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Ariad Pharmaceuticals, Inc.

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Paris Panayiotopoulos, President and CEO, responded to a question regarding the timing for data from the OPTIC and OPTIC-2L trials. He stated, "I will give you some color on that. So as you know, both the OPTIC and the OPTIC-2L trials are underway. We have guided generally to first data from OPTIC probably in 2017, given the need to have a reasonable follow-up on those patients and as we get further into the trial, we will probably refine that. OPTIC-2L, we projected two years for enrollment, so that takes us to approximately the end of 2017, and then interim data potentially in 2018."
Source: Q4 2015 earnings conference call, 2/23/16.

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ARIAD Announces Initiation of OPTIC-2L Randomized Phase 3 Trial of ponatinib vs. nilotinib in Second-Line Patients with Chronic-Phase Chronic Myeloid Leukemia

CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)--Dec. 7, 2015-- ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced the initiation of a randomized Phase 3 trial of Iclusig® (ponatinib) in second-line patients with chronic myeloid leukemia (CML) in the chronic phase (CP). The OPTIC-2L (Optimizing Ponatinib Treatment In CML, Second Line) trial is designed to investigate the efficacy and safety of ponatinib, administered at two starting doses, compared with nilotinib, in patients who are resistant to front-line treatment with imatinib. The primary endpoint of the OPTIC-2L study, now open for patient enrollment, is major molecular response (MMR) by 12 months. Approximately 600 patients are expected to be enrolled at clinical sites in Europe, Asia, Latin America and Canada.

“Physicians treating CML patients will be extremely interested in the outcome of this clinical trial in which ponatinib -- at two different doses -- will be compared to nilotinib in patients resistant to imatinib,” stated Dr. D. Selleslag, Department of Hematology, St-Jan Bruges-Ostend Hospital in Belgium. “By comparing ponatinib to nilotinib in the second-line setting, we will garner valuable, randomized clinical data to better understand the potential utilization of ponatinib in this broad patient population.”

Major Design Features of the Trial

This study is designed to demonstrate superiority of ponatinib over nilotinib and will enroll patients with CP-CML who have become resistant to imatinib and have received no other tyrosine kinase inhibitor. These patients will be randomized to receive once-daily administration of ponatinib at a starting dose of either 30 mg (cohort A) or 15 mg (cohort B), or 400 mg of nilotinib administered twice daily (cohort C). Patients will be randomized in a ratio of 1:2:1 respectively. Upon reaching MMR, patients in cohort A will have their daily dose of ponatinib reduced to 15 mg and patients in cohort B will have their dose reduced to 10 mg.

The primary endpoint of the trial is MMR by 12 months for each cohort. Secondary endpoints include rate of vascular occlusive events in each cohort, rates of adverse events and rates of serious adverse events.

“The OPTIC-2L trial is the first direct randomized comparison of ponatinib to an approved BCR-ABL tyrosine kinase inhibitor following imatinib therapy. We expect this trial to provide important head-to-head data regarding the efficacy and safety of treating patients with ponatinib versus nilotinib in the second-line,” said Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD. “The trial will examine lower ponatinib starting and maintenance doses than presently approved, along with a direct comparison to nilotinib, from which we may be able to obtain regulatory authorizations that would provide patients with more treatment options in an earlier line of therapy.”

Patients will be enrolled at up to 90 cancer centers in Europe, Asia, Latin America and Canada. For more information about the trial, patients and physicians should call the U.S. toll-free number 855-552-7423, the EU toll-free number 800 00027423, or the international number +1 617-503-7423 or email ARIAD at ClinicalTrials@ariad.com.
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Source: press release, 12/07/15. http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=2...

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A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib
Estimated Enrollment: 600
Study Start Date: December 2015
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02627677?term=OPTIC-2L&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Iclusig (Ponatinib) CMLOncology HematologicCML/ ALL Ph+Tyrosine kinase inhibitorBcr-Abl (T315I)

Mechanism of action: Iclusig (Ponatinib hydrochloride) is an orally bioavailable multitargeted receptor tyrosine kinase (RTK) inhibitor with potential antiangiogenic and antineoplastic activities. Ponatinib hydrochloride inhibits unmutated and all mutated forms of Bcr-Abl, including T315I, the highly drug therapy-resistant missense mutation of Bcr-Abl. This agent also inhibits other tyrosine kinases including those associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptors (FGFRs); in addition, it inhibits the tyrosine kinase receptor TIE2 and FMS-related tyrosine kinase receptor-3 (Flt3). RTK inhibition by ponatinib hydrochloride may result in the inhibition of cellular proliferation and angiogenesis and may induce cell death. Bcr-Abl is a fusion tyrosine kinase encoded by the Philadelphia chromosome.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2018-01-01 - 2018-06-30

Results: Pending