Monday, February 25, 2008

GTx Surges on Late-Stage Trial Results (The Street)

Shares of GTx(GTXI) soared nearly 50% Monday after the biopharmaceutical company said its Acapodene drug showed success in a late-stage study in reducing side effects from certain prostate cancer treatments. The Memphis, Tenn.-based company's shares recently were up $6.21, or 48%, to $19.10. The phase III trial looked at Acapodene in patients receiving androgen deprivation therapy, a common first line treatment for advanced prostate cancer patients. Acapodene, or toremifene citrate 80 mg, is designed to fight the side effects of the hormone therapy, such as loss of bone density, fractures and increased cholesterol and heart attack risk. GTx said the drug reduced vertebral fractures by 50% in patients who were given at least one dose of the drug or placebo and who had at least one evaluable study radiograph. There was a 5% rate of these fractures in the placebo group. Of those who were more than 80% compliant with the treatment, the drug reduced the fractures by 61%. GTx said Acapodene also resulted in a statistically significant increase in bone mineral density. It also showed a statistically significant decrease in LDL, or "bad," cholesterol, and an increase in HDL, or "good" cholesterol, among other things. The company said the drug had a favorable safety profile and was well tolerated. Based on the results, it will file a new drug application for Acapodene by this summer. GTx licensed the rights to toremifene citrate from Finnish drug company Orion for all indications worldwide, except breast cancer outside the U.S. GTx also has a development and collaboration agreement with French specialty pharmaceutical company Ipsen in Europe. Ipsen is responsible for filing the drug for regulatory approval in Europe, but GTx will seek its approval and commercialize it in the U.S. GTx also markets Fareston, a treatment for metastatic breast cancer in postmenopausal women.