Gimatecan (ST1481) is an orally active camptothecin analog which interacts with the Topoisomerase I-DNA complex,inducing S-phase specific cytotoxicity.Gimatecan has been very well tolerated in more than 500 patients treated with the drug in phase Ⅰ and Ⅱ programs, showing a well defined and manageable safety profile.In particular, Gimatecan resuted of potential therapeutic interest in gynaecological malignancies.In fact a phase Ⅱ study in progressive or recurrent advanced epithelial ovarian, fallopian tube or peritoneal cancer has been completed with 69 heavily pre-treated evaluable patients of which 50 had either platinum-resistant or refractory disease.In this poor prognosis population 17 patients (24.6%) achieved a Partial Response (PR) by CA-125 criteria and/or RECIST as assessed by a panel of independent radiologists and 22 patients (31.9%) achieved stable disease (SD), with a median duration (PR + SD) of 27.3 weeks, for an overall benefit (PR + SD) of 56.5%.The overall benefit was 48% and 79%,when considering the platinum refractory/resistant and the partially sensitive subgroups.OS was 12.4, 23.3 and 16.2 months in the platinum resistant, platinum partially sensitive and overall population, respectively.Moreover, Gimatecan is potentially active in endometrial cancer and breast cancer where activity has also been documented.These efficacy results together with a good acceptance of the oral treatment by the patients and a manageable toxicity profile suggest Gimatecan as a promising new agent in heavily pretreated ovarian cancer patients and justify further clinical development of the study drug more broadly in gynecological cancer indications.A specific development effort is being pursued in China to explore this opportunity.