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Acapodene Meets Primary And Key Secondary Endpoints In Phase III Clinical Trial In Advanced Prostate Cancer Patients On Androgen Deprivation Therapy

Ipsen (Paris:IPN) announced that GTx Inc. (NASDAQ: GTXI), from which it licensed the European rights for Acapodene® (toremifene citrate 80 mg) in September 2006, presented the results of the first phase III study evaluating the efficacy and safety of toremifene citrate 80mg daily, on multiple side effects of androgen deprivation therapy (ADT) in advanced prostate cancer patients. On the basis of these positive results, Ipsen intends to file toremifene citrate 80 mg for this indication in the European Union before year-end 2008. Androgen deprivation therapy using either luteinizing hormone releasing hormone or surgical castration is the most common treatment for advanced prostate cancer and have clearly demonstrated their efficacy. However, their impact on testosterone and oestrogen levels could result in a decrease of bone mineral density (BMD) potentially leading to osteoporotic fractures, and other adverse effects such as lipid changes, gynecomastia and hot flashes.

Stéphane Thiroloix, Executive Vice President, Corporate Development of Ipsen, said: "We are very pleased with the results of this clinical trial, which confirm the efficacy and the good safety profile of toremifene citrate 80 mg. Subject to regulatory approval, this drug has the potential to address a significant unmet medical need by providing a new therapeutic approach to treat the side symptoms of androgen deprivation therapy. This product is an excellent fit with Ipsen's existing Decapeptyl® franchise, reinforcing our positioning in the treatment of hormone-dependent diseases and broadens the range of our prostate cancer related product portfolio."

About the study

In this large phase III study, 1389 ADT patients were randomized to evaluate the efficacy and safety of toremifene citrate 80 mg compared to placebo over two years in approximately 150 clinical sites in the United States and Mexico. All men enrolled were over 50 years or older with histologically documented prostate cancer, serum prostate specific antigen (PSA) 4 ng/ml or less and a history of orchiectomy, or treatment with GnRH agonist for at least 6 months or intermittent treatment with a GnRH agonist for at least 12 months. The primary endpoint of this study was reached with a significant reduction (p





Acapodene îndeplineºte primar ºi secundar cheie de obiective în studiul clinic de fazã III la paciente cu cancer de prostatã avansat pe Androgen privarea terapie - Acapodene Meets Primary And Key Secondary Endpoints In Phase III Clinical Trial In Advanced Prostate Cancer Patients On Androgen Deprivation Therapy - articole medicale engleza - startsanatate