Novogen has announced the results of a Phase II clinical trial of its investigational wound healing compound, Glucoprime, in venous stasis ulcers.
The trial was conducted in Australia by Novogen subsidiary, Glycotex Inc., which holds the rights to the Novogen glucan technology.
The trial involved 60 patients with chronic deep venous stasis ulcers of the legs.
In the double-blind trial, patients were randomized either to a placebo arm, or to low-dose (0.1%) Glucoprime arm or high-dose (1%) Glucoprime arm.
The Glucoprime was formulated as a gel and applied to the wound surface three times weekly.
Treatment was over 12 weeks and the ulcers were monitored for size every two weeks.
Glucoprime was assessed for its effect on both the rate of wound closure and the degree of healing.
Glucoprime promoted the rate at which wounds healed, with Glucoprime- treated ulcers healing at a significantly faster rate (2 millimeters per day) compared to placebo-treated ulcers.
The overall mean level of healing over the 12 weeks was 10 percent for the placebo group, 59 percent for the low-dose, Glucoprime arm, and 55 percent for the high-dose, Glucoprime arm. The outcome was confounded by the large discrepancy in the size of the ulcers, with the two Glucoprime treatment groups having substantially larger average ulcer sizes than the placebo group, despite patients being randomized.
This discrepancy will be addressed in future studies based on guidance issued by the U.S. Food and Drug Administration (FDA) on development of products for treatment of chronic wounds, which suggest stratification based on ulcer size prior to randomization.
The trial was conducted at two sites in Australia -- Royal North Shore Hospital, Northern Metropolitan Area Health Service in Sydney, and Heidelberg Repatriation Hospital in Melbourne. The Principal Investigators were Dr. Rod Lane and Professor Michael Woodward.
Dr. Rod Lane said the results were very encouraging, given the chronic nature of the wounds and the fact that every other product his team had looked at over the years had failed to promote healing to a meaningful level.
"This is a substantial community health problem, and one that is likely to get larger as our life expectancy increases," Dr. Lane said.
"Glucoprime is a highly promising compound," Dr. Lane added.
Professor Michael Woodward said there was a need for better products to promote wound healing.
"The pain, suffering and cost for medical treatment of leg ulcers is immense, and these results are very encouraging," Professor Woodward said.
Executive Director of Glycotex, Inc., Professor Graham Kelly, said the result confirmed confidence in the ability of Glucoprime to promote wound healing.
"The fact that it has had such a positive effect in such difficult wounds where standard care has failed suggests that the technology has utility across a wide range of tissue repair applications," Professor Kelly said.
"Our intention in the first instance is to conduct a regulatory study with a view to getting this product approved for marketing for treatment of venous stasis ulcers."
Glycotex is also planning on pursuing other applications of this product and the technology in general across a range of wound healing applications.