Neurobiological Technologies, Inc. (NASDAQ: NTII), a biotechnology company, has their focus on acquiring and developing central nervous system (CNS) related drug candidates. The company strategically in-licenses late-stage CNS agents and then pursues regulatory approval and commercialization. Neurobiological’s goal as a company is to develop and market drug candidates in the United States, Europe and Asia while possibly seeking partnerships with pharmaceutical and biotechnology companies. For further information, visit the Company’s web site at www.ntii.com.
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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.
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Neurobiological Technologies, Inc. (NASDAQ: NTII) is a biopharmaceutical company focused on developing innovative and leading agents for central nervous system conditions and other serious medical conditions. The company seeks out drug candidates related to the central nervous system, and develops therapies for neurological conditions that occur in connection with dementia, Alzheimer’s disease, ischemic stroke, neuropathic pain, and brain cancer. They employ a strategy of in-licensing late-stage CNS agents and strive to gain regulatory approval and commercialization, either independently or with a strategic partner.
Neurobiological Technologies most advanced product candidate is Viprinex™ (ancrod), a drug for treating acute ischemic stroke. The product is in Phase 3 of clinical testing as a novel investigational drug with multiple mechanisms of action that are specifically designed to double the time period that patients can be treated after the onset of a stroke. Acute ischemic stroke is one of the most common, debilitating and costly diseases in the world, for which there are few acceptable treatment options. NTI’s pipeline also includes a phase 3 investigational drug for brain swelling and other drug candidates in early-stage development for Alzheimer’s and Huntington’s diseases.
The company’s other two products include XERECEPT and MEMANTINE (Namenda®). XERECEPT is an original agent being investigated for the treatment of brain swelling associated with brain tumors, and possesses the potential to enhance functional independence and a subsequent reduction in the required level of care. Currently, the drug is being tested in two pivotal Phase III clinical studies, which are taking place in the United States and Canada. MEMANTINE (Namenda®) will be used to combat moderate to severe dementia and Alzheimer’s disease. NTI has an exclusive marketing arrangement that gives them the right to receive royalty payments from Merz and their marketing partners.
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