Novogen (NVGN) Announces FDA Acceptance of Cantrixil IND; Will Commence Phase 1
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Novogen Ltd (Nasdaq: NVGN) announced that it had received confirmation from the United States Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for Cantrixil (TRX-E-002-1) had been successfully opened, and the phase I study of Cantrixil in patients with ovarian cancer may therefore proceed as planned.
Dr James Garner, CEO of Novogen, commented, "We are grateful to the FDA for their thorough and comprehensive review of our submission, and we are pleased to have their approval to move forward with the study. The team is already working alongside Quintiles, our contract research organisation, to make the necessary submissions to human research ethics committees at each of the participating sites, and we continue to anticipate initiation of the phase I study in the fourth quarter of 2016, as previously indicated."
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