Exhibit 99.1
------------
ARIAD Initiates First Clinical Trial of Oral AP23573 in Combination
with Doxorubicin Chemotherapy
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 14, 2006--ARIAD
Pharmaceuticals, Inc. (Nasdaq:ARIA) today announced initiation of
enrollment of advanced cancer patients in a Phase Ib clinical trial of
its novel mTOR inhibitor, AP23573, in combination with doxorubicin - a
long-standing chemotherapeutic agent and the mainstay of treatment for
a broad range of cancers and hematologic malignancies. In particular,
doxorubicin is widely used in soft-tissue and bone sarcomas, as well
as breast, ovarian and endometrial cancers - all potential targets for
AP23573 treatment.
Preliminary Phase 2 clinical results have demonstrated striking
clinical-benefit responses and 6-month progression-free survival in
patients with advanced sarcomas who received single-agent AP23573. The
Company is on track to initiate a Phase 3 trial of single-agent
AP23573 in advanced sarcomas later in 2006.
"Given the clinical-benefit responses observed to date with
single-agent AP23573 in patients with advanced sarcomas and the strong
mechanistic rationale for combining doxorubicin with mTOR inhibition,
this trial represents an important step in our global development plan
for AP23573," said Harvey J. Berger, M.D., chairman and chief
executive officer of ARIAD. "We believe that this clinical study is
the first trial aimed at evaluating the combination of an mTOR
inhibitor and doxorubicin and highlights the favorable safety profile
that we have seen with AP23573."
Doxorubicin is generally considered the current standard of care
for front-line treatment of patients with sarcomas. The alkylating
agent, ifosfamide, is often used in conjunction with doxorubicin in
this clinical setting. Once the tolerability and optimal dosing
regimen of AP23573 in combination of doxorubicin are determined, the
feasibility of adding ifosfamide will be assessed. As a result, the
efficacy of AP23573 along with both chemotherapies as front-line
therapy in patients with sarcomas may be studied.
AP23573 is already under study in additional Phase 1b clinical
trials in combination with two other widely used cytotoxic agents,
paclitaxel and capecitabine.
This non-randomized, dose-escalation trial will evaluate the
safety and tolerability, pharmacokinetics, and anti-cancer activity of
AP23573 in combination with various doses of intravenous doxorubicin.
Up to approximately 60 patients in whom doxorubicin therapy is
clinically indicated will be enrolled in the trial at three centers in
the United States. The trial will predominantly include patients with
certain sarcomas, as well as breast, ovarian, and endometrial cancers.
Additional information about this trial is available on the web at
http://www.clinicaltrials.gov/ct/show/NCT00288431?order=3
Despite advances in cancer therapy, prolonged cancer remission
remains difficult to achieve in many types of solid tumors. Additional
treatment options are needed for patients whose cancer is progressing
and unresponsive to currently available therapies. Novel molecularly
targeted agents - such as AP23573 - combined with traditional
cytotoxic agents - such as doxorubicin, paclitaxel, and capecitabine -
are being studied in new regimens to identify more effective
treatments for patients with advanced cancers.
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 the
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 disease 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 "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 current
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
successfully enroll and conduct preclinical and clinical studies of
product candidates such as the clinical trials referred to in this
press release, risks and uncertainties that clinical trial results at
any phase of development, including the results of clinical trials to
date or expected in the future described in this press release, may be
adverse or may not lead to regulatory approval of any of our or any
collaborator's product candidates, risks and uncertainties regarding
the Company's ability to accurately estimate the timing and actual
research and development 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 or our
collaborator's ability to manufacture our product candidates on a
commercial scale or to supply our product candidates to collaborators,
risks and uncertainties of third-party intellectual property claims
relating to our and any collaborator's product candidates, and risks
and uncertainties relating to regulatory oversight, the timing, scope,
cost and outcome of legal proceedings, including litigation 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 risks detailed in the Company's public filings
with the Securities and Exchange Commission, including ARIAD's Annual
Report on Form 10-K, as amended, for the fiscal year ended December
31, 2004. 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.
Ed Fitzgerald
617-621-2345
or
Sheryl Seapy (Media)
Pure Communications
949-608-0841