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NEUROBIOLOGICAL TO LAUNCH MORE TRIALS OF VIPRINEX FOR STROKE

February 13, 2007

Neurobiological Technologies has presented new analysis of data from ongoing clinical trials of Viprinex, and the company has announced it plans to initiate two new Phase III trials of the drug.

Viprinex (ancrod) is a definbrinogenating agent derived from the venom of the Malayan pit viper.

"The ancrod data support the role of fibrinogen in influencing stroke outcome and the potential role for ancrod in treating strokes by lowering fibrinogen levels," David Levy, vice president of clinical development, said. "Analysis of data from prior clinical trials also appears to suggest that the dosing level of the current Phase III trials may provide definitive safety and efficacy of ancrod in ischemic stroke."

The company is moving forward with two international, placebo-controlled, Phase III trials of Viprinex as part of the Ancrod Stroke Program (ASP). These trials, known as ASP-I and ASP-II, will evaluate whether a brief infusion of Viprinex begun up to six hours after onset of stroke symptoms can minimize neurological damage, while maximizing functional outcomes in stroke patients. The primary endpoint is death or disability at 90 days. Each of these trials will enroll 650 patients.

In the ASP studies, patients will receive a single two- to three-hour infusion of Viprinex, leading to a significantly lower overall dose than that used in previous Phase III studies, which employed dosing over five to seven days. The aim is to lower the fibrinogen rapidly, while avoiding prolonged low fibrinogen levels. The company hopes that this modified dosing schedule will improve both the potential safety and efficacy of the drug.

Viprinex has a two-fold mechanism of action to address three dynamics in acute ischemic stroke -- anti-coagulation, fibrinolysis and improved blood viscosity -- according to the company.