Kura Oncology Announces First Patient Dosed in an Investigator-Sponsored Phase 2 Trial of Tipifarnib in Patients With HRAS Mutant Urothelial Cancer

Kura Oncology, Inc.

, today announced that the first patient has been dosed in an investigator-sponsored Phase 2 trial of its lead drug candidate, tipifarnib, an inhibitor of protein farnesylation, in cancer patients with urothelial carcinoma tumors characterized by HRAS mutations. The study is being conducted under the direction of Se Hoon Park, M.D., Ph.D. in the Division of Hematology-Oncology at the Samsung Medical Center in Seoul, South Korea. "This study, in combination with our ongoing Phase 2 study in HRAS mutant tumors, should provide further insight into tipifarnib's activity in HRAS mutant tumors and broaden our understanding of its mechanism of action," said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura Oncology. "We are pleased to support the efforts of Dr. Park and his colleagues at the Samsung Medical Center." "The development of new drugs for patients with refractory urothelial cancer is an important unmet medical need," said Dr. Park, lead investigator of the study. "There is a compelling scientific rationale to evaluate the role of HRAS and the activity of tipifarnib in this setting." The primary objective of the Phase 2 study is to investigate the antitumor activity, in terms of objective response rate, of tipifarnib in patients with locally advanced, unresectable or metastatic, relapsed and/or refractory urothelial cancer tumors that carry HRAS mutations. Secondary objectives include evaluation of progression-free survival, duration of response and safety. It is planned that the study will enroll up to 18 patients.