FDA grants Orphan Drug Designation to Advaxis' ADXS-HPV for HPV-associated head and neck cancer

Nov 6 2013

Advaxis, Inc., (NASDAQ:ADXS), a leader in developing the next generation of cancer immunotherapies, announced that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated head and neck cancer.

Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and potentially a seven year market exclusivity period.

"We are very pleased to have been granted an orphan drug designation for ADXS-HPV in this unmet medical need," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Patients with head and neck cancer have limited treatment options and we hope to improve their survival by developing ADXS-HPV for this indication. We plan to initiate an additional Phase 1/2 study in early stage head and neck cancer for ADXS-HPV with a nationally recognized center of excellence, and we will continue the ongoing Phase 1 study being sponsored by the University of Liverpool and Aintree University Hospitals NHS Foundation Trust that is evaluating the safety and efficacy of ADXS-HPV when combined with standard chemotherapy and radiation treatment in patients with head and neck cancer."

"Receiving orphan drug designation for ADXS-HPV in head and neck cancer is excellent news for a technology that may offer the potential to treat an indication with few therapy options, and, importantly, it helps define a clear path forward to registration," commented Daniel J. O'Connor, President and Chief Executive Officer of Advaxis.