Exhibit 99.1
ARIAD Presents Additional Efficacy Data on AP23573, Novel mTOR
Inhibitor, in Phase 2 Advanced Sarcoma Trial
AP23573 Clinical-Benefit Response Is a Strong Predictor of
Improved Overall Survival
CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 3, 2007--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced additional
positive efficacy data on AP23573 - its novel mTOR inhibitor - from
further analysis of its ongoing Phase 2 trial of AP23573 in patients
with metastatic and/or unresectable soft-tissue and bone sarcomas. The
expanded analysis focuses on the 60 patients with an AP23573
clinical-benefit response (CBR) - the primary endpoint of the
212-patient trial - and its relationship to overall survival. The new
results demonstrate that documented disease stabilization and/or tumor
regression with single-agent AP23573 is a strong predictor of improved
overall survival.
Patients with an AP23573 CBR - tumor regression or disease
stabilization for at least 16 weeks - had a median overall survival of
approximately 17 months, nearly double that of the overall trial
population (vs. approximately 9 months). Cox regression analyses
performed using a series of potential predictors of survival showed
that CBR was the best predictor of survival among all variables
tested.
"These results provide further evidence of the beneficial effects
of AP23573 in patients with advanced sarcomas and demonstrate that the
disease stabilization and tumor regression responses achieved with
AP23573 in this patient population led to clinically meaningful
prolongation of overall survival," said Harvey J. Berger, M.D.,
chairman and chief executive officer of ARIAD. "We are continuing to
move rapidly to launch our randomized, worldwide Phase 3 clinical
trial of oral AP23573 in patients with metastatic sarcomas in the
third quarter of this year."
Sant Chawla, M.D., co-principal investigator of the study,
presented the results at the 43rd annual meeting of the American
Society of Clinical Oncology in Chicago, IL.
Camille L. Bedrosian, M.D., chief medical officer of ARIAD, added,
"the data from the overall survival analysis of the Phase 2 trial
further support our Phase 3 trial design and strategy, which focuses
on metastatic sarcoma patients who have experienced a favorable
response to prior chemotherapy and have at least stable disease. We
believe this well-defined patient population has the greatest
likelihood of achieving sustained clinical benefit from treatment with
a new molecularly targeted agent such as AP23573."
Advanced Sarcoma Phase 2 Trial Design and Previously Reported
Results
At previous meetings, ARIAD announced that AP23573 demonstrated
efficacy and was well tolerated as a single agent in this multi-center
Phase 2 trial of patients with advanced sarcomas, at least 90% of whom
had progressive disease. The efficacy of AP23573 was evaluated using
two closely related measures of disease progression: CBR
(characterized as tumor regression - complete regression or partial
response - or disease stabilization for at least four cycles by RECIST
guidelines), and progression-free survival (PFS, reported as the
six-month rate and the median duration). The primary end-point of the
trial - evidenced by CBR rates - was achieved in the three most
prevalent types of sarcomas (i.e., bone sarcoma, leiomyosarcoma, and
liposarcoma), and treatment with AP23573 more than doubled PFS when
compared to historical control data from the European Organization for
Research and Treatment of Cancer (EORTC). Sixty-one of the 212
patients in the trial achieved an AP23573 CBR; these patients had a
PFS rate at six months of 70% and median PFS of 36 weeks. The PFS rate
in this patient subset was nearly triple that of the overall
population (vs. 24%), and the median PFS was approximately 21 weeks
longer than that of the overall trial population (vs. 15 weeks).
About AP23573
ARIAD's lead product candidate, AP23573, is a novel small-molecule
inhibitor of the protein mTOR, a "master switch" in cancer cells.
Blocking mTOR creates a starvation-like effect in cancer cells by
interfering with cell growth, division, metabolism, and angiogenesis.
AP23573 is currently in Phase 1 and 2 clinical trials in patients with
solid tumors and hematologic cancers. AP23573 has been designated both
as a fast-track product and an orphan drug by the U.S. Food and Drug
Administration and as an orphan drug by the European Medicines Agency
for the treatment of soft-tissue and bone sarcomas. In addition to its
program in oncology, ARIAD is collaborating with Medinol Ltd. to
develop stents and other medical devices that deliver AP23573 to
prevent reblockage at sites of vascular injury following
stent-assisted angioplasty.
About ARIAD
ARIAD is engaged in the discovery and development of breakthrough
medicines to treat cancer by regulating cell signaling with small
molecules. The Company is developing a comprehensive approach to
patients with cancer that addresses the greatest medical need -
aggressive and advanced-stage cancers for which current treatments are
inadequate. Medinol Ltd. also is developing stents and other medical
devices that deliver ARIAD's lead cancer product candidate to prevent
reblockage at sites of vascular injury following stent-assisted
angioplasty. ARIAD has an exclusive license to pioneering technology
and patents related to certain NF-(kappa)B treatment methods, and the
discovery and development of drugs to regulate NF-(kappa)B
cell-signaling activity, which may be useful in treating certain
diseases. Additional information about ARIAD can be found on the web
at http://www.ariad.com.
This press release contains "forward-looking statements,"
including statements related to the efficacy of AP23573 and the
initiation of our Phase 3 clinical trial of AP23573 in metastatic
sarcomas in the third quarter of 2007. 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, the costs associated with our
research, development, manufacturing and other activities, the conduct
and results of pre-clinical and clinical studies of our product
candidates, difficulties or delays in obtaining regulatory approvals
to market products resulting from our development efforts, our
reliance on partners and other key parties for the successful
development, manufacturing and commercialization of products, the
adequacy of our capital resources and the availability of additional
funding, patent protection and third-party intellectual property
claims relating to our and any partner's product candidates, the
timing, scope, cost and outcome of legal and patent office proceedings
concerning our NF-(kappa)B patent portfolio, the potential acquisition
of or other strategic transaction regarding the minority stockholders'
interests in our 80%-owned subsidiary, ARIAD Gene Therapeutics, Inc.,
future capital needs, key employees, markets, economic conditions,
prices, reimbursement rates, competition and other factors detailed in
the Company's public filings with the U.S. Securities and Exchange
Commission. The information contained in this document 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.
CONTACT: ARIAD Pharmaceuticals, Inc.
Edward M. Fitzgerald, 617-621-2345
or
Pure Communications
Andrea L. Johnston, 910-616-5858