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Novogen secures key US drug study approval

AAP logoAAP 12/09/2016 Lilly Vitorovich

Biotech Novogen says it has received US Food and Drug Administration approval to start the first phase of in-human studies of its ovarian cancer drug Cantrixil.

Novogen said the phase one study remains on track to start in the fourth quarter of 2016, in line with Novogen' guidance, after receiving FDA investigational new drug application approval.

Chief executive James Garner said Novogen would now work with its contract research organisation Quintiles on the necessary human research ethics committees applications "and we continue to anticipate initiation of the phase I study in the fourth quarter of 2016, as previously indicated".

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