AstraZeneca: Phase 2b trial shows NXY-059 well-tolerated in intracerebral hemorrhage patients

By E. Janene Geiss

Philadelphia, March 14 - AstraZeneca AB announced Tuesday results from the phase 2b safety and tolerability trial for NXY-059 in acute intracerebral hemorrhage patients that showed the drug to be well-tolerated.

Although AstraZeneca is developing NXY-059 for the treatment of acute ischemic stroke, it was felt important to assess the safety and tolerability of NXY-059 in intracerebral hemorrhage as treatment may be started prior to a neuroimaging confirmation of the diagnosis of acute ischemic stroke, according to a company news release.

The data showed that the safety and tolerability of NXY-059 in intracerebral hemorrhage patients was similar to a placebo, with comparable mortality rates (20% in each group) and there was no difference seen between the NXY-059 and placebo groups on the secondary endpoint of stroke outcomes in the study, officials said.

"Our evolving understanding of the safety and tolerability profile of NXY-059 in acute stroke conditions is enhanced greatly by the ... trial results. The results show that NXY-059 was well-tolerated in the studied patients with intracerebral hemorrhage and that the overall safety profile was similar to the profile seen in acute ischemic stroke patients," Tomas Odergren, global product director for NXY-059, said in the release.

The study, called Chant, was a double-blind, randomized, placebo-controlled, parallel-group, multi-center, phase 2b study to evaluate the safety and tolerability of NXY- 059 in patients with acute intracerebral hemorrhage. Stroke outcomes were explored as a secondary objective. Patients were randomized to receive NXY-059 or a placebo within six hours of intracerebral hemorrhage onset. A total of 603 patients from 20 countries were treated.

Safety and tolerability in the trial were assessed in terms of mortality, adverse events, neuroimaging scans, presence of abnormal findings on vital signs, laboratory assessments and by electrocardiography.

NXY-059, which has a proposed mechanism of action of free radical trapping, is being studied as a neuroprotectant in phase 3 clinical trials for the treatment of acute ischemic stroke by AstraZeneca and licensed from Renovis, Inc., officials said.

Renovis is a biopharmaceutical company primarily focused on the discovery and development of drugs for neurological diseases and disorders. NXY-059 is its most advanced candidate, exclusively licensed to AstraZeneca.

In addition to proprietary research programs in the areas of neuroprotection, pain and inflammation, Renovis has a worldwide collaboration and license agreement with Pfizer to research, develop and commercialize small molecule VR1 antagonists, and a research and development collaboration with Genentech to discover and develop anti-angiogenesis drugs and drugs that promote nerve re-growth following nervous system injury.

The phase 3 efficacy trials for NXY-059 in acute ischemic stroke are being conducted worldwide in about 400 centers across 40 countries to evaluate the effect of the compound in acute ischemic stroke patients. These countries and regions include Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America.

Dependent on the outcome of the trial, AstraZeneca said it plans to file regulatory submissions for NXY-059 for acute ischemic stroke in Europe and the United States in the first half of 2007.

AstraZeneca is a London-based health care business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of health care services.

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