Interim results of a Canadian Phase I/II trial of NeoTherapeutics'orally-administered AIT-082 in Alzheimer's patients, indicate that the drug was well-tolerated with no adverse reactions observed.
So far, eight of the 10 patients enrolled in the trial have completed the dosing phase, and analyses of the patients' blood have shown that the drug was absorbed into the bloodstream. An evaluation of cognitive function will be made after all the patients have completed their dosing regimen and the data are properly reviewed, says the company.
NeoTherapeutics plans to initiate additional dose-ranging Phase I/II studies in Canada, and repeated dosing studies on larger numbers of patients will be needed to determine whether any side effects or clinical benefits will result from the long-term administration of the drug.
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