Novogen drug reduces cardiovascular risk, subsidiary to list on NASDAQ

Biopharmaceutical company Novogen's (ASX:NRT) cardiovascular drug trans NV-04 has shown a significant reduction in blood pressure and reduced arterial stiffness in a Phase Ib clinical trial.

The trial of trans NV-04, a synthetic isoflavone metabolite, was completed at the Baker Heart Research Institute in Melbourne.

The drug was administered orally to 25 overweight middle-aged men and women who suffered from at least two complications of being overweight: abnormal blood fats; high blood glucose; or raised blood pressure.

"Being a phase I study the primary interest was to look at tolerability," said Novogen's research director Alan Husband. "We found the drug was safe. We were able to give a therapeutic dose without any untoward effect."

The double-blinded trial also found that arterial stiffness (measured across the large arteries of the chest and abdomen by a non-invasive technique) was significantly reduced with trans NV-04 treatment. Blood pressures, both systolic and diastolic, were also significantly lowered.

"We all know that high blood pressure is bad for us," said Husband. "It's perhaps less well known that hardening of the arteries, or loss of arterial elasticity, is also very positively linked with heart attack risk."

Previous studies carried out by the Baker Heart Research Institute have shown that arterial stiffness can be reduced with naturally occurring dietary isoflavones, which explains why Novogen's synthetic isoflavonoid compounds have demonstrated similar results.

"We have some compounds in the R&D pipeline which are looking even better than trans NV-04 when we test them in animal models. So we will be taking those into the clinic too next year," said Husband.

It is expected that further phase Ib studies using higher doses of trans NV-04 adminstered over longer periods of time will begin early next year, said Husband.

"Then after that we would probably look at patients that have real disease -- not just those at risk -- patients who may have had bypass surgery or may have recovered from heart attacks, and see if we can modify their prognosis," he said.

Glycotex to list on NASDAQ

Novogen's US-based subsidiary, Glycotex, has filed a registration statement with the Securities Exchange Commission to list on the NASDAQ national market.

"It's not easy to get to this point," said Novegen's CEO Christopher Naughton. "A lot of work goes into this, planning and so on. Getting the registration statements filed is a very major milestone."

A clinical stage biopharmaceutical company, Glycotex is discovering and developing drugs for human wound healing and tissue repair.

Common stock units in Glycotex' initial public offering (IPO) will consist of one Glycotex share and one warrant to purchase one share. According to Glycotex' registration statement, the proposed total to be raised from the offering of its common stock units is US$39 million.

"For Novogen, it means a distinct entity, a separate company and a different technology operating in the US under it's own financing," said Naughton.

The IPO will be underwritten by Janney Montgomery Scott LLC.