Novogen Limited is commencing a Phase II human clinical trial of its novel skin ulcer repair compound, Glucoprime.
The trial is being conducted in three Australian centers -- Royal North Shore Hospital (RNSH), Blacktown Hospital and South Sydney Vascular Centre -- the major clinics in Sydney for the treatment of vascular ulcers. Sixty patients will be enrolled in the study.
Glucoprime is a carbohydrate-based drug designed to stimulate wound healing in skin ulcers in which the normal healing process is delayed. This includes ulcers due to diabetes, bed-sores, arterial disease, and poor circulation. The drug is based on the Novogen glucan technology.
Collectively, these ulcers are estimated to affect five percent of patients over the age of 50 worldwide and can affect as many as 15 percent of chronically hospitalized patients. Venous insufficiency ulcers are one of the most common forms of skin ulcers in the world, and the problem is a major health issue.
The Novogen glucan technology is licensed to Novogen's U.S. subsidiary company, Glycotex Inc, which is undertaking the clinical development of the product.
Novogen Group Research Director Professor Alan Husband said, Glycotex had been developing its glucan technology intellectual property over the past two years.
Novogen holds patents covering the use of Glucoprime for the treatment of vascular ulcers in the U.S., the United Kingdom and Australia. Patent applications have been lodged for other major territories.