Ariad initiates PII trial for prostate cancer
ARIAD Pharmaceuticals has initiated enrollment of patients with prostate cancer who have become refractory to standard hormone therapy in a multi-centre Phase II clinical trial of its novel mTOR inhibitor, AP23573, as a single agent.
ARIAD Pharmaceuticals has initiated enrollment of patients with prostate cancer who have become refractory to standard hormone therapy in a multi-centre Phase II clinical trial of its novel mTOR inhibitor, AP23573, as a single agent.
Prostate cancer is the most common cancer diagnosis in men other than skin cancer. Progression to hormone-refractory disease is associated with a very poor prognosis, and current therapeutic options are severely limited.
This non-randomised study will evaluate the clinical benefit of AP23573 in well characterised prostate cancer patients. Up to 35 patients will be enrolled in the trial at several centres in the United States. 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.
'In addition to this new trial in prostate cancer, AP23573, which was designated as a fast-track product by the FDA for the treatment of sarcomas, is being studied in diverse solid tumours and haematologic malignancies,' said Dr Harvey Berger, chairman and chief executive officer at Ariad. 'Earlier this year, we established a series of drug development goals, including launching this trial in a large potential clinical indication, and we are on track to achieve each of these key milestones.'
About AP23573
The small-molecule drug, AP23573, starves cancer cells and shrinks tumours by inhibiting the critical cell-signaling protein, mTOR, which regulates the response of tumour cells to nutrients and growth factors, and controls tumor blood supply and angiogenesis through effects on Vascular Endothelial Growth Factor (VEGF) in tumour and endothelial cells. AP23573 also blocks the proliferation and migration of vascular smooth muscle cells, the primary cause of narrowing and reblockage of injured arteries, and is an analogue of sirolimus, another mTOR inhibitor that has been approved for use in drug-eluting stents. AP23573 is currently in Phase I and II clinical trials in patients with solid tumours and haematologic cancers. AP23573 has been designated a fast-track product by the U.S. Food and Drug Administration for the treatment of soft tissue and bone sarcomas.