective immune response. Multikine changes the type of immune cell that attacks the tumor from a CD-8 cell to a CD-4 cell. This is important because tumors are able to defend themselves against the normal CD-8 cell attack, but appear to be unable to defend themselves against the CD-4 cell attack. The CD-4 cell breaks what is known as “tumor tolerance,” thereby allowing the immune system to see and attack the tumor. 2. Multikine has been shown to render cancer cells much more susceptible to radiation and chemotherapy treatments, thereby making these treatments much more effective. The combination of both of these is very important because Multikine will fight the tumor on two fronts, without toxicity. -- Results: In a Phase II clinical trial, Multikine was shown to increase overall survival by 33% 3.5 years after the first treatment. -- Its effect on recurrence of cancer: Chemotherapy, surgery and radiation do not always succeed in killing all the cancer cells. The persistence of cancer cells is responsible for cancer recurrence. Multikine is injected around the tumor and into the local lymph nodes because those areas are the most likely places for the cancer to recur if any of the cancer cells survive. Multikine uses the immune system to kill those cancer cells before they cause tumor recurrence. -- Safety: Multikine has been shown to be safe and non-toxic in multiple studies. This was not surprising because Multikine consists of naturally derived substances given in very small dosages, just as the body does itself every day. -- Potentially useful for multiple tumors: Despite the fact that the Multikine treatment given to each patient is the same (i.e., not patient specific), the immune response induced by Multikine is completely targeted to the patient’s own tumor. This means that Multikine may be useful against many different tumors. Multikine has already shown activity in small studies in cervical dysplasia/neoplasia and prostate cancer. One of its mechanisms of action suggests that it should also be developed as an enhancement of radiation and chemotherapy. -- Clinical Status: Multikine is currently cleared for a Phase III clinical trial in the US and Canada in advanced primary head and neck cancer patients. These are recently diagnosed, not yet treated patients. Head and neck cancer is an aggressive cancer that accounts for about 500,000 - 600,000 new annual cases of cancer world-wide. Advanced primary head and neck cancer patients typically have a 50% chance of survival three years following the first treatment. Treatments for newly diagnosed head and neck cancer have not significantly improved over the last 50 years and therefore constitute a clear unmet medical need. The Phase III study, which is designed to prove that Multikine works, is expected to enroll about 800 advanced primary head and neck cancer patients worldwide. In its last Phase II clinical trial Multikine increased overall survival by 33%. The Phase III study will need to show a 10% increase in overall survival to be successful. -- Market size: The current Phase III clinical trial pits Multikine plus the standard of care treatments against the standard of care treatments alone. A win for the Multikine treatment group would mean that every patient with advanced primary head and neck cancer is supposed to get Multikine. This would translate into a market potential of $15 billion.
We believe that Multikine will ultimately be added to the cancer treatments of many solid tumors. This it will have a huge impact on the treatment of cancer because curing more patients with the first cancer treatment will significantly decrease the number of cancer deaths. We thank you for being part of this dream.
As shareholders we truly value your participation in and support of our company. In an effort to improve our image, which has not yet caught up to where the company is today, we are currently redeveloping our corporate identity and redesigning our website. You are our most important advocates and we want your voice to be heard. We would like to collect some personal letters from you that describe why you support CEL-SCI and Multikine, and what your hopes are for Multikine. Our hope is to publish these letters on our website. Please mail these letters to Gavin de Windt, Investor Relations Manager, CEL-SCI Corporation, 8229 Boone Boulevard, Suite 802, Vienna, VA 22182, USA or send it by e-mail to gdewindt@cel-sci.com .
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 Corporation
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460,gdewindt@cel-sci.com
Web site: http://www.cel-sci.com/
