Novogen and CanTx appoint contract manufacturers to produce clinical batches of Cantrixil

CanTx and Novogen expect to file an Investigational New Drug (IND) application for Cantrixil early next year and to advance this compound into the clinic by mid- 2015.

Cantrixil, being developed by CanTx Inc, a joint venture company between Novogen and Yale University, has been developed specifically to treat cancers wholly or largely confined to the abdomen.

It is comprised of the active drug, Trx-1, contained within a cyclodextrin carrier and is intended to be injected into the peritoneal cavity of patients. If shown to be as safe and as effective in clinical studies as it has in animal studies, Cantrixil could be the first anti-cancer drug approved as an intra-peritoneal therapy.

The potential of Cantrixil has emerged from studies at Yale, where researchers have developed ground-breaking screening tools to assess new drug candidates in the treatment of ovarian cancer.

"I have tested over a hundred new compounds in this model from many companies and never achieved any result that would give me confidence to take any of them into the clinic. Trx-1 was the first drug to show potent efficacy in the laboratory in killing ovarian cancer stem cells, the cells responsible for tumor growth and recurrence," said Professor Gil Mor, M.D., Director of the Reproductive Science Division at the Department of Obstetrics Gynecology and Reproductive Science at Yale.

"We decided that the best way to use Trx-1 was to inject it directly into the abdominal cavity where the ovarian cancer stem cells occur and are establishing the cancer. That was the concept behind Cantrixil and I am delighted to say that we found that it worked in our animal model."

Trx-1 is the first drug shown to have any meaningful anti-cancer action against ovarian cancer stem cells, and Cantrixil is the first product shown to block the development of carcinomatosis in a mouse model developed by Yale to replicate the growth of ovarian cancer in women.

The companies chose Illinois-based Regis Technologies, Inc, for its ability to scale-up quickly and with extensive experience in chiral chemistry. Regis will be producing the active pharmaceutical ingredient, Trx-1.

Maryland-based Pharmaceutics International, Inc., will manufacture the finished dosage form of Trx-1 in cyclodextrin as a sterile injectable formulation that meets stringent manufacturing, sterility and stability regulations set down by the U.S. Food and Drug Administration (FDA).

"It is a pleasure to be working with two great CMOs. Both have proven track records in being able to meet exacting standards and timelines," Dr. Andrew Heaton, Novogen Group Vice-President, Drug Discovery and Manufacture, said.

"Both also have a strong history of assisting companies with the development of formulations, from pre-clinical through to commercial manufacture. Having relationships with such companies also meets our long term corporate goal of seeing Cantrixil progress from an experimental to a commercial product."

Novogen Group CEO, Graham Kelly, PhD, emphasized the significant nature of these contracts. He said: "We are developing a product that we expect eventually to be the first anti-cancer drug approved specifically as an intra-peritoneal therapy. A number of hospitals currently give standard anti-cancer drugs intra-peritoneally off-label for the treatment of ovarian cancer and some other abdominal cancers, but that heightens their toxicity, meaning that this approach remains cautious. In our hands, Cantrixil has proven to be well tolerated in animals at doses delivering a significant anti-cancer effect."

"This is an exciting path that we are now on," Dr. Kelly continued. "The manufacturing programs currently underway will furnish us with sufficient drug to complete the IND process and to undertake Phase 1 studies in patients with late-stage ovarian cancer in 2015."Trx-1has been licensed by Novogen to CanTx.