FutureChem Submits Clinical IND for Prostate Cancer Diagnostic Radiopharmaceutical to US FDA

[Asia Economy Reporter Eunmo Koo] FutureChem, a company specializing in the development of new radiopharmaceutical drugs, announced on the 2nd that its U.S. subsidiary, FutureChemUSA, has submitted an Investigational New Drug (IND) application for the Phase 1 clinical trial of ProstaView (FC303), a radiopharmaceutical for prostate cancer diagnosis, to the U.S. Food and Drug Administration (FDA).

ProstaView is a radiopharmaceutical that selectively binds to prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer, for diagnosing prostate cancer. It is a new drug independently developed by FutureChem. This is the first time a Korean radiopharmaceutical company has applied for FDA approval for global clinical trials starting from candidate substance discovery.

FutureChem began full-scale development by presenting the non-clinical results of ProstaView at the European Association of Nuclear Medicine conference in October 2018, and started domestic Phase 1 clinical trials in June last year. Additionally, to enter the U.S. market, it signed a clinical trial agreement with Johns Hopkins Hospital and a supply contract with GE Healthcare, completing preparations for U.S. market entry.

A FutureChem official stated, “It is expected to take about two months to obtain IND approval, and once approved, we plan to immediately begin full-scale clinical trials centered on Johns Hopkins University.” He added, “Negotiations for entry into the European and Chinese markets are also underway, so we will accelerate market expansion after entering the U.S.”

According to data from the American Cancer Society, approximately 165,000 new cases of prostate cancer occurred in 2018 alone, with 29,000 deaths. The market size in the U.S. alone exceeds $400 million annually.

FutureChem currently holds a total of five new drug candidates (pipelines) and is focusing on the development of new PSMA-based prostate cancer diagnostic and therapeutic drugs. The domestic Phase 1 clinical trials for prostate cancer diagnostic drugs are being conducted at Seoul St. Mary’s Hospital and the Korea Institute of Radiological & Medical Sciences. For Parkinson’s disease diagnostic drugs, FutureChem is preparing an IND application for U.S. clinical trials through the Department of Neurology at Columbia University and the local CRO company Advanced Clinical for its PDView product.

This content was produced with the assistance of AI translation services.