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Title: Treatment With Toremifene Improves Lipid Profile and Bone Mineral Density in Patients Receiving Hormonal Therapy for Prostate Cancer: Presented at PCS

"Treatment With Toremifene Improves Lipid Profile and Bone Mineral Density in Patients Receiving Hormonal Therapy for Prostate Cancer: Presented at PCS"

By Ed Susman KISSIMMEE, FL -- February 27, 2007 -- Patients on hormonal therapy for treatment of prostate cancer appear to get a double benefit from the selective oestrogen receptor modulator toremifene (Acapodene), doctors said here at the 3[^rd Prostate Cancer Symposium.

"These interim results suggest that toremifene has the potential not only to reduce the risk of fractures in men with advanced prostate cancer, but also to improve cholesterol levels, addressing another significant side effect of the standard treatment for this disease," said Matthew Smith, MD, PhD, associate professor of medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States.

Androgen deprivation therapy, the standard treatment for men with advanced prostate cancer, has been shown to decrease bone mineral density and increase fracture risk, Dr. Smith said in an oral presentation on February 23^rd.

In his study, Dr. Smith and colleagues enrolled 1,392 men age, who were 50 and older and were being treated with androgen deprivation therapy for advanced prostate cancer at several centers in the United States and Mexico. The men were randomly assigned to receive toremifene 80 mg/day or placebo for 2 years.

An interim analysis involving the first 197 men showed that treatment with toremifene significantly increased bone mineral density at the lumbar spine (P < .001), at the hip (P = .001) and at the femoral neck (P = .009) when compared with placebo. In fact, while bone mineral density was increased for patients on toremifene, bone mineral density decreased in all three areas among the patients who were on placebo.

The interim results lipid profiles showed:

· 8% reduction in total cholesterol compared with 1% decline with placebo (P = .001).

· 8% decline in low-density lipoprotein cholesterol compared with a 1% increase with placebo (P = .003).

· 1% increase in HDL cholesterol compared with a 5% decline with placebo (P = .018).

· 13% fall in triglycerides compared with a 7% increase with placebo (P = .009).

· 7% fall in the total cholesterol/HDL ratio compared with a 6% increase with placebo (P < .001).

Dr. Smith said the ongoing study will evaluate whether these changes will results in fewer fractures and fewer cardiac events.

The study was sponsored by GTx, Inc. The symposium is cosponsored by the American Society of clinical Oncology, the American Society for Therapeutic Radiology and Oncology and the Society of Urologic Oncology.

[Presentation title: Toremifene Citrate Increases Bone Mineral Density in Men Receiving Androgen Deprivation Therapy for Prostate Cancer. Abstract 149. Toremifene Significantly Lowers Total Cholesterol, LDL, And Triglycerides And Raises HDL In Men Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer. Abstract 150]

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