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news.Ariad Pharmaceuticals has started recruiting patients with prostate cancer who have become refractory to standard hormone therapy in preparation for a multi-center phase II clinical trial of its novel mTOR inhibitor, AP23573, as a single agent.
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Prostate cancer is the most common cancer diagnosis in men other than skin cancer. Despite hormone treatment the disease resurfaces in many patients. When this occurs the patient is said to have hormone-refractory disease, a situation believed to arise from increasing androgen independence in prostate cancer cells.
Progression to hormone-refractory disease is associated with a very poor prognosis, and current therapeutic options are severely limited. Participants enlisted in the Ariad study will be those who have become refractory to standard hormone therapy.
This non-randomized study will evaluate the clinical benefit of AP23573 in well-characterized prostate cancer patients. Up to approximately 35 patients will be enrolled in the trial at several centers in the US. AP23573 will be administered intravenously using a weekly dosing regimen.
Patients will be followed for at least nine months after enrollment but may continue on AP23573 until disease progression occurs. Data on multiple mTOR-pathway biomarkers will be obtained to help identify patients who are most likely to benefit from treatment with AP23573.
AP23573 has already been designated as a fast-track product by the FDA for the treatment of sarcomas, is currently being studied in diverse solid tumors and hematologic malignancies.
Dr Harvey Berger, chairman and CEO at Ariad, said a number of drug development goals had already been achieved and believes the company is on track to achieve its key milestones.