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news.Biotech drug developer Neurobiological Technologies has been granted FDA fast track status for its investigational drug, Viprinex, for its intended use in ischemic stroke.
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The fast-track designation will provide for expedited regulatory review for Viprinex (ancrod), which is under development for decreasing disability in patients with acute non-hemorrhagic stroke, treated within six hours of symptoms.
“In my 40 plus years of experience in this industry, it is often one product that transforms a company to the next level. I believe that Viprinex (ancrod) has this potential for NTI,” said Paul Freiman, president and CEO of Neurobiological Technologies (NTI).
“There is a large unmet need in the treatment of ischemic stroke and if we prove in the clinic that Viprinex (ancrod) indeed has a positive outcome, we can become a very different company.”
Viprinex was previously studied in approximately 2,000 patients in various clinical studies in the US and Europe. Currently, the only available therapy for ischemic stroke must be administered within the initial three hours, significantly limiting the number of patients that may be treated.
It is estimated that less than 5% of stroke patients are suitable for current therapies and less than 3% actually receive treatment. The estimated direct and indirect costs of stroke in the US in 2004 are thought to be $53.6 billion.