Amphotec In Bone Marrow Transplants

Data from five open-label trials involving 220 bone marrow transplant patients shows that Sequus Pharmaceuticals' Amphotec (amphotericin B colloidal dispersion) is safe and effective in the treatment of severe fungal infections in this patient population.

This retrospective review, presented at the 9th Symposium on Infections in the Immunocompromised Host held in Italy last month, showed an overall response rate to Amphotec of 53% in 99 patients with well-documented fungal infections who received a minimum of seven days' treatment. The response rate for Candida infections was 67%.

Amphotec did not cause nephrotoxicity in this high-risk patient group, 79% of whom received allogeneic transplants. There was no evidence of increased nephrotoxicity in patients receiving concurrent ciclosporin and/or aminoglycosides. Fever (12%) and chills (11%) were the most commonly-reported related side effects. In the studies, the average daily dose was 4.1mg/kg and the average duration of treatment was 23 days. The drug is already approved in 10 countries, and a New Drug Application is currently being reviewed in the USA.