On December 14, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that the European Medicines Agency (EMA) has granted Orphan Drug Designation to axalimogene filolisbac for the treatment of anal cancer (Press release, Advaxis, DEC 14, 2015, View Source [SID:1234508560]). Schedule your 30 min Free 1stOncology Demo! "We’re pleased to announce Advaxis’ second EMA Orphan Drug Designation within four weeks, which strengthens our pipeline and confirms the potential that Lm Technology immunotherapies may offer to patients with high unmet medical needs," said Daniel J. O’Connor, CEO of Advaxis. "Our clinical program in anal cancer is building momentum as a result of this designation, the encouraging preliminary data in patients with anal cancer, as well as the honor of receiving the Farrah Fawcett Foundation’s ‘Medical Visionary Angel Award’ for our commitment to innovative research in anal cancer and HPV-related cancers. Receiving Orphan Drug Designation moves us one step closer to our goal of bringing a valuable new treatment to patients as quickly as possible."
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Orphan Drug Designation in the European Union (EU) is granted to drugs or biologics that treat a life-threatening or chronically debilitating rare disease affecting fewer than five in 10,000 individuals in the EU. Products receiving orphan drug designation are eligible to receive market exclusivity for a period of up to ten years, as well as development incentives such as regulatory and protocol assistance and scientific advice.
About Anal Cancer
Anal cancer is a fairly rare form of cancer in the United States, but the number of new anal cancer cases has been rising for years. The risk of being diagnosed with anal cancer in one’s lifetime is about 1 in 500. According to the American Cancer Society, approximately 7,270 new cases of anal cancer were diagnosed and about 1,010 people died of the disease in 2014.
About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of anal cancer.