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news.CASI Pharmaceuticals has received approval from the China Food and Drug Administration (CFDA) to conduct a Phase II clinical trial with its proprietary drug candidate ENMD-2076 in soft tissue sarcoma patients in China.
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ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a kinase selectivity profile and multiple mechanisms of action.
This is the company’s second approval to start a Phase II clinical trial in an oncology indication with ENMD-2076 in the country, followed by CFDA’s approval in July to start a Phase II trial in triple-negative breast cancer patients.
CASI chief executive officer Ken Ren said: "As an expansion of our Phase 2 trial currently ongoing in North America in soft tissue sarcoma, the data generated in China can be used to support regulatory filings in both China and worldwide.
"We are very excited about advancing our pipeline for both China and the global market, which now includes the recently licensed commercial-stage oncology products ZEVALIN and MARQIBO, and the Phase 3-completed Captisol-Enabled melphalan.
"We are on track with our plan for commercialization of ZEVALIN in Hong Kong and regulatory filings of ZEVALIN and MARQIBO in applicable greater China territory."
The company said that ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase, which is a key regulator of mitosis (cell division) and is often over-expressed in human cancers.