Date: 2015-04-07
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 28th Annual European Association of Nuclear Medicine (EANM) Congress being held in Hamburg, Germany
Company: Progenics Pharmaceuticals (USA - NY) FUJIFILM RI Pharma (Japan)
Product: 1404
Action
mechanism: imaging agent/radiopharmaceutical. 1404 is a targeted small molecule designed to visualize prostate cancer by targeting prostate specific membrane antigen (PSMA).
Disease: prostate cancer
Therapeutic area: Cancer - Oncology - Diagnostic
Country: Japan
Trial details:
Latest
news: * On October 12, 2015, Progenics Pharmaceuticals announced the presentation of additional data from a Phase 2 trial of its PSMA-targeted imaging agent candidate, 1404, at the 28th Annual European Association of Nuclear Medicine (EANM) Congress being held in Hamburg, Germany. Results from the Phase 2 trial in high-risk patients undergoing radical prostatectomy were presented by Professor Karolien Goffin, M.D., Ph.D., University Hospitals Leuven, and included previously reported sensitivity and accuracy data for 1404 and data related to the uptake of 1404 in the lobes of the prostate gland. New data presented at the meeting demonstrate that 1404 uptake in the prostate gland is significantly higher in prostate cancer patients with upgraded Gleason scores at radical prostatectomy from those who are downgraded at radical prostatectomy. * On April 7, 2015, Progenics Pharmaceuticals announced that its partner, FUJIFILM RI Pharma Co. Ltd. (Fuji), 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. 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.
In the Phase 2 study, 31% (25/81) of evaluable patients had their biopsy Gleason score upgraded to >7 or downgraded to ?7 by histopathologic assessment of the prostatectomy specimen. Of patients upgraded to a Gleason score >7, 79% (11/14) demonstrated high lesion uptake of 1404 with a mean tumor to background ratio (TBR) of 47:1. Of patients downgraded to Gleason score ?7, 91% (10/11) had significantly (p<0.001) lower lesion uptake of 1404 with a mean TBR of 16:1.
