Novogen picks CMOs for ovarian cancer drug

Novogen (ASX:NRT) has selected two CMOs to produce clinical batches of the experimental anticancer drug Cantrixil in advance of phase I trials planned for next year.

Cantrixil is being developed by oncology drug developer CanTx Inc, a joint venture between Novogen and Yale University, to treat cancers wholly or largely confined to the abdomen.

Regis Technologies has been chosen to produce the active ingredient Trx-1 and Pharmaceutics International has been chosen to manufacture the finished dosage form of Trx-1 in cyclodextrin. Both CMOs are based in the US.

The treatment is designed to be injected into patients’ peritoneal cavities and, if found to be effective in humans, could wind up being the first anticancer drug approved as an intra-peritoneal therapy.

CanTx and Novogen plan to file an Investigational New Drug application for Cantrixil early next year and enter the clinic by mid-2015.

Trx-1 is the first drug shown to have meaningful anticancer activity against ovarian cancer stem cells. During animal studies, Cantrixil was able to block the development of carcinomatosis in a mouse model of ovarian cancer.

“It is a pleasure to be working with two great CMOs,” Dr Andrew Heaton, Novogen group vice president for drug discovery and manufacture, said. “Both have proven track records in being able to meet exacting standards and timelines.”

Novogen (ASX:NRT) shares were trading unchanged at $0.145 as of around 1 pm on Monday.