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Oncology Venture cleared for Phase 2 trial
October 2018
SHARING OPTIONS:

HOERSHOLM, Denmark—The U.S. Food and Drug Administration recently accepted Medical Prognosis Institute A/S and Oncology Venture AB and Oncology Venture US Inc.’s Investigational Device Exemption and Investigational New Drug Application to begin a Phase 2 clinical trial. The trial will focus on treating advanced ovarian cancer with the PARP inhibitor 2X-121 (in-licensed from Eisai in 2017), and will use the company’s Drug Response Predictor to identify patients most likely to respond to the treatment. The multicenter trial will be conducted in the United States and Germany, with an expected enrollment of up to 30 patients. The primary endpoint is antitumor efficacy—looking at partial or complete remission—with secondary endpoints consisting of a safety evaluation and other efficacy factors.

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