FutureChem said Monday that it has recently entered full-scale clinical trials with the first dose of its radiopharmaceutical, FC705, in patients with metastatic castration-resistant prostate cancer (mCRPC) in a U.S. phase 2a study.
Prostate cancer is the leading male cancer killer in the United States, with nearly 270,000 new cases diagnosed annually.
FutureChem's FC705 is a prostate cancer treatment developed using a best-in-class strategy that maximizes therapeutic efficacy through higher tumor uptake than competitive drugs while minimizing side effects, such as radiation, at half the dose, the company said.
The U.S. clinical trial of FC705 was conducted at five centers, including the University of Maryland Medical Center. It showed an objective response rate (ORR) and disease control rate (DCR) of 100 percent in phase 1, with PSA (prostate-specific antigen) reductions in all patients in the trial.
In the U.S. phase 2a study, the 100 mCi dose will be repeated in 20 patients, evaluating the safety and efficacy of the drug in patients with castration-resistant metastatic prostate cancer.
"The Korean phase 2 clinical trial is going on with plans to complete all repeat doses within the year," a FutureChem official said. "We look forward to achieving rapid results with this first patient dose in the U.S. phase 2a clinical trial."
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