1404 is a molecular imaging diagnostic compound candidate being developed by Progenics Pharmaceuticals to detect both primary and metastatic prostate cancer. The compound is proposed as a diagnostic and monitoring tool to assess disease progression in prostate cancer patients at different stages of the disease.

If approved as an imaging agent, the use of 1404 in clinical practice may simplify the monitoring of patients under active surveillance, as well as improve the diagnostics of patients for whom surgical removal of the prostate is recommended.

How 1404 works

Most prostate cancer cells express a protein called prostate-specific membrane antigen (PSMA). The protein is located on the surface of cancer cells. 1404 is a small molecule that contains the radioactive isotope Technetium-99m. It specifically binds to PSMA; so, in effect, it radioactively labels the cancer cells. The location of radioactive labels in the body then can be determined using a technique called single-photon emission computerized tomography (SPECT) or positron emission tomography (PET), allowing physicians to pinpoint the exact position of cancerous tissues and metastases in a patient’s body. This enables surgeons to remove all affected tissues during surgery. In patients under active surveillance, the use of 1404 helps to monitor the progress of the disease and detect any unfavorable changes at an early stage.

1404 in clinical trials

The results of a multicenter, open-label Phase 2 study (NCT01667536) in men at high-risk of prostate cancer demonstrated that the use of 1404 allows a better assessment of the extent and stage of prostate cancer compared to biopsy. Importantly, the results obtained using 1404 can be used instead of the Gleason score, a standard prostate cancer grading system based on the microscopic investigation of biopsy samples.

A Phase 3 open-label study (NCT02615067), designed to evaluate the specificity and sensitivity of 1404 to identify patients with or without clinically significant prostate cancer, is ongoing. The study is enrolling men with newly diagnosed or low-grade prostate cancer whose biopsy results make them candidates for active surveillance. The interim analysis of the trial results led to the recommendation of its continuation.

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