Aronex Pharmaceuticals Ph II/III Data With Nyotran

2 December 1996

- Aronex Pharmaceuticals has reported interim results of its Phase II/III clinical trials with Nyotran, a liposomal formulation of the antifungal nystatin. Tested at a daily dose of 2mg/kg over a period of 13 days, a 74% response rate was noted in 33 patients with the potentially-fatal systemic fungal infection candidemia. Patients remained infection-free for up to six weeks after treatment. Nyotran was also well-tolerated and no reports of drug-related fever or chills were recorded. Only 6% saw a doubling of serum creatinine levels, which indicates kidney impairment. These side effects are often associated with other therapies for the same indication, says the company. Double-blind, comparative Phase III trials are underway in the USA and Europe, with the completion of the US trial expected in late 1997, after which time it hopes to file a New Drug Application with the US authorities.

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