A Novel mTOR Inhibitor in Phase 2 as a Single Agent for Refractory Prostate cancer
May 4, 2005 - 10:15:00 PM
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"In addition to this new trial in prostate cancer, AP23573, which was designated as a fast-track product by the FDA for the treatment of sarcomas, is being studied in diverse solid tumors and hematologic malignancies. Earlier this year, we established a series of drug-development goals, including launching this trial in a large potential clinical indication, and we are on track to achieve each of these key milestones."
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By ARIAD Pharmaceuticals, Inc.,
[RxPG] ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced initiation of enrollment of patients with prostate cancer who have become refractory to standard hormone therapy in a multi-center Phase 2 clinical trial of its novel mTOR inhibitor, AP23573, as a single agent. Prostate cancer is the most common cancer diagnosis in men other than skin cancer. Progression to hormone-refractory disease is associated with a very poor prognosis, and current therapeutic options are severely limited.
This non-randomized study will evaluate the clinical benefit of AP23573 in well-characterized prostate cancer patients. Up to approximately 35 patients will be enrolled in the trial at several centers in the United States. AP23573 will be administered intravenously using a weekly dosing regimen. Patients will be followed for at least nine months after enrollment but may continue on AP23573 until disease progression occurs. Data on multiple mTOR-pathway biomarkers will be obtained to help identify patients who are most likely to benefit from treatment with AP23573.
"In addition to this new trial in prostate cancer, AP23573, which was designated as a fast-track product by the FDA for the treatment of sarcomas, is being studied in diverse solid tumors and hematologic malignancies," said Harvey J. Berger, M.D., chairman and chief executive officer at ARIAD. "Earlier this year, we established a series of drug-development goals, including launching this trial in a large potential clinical indication, and we are on track to achieve each of these key milestones."
About Prostate Cancer
It is estimated that more than 230,000 cases of prostate cancer will be diagnosed in the U.S. in 2005, and over 30,000 deaths will occur as a result of this disease. According to the American Cancer Society, one in six men will be diagnosed with prostate cancer during his lifetime. The exact cause of prostate cancer is unknown, although certain risk factors such as age, family history, race, diet and exercise have been linked to the disease. Overall, prostate cancer causes approximately 10 percent of all cancer-related deaths in men. Chemotherapy is the standard treatment for patients with hormone-refractory disease; however, its limitations are well documented in the literature as all patients eventually become resistant to chemotherapy over time.
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) in tumor and endothelial cells. AP23573 also blocks the proliferation and migration of vascular smooth muscle cells, the primary cause of narrowing and reblockage of injured arteries, and is an analog of sirolimus, another mTOR inhibitor that has been approved for use in drug-eluting stents. AP23573 is currently in Phase 1 and 2 clinical trials in patients with solid tumors and hematologic cancers. AP23573 has been designated a fast-track product by the U.S. Food and Drug Administration for the treatment of soft tissue and bone sarcomas.
Publication:
U.S. Food and Drug Administration (FDA)
On the web:
www.ariad.com 
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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 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 ability to manufacture our product candidates on a commercial scale or to supply our product candidates to our collaborator for use in its product candidates, risks and uncertainties regarding our and our collaborator's ability to successfully enroll and conduct preclinical and clinical studies of product candidates, including the clinical trial described in this release and our collaborator's medical device product candidates to treat vascular disease, risks and uncertainties that clinical trial results at any phase of development may be adverse or may not be predictive of future results or lead to regulatory approval of any of our or our collaborator's product candidates, risks and uncertainties of third-party intellectual property claims relating to our and our 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 our 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.
Contacts
(Investors)
ARIAD Pharmaceuticals, Inc.
Tom Pearson, 617-621-2345
or
(Media)
Pure Communications
Sheryl Seapy, 949-608-0841
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