CEL-SCI Corporation

Arizona Cancer Research Alliance & 21st Century Oncology to Enroll Patients in CEL-SCI's Global Phase III Head and Neck Cancer Trial

CEL-SCI Corporation today announced it has expanded its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the U.S. with the addition of a new site in Scottsdale, Arizona. The 21st Century Oncology clinic in Scottsdale, along with the Arizona Cancer Research Alliance, has just joined the study and is actively screening patients for enrollment into the trial. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer.

CEL-SCI Reports March 2014 Is Record Month for Patient Enrollment in Phase III Head and Neck Cancer Trial

CEL-SCI Corporation today announced that during the month of March the Company enrolled 14 patients with advanced primary, not yet treated, head and neck cancer into its global Phase III head and neck cancer trial. This marks the largest number of patients enrolled in the Company’s trial with its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in any month to date.

First U.S. Clinical Site Opens for Cel-Sci's Global Phase III Immunotherapy Head and Neck Cancer Trial Expansion

CEL-SCI Corporation announced its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) has activated its first U.S. clinical trial expansion site at 21st Century Oncology in Greenville, North Carolina. The trial is already active in dozens of hospitals and clinical centers in 12 countries.

CEL-SCI Reports 146 Patients Enrolled in Its Phase III Immunotherapy Head and Neck Cancer Trial

CEL-SCI Corporation reported accelerating progress in patient enrollment in the Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection). Approximately 146 patients have been enrolled in the Phase III study to date.

U.S. Navy Approves Start of CEL-SCI'S Phase I Trial for Treatment of Anal Warts in HIV/HPV Co-Infected Patients

CEL-SCI Corporation announced today the Institutional Review Board (IRB) of the U.S. Navy’s Naval Medical Center San Diego (NMCSD), has approved the start of a Phase I dose escalation study of the Company’s investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in HIV/HPV co-infected men and women with peri-anal warts. This approval marks the third indication for which Multikine is being investigated in clinical trials. Multikine is currently being investigated in the largest Phase III trial in the world for the treatment of head and neck cancer. It has previously been evaluated as a potential treatment for cervical dysplasia in HIV/HPV co-infected women and a Phase II study to further investigate this indication is currently in the planning stages.

Cel-Sci Receives Government Approval in Serbia to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer

CEL-SCI Corporation announced today that it has received approval from the Medicines and Medical Device Agency of Serbia to begin enrollment of subjects in its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Serbia is the 11th country from which approval to participate in the world’s largest Phase III trial for the treatment of head and neck cancer has been obtained. The clinical sites in Serbia are expected to become active in the next few weeks. Approximately 72 of the worldwide total of 880 patients for the study are expected to be enrolled in Serbia.

CEL-SCI Receives Government Approval in Bosnia and Herzegovina to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer

Further advancing one of the largest Phase III trials for head and neck cancer in the world, CEL-SCI Corporation announced today that it has received approval from the Agency for Medicaments and Medical Devices of the government of Bosnia and Herzegovina to begin enrollment of subjects into the Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Bosnia and Herzegovina is the 10th country into which CEL-SCI has now expanded its global Phase III trial. This also marks the Company’s milestone in receiving approval to commence accrual in one-half the number of countries in the currently planned expansion of the study. The trial is expected to expand into a total of approximately 100 clinical centers in 20 countries. CEL-SCI expects to enroll approximately 30 patients in Bosnia and Herzegovina through three clinical centers.

CEL-SCI Conducts Meeting of North American Clinical Centers to Support Success of Its Phase III Cancer Trial with Multikine

CEL-SCI Corporation announced that it has held the Investigator Meeting for the North American clinical investigators participating in the ongoing international Phase III clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Inj.). Investigators from 14 clinical centers in Canada and the U.S who are participating in the Phase III clinical trial for head and neck cancer were in attendance. The Investigator Meeting for the 56 clinical centers in Europe that are participating in the study was held in October 2013. A total of approximately 880 patients are expected to be enrolled in the Phase III study. Patients are also being enrolled in the Phase III study in Israel and Taiwan where CEL-SCI's partners Teva Pharmaceuticals and Orient Europharma are based.

CEL-SCI Receives Croatian Government Approval to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer

CEL-SCI Corporation announced that it has received approval from the Health Protection Administration, Ministry of Health, of the Croatian Republic to begin enrollment of subjects into the Phase III clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Croatia is the ninth country into which CEL-SCI has expanded its global Phase III trial. The trial is expected to be conducted in about 100 clinical centers worldwide. CEL-SCI expects to enroll approximately 40 patients in Croatia through four clinical centers.

CEL-SCI Corporation Announces IDMC Conclusions from Interim Review of Phase III Head and Neck Cancer Trial Data

CEL-SCI Corporation announced today that a second interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine* (Leukocyte Interleukin, Injection) investigational new drug immunotherapy was conducted by an Independent Data Monitoring Committee (IDMC). The IDMC said that the data raised no safety concerns, and recommended that the Phase III study continue unmodified.