First Marketing Approval For Virulizin

Canadian biotechnology firm Imutec has been granted its firstregulatory approval, in Mexico, for its malignant melanoma treatment Virulizin. The approval is based on a Phase II study of the drug conducted in Mexico. Imutec said a launch in Mexico would depend on finding a partner to market the drug there, and that this should occur before the end of the year.

The product is described as a macrophage activator, and comes in a liquid formulation for intramuscular injection. It is purified from bovine bile in a Good Manufacturing Practice production facility located in Toronto. Imutec chief executive Philippe Lacaille noted that the company is also looking into filing for registration of Virulizin in other parts of the world for malignant melanoma, while its clinical programs for the drug progress in the USA and Canada.

The Phase II study was completed in 1993 and was conducted at the National Cancer Institute in Mexico. The results showed that the one-year survival rate for Virulizin-treated patients was 61%, compared to 13% for historical controls. Improvements in quality of life were also noted. Another Phase II study in patients with pancreatic cancer has been completed, with one-year survival rates of 38% for Virulizin (14% for historical controls).