Ayala Pharmaceuticals Inc (ADXS)

[jaxstraw]

Advaxis’ AXAL Receives Fast Track Designation by FDA as Adjuvant Therapy for High-Risk Locally Advanced Cervical Cancer

On July 21, 2016, the Company announced that the U.S. Food and Drug Administration (“FDA”) had 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 recently granted by the FDA.

AXAL is a targeted immunotherapy which attacks human papillomavirus-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.

The FDA established the Fast Track Drug Development Program under the FDA Modernization Act of 1997. The program is designed to facilitate the development and expedite the review of therapies intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The advantages of Fast Track designation include actions to help expedite development, including opportunities for frequent interactions with the FDA to discuss all aspects of development to support approval, eligibility for priority review at the time of Biologics License Application submission and early review of portions of the application before submitting a complete application.