GE Healthcare, a unit of the General Electric Company (NYSE: GE), today will present results of a phase 1 study of anti-[18F]FACBC at the 57th annual meeting of the Society of Nuclear Medicine in Salt Lake City, Utah. The presentation closely follows the launch of the phase 2 clinical development program for anti-[18F]FACBC, which was initially discovered and developed by Emory University, Atlanta, Georgia, and was licensed to Nihon Medi-Physics Co., Ltd. (NMP) of Japan. Anti-[18F]FACBC is under development by GE Healthcare under a sub-license from NMP, which is currently conducting a phase 1 study of the compound in Japan.
Anti-[18F]FACBC is a synthetic amino acid analogue-based PET imaging agent being developed by GE Healthcare as a clinical diagnostic tool. The goal of GE Healthcare's phase 1 program was to test the potential utility of anti-[18F]FACBC at delineating primary prostate tumors, lymph node metastasis, and seminal vesicle involvement. The study included six patients with primary prostate cancer who underwent up to 120 minutes of dynamic positron emission tomography/computed tomography (PET/CT) imaging. Visual and quantitative imaging assessments were performed. Standardized Uptake Value (SUV) analysis of malignant and normal prostate tissue was correlated with standard-of-care imaging and biopsy results.
"Anti-[18F]FACBC could provide valuable additional information to the physician treating cancer patients like monitoring of early recurrence and playing a role in radiotherapy treatment planning," said Silvia Johansson, MD, Department of Oncology & Nuclear Medicine, Uppsala University Hospital, Uppsala, Sweden. "We are particularly excited by anti-[18F]FACBC's potential for providing crucial information that is not available with today's diagnostic tools, a benefit that will ultimately help in improving cancer care."
The anti-[18F]FACBC phase 2 clinical development program was initiated at the end of April 2010 with the launch of study IND 107707. A total of 80 patients scheduled for prostatectomy will be enrolled at multiple sites in the USA and Europe.
FDA strengthens AI regulation to ensure patient safety and innovation in healthcare