SGX stops Ph II/III Troxatyl AML study

US drugmaker SGX Pharmaceuticals says that it has discontinued its Phase II/III trial of Troxatyl (troxacitabine) based on the recommendations of an independent safety monitoring board. The interim data from the study, which was an assessment of the drug as a third-line treatment for acute myelogenous leukemia, indicated that response-rates were unlikely to demonstrate a therapeutic benefit. The company stressed that the decision to stop the trial was due to a lack of evidence for clinical efficacy, rather than any safety concerns.

SGX originally acquired worldwide rights to the drug from UK firm Shire Pharmaceuticals in 2004 (Marketletters passim). The firm's president, Mike Grey, said that, "although we are disappointed with the results of Troxatyl in this very difficult to treat third-line AML population, Troxatyl has produced interesting clinical results in other indications and we remain optimistic for its potential in these other indications." He added that the firm would carry out a detailed review of the data to determine the most appropriate development path for the drug.