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CEL-SCI Trial in Bosnia Approved

Brings number of countries to 10 in head & neck cancer trial

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

CEL-SCI Corp. has received approval from the Agency for Medicaments and Medical Devices of the government of Bosnia and Herzegovina to begin enrollment of subjects into its Phase III Head and Neck Cancer clinical trial of investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection). Bosnia and Herzegovina is the 10th country into which CEL-SCI has expanded this 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.

Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. CEL-SCI is currently accelerating enrollment in its Phase III clinical trial for Multikine by adding a large number of clinical centers. In addition to these centers, the trial also benefits from clinical centers in CEL-SCI’s partners’ territories, Teva Pharmaceuticals in Israel and Orient Europharma in Taiwan.

The Multikine study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant, 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival rate of these patients. The company plans to complete enrolling subjects in 2H15.

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