Novogen drug said to promote wound healing

A phase II trial conducted by Novogen (ASX:NRT) subsidiary Glycotex has found that its wound healing compound Glucoprime promotes healing in venous stasis ulcers.

US-based Glycotex is licensed by Novogen to develop its glucan technology platform and Glucoprime is a patented form of glucan, a carbohydrate extracted from yeast cell walls.

"In the past different compounds have promoted different parts of the wound healing cascade but they've never resulted in over all wound healing," said Glycotex executive director Prof Graham Kelly. "This is the first time that anyone's actually achieved complete wound healing."

Kelly said Glucoprime worked by stimulating the wound macrophages, the cells that drive the wound healing cascade.

"By stimulating the macrophages we've got them to release all the different cytokines that you need and that has lead in turn to the complete healing process being obtained," he said.

The 12-week double-blinded trial involved 60 patients with chronic deep venous stasis ulcers of the legs who were randomised for treatment with a placebo or a low- or high-dose of Glucoprime. The trial was conducted at two sites in Australia -- Royal North Shore Hospital in Sydney, and Heidelberg Repatriation Hospital in Melbourne.

The Glucoprime was formulated as a gel containing either 0.1 per cent or 1.0 per cent of the active ingredient and then applied to the wound surface three times weekly. The trial found that Glucoprime promoted the rate at which wounds healed, with the overall mean level of healing over the 12 weeks being 10 per cent for the placebo, 59 per cent for the low-dose of Glucoprime and 55 per cent for the higher dose.

However, the results were confounded by a discrepancy in wound size.

"When it came to comparing the active versus the placebo, we were stuck with a problem, where in the placebo group we had this enormous standard deviation because so many wounds got worse," said Kelly.

"Where we could get a statistical analysis was the rate of healing because where a wound is getting worse that's a negative result, so statistically you could get a positive outcome. That's what we relied on for this result."

Future trials of Glucoprime will address this problem by using recently published US Food and Drug Administration (FDA) wound healing study guidelines.

Kelly said that a phase III trial of Glucoprime is anticipated to begin in the US before the end of the year.

"The trial will use the same sort of patients but we'll be a lot more careful this time with the sorts of ulcers we start with so we avoid the problem we've had in the past," he said.