The radioactive pharmaceuticals corporation FutureChem announced on the 5th that it has received approval from the Ministry of Food and Drug Safety for the clinical trial plan (IND) of its prostate cancer treatment candidate FC705.
Radioactive pharmaceuticals work by diagnosing targets or destroying aberrant cells using radiation emitted by radioactive isotopes. This occurs when radioactive isotopes bind with proteins that are highly expressed in prostate cancer.
The upcoming domestic phase 3 clinical trial will target patients with metastatic castration-resistant prostate cancer. It is designed as a randomized clinical trial comparing a standard treatment (BSC) and optimal supportive care (SoC) monotherapy group with an FC705 combination therapy group.
The plan is to recruit a total of 114 patients from eight medical institutions, including Seoul St. Mary's Hospital. Major evaluation indicators for assessing treatment effectiveness (efficacy) will include ▲radiological progression-free survival ▲overall survival rate ▲objective response rate and disease control rate based on imaging evaluations.
The company plans to verify efficacy and safety by reflecting various indicators that comply with global standards.
A FutureChem representative noted, "The approval of this phase 3 plan is not only the result of the efforts of the research and development team but also an important milestone in providing new treatment opportunities for patients," adding, "We will actively communicate with the Ministry of Food and Drug Safety for conditional approval."