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Pharmaceutical giant Ipsen has revealed the first results of a phase III study evaluating the safety of Acapodene (toremifene citrate) in advanced prostate cancer patients.
The firm licensed the European rights for the treatment in September 2006, and presented the results of the drug on multiple side-effects of androgen deprivation therapy (ADT).
Ipsen now plans to file an application for the drug to be used for this indication in the EU by the end of the year.
Stephane Thiroloix, Ipsen executive vice president, corporate development, said: “We are very pleased with the results of this clinical trial, which confirm the efficacy and the good safety profile of toremifene citrate 80mg.
“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.”
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