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Pursuant to the agreement, CEL-SCI will provide tumor samples of Multikinetreated and untreated matched control patients to the NIHCC, which will thenuse the latest molecular genomic microarray technology developed by Dr.Marincola's laboratory to look for molecular genomic differences in the tumormicroenvironment in patients with squamous cell carcinoma of the head andneck. Should these pre-clinical experiments find significant differencesbetween the Multikine treated and untreated patients, a formal collaborationbetween CEL-SCI and the NIHCC may be developed in order to expand the study toinclude patients from CEL-SCI's Pivotal global Phase III clinical trial.
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"Multikine's potential to change the tumor microenvironment and, in doingso, break tumor tolerance has been a long-time goal of anti-cancerimmunotherapy. We are very excited to be working with Dr. Marincola and theNIH Clinical Center to determine the molecular basis of Multikine's ability tocause tumor microenvironment changes," said Dr. Talor, Senior VP of Researchand Manufacturing at CEL-SCI and the developer of Multikine.
About CEL-SCI's Phase III Cancer Drug Multikine:
CEL-SCI is developing Multikine for approval as a first-line indication inhead and neck cancer. The company's upcoming Pivotal global Phase III clinicaltrial is an 800 patient study designed to demonstrate that administration ofits anti-cancer drug Multikine to head and neck cancer patients before theyreceive their first conventional cancer treatment will increase theirsurvival. Head and neck cancer is one of the world's biggest cancersaffecting about 650,000 people per annum.
In Phase II clinical trials Multikine was shown to be safe andwell-tolerated, and to improve the patients' overall survival by 33% at amedian of three and a half years following surgery. The U.S. Food and DrugAdministration (FDA) gave the go-ahead for a Phase III clinical trial withMultikine in January 2007 and granted orphan drug status to Multikine for theneoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck,in May 2007. In the summer of 2007 CEL-SCI started construction of themanufacturing facility to produce Multikine for the global Phase III trial andsubsequent sale following approval. This facility is expected to be completedsoon.
Multikine, a patented defined mixture of naturally derived cytokines isthe first immunotherapeutic agent in a new class of drugs called "ImmuneSIMULATORS." Immune SIMULATORS simulate the way our natural immune systemacts in defending us against cancer. As opposed to other immunotherapieswhich are designed to target a single or limited number of specific antigensor molecules, Immune SIMULATORS are multi-targeted; they simultaneously causea direct and targeted killing of the specific tumor cells and they activatethe immune system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as afirst-line standard of care treatment for cancer. It is administered prior toany other cancer therapy because that is the period when the anti-tumor immuneresponse can still be fully activated. Once the patient has advanced disease,or had surgery or has received radiation and/or chemotherapy, the immunesystem is severely weakened and is less able to mount an effective anti-tumorimmune response. Other immunotherapies are administered after the patient hasreceived chemotherapy and/or radiation therapy, which can limit theireffectiveness.
The Company has operations in Vienna, Virginia and Baltimore, Maryland.CEL-SCI's other products, which are currently in pre-clinical stage, haveshown protection against a number of diseases in animal tests and are beingtested against diseases associated with bio-defense.
NO ENDORSEMENT OF ANY ORGANIZATION, PRODUCT OR SERVICE MENTIONED IN THISARTICLE IS INTENDED OR INFERRED BY THE NATIONAL INSTITUTES OF HEALTH OR ITSEMPLOYEES.
SOURCE CEL-SCI Corporation
