Tenecteplase enters phase III TIMELESS trial to treat acute ischemic stroke

Genentech recently initiated the Phase III TIMELESS trial to evaluate TNKase (tenecteplase) in people with acute ischemic stroke (AIS) when treated from four and a half up to 24 hours after the onset of symptoms and using advanced imaging technology to identify eligible patients. There are currently no FDA approved medicines for people with AIS beyond three hours after the onset of symptoms.

Genentech’s 23-year history in AIS was established with Activase (alteplase), the current standard-of-care in the United States, and the first and only clot-dissolving tissue plasminogen activator (tPA) .

Comment: In an acute ischemic stroke, the blood supply to part of the brain is cut off by a blood clot. The clot-busting drug alteplase is the only approved drug treatment for acute ischaemic stroke, but must be given within 4.5 hours of symptom onset. Unfortunately, at least 20% of patients currently wake up with their stroke symptoms - called ‘wake up stroke’. These patients are currently not eligible for clot-busting treatment, but it is likely that their stroke happened just before awakening. In the TIMELESS study researchers will be using the newer clot-busting drug tenecteplase, which is likely to improve the blood supply to the brain more quickly, so promoting a better recovery.