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Biotech / Medical : ARIAD Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: SecularBull who wrote (1497)	4/26/2005 4:59:12 PM
From: sjemmeri	Respond to of 4474

ARIAD Begins Patient Enrollment in Two Clinical Trials of AP23573 in Combination with Cytotoxic Agents; First Trials of AP23573 Led by European Clinical Investigators April 26, 2005 07:30:02 (ET) CAMBRIDGE, Mass., Apr 26, 2005 (BUSINESS WIRE) -- ARIAD Pharmaceuticals, Inc. (ARIA, Trade) 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. . . .