NTII Neurobiological Technologies (MM)

EMERYVILLE, Calif., Nov. 9 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (NASDAQ:NTII), today commented on the recent developments reported for a number of clinical trials for the treatment of ischemic stroke sponsored by other companies and how these relate to NTI's stroke product candidate, Viprinex(TM) (ancrod). Paul Freiman, president and CEO stated, "The stroke community was rocked last week by the AstraZeneca/Renovis announced failure of its phase III clinical trial in stroke. We have learned that a Japanese company also suspended their clinical trial program for stroke. Paion/Forest had a temporary suspension of their clinical trial program for Desmoteplase and fortunately, were allowed to restart their trials. Several of our shareholders have noted these recent failures, as well as the poor track record for stroke trials generally. After all, there have been over sixty failures with stroke related products in the past decade." Mr. Freiman added, "However, we are aware of three historical successes in phase III clinical trials for ischemic stroke. The first is tPA, which is the only approved product for this indication. Second is prourokinase, which has not been fully developed for stroke. The third compound was a successful ancrod trial in the United States. The commonality of these three successes is that they are all reperfusion agents, allowing blood to flow back to the brain. The failures fall into different therapeutic categories, including that of neuroprotection. tPA and prourokinase, along with the experimental agent, Desmoteplase, are all fibrinolytic in nature, allowing for the reopening of blocked blood vessels. Viprinex shares this fibrinolytic activity as one of three biological processes that takes place when administering our drug candidate." Mr. Freiman continued, "Viprinex acts directly on fibrinogen, which prevents clot formation from taking place. At the same time, it indirectly affects the plasminogen-plasmin pathway by stimulating higher plasmin levels that essentially cause the breaking up of the clot (fibrinolysis). Thirdly, blood viscosity is decreased, which may play an important role in maintaining some degree of collateral blood flow to the brain. These direct and indirect mechanisms lead to a triple biological effect, not believed to be present with the other named agents. Of course, our hope is to provide a drug for acute ischemic stroke that will limit the amount of intracranial hemorrhage seen with fibrinolytic agents while still maintaining a high degree of efficacy in a six-hour time window. This is being tested in two large phase III clinical trials being run by NTI. These trials are based on three legacy trials run by the original developer, Knoll Pharmaceuticals. Two of these trials conducted in the U.S. were successful, while one phase III trial failed in Europe with an increased incidence of intracranial hemorrhaging. Since there were over 1,900 patients in those three trials, we had a virtual treasure trove of information to work with in developing a new dosing program to attempt to address the problems seen in the failed European trial. Rather than infusing the drug for five days, as Knoll did, we are providing a one-day infusion, at a dose that we feel will provide the optimal effect/side effect ratio. Further, while we realize that we are likely to confront tougher regulatory standards for approval, we are hopeful that we have designed trials that can meet those standards." Mr. Freiman concluded, "In summary, we believe that Viprinex is different than other stroke drugs in clinical development and despite a difficult week for stroke, we remain on track to complete our clinical trial program and remain optimistic about the prospects for Viprinex." About Neurobiological Technologies, Inc. NTI is a biotechnology company engaged in the business of acquiring and developing central nervous system related drug candidates. The Company is focused on therapies for neurological conditions that occur in connection with ischemic stroke, brain cancer, Alzheimer's disease and dementia. The Company's strategy is to in-license and develop later-stage drug candidates that target major medical needs and that can be rapidly commercialized. NTI's experienced management team oversees the human clinical trials necessary to establish preliminary evidence of efficacy. For further information, please visit NTI's website at http://www.ntii.com/ . 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 need for additional capital, risks related to clinical trials and the regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, the risks associated with the cost of clinical development efforts, and other risks detailed from time to time in our Annual Report of Form 10-K and other filings with the Securities and Exchange Commission. 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, CEO of Neurobiological Technologies, Inc., +1-510-595-6000; or investors, Marlon Nurse, VP, Investor Relations, of Porter, LeVay & Rose, +1-212-564-4700, for Neurobiological Technologies, Inc. Web site: http://www.ntii.com/

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