Neuro Biotech combines trials for Virpinex

California, USA-based firm Neurobiological Technologies says that, following a meeting with the Food and Drug Administration to discuss the Viprinex (ancrod) Phase III clinical program for acute ischemic stroke, the company plans to consolidate and analyze data from its two concurrently running double-blind clinical trials into a single pivotal study. This new plan will accelerate the timing of the trial's efficacy and safety data to mid-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 firm says.

"This is game-changing for us, our shareholders and patients," said chief executive Paul Freiman. "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," he added.