NXY 059: CPI 22, NXY 059G.

Abstract

NXY 059 [CPI 22, NXY 059G], a nitrone with free radical trapping properties, has potential in the treatment of ischaemic stroke.This profile has been selected from R&D Insight, a pharmaceutical intelligence database produced by Adis International Ltd. NXY 059 is based on Centaur Pharmaceuticals' proprietary Nitrone-Related Therapeutics (NRT) technology. A generic form of NXY 059, NXY 059G, has been synthesised. On 12 December 2002, Centaur Pharmaceuticals was acquired by, and integrated into, Renovis. AstraZeneca has exclusive worldwide rights to NXY 059, under a licence from Centaur Pharmaceuticals; the licensing agreement is continuing with Renovis. Renovis will receive a significant milestone payment and retains a co-promotion option for NXY 059 in the US. In addition, Renovis is entitled to royalties on profits from worldwide sales of the drug once commercialised. Centaur received a cash payment of $US1.25 million, and up to 30% of Renovis stock in exchange for these assets. In May 2003, AstraZeneca announced the initiation of two major phase III pivotal clinical trials to determine the effect of NXY 059 on disability and neurological recovery in acute ischemic stroke patients. The trials, known as the SAINT (Stroke-Acute-Ischaemic-NXY-Treatment) trials, will compare the efficacy and safety of a 72-hour intravenous infusion of NXY 059 given within 6 hours of the onset of symptoms vs placebo. The studies will enrol >3000 patients. The SAINT I trial will involve 200 centres across 24 countries in Europe, Asia, Australia and South Africa. The SAINT II trial will involve patients from approximately 150 sites in the US, Canada and South America. AstraZeneca is evaluating NXY 059 in a phase I clinical study in the US. Phase III trials of NXY 059 have begun in the UK and Sweden for the treatment of stroke. In November 2000, Centaur Pharmaceuticals announced that the Japanese regulatory authorities approved AstraZeneca's regulatory filings for phase I clinical studies of NXY 059 in Japan. The purpose of these studies is to investigate the safety and tolerability of 8h and 24h IV infusions of NXY 059 in 56 healthy Japanese male subjects. A secondary objective will be to evaluate the pharmacokinetics of NXY 059 in these volunteers.