Ariad announces oral dosage safe for anti-cancer drug AP23573

By Ted A. Knutson

Washington, Nov. 17 - Ariad Pharmaceuticals, Inc. said Thursday that the oral dosage form of its novel mTOR inhibitor AP23573 can be administered safely using several daily and intermittent dosing schedules and achieves blood levels and mTOR inhibition consistent with those observed with intravenous administration.

AP23573 starves cancer cells and shrinks solid 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 in tumor and endothelial cells.

"We have developed a well-tolerated and bioavailable oral dosage form of AP23573 and are defining the optimal dosing regimen for use in future clinical trials," said Harvey J. Berger, chairman and chief executive officer of Ariad, in a news release. "These findings, combined with the positive phase 2 sarcoma data announced yesterday [Wednesday], continue to advance our global development plan for AP23573."

Fifty-eight patients with various types of solid tumors have been enrolled so far in this dose-escalation phase 1b trial of three different dosing regimens of oral AP23573: (1) daily dosing (no interruptions), (2) daily dosing for three out of four weeks (one-week interruption each month), and (3) daily for four consecutive days out of seven days each week (three-day interruption each week), the company said in the release. Patients have relapsed or refractory cancers.

Initial data is being presented on the first 45 patients. Ariad said all three dosing regimens are well tolerated and result in similar treatment-related adverse events and early anti-tumor activities. To date, no different adverse events attributable to oral administration of the drug have been observed, the company said in the news release.

Cambridge, Mass.-based Ariad is engaged in the discovery and development of medicines to treat disease by regulating cell signaling with small molecules.

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