Ideance, Anticancer New Drug Candidate Passes FDA Clinical Trial Plan
[Asia Economy Reporter Cho Hyun-ui] IDIANS, a subsidiary of Ildong Holdings, has passed the clinical trial plan (IND) review by the U.S. Food and Drug Administration (FDA) for its new drug candidate 'IDX-1197'.
According to Ildong Holdings on the 21st, IDIANS plans to soon start clinical trials locally for combination therapy targeting stomach cancer. IDX-1197 is a targeted anticancer drug candidate that treats cancer by utilizing the mechanism of action of the PARP enzyme and the characteristics of cancer cell DNA.
In the recently completed domestic Phase 1 clinical trial, IDX-1197 confirmed clinical efficacy and safety across a wide range of doses when used as monotherapy. It is also described as having characteristics that make it suitable for application in combination therapy.
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Currently, IDIANS is conducting Phase 1b/2a clinical trials at 18 domestic clinical trial institutions to verify the effects of IDX-1197 monotherapy on seven types of cancers, including breast and ovarian cancer. A representative from Ildong Holdings stated, "This clinical trial is also conducting efficacy studies on cancer types for which existing PARP inhibitors have not been approved."
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