AP23573 was recently designated as a fast-track product by the FDA for the treatment of sarcomas. Ariad hopes oral administration would 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 centres in the US.
An intravenous dosage form of AP23573 is currently being studied in multiple phase I and II 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 favourable 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 Berger, chairman and CEO 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.”