EXHIBIT 99.1
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ARIAD Presents Positive Efficacy Data on AP23573, Novel mTOR Inhibitor,
in Phase 2 Advanced Sarcoma Cancer Trial; Investor Call to Discuss Results and
Development Plans at 6:30 p.m. ET Tonight
ATLANTA & CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 5, 2006--ARIAD
Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that AP23573 - its novel
mTOR inhibitor - demonstrated efficacy and was well tolerated as a single agent
in a multi-center Phase 2 trial in metastatic and/or unresectable soft-tissue
and bone sarcomas involving 212 patients, at least 90% of whom had progressive
disease. The primary end-point of the trial - evidenced by clinical-benefit
response rates - was achieved in the three most prevalent types of sarcoma
(i.e., bone sarcoma, leiomyosarcoma and liposarcoma). Treatment with AP23573
more than doubled progression-free survival when compared to historical control
data published by the European Organization for Research and Treatment of Cancer
(EORTC).
"What do these results mean for sarcoma patients? The period of time that
patients remained stable - in other words, their disease didn't get worse - was
at least twice as long on AP23573 as would be expected. What does this mean for
ARIAD? We now have consistent evidence of efficacy of our lead cancer product
candidate in all major sub-types of sarcoma, setting the stage for the Phase 3
clinical trial and subsequent commercialization," said Harvey J. Berger, M.D.,
chairman and chief executive officer of ARIAD.
Plans for Phase 3 Trial
Based on the Company's ongoing interactions with the Food and Drug
Administration (FDA) and the European Medicines Agency (EMEA), ARIAD plans to
conduct a randomized, worldwide Phase 3 clinical trial of oral AP23573 in
patients with advanced sarcomas.
As in the Phase 2 trial, eligible patients will have a broad range of
metastatic and/or unresectable soft-tissue and bone sarcomas. However, unlike
the Phase 2 trial, patients enrolled in the pivotal trial will have at least
stable disease following a favorable response to chemotherapy. The goals of the
trial will be to prolong progression-free and overall survival for these
patients. AP23573 was granted Fast Track status by the FDA for both soft-tissue
and bone sarcomas in April 2005.
Comprehensive AP23573 Phase 2 Trial Results from Entire Study Population
The following results were presented this afternoon by Dr. Sant Chawla,
co-principal investigator of the study, in an oral session during the 42nd
annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta,
Georgia (See, Trial Design section for definitions):
-- The AP23573 clinical-benefit response (CBR) rate for the overall trial
was 29%.
-- The CBR rates were not statistically different among the four
sub-groups (i.e., bone, 30%; leiomyosarcoma, 33%; liposarcoma, 30%;
and other, 23%).
-- The primary endpoint of the trial was achieved for the three most
prevalent types of advanced sarcomas.
-- The AP23573 progression-free survival (PFS) rate at six months for the
overall trial was 24%.
-- The PFS rates were not statistically different between the bone and
soft-tissue sarcoma sub-groups (25% vs. 23%, respectively). The PFS
rates also were not statistically different among the four sub-groups.
-- The median AP23573 PFS for the overall trial was 15 weeks, with no
statistically significant differences among the four sub-groups.
-- Treatment with AP23573 more than doubled PFS when compared to
historical control data (i.e., a surrogate for placebo data) published
by the EORTC. See, Van Glabbeke, M. et al. (2002) Eur J Cancer 38:543
(reprint available at www.ariad.com).
-- AP23573 PFS rate of 23% vs. 8% in the EORTC analysis.
-- AP23573 median PFS of 15 weeks vs. 7 weeks in the EORTC analysis.
-- The CBR and PFS data were not statistically different between
stages 1 and 2 of the Simon's two-stage design.
-- The AP23573 side effects were generally mild or moderate and
reversible, with the most common being mouth sores, fatigue, increased
triglycerides, low red blood cell count and nausea.
Camille L. Bedrosian, M.D., chief medical officer of ARIAD, added, "The
patients in our Phase 2 trial had very advanced sarcomas; most were unresponsive
to chemotherapy and had disease progression at the time of entry into the trial.
In contrast, we have chosen a less advanced sarcoma population to study in Phase
3 in which patients had clinical benefit from chemotherapy and we believe will
have the greatest likelihood of survival benefit from a new molecularly targeted
agent such as AP23573."
Phase 2 Clinical Trial Design
The Phase 2 trial included four well-defined sub-groups of sarcomas (i.e.,
bone sarcomas and three sub-groups of soft-tissue sarcomas - leiomyosarcoma,
liposarcoma, and other). Patients received a fixed-flat dose of 12.5 mg of
AP23573 intravenously using a daily dosing regimen of drug (i.e., five days on,
nine days off, drug and 4-week cycles).
The efficacy of AP23573 was evaluated using two closely related measures of
disease progression: clinical-benefit response (CBR; characterized as tumor
regression - complete or partial response - or disease stabilization for at
least 4 cycles by RECIST guidelines), and PFS (estimated using Kaplan-Meier
analysis and reported as the six-month rate and the median duration). All
measures of efficacy were evaluated in the entire study population and each of
the four sarcoma sub-groups.
The trial was designed to determine the CBR rate independently for each of
the four sarcoma sub-groups - the primary end-point of the trial. AP23573 was
considered effective if at least 25% of patients in that sub-group, a value
predefined by the statistical plan, demonstrated CBRs.
Investor Conference Call Reminder
ARIAD will host an investor conference call today, Monday, June 5, 2006 at
6:30 p.m. (ET), to discuss the results in further detail. The webcast can be
accessed by visiting the investor relations section of the Company's website at
http://www.ariad.com/investor or by dialing 1-888-396-2298 (domestic) or
617-847-8708 (international) five minutes prior to the start time and providing
the passcode 73326584. A replay of the call will be available on the ARIAD
website approximately two hours after completion of the call and will be
archived for two 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.
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 the Phase 3 pivotal trial described in this press release,
risks and uncertainties that clinical trial results at any phase of development,
including the results of our advanced sarcoma trial 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, 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, including ARIAD's Annual Report on Form 10-K for the fiscal
year ended December 31, 2005. 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.
Investors
Ed Fitzgerald, 617-621-2345
or
Media
Pure Communications
Sheryl Seapy, 949-608-0841