Advaxis, Inc., (OTCQB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, 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 anal cancer.
“We are very pleased to have been granted an orphan drug designation for ADXS-HPV in this unmet medical need”
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 anal cancer have limited treatment options and we hope to improve their survival by developing ADXS-HPV for this indication. We will continue the ongoing Phase 1/2 study being coordinated by Brown University Oncology Group that is evaluating the safety and efficacy of ADXS-HPV when combined with standard chemotherapy and radiation treatment in patients with anal cancer."