Cel Sci Corporation (CVM)

[gambinilive]

Multikine® Phase III Clinical Trial Design

Study Summary: A Pivotal Phase III, Open-label, Randomized, Multi-center Global Study of the Effects of Multikine Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity Versus Standard of Care Only.

Objectives: The primary objective is to determine the efficacy of peri-tumoral and peri-lymphatic injection of Multikine given prior to Standard of Care (SOC) as measured by overall survival. The secondary objectives are to evaluate the effects of Multikine® treatment on the cumulative incidence of local-regional control, progression-free survival, tumor response, tumor histopathology, and quality of life, while confirming Multikine® safety.

Number of Subjects: Approximately 800

Clinical Centers: 40 - 50 (globally distributed; North and South America, Europe, Asia)