FDA approves IND for Cantrixil study

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Novogen (ASX:NRT) has announced it has received confirmation from the US FDA that the Investigational New Drug (IND) application for Cantrixil (TRX-E-002-1) has been successfully opened, and the phase I study of Cantrixil in patients with ovarian cancer can proceed as planned.

Dr James Garner, CEO of Novogen, said, “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.”

Cantrixil is a cyclodextrin-based formulation of the active ingredient, TRX-E-002-1, which has shown in vitro and in vivo anti-cancer activity in a range of tumour types.

Novogen anticipates that, if approved, the drug could be used as an intra-peritoneal chemotherapy, either alone or in combination with other agents, and in one or more cancers of the abdominal or pelvic cavity (e.g. ovarian, uterine, colorectal or gastric carcinomas).