Enrollment Completed for Phase 3 Trial Evaluating 1404 Radioactive Imaging Agent

Enrollment Completed for Phase 3 Trial Evaluating 1404 Radioactive Imaging Agent

Progenics Pharmaceuticals has completed enrollment in the Phase 3 study assessing its PSMA-targeted imaging agent 1404 as a tool to identify prostate cancer patients with clinically significant disease.

“The results of this large-scale Phase 3 study will provide important insights on the potential of our novel imaging agent to accurately and non-invasively detect and monitor patients with low-grade prostate cancer,” Mark Baker, CEO of Progenics, said in a press release. “We believe that 1404 has the possibility to transform the practice of active surveillance, and we look forward to providing top-line results in the third quarter.”

1404 is a molecular imaging agent designed to target the prostate specific membrane antigen (PSMA), a protein that is found in 95 percent of prostate cancer cells. The molecule also contains the radioactive isotope Technetium-99m, allowing it to be seen in single-photon emission computed tomography (SPECT).

When bound to the PSMA protein, 1404 is expected to provide a sensitive and accurate image of the localization and concentration of prostate cancer cells. The tool may enable more precise biopsies and targeted strategies to manage the disease.

The proSPECT-AS trial (NCT02615067) includes 450 men with newly-diagnosed or low-grade prostate cancer. Patients were enrolled across 45 clinical centers in the United States and Canada.

All participants had prostate tumors up to grade 3 or 4, and some were suitable candidates for active surveillance.

Within three to six hours of receiving single injection of 1404, patients underwent a pelvic SPECT and whole body planar (skeletal) scan.

Within 42 days of 1404 dosing, patients may choose to undergo radical prostatectomy or a prostate biopsy. Tissue samples then will be compared against the imaging scans to determine if 1404 is specific enough to identify patients without clinically significant disease, and sensitive enough to identify those with clinically significant prostate cancer.

In a prior open-label Phase 2 study (NCT01667536) researchers found that 1404 provides a better assessment of the progression and stage of prostate cancer in men at high-risk of prostate cancer, compared to standard methodologies. The findings suggest that 1404 may be used as a surrogate diagnosis tool for the tissue Gleason scoring method, which evaluates a patient’s prognosis based on cell morphology.