ADVAXIS RECEIVES ORPHAN DRUG DESIGNATION IN THE EUROPEAN UNION FOR ADXS-HER2 FOR THE TREATMENT OF OSTEOSARCOMA
Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, announced that the European Medicines Agency (EMA) granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma.
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“Receiving Orphan Drug Designation from the EMA is another significant step forward for Advaxis as we continue to advance ADXS-HER2,” said Daniel J. O'Connor, CEO of Advaxis. “We recently initiated our first-in-human study of our lead Lm Technology™ immunotherapy product for HER2 expressing solid tumors and we hope to expand that trial into four HER2 expressing tumor types, including breast, gastric, esophageal and osteosarcoma.”
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Orphan Drug Designation in the 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 European Union. 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.