Novogen investigates fast track to local production

Following highly successful Phase I trials, Sydney-based isoflavone biotech Novogen is considering fast-tracking FDA approval for its new anti-cancer drug Phenoxodiol.

"The results from our trial so far have been very promising, and we are considering applying for fast-track approval if the safety record stands up. This could mean a product to market in about 18 months or two years," said executive director Graham E Kelly.

Kelly went on to indicate that the company could set up a full manufacturing process in Australia -- most likely Sydney -- if the remaining trials prove the potential of the drug.

"We already have a pilot plant working here, and setting up a full-scale production facility would be quite possible. The government has given us lots of support and we would like to retain the manufacturing capacity here if we can," he said.

He also cited the delays inherent in signing overseas deals as a reason for looking to a home manufacturing base. Large drug companies are often recognised as good at getting drugs to market, but not so good at getting them to Phase II trial level.

"We haven't sought any [outside] licensing deals so far as we have plenty of cash to do it ourselves. We also have the ability to be more nimble and get approvals quicker than some of the big pharma," he added.

Phenoxodiol is based on genistein, a naturally occurring compound found in chick peas and soy products which has established anti-cancer capabilities. Kelly said the compound had proved surprisingly successful in treating a very wide range of human cancers, and had therapeutic potential across a large proportion of tumour types.

"It was something of a puzzle to begin with why phenoxodiol was so effective against such a large range of cancers. In US tests, its action was screened across 75 different tumour types, and it had effectiveness against virtually all of them," he said.

Despite the drug's prospective glowing future, Kelly said he was disappointed with local reaction from both research and financial communities. He asserted that phenoxodiol had enormous potential, but had so far attracted less attention than it deserved on the Australian scene.

"For some reason the news isn't yet out in the scientific and investment communities. This drug seems to be effective on all human tissue types, which is very unusual. It's a really exciting development, and I have to say I'm surprised Australians are not more excited about it," he argued.

Novogen is targeting squamous-cell and ovarian cancers at this stage of testing, and sees the drug as part of a synergistic therapy approach in combination with existing anti-cancer treatments. This will allow notably smaller doses of the compound to perform effectively, said Kelly.

"We are also looking at using the drug for treating prostate, leukaemia and skin cancers. Research at Purdue University in Indiana has demonstrated a link between phenoxidiol and a protein found in all types of human cancer cells. This is a very, very significant finding," he added.