Leading next-generation cancer immunotherapies developer Advaxis announced it has received Orphan Drug Designation from the U.S. Food and Drug Administration Office of Orphan Products Development for lead drug candidate ADXS-HPV to treat head and neck cancer associated with human papillomavirus (HPV).
Granted to drug therapies intended to treat diseases or conditions affecting fewer than 200,000 people in the U.S., 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.
HPV-associated head and neck cancer represents an unmet medical need in the U.S., and patients with these cancers have limited treatment options. Advaxis hopes to improve survival rates for these patients by developing ADXS-HPV for this indication. The company intends 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. The company will continue the ongoing Phase 1 study that is being sponsored by the University of Liverpool and Aintree University Hospitals NHS Foundation Trust, which is evaluating the safety and efficacy of ADXS-HPV when combined with standard chemotherapy and radiation treatment in patients with head and neck cancer.
A clinical-stage biotechnology company, Advaxis is engaged in the development of next-generation immunotherapies for cancer and infectious diseases. The company's immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bioengineered to secrete an antigen/adjuvant fusion protein(s) designed to redirect the powerful human immune response from the bacterium to the cancer itself.
For more information, visit advaxis.com
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