• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

ARIAD Begins Patient Enrollment in Two Clinical Trials of AP23573 in Combination With Cytotoxic Agents; First Trials of AP23573 Led By European Clinical Investigators

Posted on: Tuesday, 26 April 2005, 09:00 CDT

ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced initiation of enrollment of advanced cancer patients at major European cancer centers in two multi-center Phase 1b clinical trials of its novel mTOR inhibitor, AP23573, combined with the widely used chemotherapeutic agents, paclitaxel or capecitabine.

These non-randomized, dose-escalation studies will evaluate the safety and tolerability, pharmacokinetics, and anti-cancer activity of AP23573 in combination with paclitaxel or capecitabine. The primary goal of these studies is to determine the optimal dosing regimen for AP23573 when used in combination with each of these cytotoxic drugs, predominantly in patients with progressive breast, ovarian, non-small-cell lung, and prostate cancers, as well as certain sarcomas. Up to approximately 110 cancer patients will be enrolled in the two trials at three to five centers in Italy and Switzerland.

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 paclitaxel and capecitabine - are being studied in new regimens to identify more effective treatments for patients with advanced cancers. Preclinical studies conducted by ARIAD scientists and others support the decision to prioritize these combination trials in the development of AP23573.

"With the recent designation of AP23573 as a fast-track product by the U.S. Food and Drug Administration for the treatment of soft-tissue and bone sarcomas and enrollment in these new combination trials, we are on track to achieve our key product development goals for this year," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "The initiation of these two studies also launches the European phase of our global development plan for AP23573."

At last year's American Association for Cancer Research (AACR) annual meeting, ARIAD investigators presented results of preclinical studies showing that AP23573 augments the anti-cancer activity of certain cytotoxic agents when given in combination. Further support for these combinations comes from recently published studies demonstrating that mTOR inhibitors may make cancer cells more vulnerable to the cytotoxic effects of chemotherapy (e.g., by enhancing paclitaxel-induced cancer cell death).

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.

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 our product candidate to treat cancer 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 including those described in this release 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.

Source: Business Wire

More News in this Category