AL-108 is being tested on Alzheimer's first, but they plan to try it for MS too, so I figure these Phase I safety studies won't have to be done all over again for MS since they are done on healthy adults.
Allon Therapeutics product AL-108 successful in Phase Ia clinical trial
June 15 -- CNW -- Allon Therapeutics, The Neuro Protection Company(TM), announced today that a Phase Ia human clinical trial of the company's first product AL-108 has demonstrated that a single dose administered at up to 15 milligrams was safe and well tolerated in healthy adults. AL-108 is being developed as a treatment for Alzheimer's disease.
Gordon McCauley, President and CEO of Allon, said the next step in the clinical evaluation of AL-108 is a Phase Ib clinical trial with healthy elderly subjects scheduled to begin in Q3 2005. The trial is expected to be completed in Q4 2005 and results available early in Q1 2006.
The Phase Ia trial conducted in Q1 2005 was a double-blind, placebo- controlled, randomized, single ascending intranasal dose study to evaluate
AL-108's safety, tolerability and pharmacokinetics in healthy subjects.
The 30 subjects were randomized to one of five dose groups. A single subject in each group received placebo. The dose groups were one, three, 10, 12.5 and 15 milligrams of AL-108 or placebo administered intranasally. Approximately two-thirds of the subjects were female (63%) and the mean age was 31 years (range 19 to 44 years). The study was conducted by MDS Pharma in Phoenix, AZ.
"This Phase Ia trial has been a complete success," McCauley said. AL-108 appears to be safe, well tolerated and no serious adverse events were reported. None of the chemistry, hematology or urinalysis laboratory results was considered to be clinically significant by the principal investigator. Furthermore, there were no clinically significant changes in electrocardiograms or vital signs measured in any subject during the observation period."
http://www.newswire.ca/en/releases/arch ... c1851.html