Ariad planning to test AP23573 in wide range of earlier-stage sarcomas in phase 3 clinical trial

By Jennifer Lanning Drey

Eugene, Ore., Sept. 18 - Ariad Pharmaceuticals, Inc. is planning a worldwide randomized phase 3 clinical trial of its lead compound AP23573 to be conducted in a broad range of sarcoma patients, Timothy Clackson, chief scientific officer of Ariad, said Monday at the Leerink Swann & Co. cancer roundtable.

The trial will be performed with patients who have had a favorable response to chemotherapy and will be done at an earlier stage than the company's phase 2 clinical trials of the drug, Clackson said.

The phase 3 clinical trial will study prolonged progression-free survival and overall survival, he said.

The drug will be administered after chemotherapy, at a time patients would normally not be receiving treatment, and therefore will have a placebo arm, which maximizes the chances of clinical success, Clackson said.

"We really believe this trial design plays to the strengths of AP23573," he said.

A phase 2 clinical trial of AP23573 found that the drug doubled the time in which the disease was stable and was well-tolerated in a phase 2 trial in metastatic and/or unresectable soft-tissue and bone sarcomas.

Ariad is also pursing AP23573's potential in other oncology indications.

"We view sarcoma as a very promising and validated gateway opportunity for initial registration and marketing of the compound, but it's clear that the 573 story stretches beyond sarcoma to touch many other potential indications in the oncology area."

Other phase 1 and phase 2 trials conducted by Ariad have shown AP23573 to have activity in cancers, including non-small cell lung, prostate, bladder, renal and head and neck, Clackson said.

"Ariad 573 is clearly a key value driver for the company, and we believe it has blockbuster potential because of its ability to be developed over multiple oncology indications," Clackson said.

Located in Cambridge, Mass., Ariad develops medicines to treat cancer by regulating cell signaling with small molecules.

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