XinlayT (atrasentan) Expanded Access Program

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Xinlay™ (atrasentan) Expanded Access ProgramPosted August 22, 2005

Abbott Laboratories has received U.S. Food and Drug Administration (FDA) permission to initiate an expanded access program for the investigational agent known as Xinlay™ (atrasentan) in the U.S. for eligible men with late-stage, hormone-refractory prostate cancer. The study will begin later this summer.

Expanded access programs are designed to make investigational agents available at the earliest opportunity for the treatment of patients with a serious disease for which no comparable or satisfactory alternative drug or other therapy is available.

A new drug application (NDA) for Xinlay is currently under review by the FDA and is based on Phase II and III clinical trials in men with metastatic hormone-refractory prostate cancer. The NDA submission contains clinical data regarding disease progression and delay in time to onset of bone pain.

For the thousands of patients whose prostate cancer spreads to other organs, the disease remains incurable. The cancer in hormone-refractory prostate cancer patients often spreads to their bones and patients are left with few treatment options. Bone pain from metastases is one of the more disabling manifestations of advanced prostate cancer.

About Xinlay

Xinlay is an investigational, oral, once-daily, non-hormonal, non-chemotherapy, agent that belongs to a class of compounds known as selective endothelin-A receptor antagonists (SERA™). SERAs disturb the effect of endothelin-1 (ET-1), one of the proteins thought to be involved in the stimulation of the spread of cancer cells.

Xinlay is currently being studied in several stages of prostate cancer. Trials are ongoing in men with hormone-refractory prostate cancer that has not spread (non-metastatic), and in combination trials with approved treatments for advanced prostate cancer.

Who is eligible for the EAP?The Xinlay EAP will be open to patients with metastatic HRPC who have not received chemotherapy. The primary inclusion criteria require that patients are progressing with their disease despite androgen deprivation therapy as demonstrated by a rise in PSA. Patients must be surgically or pharmacologically castrate, with evidence of metastatic disease. Patients in the study will be treated until disease progression as determined by their physician or until Xinlay is approved. Patients currently enrolled in M01-244, a Xinlay study in men with HRPC that has not spread (non-metastatic), will not be eligible for the EAP.

When will the EAP be initiated?Patient enrollment into the EAP will begin late summer, 2005. Further details regarding trial site locations and contact information will be available in the coming weeks.

Will the program be available outside of the U.S.?The program has not been initiated in other countries at this time

For More Information

Talk to the physician who is treating your prostate cancer to see if you are eligible to participate in the Xinlay Expanded Access Program study. Your physician may call 1-866-4ABTONC for more information about participating sites and patient enrollment criteria.

http://www.prostate-cancer.org/research/atrasentan_access.html

Kathy Meade

Arlington Educational Consulting

http://www.vapcacoalition.org/

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September is Prostate Cancer Awareness Month