Oncology and immunology specialist Tiziana Life Sciences has exclusively licensed milciclib from Nerviano Medical Sciences Group, an Italian cancer therapy company.
Milciclib blocks the action of cyclin-dependent kinases, specific enzymes involved in cell division as well as a number of other protein kinases. It is currently in Phase II trials for thymic carcinoma in patients previously treated with chemotherapy, and has demonstrated that it is well-tolerated in over 263 patients in Phase I and II trials. It has been granted orphan designation by the European Commission and the US Food and Drug Administration to treat malignant thymoma/thymic epithelial tumors. Tiziana intends to initiate a Phase III study in this indication in 2016, if the ongoing phase II trial is successful.
Preclinical studies by Nerviano have shown that milciclib has potential in other cancer indications, specifically breast and liver. Tiziana plans to immediately enroll patients into a Phase II trial in hepatocellular carcinoma and will explore the potential for the same in breast cancer.
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