Ariad's AP23573 produces tumor regression in 27% of sarcoma patients in phase 2 trial

By Angela McDaniels

Seattle, Nov. 16 - Ariad Pharmaceuticals Inc. said interim data from an ongoing phase 2 clinical study shows that 27% of 188 evaluable patients with advanced bone and soft-tissue sarcomas treated with AP23573 have sustained tumor regression and/or disease stabilization.

In addition, the six-month progression-free survival rate in AP23573-treated patients in the first stage of the trial was 22%, which compares favorably with the historical rate of 8%, the company said.

The primary objective of the 212-patient, multicenter clinical trial is to assess the efficacy and safety of AP23573 in advanced sarcomas. Patients receive a fixed dose of 12.5 mg of AP23573 intravenously using a daily dosing regimen - five days on, nine days off.

The trial was designed to determine whether a clinical-benefit response rate of at least 25% can be achieved in each sarcoma group, the company said, and enrollment has exceeded projected targets due to high patient and clinician interest.

Almost all patients in the current trial had failed alternative anticancer treatments and had progressive disease upon entering the trial, the company said.

The data was presented during the European Organization for Research and Treatment of Cancer, National Cancer Institute and American Association for Cancer Research International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

Sarcomas are cancers of the connective tissue, including bones, muscle, fat, cartilage and joints. There are roughly100,000 sarcoma patients overall in the United States, the company said.

Ariad's 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, the company said.

Ariad is a Cambridge, Mass., pharmaceutical company that develops medicines to treat disease by regulating cell signaling with small molecules.

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