NTII Neurobiological Technologies (MM)

Attains Milestone of 50 U.S. Sites EMERYVILLE, Calif., Aug. 24 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NASDAQ:NTII), (NTI(R)), a biotechnology company engaged in the business of acquiring and developing central nervous system (CNS) related drug candidates, today announced that it has completed its targeted U.S. site selection for its first global Phase III trial for Viprinex(TM) (Ancrod Injection) in acute ischemic stroke. The Ancrod Stroke Program (ASP) includes two double-blind, randomized, placebo-controlled clinical trials, ASP-I and ASP-II. Patients who qualify for enrollment into the clinical trials will receive a 3-hour intravenous infusion of Viprinex or placebo within 6 hours of stroke onset. Each trial is planned to enroll 650 patients. The company expects that the trials will be conducted at up to 130 sites worldwide and that 70% of the ASP-I sites and 50% of the ASP-II sites will be located within the U.S. Paul Freiman, President and CEO of Neurobiological Technologies, said, "Completing the first stage of U.S. site selection is an important milestone for the ASP trials. With 50 U.S. sites selected, this will continue to broaden our testing of Viprinex in patients who have suffered an acute ischemic stroke. In addition to reaching our goal in the U.S., we are also well on our way towards completing our goal of 15 non-U.S. sites for the ASP-I trial. Thus far we have gained approval and acquired sites in several countries, including the Netherlands, the Czech Republic, Russia, Australia, New Zealand and South Africa, making this trial truly global in nature. With the completion of U.S. site selection and our progress selecting sites outside of the U.S., we expect the pace of patient enrollment to pick up and to move close to our targeted patient enrollment levels." Mr. Freiman concluded, "One of the primary goals for the treatment of acute ischemic stroke is improving the blood flow through a blocked vessel so that the flow of oxygen and nutrient supply to brain tissue is not interrupted or compromised. We hope to demonstrate that Viprinex has the potential to double the available treatment window following the onset of stroke symptoms, from three to six hours, thus expanding the potential number of patients who can be treated." About Viprinex(TM) Derived from the venom of the Malayan pit viper, Viprinex is a thrombin-like enzyme that is highly specific to fibrinogen. When administered systemically, Viprinex, a defibrinogenating agent, has been shown to rapidly deplete plasma fibrinogen. The effects of defibrinogenation are anticoagulation, improved blood viscosity and an indirect fibrinolytic or clot lysing action. Combined, these effects provide a perfusion strategy that has the potential to be uniquely effective at lysing blood clots and then maintaining reperfusion to the affected areas of the brain. To access details of the clinical trials, including clinical sites, please go to http://www.clinicaltrials.gov/ and search for "Viprinex." About Neurobiological Technologies NTI is a drug development company focused on the clinical evaluation and regulatory approval of neuroscience drugs. The company's strategy is to in-license and develop early- and later-stage drug candidates that target major medical needs and which can be rapidly commercialized. NTI's experienced management team oversees the human clinical trials necessary to establish preliminary evidence of efficacy. We anticipate that we will continue to acquire and develop late-stage neurologic drug candidates and will develop the resources to market these drugs in selected world regions. Our goal is to develop and market drug candidates in the United States, Europe and Asia, and we may seek partnerships with pharmaceutical and biotechnology companies to assist us. NOTE: Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, and other risks detailed from time to time in our Securities and Exchange Commission filings. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. We disclaim, however, any intent or obligation to update these forward-looking statements. DATASOURCE: Neurobiological Technologies, Inc. CONTACT: Paul E. Freiman, President & CEO of Neurobiological Technologies, Inc., +1-510-595-6000; or Cheryl Schneider, VP - Investor Relations, Porter, LeVay & Rose, Inc., +1-212-564-4700, for Neurobiological Technologies, Inc. Web site: http://www.ntii.com/

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