DULLES, Va., May 12, 2023 /PRNewswire/ — SOFIE Biosciences (SOFIE), a recognized United States producer and designer of radiopharmaceuticals, has actually dosed and imaged the very first client with [18F]FAPI-74 in its United States Clinical Trial of flourine-18 identified Fibroblast Activation Protein Inhibitor (FAPI). This research study is a Phase 2, Multicenter, Non-randomized Study of [18F]FAPI-74 family pet for imaging clients with intestinal cancers, consisting of hepatocellular cancer, cholangiocarcinoma, stomach, pancreatic and colorectal cancer (NCT05641896).
The medical trial follows the United States FDA gave SOFIE an active IND in assistance of this research study in November of 2022. The research study was gone for its very first website in Boston under Principal Investigator, Shadi Esfahani, MD, MILES PER HOUR. Additional websites remain in the procedure of activation and expected to begin recruitment in the coming weeks.
Sherly Mosessian, Ph.D., SOFIE’s Chief Scientific Officer, commented, “We are enjoyed see the launch of the research study and imaging of the very first client in this potential research study. Tremendous guarantee exists in diagnostic and buddy diagnostic usage of FAPI family of substances, particularly in intestinal cancers. Flourine-18 identified FAPI opens lots of possibilities in FAP targeting, and we are thrilled to be driving this item forward to open more of its capacity.” The dedication to enhancing client care through usage of radiopharmaceuticals for imaging and treatment is an expert and personal objective of SOFIE’s. Frank Valla, SOFIE’s Director of Clinical Development and FAPI CMC lead, included, “The pledge of FAP targeting in intestinal cancers and the acknowledgment of this essential turning point for client care brings excellent enjoyment to the field along with sense of personal satisfaction after having actually lost my dad to Colorectal Cancer in 2007.”
This research study is the 2nd SOFIE FAPI item in a medical research study. SOFIE is presently carrying out a Phase 2 medical research study with the lead Galium-68 identified FAPI item, [68Ga]FAPI-46, in Pancreatic Ductal Adenocarcinoma clients (NCT05262855).
About SOFIE
SOFIE’s vision is to enhance client results by establishing and providing molecular diagnostics and rehabs (theranostics). With its robust radiopharmaceutical production and circulation network, fully grown agreement production services, and now, high worth theranostic copyright, SOFIE is poised to provide on the pledge of radiopharmaceuticals. For more details, contact [email protected].
About FAPI
Fibroblast Activation Protein (FAP) is extremely revealed in cancer involved fibroblasts (CAF) throughout a number of growth entities. Developed by the group at the Heidelberg University, quinoline-based family pet tracers that function as FAP inhibitors (FAPI) have actually revealed motivating lead to pre-medical and clinical research studies. SOFIE has actually accredited the rights for diagnostic and buddy diagnostic usage of FAPI family of substances from Heidelberg University.
About [18F]FAPI-74
[18F]FAPI-74 is the lead Fluorine-18 radiolabeled family pet tracer of FAPI family of substances. It has actually shown favorable dosimetry, avidity, safety and biodistribution profile open for detection of FAP-expressing cells in clients with different cancers. This radioligand for imaging is presently enhanced for production within SOFIE and its medical trial partners.
Media Contact:
Dawn Allen
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SOURCE Sofie Biosciences
