Advaxis, a clinical-stage biotech company focused on developing the next generation of immunotherapies for cancer and infectious diseases, has submitted an application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) Office for ADXS-HPV, the company’s lead drug candidate for the treatment of invasive cervical cancer.
“We are optimistic about our request for Orphan Drug Designation for ADXS-HPV in the indication of invasive cervical cancer,” Dr. Robert Petit, chief scientific officer of Advaxis stated in the press release.
The company recently presented data from its phase II study of ADXS-HPV at the 2013 ASCO Annual Meeting, demonstrating DXS-HPV as an active treatment for cervical cancer, with the potential to become a non-chemotherapy treatment option capable of improving survival for women with cervical cancer.
“We believe that ADXS-HPV will become an important new treatment for this unmet medical need. Orphan Drug Designation could expedite our ability to help women with cervical cancer worldwide, including the 12,340 U.S. women the American Cancer Society estimates will be newly diagnosed in 2013,” Dr. Petit added.
The FDA grants Orphan Drug Designation to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people. The designation provides the company with several advantages.
“If granted, Orphan Drug Designation for our lead product candidate, ADXS-HPV, for the treatment of human papillomavirus, or HPV, associated cervical cancer, would provide the opportunity to gain several very key incentives for Advaxis, including the potential for seven years of market exclusivity for ADXS-HPV if the product is approved by the FDA, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain significant administrative filing fees,” Daniel J. O’Connor, executive vice president of Advaxis stated. “These incentives, if achieved, will increase the potential value of ADXS-HPV.”
For more information visit www.advaxis.com
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