NTI plans to consolidate Phase III ischemic stroke trial data

This new plan will accelerate the timing of the trial’s efficacy and safety data to mid-2009, the company said. The previously announced interim analysis based on the first 500 treated patients is estimated to be completed by January 2009.

When a total of 650 treated patients has been accrued in the two trials, which is expected to occur in the first quarter of 2009, enrollment will be closed and the data will be merged into one blinded dataset. Since the two concurrent Phase III studies employ the same protocol and patient entry criteria, the validity of the single merged study remains the same as initially designed for the two individual studies.

The interim analysis will be conducted by an independent data safety monitoring board (DSMB) that will examine futility as well as safety. This constitutes a ‘go, no-go’ decision point for the Viprinex clinical program. Passing the futility analysis would indicate that the drug has met predetermined interim efficacy criteria, the company said.

Because full enrollment of the consolidated trial is expected to be completed in the first quarter of 2009, Neurobiological Technologies (NTI) will not perform a superiority analysis during the interim review, in order to avoid taking a significant statistical penalty at the conclusion of the trial.

Paul Freiman, president and CEO of NTI, said: This is game-changing for us, our shareholders and patients. This new plan allows us to obtain data much sooner to guide future clinical and business decisions. If results are positive, we will be able to move the program forward with much more information and a higher level of confidence. If the study fails, we will be able to curtail spending on the program at a much earlier point in time, saving precious financial resources.