IND for the First siRNA Oncology Drug, STP705, Filed and Deemed Safe to Proceed to Clinic by the U.S. FDA
Germantown, MD, USA (August 20, 2018) – Amarex Clinical Research announces today that an oncology IND application has received a safe to proceed notification from the U.S. FDA. This study will be conducted in collaboration with study sponsor, Sirnaomics, Inc., a leading RNA interference (RNAi) therapeutics biotech company, and marks one of the first siRNA (small interfering RNA) drug trials in oncology.
STP705, belonging to Sirnaomics, Inc., has already received U.S. and Chinese FDA IND approval for Hypertrophic Scar Reduction and was granted Orphan Drug Designation (ODD) in 2017 by the U.S. FDA to treat Cholangiocarcinoma (CCA) and Primary Sclerosing Cholangitis (PSC). STP705 is an anti-cancer/anti-fibrosis siRNA therapeutic that inhibits tumorigenesis by silencing both TGF-β1 and COX-2 gene expression within cancer cells. Cells in the liver are targeted through utilization of a proprietary polypeptide nanoparticle (PNP)-enhanced delivery system. The company plans to have two clinical trials running by the end of 2018 in the U.S., Europe and China.
President & CEO of Amarex, Dr. Kazem Kazempour, stated that, “Our research team worked diligently to secure the approval of this IND, and we are pleased to continue working in this area as there is a critical need for innovative therapies in the treatment of Cholangiocarcinoma. We are optimistic that STP705 will prove to be a valuable new treatment.”
“We have worked with Amarex on numerous projects and they consistently deliver high quality reliable service by leveraging a broad array of clinical and regulatory expertise. What sets them apart from other CRO’s is a creative entrepreneurial approach to drug development. They go beyond the technical aspects of clinical trial development and work with the sponsor to drive value and increase chances for success.” stated Michael Molyneaux MD CMO for Sirnaomics.
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications and Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
Book a meeting or send us a message to talk to one of our experts.