FutureChem Applies to US FDA for Clinical Phase 1/2a Trial of Prostate Cancer Treatment 'FC705'

[Asia Economy Reporter Lee Gwan-joo] FutureChem announced on the 29th that it has applied to the U.S. Food and Drug Administration (FDA) for Phase 1 and 2a clinical trials of its prostate cancer treatment 'FC705.'

The U.S. clinical trials are scheduled to be conducted at the University of Maryland Medical Center and five other institutions. The plan is to evaluate the safety and efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).

In Phase 1, a single dose of 100mCi will be administered to six patients, and in Phase 2a, repeated doses of 100mCi will be given to 20 patients.

A FutureChem official stated, "In the interim report of the domestic Phase 1 trial, PSA (prostate-specific antigen) levels decreased by up to 92% in castration-resistant metastatic patients participating in the trial, confirming high efficacy even with a single low dose," adding, "With the FDA approval of the competing drug Pluvicto, we view the success potential of FutureChem's FC705 very highly."

Meanwhile, FutureChem's domestic Phase 1 trial is in its final stages, and earlier in February, based on the efficacy confirmed at the 100mCi dose in Phase 1, the company applied for domestic Phase 2 clinical trials.

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