CASI Pharma (CASI) Reports ENMD-2076 Phase 2 Met Stage 1 Endpoint in FLC

August 16, 2016 7:07 AM EDT

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CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced that its Phase 2 trial of ENMD-2076 in fibrolamellar carcinoma (FLC) has met its Stage 1 endpoint of objective response for non-futility based on the pre-specified interim analysis criteria and will advance to Stage 2 development.

Rong Chen, M.D., CASI's Chief Medical Officer, commented, "The trial is to evaluate safety and efficacy of ENMD-2076 as a single agent in a total of 29 locally-advanced or metastatic FLC patients. It uses a Simon's optimal two-stage design to allow for an early determination of potential futility in the 16 patients of Stage 1. An additional 13 patients will be recruited in Stage 2 to allow an overall final analysis with sufficient power. Having met the Stage 1 endpoint, we will now advance the trial to Stage 2 development. Meanwhile, the Stage 1 remains ongoing with approximately one-third of the patients still under treatment. A full interim analysis will be conducted and reported after all 16 patients have reached study endpoint of responses."

Ken Ren, Ph.D., CASI's Chief Executive Officer, commented, "We are pleased to see our FLC trial advance into Stage 2, which upon completion will increase the amount of data of ENMD-2076 in FLC patients. FLC is a life-threatening disease that typically affects young adults and is currently without any systemic treatment. Based on results to date, we are encouraged by the potential of ENMD-2076 to address the unmet medical needs of these patients. We are thankful to our investigators for their dedication to the program and to our FLC patients who make the trial meaningful and drive our purpose."

More information about the trial can be found at

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