The trial will evaluate the anti-tumor activity and tolerability of repeated doses of ADH-1 (Exherin) on an every three-week schedule in patients whose tumors express the molecular target, N-cadherin.
This trial, the first in the company’s phase II ADH-1 program, is expected to enroll up to 60 patients and will include eight different tumor types. This will include some more common cancers such as breast and lung as well as some rare cancers like adrenocortical and esophageal. The trial size could be increased beyond 60 patients, depending on the level of anti-tumor activity noted.
ADH-1 is a molecularly targeted anticancer drug that selectively targets N-cadherin, a protein that plays a major role in holding together and stabilizing cells that make up blood vessels and certain tumor cells.
“The encouraging anti-tumor activity that we observed in our phase I ADH-1 trial has prompted us to proceed directly with single-agent phase II studies in addition to the previously planned and ongoing phase Ib/II trials,” said Dr William Peters, chairman and CEO of Adherex. “Now, our priorities are to determine the optimal dose, schedule and tumor types as quickly as possible for our subsequent studies.”
Adherex expects the trial to conclude in the second half of 2006.