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

To: PuddleGlum who wrote (1509)	5/26/2005 3:54:45 PM
From: tuck	Read Replies (1) \| Respond to of 4474

>>CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 26, 2005-- ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA - News) today announced initiation of enrollment of patients with relapsed and/or refractory cancers in the first multi-center Phase 1b clinical trial of the oral dosage form of its novel mTOR inhibitor, AP23573, which was recently designated as a fast-track product by the U.S. Food and Drug Administration for the treatment of sarcomas. Oral administration (tablets) should permit greater flexibility in dosing and greater convenience for patients, reducing dependency on a hospital or clinic based treatment regimen. This non-randomized, dose-escalation study will evaluate the safety, anti-cancer activity, pharmacokinetics, and bioavailability of AP23573 tablets administered in three different oral dosing regimens. Up to approximately 150 cancer patients will be enrolled in the trial at three to five leading cancer centers in the United States. An intravenous dosage form of AP23573 is currently being studied in multiple Phase 2 and 1b clinical trials in patients with hematologic malignancies and solid tumors, including bone and soft-tissue sarcomas, prostate, breast, ovarian, non-small-cell lung and brain cancers. In studies conducted to date, AP23573 has exhibited a favorable safety profile and broad anti-cancer activity. "The initiation of patient enrollment in the first clinical trial of our newly developed oral dosage form of AP23573 represents another major milestone for ARIAD," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "Based on the clinical results and patient benefit seen to date with the intravenous form of AP23573, we expect to move quickly through this oral bridging study which should allow us to proceed with one or both dosage forms in key registration trials." "The availability of both dosage forms should provide added flexibility and therapeutic options as we develop AP23573 as a fast-track product for patients with sarcoma," said Camille L. Bedrosian, chief medical officer of ARIAD. 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. << snip Cheers, Tuck