Allon Therapeutics Inc, the neuro protection company, had commenced dosing of a phase I clinical trial to evaluate the pharmacokinetics of AL-108 (intranasal administration) or AL-208 (intravenous administration) in the blood and cerebrospinal fluid (CSF) of healthy adult subjects.
The trial would complement the safety, tolerability and efficacy data from three phase II human clinical trials from which Allon will release results during 2008. Results from the phase I trial will be used to optimise design of the next stage of clinical trials for AL-108 and AL-208. The phase I trial will also supplement extensive animal data on the pharmacokinetics of AL-108 and AL-208.
"Positive results from the three phase II trials would establish AL-108 and AL-208 as the first drugs under development to demonstrate in patients an impact on the mechanisms that lead to physical damage in the brain," said Gordon McCauley, president and CEO, Allon.
"This phase I trial will study how the human body handles our drugs after either intranasal or intravenous administration. In particular, we will obtain a better understanding of the rate at which our drug moves through the bloodstream and into the brain. " added McCauley. A total of 18 subjects will participate in the open label, trial examining various doses after a single administration.
AL-108 is being evaluated in a phase II trial in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease (AD), and in a phase II trial in cognitive impairment associated with schizophrenia (CIAS).
AL-208 is being evaluated in a phase II trial as a prevention for the mild cognitive impairment (MCI) resulting from ischemic damage during coronary bypass graft surgery (CABG). Trial results will also indicate AL-208's potential as a treatment for the ischemic damage resulting from stoke.
Allon Therapeutics Inc. is a clinical-stage biotechnology company developing treatments for major neurodegenerative conditions. Allon has three phase II human efficacy trials under way pursuing three large underserved markets: Alzheimer's disease, stroke and cognitive impairment associated with schizophrenia.