About Fast Track Designation
The U.S. FDA's Fast Track is a designation for expedited review to facilitate the development of drugs for the treatment of serious or life-threatening conditions which address an unmet medical need.
About Orphan Drug Designation
The U.S. FDA's Office of Orphan Products Development (OOPD) provides incentives for sponsors to develop products for rare diseases. The Agency's Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for development incentives, including marketing exclusivity in the U.S. for seven years after product approval, tax credits, and exemption from the prescription drug user fee.
About Pancreatic Cancer
According to the American Cancer Society's recent estimates, approximately 53,000 people will be diagnosed and approximately 41,800 people will die from this form of cancer in the United States in 2016. Pancreatic cancer accounts for only three percent of all cancer cases in the United States, but is attributed to approximately seven percent of all cancer deaths.
Cancer of the pancreas usually develops without early symptoms. As a result, more than half of patients are diagnosed at a late stage, when one- and five-year survival is only 15% and 2%, respectively.
AM0010 is a PEGylated 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
Founded in 2012, ARMO BioSciences is a clinical-stage company developing immunotherapies focused on multiple difficult-to-treat oncology indications. The company's lead immunotherapy AM0010, a PEGylated form of recombinant human IL-10, primes the tumor micro-environment for immune-mediated therapies and has demonstrated durable clinical responses in several types of cancer, as both a single agent and in combination with standard-of-care chemotherapy or anti-Programmed Cell Death Protein (anti-PD-1) monoclonal antibodies. ARMO plans to initiate the first of several potentially registration-enabling studies for AM0010 in solid tumors. The company also has a robust pipeline of 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.