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news.US-based CASI Pharmaceuticals has received approval from the China Food and Drug Administration (CFDA) to conduct a global Phase II clinical trial of ENMD-2076, an orally-active, Aurora A/angiogenic kinase inhibitor, in patients with ovarian clear cell carcinoma (OCCC).
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The approval will allow the company to expand its Phase II OCCC trial currently underway in multiple centers in North America with Princess Margaret Cancer Centre in Canada as the lead institution.
According to the company, this will be its third approval of a global Phase II trial in China, the first being for advanced triple-negative breast cancer and the second for advanced soft tissue sarcoma.
CASI chief executive officer Ken Ren said: "Our excitement about this trial is two-fold. First, CFDA’s approval of this third application supports our commitment to our global development strategy for ENMD-2076 to include China as an important component under our US/China development model.
"Second, we will be able to explore the therapeutic potential of ENMD-2076 in the Chinese OCCC patient population which may show a distinct sensitivity profile."
In addition to the Aurora A kinase, ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets.
ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases, which have been shown to major roles in the pathology of several cancers.
Currently, the company is preparing for a Phase II trial of ENMD-2076 in fibrolamellar carcinoma.