ARMO BioSciences, Inc., a clinical-stage immuno-oncology company, announced that the European Commission (EC) has granted the Company’s lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) Orphan designation for the treatment of pancreatic cancer. The EC’s approval follows a positive opinion in November 2016 from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products.
Previously, AM0010 received the U.S. Food and Drug Administration’s (FDA) Orphan Drug and Fast Track designations for pancreatic cancer. ARMO plans to initiate enrollment of an international pivotal Phase 3 clinical trial, using AM0010 in combination with FOLFOX as second-line therapy in patients with advanced metastatic pancreatic cancer.
“With Orphan designations in Europe and the United States, we are committed to accelerating AM0010’s development for this difficult-to-treat cancer, which unfortunately has the highest mortality rate of all major cancers,” said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. “We are motivated by the U.S. and EU regulatory agencies’ recognition of the urgent need to develop new therapeutic options for pancreatic cancer patients and are eager to begin dosing the first patients in our pivotal Phase 3clinical trial shortly.”