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The product Xinlay™ (atrasentan), which is not yet FDA-approved, is available to some patients with advanced prostate cancer through an expanded access program. Xinlay is a promising agent that has shown an ability to delay time to disease progression and decrease the frequency of bone pain in patients with advanced, hormone-refractory prostate cancer.

The prostate gland is part of the male reproductive system and produces some of the fluid that transports sperm during male ejaculation. In prostate cancer, cancer cells form in the tissues of the prostate. After skin cancer, it is the most common form of cancer diagnosed in men. The outlook is good prostate cancer patients-during the past 20 years, overall survival rates for all stages of prostate cancer have improved dramatically. Current treatment options for prostate cancer include watchful waiting, surgery, chemotherapy, radiation or hormonal therapy. Hormonal therapy is designed to lower the presence or block the effects of testosterone, which stimulates the growth of hormone-dependent types of prostate cancer. Some forms of prostate cancers, known as hormone refractory or resistant prostate cancer, can become resistant to hormonal therapy, requiring an alternative approach.

Previous trials have indicated that Xinlay is successful in delaying cancer progression and improving quality of life in men with hormone resistant prostate cancer. Xinlay can be taken orally and disrupts pathways that are involved in replication of cancer cells. This agent tends to be much better tolerated than chemotherapy agents.

Researchers in this recent study reviewed previous studies evaluating the effects of Xinlay in terms of time to disease progression. These studies included over 1,000 men with hormone resistant prostate cancer who were randomized to receive either Xinlay or a placebo (inactive substitute). Overall, Xinlay provided significant improvements in time to disease progression and bone pain over placebo. After 3 months, the probability of remaining progression free was improved by 10 percent among the patients treated with Xinlay. After 6 months, the probability of remaining progression free had improved to 22 percent among the patients treated with Xinlay, when compared with the placebo treatment group. Additionally, patients treated with Xinlay were 18 percent less likely to experience bone pain than those patients who were treated with a placebo.

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Patients with metastatic hormone-refractory prostate cancer may wish to speak with their physician regarding access to Xinlay through a clinical trial or the expanded access program.

Reference: United States Securities and Exchange Commission. Form 8-K, Item 7.01 Regulation FD Disclosure: Xinlay Expanded Access Progam. Washington D.C.; June 23, 2005. Commission File Number 1-2189.

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