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news.Casi Pharmaceuticals has filed an application with China's Food and Drug Administration (FDA) seeking approval to conduct a phase II clinical trial of its drug candidate, ENMD-2076, in fibrolamellar carcinoma (FLC) patients.
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ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. It inhibits a distinct profile of angiogenic tyrosine kinase targets.
Aurora kinases are key regulators of mitosis and are often over-expressed in human cancers.
The company said that its drug candidate also targets the VEGFR, Flt-3 and FGFR3 kinases, which have been shown to play major roles in the pathology of several cancers.
In phase I clinical trials, ENMD-2076 has showed promising activity in solid tumors including ovarian, breast, liver, renal and sarcoma, as well as in leukemia and multiple myeloma.
Currently, ENMD-2076 is being evaluated in phase II clinical trials in multiple indications, including triple-negative breast cancer, soft tissue sarcoma and ovarian clear cell carcinomas and is preparing for a phase II trial in fibrolamellar carcinoma.
Casi CEO Ken Ren said: "We are very pleased with the CFDA’s acceptance of our application package and look forward to working with them to move the process towards approval.
"This is our fourth application to conduct a new drug clinical trial in China for ENMD-2076. We received approval for our first three applications to conduct trials in ovarian clear cell carcinoma, soft tissue sarcoma, and triple negative breast cancer (TNBC), the latter of which was initiated recently and is currently enrolling patients."
The phase II trial in China will be an extension of a phase II trial in the US that is expected to be started in the third quarter.
ENMD-2076 has received orphan drug designation from the US FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia, and hepatocellular carcinoma.
"In addition to patents already issued in the US, China, Japan, Canada, and Australia among others, we have recently secured patent protection in Switzerland, Spain, Germany, France, UK, Sweden, Korea and other territories.
"These recently issued patents add to our robust intellectual property portfolio," Dr Ren added.