Adherex Technologies Inc, a biopharmaceutical company with a broad portfolio of oncology products under development, said it has completed patient enrolment in the phase I portion of the clinical trial of systemic ADH-1 in combination with isolated limb infusion melphalan and is proceeding with a multi-institutional phase IIb expansion of the study.
"We have completed the phase I portion of this study at Duke with a satisfactory safety profile at all three ADH-1 doses tested and initial tumour response data that have exceeded our expectations based upon the centre's historical experience with mephalan alone," said William P. Peters, MD, PhD, chairman and CEO, Adherex. "However, while positive, we consider the data to be early and limited both in terms of the number of patients and the length of follow-up. We have therefore decided to expand the trial to provide additional patients and more information for planning potential pivotal trials."
The company plans to expand the clinical trial of systemic ADH-1 in combination with isolated limb infusion melphalan for the treatment of melanoma by up to 25 additional patients. Further, the M.D. Anderson Cancer Center in Houston, Texas has been added as an additional clinical trial site to gain multi-institutional experience. This phase IIb expansion of the trial is anticipated to complete patient accrual by approximately mid-2008 and data will be released at an appropriate scientific venue.