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ARIAD and the U.K. National Cancer Research Institute to Collaborate on SPIRIT 3 Clinical Study
& LONDON--(BUSINESS WIRE)--Jan. 7, 2013-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Newcastle University, U.K., on behalf of the U.K. National Cancer Research Institute (NCRI) CML Working Group, today announced an agreement to collaborate on a multicenter, randomized Phase 3 trial, named SPIRIT 3, to assess the impact of switching patients with chronic myeloid leukemia (CML) being treated with a first-line tyrosine kinase inhibitor, upon suboptimal response or treatment failure, to ponatinib. The NCRI expects to begin enrollment in the trial of 1,000 patients at approximately 172 clinical research sites in the U.K. in the second quarter of 2013.
“The SPIRIT 3 study was designed in partnership with ARIAD to provide the scientific community and patients living with chronic-phase CML a deeper understanding of the most effective ways to use TKIs and whether we can improve treatment outcomes by switching patients to ponatinib, who have failed to achieve optimal response from imatinib or nilotinib,” stated Stephen G. O’Brien, Professor of Haematology at the Northern Institute for Cancer Research at Newcastle University, NCRI member and chief investigator of the SPIRIT 3 study. “We look forward to assessing ponatinib as a treatment in this setting and evaluating its potential clinical, economic and quality-of-life benefits.”
A key feature of the trial is that patients achieving stable MMR will be offered the opportunity to reduce the dose of their TKI therapy or stop treatment altogether. These patients will be monitored more closely with monthly PCR testing and will be reverted back to full-dose TKI therapy for loss of MMR at any time or rising BCR-ABL transcript ratio on two consecutive tests.
“We are deeply committed to helping physicians and CML patients improve outcomes with TKI therapy,” stated Frank G. Haluska, M.D., Ph.D., chief medical officer at ARIAD. “The SPIRIT 3 trial will evaluate the potential for ponatinib to improve outcomes in patients who have sub-optimal responses early in the course of first-line therapy for CML, by enabling those patients with a poorer prognosis to switch TKI therapy. This should have important implications for the future management of CML.”