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www.fdanews.com/articles/74290-glucoprime-promotes-healing-in-venous-stasis-ulcers

GLUCOPRIME PROMOTES HEALING IN VENOUS STASIS ULCERS

July 13, 2005

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, and involved 60 patients with chronic deep venous stasis ulcers of the legs.

Patients were randomized either to a placebo arm, or to low-dose (0.1 percent) Glucoprime arm or high-dose (1 percent) Glucoprime arm, with the drug applied in gel-form to the wound surface three times weekly. Treatment was conducted over 12 weeks, and the ulcers were monitored for size every two weeks. The drug was assessed for its effect on both the rate of wound closure and the degree of healing. The trial revealed that ulcers treated with Glucoprime healed at a significantly faster rate (2 millimeters per day) than those treated with a placebo.

Venous stasis ulcers accompany conditions such as varicose veins, where blood flow from the legs back to the heart is impeded. Pooling of blood in the lower limbs leads to skin breakdown and eventual ulceration that generally requires intensive therapy to reverse. To date, few treatments have been developed and approved. Glucoprime, an investigational product, is a patented form of (1->3) (1->6)-beta-D-glucan, a carbohydrate extracted from yeast cell walls.