ARMO BioSciences Announces First Patient Dosed in Pivotal Phase 3 Trial of Immunotherapy AM0010 for Advanced Pancreatic Cancer
Phase 3 Trial to Evaluate AM0010 in Combination with FOLFOX as Second-line Treatment for Patients with Metastatic Pancreatic Cancer
Redwood City, CA, March 29, 2017 — ARMO BioSciences, Inc., a clinical-stage immuno-oncology company, announced that the first patient has been dosed in the Company’s international Phase 3 pivotal clinical trial to evaluate its lead investigational immuno-oncology drug AM0010 (PEGylated
“Dosing the first patient in a Phase 3 trial is an important milestone in our effort to develop our novel immunotherapy for this very aggressive form of cancer,” said Peter
About the Phase 3 Trial of Immunotherapy AM0010 for Advanced Pancreatic Cancer
ARMO is conducting an international Phase 3 randomized clinical trial with AM0010 in combination with FOLFOX (folinic acid,
For more information about the clinical trial, please visit www.clinicaltrials.gov and use identifier NCT02923921.
About Pancreatic Cancer
According to the American Cancer Society’s estimates, pancreatic cancer is expected to be the third leading cause of cancer-related death in the United States in 2017. An estimated 53,670 people will be diagnosed and 43,090 people will die from this form of cancer in the United States in 2017.
Cancer of the pancreas usually develops without early symptoms until the cancer has already spread to other organs. As a result, more than half of patients are diagnosed at a late stage, when the five-year survival rate for exocrine pancreatic cancer is only about 1%.
AM0010 is a long-acting form of recombinant human
The U.S. Food and Drug Administration (FDA) and the European Commission (EC) have granted AM0010 Orphan Drug designation for the treatment of pancreatic cancer. The FDA also granted Fast Track designation for AM0010 in combination with FOLFOX as a second-line therapy in patients with pancreatic cancer.
About ARMO BioSciences
ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary products that activate the immune system of cancer patients to recognize and eradicate tumors. The Company’s lead product candidate, AM0010, stimulates the survival, expansion and killing (cytotoxic) potential of a particular type of white blood cell in the immune system called CD8+ T cells. CD8+ T cells recognize and kill cancer cells and an increased presence of intra-tumoral CD8+ T cells may result in improved prognosis and survival in patients.
In addition, ARMO is developing a robust immuno-oncology pipeline that includes validated product candidates aimed at treating a variety of cancers in combination with standard of care treatments and emerging immunotherapies.
ARMO BioSciences, Inc.
Scott Ogg, PhD
Vice President Corporate Development and Operations