AnorMED begins enrollment of patients in trial of anti-HIV drug AMD070

By E. Janene Geiss

Philadelphia, Nov. 29 - AnorMED Inc. announced the enrollment of HIV patients into its new clinical trial to evaluate the potential of AMD070 as a new anti-HIV drug.

The X4 Antagonist Concept Trial (XACT) trial is fully funded by AnorMED and is being conducted at two leading HIV research centers, one in the United States and one in the United Kingdom, according to a Tuesday news release.

XACT is an open-label, dose-finding study that may include up to four study cohorts of 12 patients each.

Patients in the first cohort will receive 200 mg of AMD070 twice daily for 10 consecutive days. The objective of the study is to determine the safety and antiviral activity of AMD070 in HIV-infected patients who harbor the CXCR4-using virus.

Anti-viral activity is measured by a 1 log reduction in the CXCR4-using virus. Initial data from this study is expected in early 2006, officials said.

"Novel anti-HIV targets are urgently needed. This is especially true for those HIV patients harboring types of virus that are resistant to currently available therapies," Stephen Becker, AnorMED director of clinical development, said in the release.

"AMD070 is the first anti-HIV drug candidate that targets the HIV entry co-receptor CXCR4. The use of CXCR4 by HIV is known to occur in up to 40% of patients, especially those with more advanced disease and those failing other treatment options," Becker added.

In order to enter and infect cells, HIV must bind to either the CXCR4 or CCR5 receptor. Combining CXCR4 and CCR5 HIV-entry inhibitors may become a new paradigm in the treatment of HIV, officials said.

AMD070 was developed at AnorMED. It targets the CXCR4 receptor and can be administered in a pill.

In addition to the XACT study, AMD070 also is being evaluated in a separate phase 1b/2a study being conducted by investigators at the U.S. Adult AIDS Clinical Trials Group.

AnorMED is a Vancouver, B.C., chemistry-based biopharmaceutical company focused on the discovery, development and commercialization of new therapeutic products in the areas of hematology, HIV and oncology.

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