ARMO BioSciences’ Immunotherapy AM0010 Receives Orphan Designation in Europe for the Treatment of Pancreatic Cancer
AM0010 Previously Received FDA’s Orphan Drug and Fast Track Designations
Redwood City, CA, December 22, 2016 —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
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
“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
About Orphan Designation in Europe
The EMA examines Orphan designation applications for candidates intended for the treatment of life-threatening or chronically-debilitating rare conditions with a prevalence of less than five in 10,000 in the European Union. Orphan designation provides a number of incentives including protocol assistance at a reduced fee, access to the centralized authorization procedure and market exclusivity for up to 10 years once the medicine is approved.
About Pancreatic Cancer
In the European Union, pancreatic cancer affects approximately 2.4 in 10,000 people, or a total of around 123,000 people using estimates from Eurostat 2016. Pancreatic cancer is a very severe and life-threatening disease that is associated with shortened life expectancy. The majority of pancreatic cancer patients are diagnosed when the cancer has spread nearby or to other parts of the body, due to the absence of symptoms in the early stages, when one- and five-year survival is only 15% and 2%, respectively.
AM0010 is a long-acting form of recombinant human
About ARMO BioSciences
ARMO BioSciences is a clinical-stage immuno-oncology company developing a pipeline of novel, proprietary medicines that activate a cancer patient’s own immune system to eradicate tumors. The company’s lead product candidate, AM0010, stimulates the survival, expansion and killing (cytotoxic) potential of CD8+
For more information, please visit www.armobio.com.
ARMO BioSciences, Inc.
Scott Ogg, PhD
Vice President Corporate Development and Operations