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ARIAD Announces Initiation of Phase 2 Trial of Ponatinib in Patients with Gastrointestinal Stromal Tumors

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 11, 2013-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the initiation of the Phase 2 trial of Iclusig® (ponatinib) in adult patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The trial is designed to provide initial clinical data evaluating the efficacy and safety of ponatinib in patients with GIST following failure of prior tyrosine kinase inhibitor (TKI) therapy.

“This trial represents an important step in ponatinib’s expanded clinical development beyond Philadelphia-positive leukemias and into solid tumors. KIT is a clinically validated oncogenic target for GIST and is known to drive approximately 85 percent of these cancers. In preclinical studies ponatinib was highly potent against activated KIT and most of its resistance mutants,” stated Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD. “Patients with GIST have limited treatment options following development of resistance to TKI therapy, and we are pleased to work with leading clinical research sites to investigate ponatinib as a new treatment for these patients.”

Trial Design

The Phase 2 trial is an open-label, multicenter trial to evaluate the efficacy and safety of ponatinib in patients with metastatic and/or unresectable GIST after prior failure of at least one TKI. Patients whose tumors have an activating mutation in exon 11 of cellular KIT, the primary driver for patients with GIST and KIT mutations, will be enrolled in Cohort A. Patients whose tumors have other activating mutations will be enrolled into Cohort B. The trial will be conducted at three investigational sites in the United States: Dana Farber Cancer Institute, Fox Chase Cancer Center and Oregon Health Science University.

A total of approximately 45 patients will be enrolled in the trial, with at least 30 patients in Cohort A. Patients will receive the same dose of ponatinib, 45 mg administered orally once daily, as used in patients with Philadelphia-positive leukemias.

The Clinical Benefit Rate (CBR), measuring disease control and defined as the composite of complete response, partial response, and stable disease lasting 16 weeks or more, is the primary endpoint for the trial and will be analyzed in Cohort A. Secondary endpoints will include progression-free survival, objective response rate, overall survival, safety and pharmacokinetic parameters.

For more information about this trial, patients and physicians should call the U.S. toll-free number 1-877-621-2302 or the international number 1-617-621-2302, or e-mail inquiries to Clinicaltrials@ariad.com.

About GIST

According to the American Cancer Society, approximately 4,000 to 5,000 people develop gastrointestinal stromal tumors (GIST) each year in the United States. Approved agents for the treatment of patients with GIST include imatinib for newly diagnosed patients, sunitinib for patients in whom imatinib has failed, and regorafenib for patients who have failed imatinib and sunitinib. Patients can develop resistance to any of these therapies by acquiring secondary KIT mutations.

About Iclusig® (ponatinib) tablets

Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

Important Safety Information for Iclusig® (ponatinib)

WARNING: ARTERIAL THROMBOSIS and HEPATOTOXICITY

Arterial Thrombosis: Cardiovascular, cerebrovascular, and peripheral vascular thrombosis, including fatal myocardial infarction and stroke have occurred in Iclusig-treated patients. In clinical trials, serious arterial thrombosis occurred in eight percent of Iclusig-treated patients. Interrupt and consider discontinuation of Iclusig in patients who develop arterial thrombotic events.

Hepatotoxicity: Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Iclusig for hepatotoxicity.

Please visit www.iclusig.com for full prescribing information, including boxed warning.

About ARIAD

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).

This press release contains “forward-looking statements” including, but not limited to, statements relating to the potential that ponatinib is an effective tyrosine kinase inhibitor against KIT in patients with gastrointestinal stromal tumors. Forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, preclinical data and early-stage clinical data that may not be replicated in later-stage clinical studies, the costs associated with our research, development, manufacturing and other activities, the conduct, timing and results of pre-clinical and clinical studies of our product candidates, the adequacy of our capital resources and the availability of additional funding, and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.

Source: ARIAD Pharmaceuticals, Inc.

ARIAD Pharmaceuticals, Inc.
For Investors
Kendra Adams, 617-503-7028
kendra.adams@ariad.com
or
For Media
Liza Heapes, 617-621-2315
Liza.heapes@ariad.com

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