Study results published in the New England Journal of Medicine indicate that giving AstraZeneca’s stroke agent, NXY-059 (previously known as Cerovive), to patients within six hours of a stroke significantly reduces some of the consequent damaging effects.
Data from the SAINT trial revealed a statistically-significant reduction in stroke-related disability in a wide range of patients taking the drug versus those on a placebo.
Commenting on the findings, Professor Kennedy Lees, the trial’s Principal Investigator and Professor of Cerebrovascular Medicine at the University of Glasgow, remarked: “This is an exciting result. A treatment confirmed to reduce disability in such a wide range of stroke patients could have a profound effect on the number of families that are devastated by stroke. For a condition that carries a worse prognosis than most forms of cancer, the development of a completely new approach to treatment would be a fantastic achievement.”
Excitement over the agent’s potential is growing as results suggest it will provide some important advantages over tissue plasminogen activator (tPA), the only drug currently marketed for the treatment of emergency ischemic stroke. According to industry experts, as tPA is only effective when administered within three hours after the stroke occurs, only about a third of patients find themselves eligible for the treatment, while NXY-059 can be taken up to six hours after, marking a more realistic time frame in which to administer therapy. In addition, reports suggest that NXY-059 has a favourable safety profile.
The rewards for an effective stroke treatment are likely to be significant, and AstraZeneca is banking on the agent’s success – particularly after setbacks to its once greatest hope, the clotbuster drug Exanta (ximelagatran). Originally known as Cerovive, the drug was licensed from US biotechnology firm Renovis, and is believed to work by trapping free radicals.
AstraZeneca plans to file regulatory submissions for NXY-059 in Europe and the US in the first half of 2007, depending on the outcomes of further clinical studies such as SAINT II, with a potential launch in 2008. If the drug does make it to market, analysts expect it to rake in sales of over $1 billion.
