EXHIBIT 99.1
ARIAD Presents Expanded Efficacy Data On AP23573, Novel mTOR Inhibitor, In Phase
2 Advanced Sarcoma Cancer Trial
VENICE, Italy and CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2006--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 bone and soft-tissue sarcomas. The expanded analysis focuses on the
61 patients with an AP23573 clinical-benefit response - the primary end-point of
the 212-patient trial - and its relation to progression-free survival.
Patients with an AP23573 clinical-benefit response (CBR) - tumor regression
or disease stabilization - had a progression-free survival (PFS) rate at six
months of 70% and a median PFS of 36 weeks. The PFS rate in this patient subset
was nearly triple that of the overall trial population (vs. 24%), and the median
PFS was approximately 21 weeks longer than that of the overall trial population
(vs. 15 weeks). These data show that CBR is a clinically useful surrogate for
PFS in this difficult-to-treat patient population.
"These results provide further evidence of the beneficial effects of
AP23573 in patients with advanced sarcomas and demonstrate that the
clinical-benefit responses achieved with AP23573 in this patient population led
to clinically meaningful prolongation of progression-free survival," said Harvey
J. Berger, M.D., chairman and chief executive officer of ARIAD. "We are moving
rapidly to launch our randomized, worldwide Phase 3 clinical trial of oral
AP23573 in patients with advanced sarcomas."
These results are being presented by Dr. Sant Chawla, co-principal
investigator of the study, at the 12th Annual Connective Tissue Oncology Society
(CTOS) Meeting in Venice, Italy, November 2 to 4, 2006.
Camille L. Bedrosian, M.D., chief medical officer of ARIAD, added, "the
data from the expanded analysis of the Phase 2 trial further support our Phase 3
trial strategy which focuses on advanced sarcoma patients who have experienced a
favorable response to prior chemotherapy and have stable disease. We believe
this 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 Results
Earlier this year, at the American Society of Clinical Oncology annual
meeting, 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 or partial response - or
disease stabilization for at least four cycles by RECIST guidelines), and 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 sarcoma (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).
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.
Some of the matters discussed herein are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995. Such
statements are identified by the use of words such as "may", "anticipate,"
"estimate," "expect," "project," "intend," "plan," "believe," and other words
and terms of similar meaning in connection with any discussion of future
operating or financial performance. Such 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 forward-looking statements.
These risks include, but are not limited to, risks and uncertainties regarding
our ability to accurately estimate the timing and actual R&D expenses and other
costs associated with the preclinical and clinical development and manufacture
of our product candidates, the adequacy of our capital resources and the
availability of additional funding, risks and uncertainties regarding our
ability to manufacture or have manufactured our product candidates on a
commercial scale, risks and uncertainties regarding our ability to successfully
recruit centers, enroll patients and conduct clinical studies of product
candidates including our Phase 3 clinical trial in advanced sarcomas referred to
in this press release, risks and uncertainties that clinical trial results at
any phase of development, including those described in this press release, may
be adverse or may not be predictive of future results or lead to regulatory
approval of any of our or any partner's product candidates, risks and
uncertainties of third-party intellectual property claims relating to our and
any partner's product candidates, risks and uncertainties related to the
potential acquisition of or other strategic transaction regarding the minority
stockholders' interests in our 80%-owned subsidiary, ARIAD Gene Therapeutics,
Inc., and risks and uncertainties relating to regulatory oversight, the timing,
scope, cost and outcome of legal and patent office proceedings, litigation,
prosecution and re-examination proceedings concerning our NF-(kappa)B patent
portfolio, future capital needs, key employees, dependence on collaborators and
manufacturers, markets, economic conditions, products, services, prices,
reimbursement rates, competition and other factors detailed in the Company's
public filings with the Securities and Exchange Commission (SEC), including
ARIAD's Annual Report on Form 10-K for the fiscal year ended December 31, 2005,
as updated from time to time in our subsequent periodic and current reports
filed with the SEC. 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: Investors
ARIAD Pharmaceuticals, Inc.
Edward Fitzgerald, 617-621-2345
or
Media
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Adriana Jenkins, 617-710-8350