Ariad Initiates Trial of Oral AP23573 in Cancer Patients

Ariad Pharmaceuticals has begun enrollment of patients with relapsed and/or refractory cancers in the first multicenter Phase Ib clinical trial of the oral dosage form of its novel mTOR inhibitor, AP23573, which was recently designated as a fast-track product by the FDA 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 nonrandomized, dose-escalation study will evaluate the safety, anticancer 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 U.S.

An intravenous dosage form of AP23573 is currently being studied in multiple Phase II and Ib 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 anticancer activity.