Today, Advaxis, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, reported the submission of an application for Orphan Drug Designation with 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. It is currently estimated that there are 50,000 new cases of head and neck cancer annually, with about 15,000 deaths.
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 a seven-year market exclusivity period.
"HPV-associated head and neck cancer is growing at an epidemic rate in the United States and other regions throughout the world. According to the U.S. Centers for Disease Control and Prevention (NASDAQ:CDC), over 80% of new cases occur in men, who are not typically part of HPV vaccination programs," stated Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Data from our Phase 2 study in recurrent cervical cancer show that ADXS-HPV is an active treatment in this HPV-associated cancer. We believe that ADXS-HPV immunotherapy will show similar activity in HPV-associated head and neck cancer, given the shared causality of the cancers. We have one ongoing Phase 1/2 study in HPV-positive head and neck cancer in the United Kingdom and plan to initiate another in the United States in 2013. We believe ADXS-HPV could become an important new non-cytotoxic treatment for patients with HPV-associated head and neck cancer."
"If granted, Orphan Drug Designation (ODD) for our lead drug candidate, ADXS-HPV, could expedite our ability to help the over 10,000 Americans that the American Cancer Society estimates will be newly diagnosed with HPV-associated head and neck cancer in 2013. ODD would also provide seven years of market exclusivity for ADXS-HPV if it is approved by the FDA, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of the $1.9 million regulatory application filing fee," added Thomas A. Moore, Chairman and CEO of Advaxis. "It is believed that the number of new HPV-caused head and neck cancers in the United States now approaches the number of new cervical cancer cases. This indication, with these incentives, if achieved, could substantially increase the potential value of the ADXS-HPV franchise."
For more information, visit advaxis.com
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