GTx' Acapodene trials get DSMB approval

Tennesee, USA-based men's health biotechnology firm GTx says that an independent Data Safety Monitoring Board has recommended that Phase III trials of Acapodene (toremifene citrate), a selective estrogen receptor modulator, continue as per the issued protocols. Currently, the drug is being assessed as a treatment for the multiple side effects of androgen deprivation therapy for prostate cancer, and as a cholesterol-lowering agent.

As Mitchell Steiner, GTx' chief executive explained, the DSBM approval is based on safety data from approximately 2,900 patients. He went on to say that the decision reduces the inherent risks associated with the development of the product, before adding that "there are more than 350,000 patient years of experience with toremifene 60mg, which has already been approved for the treatment of advanced breast cancer." Mr Steiner said that the pre-existing safety data will be a critical component in the regulatory filing that the firm is aiming to carry out in 2008.

GTx is also developing the drug as a preventative therapy designed to reduce the risk of prostate cancer in men with high-grade prostatic interepithelial neoplasia.