BioWorld International Correspondent

Dutch firm Gho Pharma BV is planning a pivotal Phase II trial of bis(maltolato)oxovanadium (BMOV) in children with severe burn wounds, following the successful conclusion of a Phase I dose-escalation study in healthy volunteers earlier this month.

The Maastricht-based company - a spinout from the University of Maastricht - will seek orphan drug designation for the product, an organic vanadium salt, on the basis that fewer than 200,000 individuals suffer severe burns annually.

At present, Gho Pharma said, there are no drugs available for the problem. "It's a totally barren area, and nobody thought about doing drug research before," said Keppel Hesselink, a consultant who is acting as program director for R&D.

Gho Pharma was established as a virtual company by Coen Gho, a physician specializing in dermatology and hair problems and the principal behind a hair treatment center in Maastricht called the Gho Clinic. Gho's work on the application of BMOV in treating hair loss led to a study of the compound in pig models of burn, which, Hesselink said, demonstrated a dramatic effect on wound healing and re-epithelialization.

Gho Pharma is developing BMOV as an intravenous formulation, which would be administered to patients during the first three days following a burn accident in order to minimize the development of secondary complications associated with progressive necrosis of the tissue beneath the primary burn site.

"This compound protects the penumbra zone [the area surrounding the burn site] from apoptosis," Hesselink said. It inhibits blood vessel loss and preserves hair follicles and sweat glands. "We think it might work as an insulin-like growth factor and an epidermal growth factor," he said.

An oral version of the compound already is in use as a dietary supplement for individuals on weight loss programs. "Many thousands of people swallow BMOV without major problems," Hesselink said. However, Gho Pharma is concentrating on intravenous delivery of the compound because of its poor oral availability.

The company aims to recruit between 250 and 300 subjects for its Phase II study, which it plans to undertake early next year in burn units in the Netherlands, Belgium, France and, possibly, Germany. The company is looking for €5 million in equity financing to fund the trial. "We feel that with these data in our hands that will not be a major issue," Hesselink said.