Phase 2 Data for Progenics' 1404 Imaging Agent Presented at EANM Congress

Progenics Pharmaceuticals, Inc.

today announced that data from a Phase 2 trial of its PSMA imaging agent candidate, 1404, have been presented at the 27th Annual European Association of Nuclear Medicine (EANM) Congress being held in Gothenburg, Sweden. 1404 is a targeted small molecule designed to "visualize" prostate cancer by targeting prostate specific membrane antigen (PSMA). Complete results from the Phase 2 trial in high-risk patients undergoing radical prostatectomy were presented by Gabriella Dabasi, Ph.D. of the Department of Nuclear Medicine at Semmelweis University in Budapest, Hungary, and included previously reported sensitivity and accuracy data for 1404, data related to the uptake of 1404 in the lobes of the prostate gland, and new data on the detection of metastatic prostate cancer in the lymph nodes using SPECT/CT with 1404. "The Phase 2 data are quite impressive and demonstrate how SPECT/CT with 1404 may provide a more accurate assessment of the presence, location and extent of prostate cancer," said Dr. Dabasi. "1404 may provide prognostic information for both primary and metastatic disease in a single procedure, which could greatly enhance the clinical decision-making process. There is a strong rationale for continued development of this promising molecular imaging agent." "Collectively, the clinical data presented at EANM underscore the potential for 1404 to change the course of care in prostate cancer," said Mark R. Baker, CEO of Progenics. "In the Phase 2 study, SPECT/CT with 1404 showed superior diagnostic utility over traditional methods, with improved sensitivity compared to histopathology and increased accuracy compared to MRI. In addition, imaging with 1404 detected lymph node involvement better than MRI. Together, these findings suggest that imaging with 1404 may guide more appropriate treatment decisions, translating into improved outcomes and a better quality of life for patients." In the Phase 2 trial, SPECT/CT imaging with 1404 showed 94% sensitivity in detecting and imaging cancer in the prostate gland of high-risk patients prior to prostatectomy. In addition, 1404 was more sensitive than MRI in detecting primary prostate cancer (94% vs. 86%) and was a good predictor of lymph node involvement at prostatectomy. SPECT/CT imaging with 1404 identified 14 (19%) more patients with suspicious lymph node sites than MRI. Uptake of 1404 in the lobes of the prostate gland showed a highly significant correlation with Gleason score (p<0.0001). The data also showed uptake of 1404 in the primary tumor was significantly lower in treated patients (p<0.0001), corresponding to a decrease in PSA over time observed in these treated patients. Additional presentations at EANM included an oral presentation by Professor Shankar Vallabhajosula, Ph.D., of Weill Cornell Medical College in New York City, which also covered previously-reported results from a Phase 1 study of 1404. A poster presented by Dr. Julia Reinfelder from FAU Erlangen-Nürnberg, Germany, will be featured during the Highlights Lecture at the EANM Closing Ceremonies on October 22nd.