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
Pure Communications
Adriana Jenkins, 617-710-8350
SOURCE: ARIAD Pharmaceuticals, Inc.
