On January 17, 2017 Kura Oncology, Inc. (Nasdaq:KURA), a clinical stage biopharmaceutical company, reported that the first patient has been dosed in its Phase 2 clinical trial of tipifarnib in patients with chronic myelomonocytic leukemia (CMML) (Press release, Kura Oncology, JAN 17, 2017, View Source [SID1234517423]). Schedule your 30 min Free 1stOncology Demo! "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 Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura Oncology.
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"New pharmaceutical treatments are urgently needed to combat this rare disease," said Eric Padron, M.D., of the Department of Hematologic Malignancies at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, a clinical investigator on this study. "Given the previous results obtained with tipifarnib in this setting and the potential to identify genetic biomarkers to prospectively select patients in future studies, we are excited to evaluate tipifarnib as a potential therapeutic for CMML."
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 the United States. These patients generally have a poor prognosis due to limited therapeutic options with only a 29% survival rate three years after diagnosis.
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, Kura Oncology is seeking to identify patients most likely to benefit from tipifarnib.