Neurobiological Technologies, Inc. (NASDAQ: NTII) announced that a recent meeting with the U.S. Food and Drug Administration to discuss a Phase 3 Clinical trial for its Viprinex was encouraging.
As a result, the company will consolidate data and patients from its two other trials into a single Phase 3 pivotal trial to be completed by mid-2009. Viprinex is designed to assist with the treatment of acute ischemic stroke. Interim trial results are now expected in January 2009.
“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,” a company news release states.
“This is game-changing for us, our shareholders and patients,” said Paul E. Freiman, president and CEO. “… 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.”
The ongoing Phase 3 clinical studies are designed to assess the efficacy and safety of Viprinex for the treatment of acute ischemic stroke when initiated within six hours of stroke onset. The studies are randomized, double-blind, placebo-controlled trials.
“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,” said Warren W. Wasiewski, M.D., Neurobiological vice president and chief medical officer.
About QualityStocks:
QualityStocks’ Small Cap Stock Newsletter is a free service that collects data from hundreds of Small-Cap online Investment Newsletters into one free Daily Newsletter Report.
Sign up for “The QualityStocks Daily Newsletter” please visit http://www.qualitystocks.net/
The Quality Stocks Daily Stock Report http://video.qualitystocks.net/
The Quality Stocks Daily Blog http://blog.qualitystocks.net/
The Quality Stocks “Ones to Watch” http://gotstocks.qualitystocks.net/
Please see disclaimer on QualityStocks website: http://disclaimer.qualitystocks.net/
No comments:
Post a Comment