The randomized, double-blind, placebo-controlled, repeat-dose study shall measure the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in 24 healthy volunteers approximately. Elliot Ehrich, Chief Medical Officer of Alkermes. These total results will support a phase 2 clinical study of ALKS 37, which will assess the safety, efficacy and tolerability of ALKS 37 in individuals with OIC. The phase 2 study is likely to begin in the first fifty % of calendar 2010. SOURCE Alkermes, Inc.. Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC Alkermes, Inc. today announced the initiation of a multidose stage 1 clinical research of ALKS 37, an active orally, peripherally-restricted opioid antagonist with potential to block the consequences of opioid agonists on gastrointestinal motility, commonly known as opioid-induced constipation .This resistance-profiling technique has effectively predicted the precise mutations that confer scientific resistance to additional tyrosine kinase inhibitors, like the BCR-ABL inhibitors found in chronic myeloid leukemia . Multiple mutations in ALK were identified that conferred resistance to PF1066, but not to AP26113. Three of these ALK mutants had been also tested in mouse tumor versions, and in each full case, AP26113 potently blocked tumor development while PF1066 was ineffective. Comparable to data on our investigational pan-BCR-ABL inhibitor, AP24534, these preclinical outcomes suggest that more potent compounds, such as AP26113, might be able to reduce the development of mutation-based drug level of resistance, mentioned Timothy Clackson, Ph.D., senior vice chief and president scientific officer of ARIAD.
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