REDWOOD CITY, Calif., Dec. 22, 2016 /PRNewswire/ -- 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 3 clinical trial shortly."
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 IL-10, which has shown sustained anti-tumor effects and a good safety/tolerability profile in patients from multiple oncology indications. Due to its enhanced half-life, AM0010 has strong immune-stimulating effects that induce the activation, proliferation, and survival of intratumoral, tumor-reactive, cytotoxic CD8+ T cells in patients. CD8+ T cells mediate the tumor clearing effect of this immuno-oncology agent.
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+ T cells and has demonstrated durable clinical responses in several types of cancer, both as a single agent and in combination with standard-of-care chemotherapy or checkpoint inhibitors. ARMO is conducting a Phase 3 registration trial with AM0010 for the treatment of pancreatic ductal adenocarcinoma. The company's robust pipeline of product candidates includes therapeutic cytokines and an anti-PD-1 checkpoint inhibitor.
For more information, please visit www.armobio.com.
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SOURCE ARMO BioSciences, Inc.