Neurobiological Technologies, Inc (NTI) announced that following a meeting with the US Food and Drug Administration to discuss the Viprinex (ancrod) phase-3 clinical programme for acute ischemic stroke, the company plans to consolidate and analyze data from its two concurrently running double-blind clinical trials into a single phase-3 pivotal trial.
This new plan will accelerate the timing of the trial's efficacy and safety data to mid-2009. 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 have been accrued in the two trials, which is expected to occur in the first quarter of 2009, enrolment will be closed and the data will be merged into one blinded dataset. Since the two concurrent phase-3 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.
"This is game-changing for us, our shareholders and patients," said Paul E Freiman, president and chief executive officer. "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 programme forward with much more information and a higher level of confidence. If the study fails, we will be able to curtail spending on the programme at a much earlier point in time, saving precious financial resources."
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 programme. Passing the futility analysis would indicate that the drug has met predetermined interim efficacy criteria.
Because full enrolment of the consolidated trial is expected to be completed in the first quarter of 2009, 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. Performing the interim futility analysis as planned does not carry any statistical penalty.
"We are very excited that after more than four years of hard work on our stroke program, we are rapidly approaching these two major milestones," stated Warren W Wasiewski, vice president and chief medical officer. "Along with the rest of the stroke-care community, which has few treatment options at its disposal, I look forward with great enthusiasm to both the DSMB recommendation and the results of trial's final analysis."
Neurobiological Technologies is a biopharmaceutical company focused on developing novel, first-in-class agents for central nervous system conditions and other serious unmet medical needs.