Advaxis, Inc., (NASDAQ: ADXS), a leader in developing cancer immunotherapies, announced today 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 immunotherapy drug candidate, for the treatment of Stage II-IV invasive cervical 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 annual grant funding, tax credits, waiver of PDUFA filing fees, and potentially a seven year market exclusivity period.
“We are very pleased that the FDA has granted Orphan Drug Designation for ADXS-HPV in Stage II-IV invasive cervical cancer,” stated Daniel J. O’Connor, Chief Executive Officer of Advaxis. “ADXS-HPV is our most advanced product candidate with encouraging Phase 2 data, the potential to proceed along a registrational pathway, and now the benefits of orphan drug status.”
“Advaxis will continue to aggressively pursue all available regulatory programs and incentives that can assist us in bringing our cancer immunotherapies to patients as quickly as possible,” stated Chris French, Vice President, Regulatory and Medical Affairs.