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Share Name | Share Symbol | Market | Type |
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Ariad Pharmaceuticals, Inc. | NASDAQ:ARIA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 23.99 | 23.80 | 22.88 | 0 | 01:00:00 |
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data on its investigational tyrosine kinase inhibitor (TKI), brigatinib (AP26113), in patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The current results include more mature efficacy data for brigatinib, including updated response rates and median duration of response in ALK+ NSCLC patients, as well as more extensive safety data for all patients in the trial.
The updated Phase 1/2 results were presented this morning at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Phase 1/2 Study
The data presented at ASCO include safety analyses on all patients in the trial (n=137) and efficacy analyses on patients with ALK+ NSCLC (n=79). The presentation is based on patient data as of February 2015 with a median time on treatment for ALK+ NSCLC patients of 12.6 months (range, 0.03 – 35.5+ months). Patient enrollment in the trial is complete, with the last patient enrolled in July 2014.
“The updated brigatinib data show an objective response rate of approximately 70 percent in crizotinib-resistant ALK-positive NSCLC patients,” stated D. Ross Camidge, MD, PhD, director of thoracic oncology at the Colorado University Cancer Center. “In addition, the median progression-free survival in this second-line patient group is now over the one-year mark.”
Key data from the study include:
Safety and Tolerability – All Patients Enrolled
Anti-tumor Activity – ALK+ NSCLC Patients
Pivotal Phase 2 ALTA Trial Enrolling Patients
A separate, pivotal global Phase 2 trial of brigatinib in patients with locally advanced or metastatic ALK+ NSCLC who have progressed on crizotinib is enrolling patients. The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of brigatinib in refractory ALK+ NSCLC patients. The trial will enroll approximately 220 patients including those with brain metastasis. Patients are randomized 1:1 to receive either 90 mg of brigatinib once per day continuously or a lead-in dose of 90 mg/day for 7 days followed by 180 mg/day continuously.
“We expect to reach full patient enrollment in the ALTA trial in the third quarter of this year,” stated Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD. “We are encouraged by the duration of responses in ALK+ NSCLC patients that have emerged from the on-going Phase 1/2 brigatinib trial, reinforcing our belief that brigatinib has the potential to address a significant unmet medical need in ALK+ NSCLC patients.”
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. Any statements contained herein which do not describe historical facts, including, but not limited to, statements regarding: updated clinical data for brigatinib, the therapeutic potential of brigatinib, and the estimated timing for completing enrollment in our ALTA clinical trial, are forward-looking statements which 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, among others: early-stage clinical data may not be replicated in later-stage clinical studies; the costs associated with our research, development, manufacturing and other activities; the adequacy of our capital resources and the availability of additional funding; our ongoing and additional clinical trials of brigatinib may not be successful or initiated, enrolled or conducted in a timely manner; regulatory developments and safety issues; competitive risks; manufacturing issues and those additional 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. All forward‐looking statements in this press release are qualified in their entirety by this cautionary statement.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150601005238/en/
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams, 617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes, 617-620-4888Liza.heapes@ariad.com
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