ARIAD INITIATES PHASE 2 CLINICAL TRIAL OF AP23573 IN PATIENTS WITH RELAPSED AND/OR REFRACTORY SARCOMAS
First global multicenter Phase 2 clinical trial of AP23573 in solid tumors
Cambridge, MA, September 30, 2004 – ARIAD Pharmaceuticals, Inc.
(Nasdaq: ARIA) today announced initiation of enrollment of patients
with bone and soft tissue sarcomas in the first multicenter Phase 2
clinical trial of its novel mTOR inhibitor, AP23573, as a single agent
in solid tumors.
This non-randomized study will evaluate the clinical benefit of AP23573
in four well-defined groups of sarcoma patients, characterized by tumor
type. Up to approximately 175 patients
will be enrolled in the trial at approximately 15 centers in the United
States and Europe.AP23573 will be administered using a daily dosing
regimen of drug.
“In our nearly completed Phase 1 clinical trials reported today at
the EORTC international cancer symposium, all evaluable patients with
relapsed and/or refractory sarcoma had evidence of anti-tumor activity
– a promising result that supports our decision to further evaluate
AP23573 in this patient population in Phase 2,”� said Harvey J. Berger,
M.D., chairman and chief executive officer of ARIAD. “Despite
advancements in anti-cancer therapy, currently available treatment
options for such patients are extremely limited due the highly
resistant
nature of this cancer. Sarcoma remains a disease with high unmet medical need.”
The study will also include use of pharmacodynamic and pharmacogenomic
biomarkers,including functional imaging, to assess the effects of
AP23573 on the mTOR pathway and to
help identify patients who are likely to benefit most from treatment with AP23573.
About Sarcoma
Sarcomas are cancers of the connective tissue, including bones,
muscles, fat, cartilage, and joints. Sarcomas can arise anywhere in the
body and are divided into two main groups – bone tumors and soft tissue
sarcomas. They are further sub-classified based on the type of cell
found in the tumor. All sarcomas share certain pathologic
characteristics. There are approximately 10,000 new cases of sarcoma
diagnosed each year in the United States and close to 40,000 sarcoma
patients being treated in the United States and Europe. More
information about sarcomas is available on the web at http://www.sarcoma.net/facts.htm and at http://www.sarcomafoundation.com/master.html?Articleld=90.
About AP23573
The small-molecule drug, AP23573, starves cancer cells and shrinks
tumors by inhibiting the critical cell-signaling protein, mTOR, which
regulates the response of tumor cells to nutrients and growth factors,
and controls tumor blood supply and angiogenesis through effects on
Vascular Endothelial Growth Factor (VEGF).
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. ARIAD also has an exclusive license to pioneering
technology and patents related to certain NF-kB treatment methods, and
the
discovery and development of drugs to regulate NF-kB 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 the Company's ability to accurately estimate
the actual research and development expenses and other costs associated
with
the preclinical and clinical development of our product candidates, the
adequacy of our capital resources and the availability of additional
funding, risks and uncertainties regarding the Company's ability to
successfully conduct preclinical and clinical studies of its product
candidates, including those clinical trials noted in this press
release,
risks and uncertainties that clinical trial results at any phase of
development may be adverse or may not be predictive of future result or
lead to regulatory approval of any of the Company's product candidates,
and risks and uncertainties relating to regulatory oversight,
intellectual property claims, the timing, scope, cost and outcome of
legal proceedings, future capital needs, key employees, dependence on
the Company's 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 for the fiscal year ended December 31, 2003. 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.
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CONTACT: Tom Pearson
(610) 407-9260
Kelly Lindenboom
(617) 621-2345