Kura Oncology Doses First Patient in Phase 2 Study of Tipifarnib in Chronic Myelomonocytic Leukemia
“Objective responses, including complete responses, have been previously observed with tipifarnib in CMML. Our goals with this Phase 2 study are to confirm the level of activity of tipifarnib in this patient population as well as to validate biomarker hypotheses that may allow us to identify those patients most likely to experience durable responses,” said
“New pharmaceutical treatments are urgently needed to combat this rare disease,” said
This Phase 2 clinical trial is designed to enroll approximately 20 patients with CMML and will evaluate the antitumor activity of tipifarnib in terms of overall response rate. Patients will receive tipifarnib administered orally, twice a day for 7 days in alternating weeks in 28 day cycles. Patient samples will be analyzed for the presence or absence of various biomarkers potentially relevant to the activity of tipifarnib. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT02807272.
About Chronic Myelomonocytic Leukemia
CMML is a clonal disorder of bone marrow stem cells that shares characteristics of both myeloproliferative and myelodysplastic diseases. CMML is characterized by increased monocytes and blasts in the peripheral blood and bone marrow, as well as dysplasia in at least one type of blood cell. CMML is estimated to have an annual incidence of approximately 1,400 patients in
About Tipifarnib
Kura Oncology’s lead program, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology,
About
Forward Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the potential utility of tipifarnib, KO-947 and KO-539, the conduct, results and timing of clinical trials and plans regarding future research and development. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that
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