This morning, CEL-SCI Corp. (CVM-NYSE Amex) announced the completion of its clinical investigator meeting held last week in Prague. The meeting, which included clinical investigators and research associates, medical monitors, quality assurance personnel, and CEL-SCI’s scientific and management teams, was held to provide protocol and Good Clinical Practice (GCP) training in anticipation of the start of CEL-SCI’s upcoming Phase III trial of Multikine® in advanced primary head and neck cancer. More than 120 participants from nine countries were present to ask questions about clinical trial conduct.
Multikine® is the first immunotherapeutic agent designed to be administered to patients before surgery as a first-line standard of care, when the immune system is still intact and capable of launching its most effective anti-tumor immune response. To the Company’s knowledge, no other comprehensive anticancer immunotherapies are being developed for first-line treatment in this manner.
The immunotherapy field recently gained momentum with the launch of Dendreon Corp.’s (DNDN-NASDAQ) Provenge®, which in April 2010 became the first FDA-approved therapeutic cancer vaccine. Provenge®, a treatment for prostate cancer, validated the possibility of harnessing the human immune system against a patient’s own cancer. CEL-SCI’s Multikine® immunotherapy, designated as an Orphan Drug by the FDA, is poised to enter a global Phase III trial in the second half of 2010 for advanced primary head and neck cancer. Head and neck cancer ranks among the most frequently occurring cancers worldwide. CEL-SCI’s trial is likely to be the largest clinical study of head and neck cancer ever conducted.