Advaxis, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, this morning announced that it has submitted an Application for Orphan Drug Designation with the FDA for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated anal cancer.
Orphan Drug Designation is reserved for drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. The Orphan Drug Designation program 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.
"The U.S. Centers for Disease Control and Prevention estimates that 85% of the 7,060 new cases of anal cancer projected for 2013 are caused by HPV. The incidence of anal cancer has increased more than twofold from 1975-2009 and is rising," stated Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Despite treatment with surgery, chemotherapy, and radiation, the 5 year survival for patients with lymph node or distant metastases is less than 50%. We hope that ADXS-HPV will improve survival for patients with HPV-associated anal cancer."
"If granted, Orphan Drug Designation for our lead drug candidate, ADXS-HPV, would 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 waiver of the $1.9 million regulatory application filing fee," added Thomas A. Moore, Chairman and Chief Executive Officer of Advaxis. "We are looking forward to initial data from our Brown University Study in anal cancer that is currently underway."
For more information, visit advaxis.com
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