NZ brain drug gets fast-track testing[ ... Read the full article ... ]
By Peter Nowak and Monique Devereux
The New Zealand Herald
07 June 2005
A New Zealand-developed drug that reduces the number of brain cells dying after injury has been fast-tracked through trials, meaning it could be on the market two years earlier than planned.
The drug, which is being developed in Auckland by Neuren Pharmaceuticals, could help hundreds of thousands of people who have suffered brain damage through road accidents, strokes and heart attacks.
The United States Food and Drug Administration (FDA) yesterday told Neuren it could proceed to phase III testing - the final stage before releasing the drug glypromate to the market - by 2006.
The move saves Neuren the $6.5 million cost of setting up and running phase II trials.
Reaction to the announcement pushed the company's shares up 25 per cent on the Australian Stock Exchange yesterday.
Neuren chief executive David Clarke said it was the first time an Australasian pharmaceutical company had been given FDA permission to skip phase II testing.
From the Neuren website, about glypromate:
Glypromate® (or Glycine-Proline-Glutamate) is a naturally occurring small molecule neuroprotectant, derived from IGF-1 (Insulin-like Growth Factor), that is produced in the brain but does not bind to IGF-1 receptors."
Anthony H. Risser | neuroscience | neuropsychology | brain