Amarex Receives SMP Letter from TFDA for an Oncology Drug Clinical Trial Treating Pancreatic Cancer
Germantown, MD, USA (September 10, 2020) – Amarex Clinical Research, LLC, an NSF International company announces today that earlier this week they received a study may proceed (SMP) letter from the Taiwan Food & Drug Administration (TFDA) to conduct the first in human clinical trial of RP-72 in Taiwan. RP-72 is a 72 amino acid propriety recombinant protein antagonist for the CXCR1 and CXCR2 receptors of interleukin-8, a drug that treats pancreatic cancer. In early 2020, Amarex also received a SMP letter from the U.S. FDA for RP-72 to treat pancreatic cancer.
Dr. Kazem Kazempour, President & CEO of Amarex stated that, “Amarex Taiwan’s regulatory department submitted the IND application for this study to the TFDA on behalf of the study sponsor, Rise. With strong effort, prudent revision, and hard work, this IND application was accepted by the TFDA under the MRCT route within 45 days. Amarex’s clinical, biometrics, and regulatory departments are expected to further manage, monitor, and work on the data analysis of this study in both the U.S. and Taiwan.”
In mid-2019, the U.S. FDA granted RP-72 Orphan Drug Designation (ODD). The FDA Orphan Drug Designation was designed to facilitate the development, and expedite the review, of drugs that are used for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 200,000 persons in the US. The Orphan Drug Act (ODA), first enacted in the US in 1983, was developed to encourage the development of drugs that treat rare diseases. The ODA provides incentives to drug sponsors intended to promote the development of promising drugs/biologics for the prevention, diagnosis and treatment of rare diseases or conditions and fosters prompt availability of therapeutically superior drugs.
About Rise Biopharmaceuticals, Inc.
Rise Biopharmaceuticals, Inc. is a pharmaceutical and life science company focused on bringing better health to the world. With a tradition of excellence in science and research, Rise is set on a mission to develop and bring innovative and breakthrough drugs and healthcare solutions to help prolong and improve patients’ lives. Founded with a specific focus in the area of oncology, Rise has developed several extremely promising anti-cancer drugs that have a broad-spectrum of applicability for multiple types of cancers, especially pancreatic cancer and lung cancer. Our goal has always been to make a positive impact and difference in the world, and we are committed to deliver innovative solutions and therapeutics to achieve this promise.
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research. Their combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information visit www.amarexus.com.
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