FutureChem's Prostate Cancer Treatment 'FC705' Receives FDA IND Approval for Phase 1/2a Clinical Trials

[Asia Economy Reporter Lee Gwan-joo] FutureChem announced on the 27th that its prostate cancer treatment 'FC705' has received approval for clinical Phase 1/2a trial plans (IND) from the U.S. Food and Drug Administration (FDA).

The clinical trials are scheduled to be conducted at six institutions in the United States. Using the 100mCi dosage determined in previous domestic trials, Phase 1 will involve single administration to 6 patients, and Phase 2a will involve repeated administration to 20 patients.

The trials will evaluate the drug's safety, pharmacodynamics such as tumor uptake coefficient, and PSA (prostate-specific antigen) response in patients with metastatic castration-resistant prostate cancer (mCRPC).

FC705 targets the PSMA (prostate-specific membrane antigen) protein, which is specifically expressed in prostate cancer, and is a next-generation radiopharmaceutical candidate that can treat prostate cancer through injection without surgical operation.

A FutureChem official stated, "This approval is significant as the clinical trials of FC705, previously conducted domestically, are expanding to the U.S. and developing into global clinical trials," adding, "Since meaningful data has been confirmed in domestic trials, we plan to start administering the first patients in the U.S. as soon as possible."

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