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news.Preliminary clinical data of AnorMed's AMD070, an HIV entry inhibitor, suggests the drug candidate is active, generally safe and well tolerated in HIV patients.
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The open label dose finding study, dubbed XACT, involves dosing of AMD070 twice daily for 10 consecutive days. There are up to 4 cohorts with a total of 12 patients per cohort.
Activity and safety data from the first 8 HIV patients enrolled in the first dose cohort, show 4/8 had significant reductions in CXCR4 viral load with an average reduction of 1.3 log. Based on this data, the company said that enrollment into the first cohort will be completed and the next dose cohort will be initiated.
“Based on these results we hope to move as quickly as possible into our next dose cohort and toward identifying the clinically optimal dose,” said Dr Stephen Becker, director of clinical development, AnorMed.
Over the next six months AnorMed said that it will continue its preclinical safety studies of lead formulations of AMD070 and complete a drug manufacture to support future clinical studies, including drug interaction studies as well as the phase IIb study planned to start by year end 2006.
HIV entry inhibitors may become a new treatment paradigm in the management of HIV. In order to enter and infect healthy cells HIV must bind to either the CXCR4 or CCR5 receptor. AnorMed’s HIV entry inhibitor program is focused on the discovery and development of drugs that target both receptors.