Advaxis, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. The investigation of AXAL in this under-served population will be conducted in accordance with the Special Protocol Assessment (SPA) recently granted by the FDA.
“This Fast Track designation for AXAL comes on the heels of the SPA agreement and underscores the collaborative efforts of Advaxis and the FDA in expediting a medically significant clinical program. This designation brings us one step closer to achieving our goal with the AIM2CERV trial, which aims to extend disease free survival for this serious and life-threatening condition and prevent disease recurrence," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.
In 2014, AXAL was granted FDA Orphan Drug designation for the treatment of invasive cervical cancer.
AXAL is a targeted immunotherapy which attacks human papillomavirus (HPV)-associated cancers by altering a live strain of Listeria monocytogenes (Lm) bacteria to generate cancer fighting T cells directed against the specific cancer antigen and neutralizing factors that protect the tumor microenvironment from immunologic attack and contribute to tumor growth.
