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Initiation of Fuji’s Phase 2 Trial for 1404
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that its partner, FUJIFILM RI Pharma, has dosed the first patient in its early Phase 2 trial of 1404 in Japan in newly-diagnosed prostate cancer patients with lymph node and/or bone metastases or at high risk for metastatic disease. 1404 is a targeted small molecule designed to visualize prostate cancer by targeting prostate specific membrane antigen (PSMA).
“1404 holds tremendous promise as the most advanced PSMA-targeted imaging agent in development today, and the initiation of this trial reflects Fuji’s commitment to 1404 following the impressive data from our own Phase 2 study,” stated Mark Baker, CEO of Progenics. “We have demonstrated that 1404 can provide diagnostic information for both primary and metastatic prostate cancer in a single scan, and we look forward to seeing the Japanese development program progress in parallel with our own plans in the United States.”
The early Phase 2 trial in Japan is a multi-center, open-label study evaluating the uptake of 1404 within the prostate gland, pelvic lymph node and/or bone metastases as well as safety in men with high risk for metastatic prostate cancer, using both whole-body planar and SPECT/CT imaging modalities.
About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen
1404 is a developmental stage radiopharmaceutical imaging agent designed to highlight the expression of distinct proteins by diseased cells. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in later-stage clinical development. Progenics’ first-in-class PSMA-targeted technology platform for prostate cancer includes an antibody drug conjugate therapeutic which completed a two-cohort phase 2 clinical trial and a small molecule imaging agent that has also completed a phase 2 trial. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra.
