The concluding meeting for the Phase II clinical trial of recombinant human hepatocyte growth factor naked plasmid injection was successfully held.

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2015-12-08


On December 4, 2015, the concluding meeting for the Phase II clinical trial of recombinant human hepatocyte growth factor naked plasmid injection was successfully held at the Taishan Hotel in Beijing. More than ten experts from eight institutions—including the sponsor, the statistical unit, and the clinical trial sites—attended the meeting.

The summary meeting began with NORTHLAND reviewing the research process of the Phase II clinical trial. Subsequently, Professor Yu Hao from Nanjing Medical University explained the statistical principles and methods used in the Phase II clinical trial. Director Gu Yongquan from the Department of Vascular Surgery at Xuanwu Hospital, Capital Medical University—the leading unit—announced the results of the Phase II clinical trial. The attending experts discussed and analyzed the process and results of the Phase II clinical trial and unanimously agreed that the project demonstrates excellent safety in clinical practice and exhibits promising therapeutic effects for lower-limb arterial ischemic disease, holding great potential for further development. They unanimously recommended proceeding with the Phase III clinical trial. Meanwhile, during this summary meeting, the attending experts also discussed the protocol for the Phase III clinical trial of this product and offered valuable feedback on inclusion and exclusion criteria as well as primary endpoints.

NORTHLAND will carefully summarize the results of the Phase II clinical trial and strive to initiate Phase III clinical research as soon as possible.

 

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