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Advaxis, Inc. (ADXS) Awarded Orphan Drug Designation For Candidate To Treat HPV-Associated Anal Cancer

Advaxis, a clinical-stage biotech developing the next generation of immunotherapies for cancer and infectious diseases, has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for ADXS-HPV, the company's lead drug candidate for the treatment of human papillomavirus (HPV)-associated anal cancer.

ADXS reports that from 1973-2000 the incidence of anal cancer in the United States increased by 160 percent among men and by 78 percent among women, 84 percent of which are caused by HPV. Individuals suffering from anal cancer face limited treatment options, and ADXS' goal is to elongate survival. ADXS-HPV is currently beings studied for this indication in a phase1/2 clinical trial.

"We are very pleased to have been granted an orphan drug designation for ADXS-HPV in this unmet medical need," Dr. Robert Petit, chief scientific officer of ADXS, stated in the press release. "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."

Orphan Drug Designation is awarded to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. The designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and the possibility for a seven-year market exclusivity period.

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