NeoTherapeutics has decided to start what it believes will be a pivotaltrial of its candidate drug Neotrofin in patients with Alzheimer's disease, with a view to accelerating a New Drug Application filing for the drug. The 24-week study, due to start in April, will focus on Neotrofin's effects on the symptoms of the disease and should be completed by the end of the year, said the firm.
Thereafter, a second and larger trial will start in the second half of 2001 and look at whether Neotrofin can modify the course of AD. If both trials are positive, NeoTherapeutics will file an amendment to its original NDA to support approval of an expanded indication for the drug, which is thought to work by stimulating progenitor cells in the brain.
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