Drug developer Novogen is a step closer to begin early trials of an experimental drug to treat late-stage ovarian cancer.
Novogen is developing the drug Cantrixil to treat the disease and is seeking "investigational new drug" status from the powerful US Food and Drug Administration (FDA).
The drug developer says the FDA is happy with the processes Novogen has put in place for the clinical development of Cantrixil ahead of planned trials in women.
Chief executive Graham Kelly said that there had been a risk the FDA would raise concerns as Cantrixil was a "first in class drug" designed to be injected into the abdomen, where the disease can spread after leaving the ovaries.
"Fortunately, no such issues were flagged," he said on Wednesday.
The phase 1 clinical trial will involve women with late-stage ovarian cancer.
Cantrixil is designed to kill ovarian cancer stem cells, which are believed to be responsible for spreading the cancer throughout the abdomen.
By injecting Cantrixil directly into the abdomen, the cancer stem cells and their daughter cells are exposed to much higher levels of the drug than would be achieved by intravenous injection.
Dr Kelly said Cantrixil had been designed to treat any form of disseminated cancer within the abdomen.
"This condition is known as peritoneal carcinomatosis and is a late-stage condition associated mostly with cancers that arise in the abdominal cavity, such as colo-rectal cancer, ovarian cancer and primary peritoneal cancer," he said.
"No standard of care exists currently for these conditions, and as far as we know.
"Cantrixil is the first product to be developed for these conditions, despite their prevalence."
Shares in Novogen were 0.5 cents higher at 14 cents at 1229 AEST.
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