VIENNA, Va., April 14 /PRNewswire-FirstCall/ -- The following letter is being released by CEL-SCI Corporation (NYSE AMEX: CVM) to its shareholders:
Dear Fellow Shareholders:
A very important event has just transpired for our company. Dendreon Corporation has announced that its pivotal Phase III trial with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The full data from the 512 patient study will be presented on April 28 at the American Urological Association conference.
The significance of Dendreon's success to CEL-SCI is great. For years most investors have shunned the cancer immunotherapy space because of the many failures of various companies involved in the space. While we at CEL-SCI have always tried to differentiate why our immunotherapy approach to treating cancer should be successful where other immunotherapy approaches have failed, the whole cancer immunotherapy space has been so tainted that it was almost impossible to be heard. The successful outcome of the Dendreon study gives the cancer immunotherapy field the needed validation to attract new money to the space. The success of Dendreon proves that it is possible to harness the human immune system against a patient's own cancer.
Geert Kersten, CEO of CEL-SCI said, "We believe that the success of Dendreon validates the cancer immunotherapy area as a promising alternative/adjunct to existing cancer therapies and think that it could lead to enhanced opportunities for CEL-SCI in both the investment and scientific communities."
About CEL-SCI's Phase III Cancer Drug Multikine:
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) has given the go-ahead for a Phase III clinical trial with Multikine and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck. Most recently CEL-SCI completed construction of the manufacturing facility to produce Multikine for the Phase III trial and subsequent sale following approval.
Multikine, a patented defined mixture of naturally derived cytokines, is the first immunotherapeutic agent in a new class of drugs called "Immune SIMULATORS". Immune SIMULATORS simulate the way our natural immune system acts in defending us against cancer. As opposed to other immunotherapies which are designed to target a single or limited number of specific antigens or molecules, Immune SIMULATORS are multi-targeted; they simultaneously cause a direct and targeted killing of the specific tumor cells and they activate the immune system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.
The Company has operations in Vienna, Virginia and Baltimore, Maryland. CEL-SCI's other products, which are currently in pre-clinical stage, have shown protection against a number of diseases in animal tests and are being tested against diseases associated with bio-defense. Another product, called CEL-2000, has shown excellent data against rheumatoid arthritis in animal tests.
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/A for the year ended September 30, 2008. 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.
|SOURCE CEL-SCI Corporation|
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