ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it has achieved full enrollment in the pivotal Phase 2 ALTA trial of its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib. This registration study enrolled approximately 220 patients at approximately 75 sites in North America, Europe and Asia.

“We are proud to have completed patient enrollment in the ALTA trial in the timeframe we established at the outset,” stated Timothy P. Clackson, president of research and development and chief scientific officer of ARIAD. “We expect data from this trial to form the basis for an NDA filing of brigatinib in patients with refractory non-small cell lung cancer in the third quarter of next year.”

The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of brigatinib (previously known as AP26113) in refractory non-small cell lung cancer (NSCLC) patients who test positive for the ALK oncogene (ALK+) and who have been treated with and progressed on their most recent crizotinib therapy. The primary endpoint of the trial is objective response rate (ORR) as measured by RECIST criteria. Brigatinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration in 2014.

Median time on treatment for patients in the ALTA trial is less than 4 months, and follow-up data are limited at this time. As a result, ARIAD now expects that first data from the trial will be submitted for presentation at the American Society of Clinical Oncology (ASCO) annual meeting in 2016. Presenting data at ASCO will also align more closely with the anticipated filing for marketing approval of brigatinib in the U.S. in the third quarter of 2016.

A randomized front-line clinical trial of brigatinib is expected begin in early 2016. This Phase 3 trial will compare brigatinib to crizotinib in approximately 300 patients with ALK+ NSCLC, who have not received prior ALK inhibitors.

About Brigatinib

Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with ALK+ NSCLC that is resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 on the basis of an ongoing Phase 1/2 trial. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for its initial regulatory review.

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).

Forward-Looking Statements

This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any statements contained herein which do not describe historical facts, including, but not limited to, statements regarding: the therapeutic potential of brigatinib; the expected timing for commencing and completing clinical trials, clinical trial data presentations, and regulatory filings; and our expectation that our Phase 2 ALTA trial will form the basis for brigatinib’s initial regulatory filing, are forward-looking statements that 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 factors, risks and uncertainties include, but are not limited to, our ability to meet anticipated clinical trial commencement and completion dates and regulatory filing dates for brigatinib; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products and product candidates; our ability to successfully commercialize and generate profits from sales of Iclusig or our other product candidates, including brigatinib, if approved; competition from alternative therapies; our reliance on the performance of third-party manufacturers for our products and product candidates and on specialty pharmacies for the distribution of Iclusig; the occurrence of adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing and other activities; the conduct and results of preclinical and clinical studies of our products and product candidates, including that preclinical data and early-stage clinical data may not be replicated in later-stage clinical studies; the adequacy of our capital resources and the availability of additional funding; patent protection and third-party intellectual property claims; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

ARIAD PharmaceuticalsFor InvestorsKendra Adams, 617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes, 617-621-2315Liza.heapes@ariad.com

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