"As part of ARIAD's global clinical development plan and registration strategy, AP23573 is being studied in multiple clinical indications as a single agent and in combination with other therapies. We look forward to announcing results from several of these trials at ASCO," said Harvey J. Berger, M.D., Chairman and Chief Executive Officer of ARIAD. "This month marks an important milestone for our mTOR inhibitor as we recognize the fourth anniversary of ongoing treatment for the first patient dosed with AP23573 - a patient with metastatic carcinosarcoma. Her continued success remains an inspiration to all of us as we move to initiating our Phase 3 clinical trial in metastatic sarcomas during the third quarter of this year."
The schedule and meeting places for the sessions, together with the abstract numbers, are listed below: -0-
Sunday, June 3, 2007 at 2:45 p.m. to 3:00 p.m. - Oral Presentation Session Title: mTOR Inhibitors: Ready for Prime Time? Abstract No. 3509 "Phase 1b study defining the optimal dosing combinations of the mTOR inhibitor AP23573 and paclitaxel (PTX)" Presenter: Diego Tosi, M.D. Location: E Hall D1 Sunday, June 3, 2007 at 8:00 a.m. to 12:00 p.m. - Poster Discussion Presentation Session Title: Gynecologic Cancer Abstract No. 5516 "A Phase 2 trial of the mTOR inhibitor AP23573 as a single agent in advanced endometrial cancer" Presenter: Nicoletta Colombo, M.D. Location: Display - E415a (Board 6), Discussion - E354a (11:00 am to 12:00 pm) Sunday, June 3, 2007 at 2:00 p.m. to 6:00 p.m. - Poster Presentation Session Title: Sarcoma Abstract No. 10076 "Survival results with AP23573, a novel mTOR inhibitor, in patients with advanced soft tissue or bone sarcomas: Update of Phase 2 trial" Presenter: Sant P. Chawla, M.D. Location: Display - S Hall A2 (Board JJ4)
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.
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 d eliver 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.
This press release contains "forward-looking statements," including statements related to initiation of our Phase 3 clinical trial in metastatic sarcomas in the third quarter of 2007. Forward-looking 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 statements. These risks and uncertainties include, but are not limited to, the costs associated with our research, development, manufacturing and other activities, the conduct and results of pre-clinical and clinical studies of our product candidates, difficulties or delays in obtaining regulatory approvals to market products resulting from our development efforts, our reliance on partners and other key parties for the successful development, manufacturing and commercialization of products, the adequacy of our capital resources and the availability of additional funding, patent protection and third-party intellectual property claims relating to our and any partner's product candidates, the timing, scope, cost and outcome of legal and patent office proceedings concerning our NF-(kappa)B patent portfolio, the potential acquisition of or other strategic transaction regarding the minority stockholders' interests in our 80%-owned subsidiary, ARIAD Gene Therapeutics, Inc., future capital needs, key employees, markets, economic conditions, prices, reimbursement r ates, competition and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. 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.
ARIAD Pharmaceuticals, Inc.
Edward M. Fitzgerald, 617-621-2345
Andrea L. Johnston, 910-681-1088