From rxpgnews.com

Prostate
A Novel mTOR Inhibitor in Phase 2 as a Single Agent for Refractory Prostate cancer
By ARIAD Pharmaceuticals, Inc.
May 4, 2005, 22:15

ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced initiation of enrollment of patients with prostate cancer who have become refractory to standard hormone therapy in a multi-center Phase 2 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-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 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 tumors and hematologic malignancies," said Harvey J. Berger, M.D., 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 Prostate Cancer

It is estimated that more than 230,000 cases of prostate cancer will be diagnosed in the U.S. in 2005, and over 30,000 deaths will occur as a result of this disease. According to the American Cancer Society, one in six men will be diagnosed with prostate cancer during his lifetime. The exact cause of prostate cancer is unknown, although certain risk factors such as age, family history, race, diet and exercise have been linked to the disease. Overall, prostate cancer causes approximately 10 percent of all cancer-related deaths in men. Chemotherapy is the standard treatment for patients with hormone-refractory disease; however, its limitations are well documented in the literature as all patients eventually become resistant to chemotherapy over time.

About AP23573

The small-molecule drug, AP23573, starves cancer cells and shrinks tumors by inhibiting the critical cell-signaling protein, mTOR, which regulates the response of tumor cells to nutrients and growth factors, and controls tumor blood supply and angiogenesis through effects on Vascular Endothelial Growth Factor (VEGF) in tumor 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 analog of sirolimus, another mTOR inhibitor that has been approved for use in drug-eluting stents. AP23573 is currently in Phase 1 and 2 clinical trials in patients with solid tumors and hematologic 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.

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