Diatos' cancer drug enters Ph II trials

Paris, France-based Diatos SA has recruited the first patient into a Phase II clinical trial program testing DTS-201, a peptidic prodrug of doxorubicin. Two international studies will evaluate the safety and efficacy of DTS-201 as a second-line therapy for patients with hormone-refractory prostate cancer and as first-line therapy in human epidermal growth factor receptor-2-negative metastatic breast cancer.

The first patient has been treated in the clinical Phase II study of DTS-201 for hormone-refractory prostate cancer patients. It is an open-label, multicenter, single-arm study conducted in eight investigational centers across Italy, France and Belgium. The primary objective is to determine a reduction in prostate-specific antigen. Safety, time to PSA progression, tumor response for measurable lesions, duration of response, progression-free survival and overall survival will be evaluated as secondary objectives.

A second trial, a pilot Phase II study, will begin shortly, assessing the overall objective response rate of DTS-201 in locally-advanced and metastatic breast cancer. Safety, duration of response and progression-free survival will be assessed as secondary objectives. Four breast cancer centers have been opened in South Africa to undertake this open-label breast cancer evaluation.