The National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), approved the collaboration with Adherex following their formal review of existing preclinical and clinical data on ADH-1, also known as Exherin.
As part of the collaboration, the NCI’s developmental therapeutics program and cancer therapy evaluation program will negotiate a cooperative R&D agreement (CRADA) with Adherex to sponsor clinical trials and additional preclinical studies of ADH-1. These studies will further evaluate the compound’s anticancer and vascular targeting effects, both as a single agent and in combination with other agents in patients with advanced resistant cancers that express the molecular target N-cadherin.
“This agreement, when fully implemented, will provide Adherex access to the NCI’s network of scientists conducting NCI-sponsored clinical trials,” said Dr William Peters, chairman and CEO of Adherex. “We anticipate the NCI will study a variety of ADH-1 administration schedules and tumor types, particularly in combination with chemotherapeutic and other anticancer therapies, and thus will effectively broaden the development of our drug.”
To date, 57 cycles of ADH-1 have been administered to 41 patients in an ongoing phase I trial. The drug has been generally well tolerated at doses of up to 840mg/m2 and is now being studied at a dose of 1,000mg/m2.