CEL-SCI Corporation (NYSE AMEX: CVM) announced that the Company held a clinical investigator meeting during the week of November 14th for its Phase III clinical trial of Multikine®, the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. The meeting was held in Prague, Czech Republic. More than 120 individuals from nine countries were in attendance.
Attendees included clinical investigators, clinical research associates, clinical research coordinators, medical monitors, quality assurance personnel and CEL-SCI’s scientific and management teams.
Clinical investigator meetings are held by clinical trial sponsors to provide protocol and Good Clinical Practice (GCP) training and allow participants an opportunity to ask questions about clinical trial conduct.
“We are excited that our meeting was met with such enthusiasm by all of the participants,” said Geert Kersten, CEL-SCI’s Chief Executive Officer.
“We discussed best practices to ensure that the study protocol will be uniformly executed throughout the world and that GCP requirements will be strictly adhered to when enrolling and treating the research subjects.
We look forward to enrolling and commencing treatment of the first subject in our global Phase III clinical trial of Multikine soon.”
CEL-SCI’s Phase III clinical trial is an open-label, randomized, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall survival rate versus the subjects treated with standard of care only. North Mississippi Health Services was the first site in the United States to approve enrollment of subjects.
CEL-SCI’s trial will be conducted in nine countries and is expected to be the largest clinical study of head and neck cancer ever conducted. It will be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted.
Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects’ tumors before the start of standard therapy.
Follow-up studies of subjects enrolled in Phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery.
The U.S. Food and Drug Administration gave clearance for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
Source: CEL-SCI Corporation