ARIAD Announces Full Enrollment in Phase 2 ALTA Trial of Brigatinib
September 15 2015 - 7:35AM
Business Wire
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150915005159/en/
ARIAD PharmaceuticalsFor InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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