On June 16, 2016 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company, reported the first patient has been dosed in a Phase 2 clinical trial of tipifarnib in patients with lower risk myelodysplastic syndromes (MDS) (Press release, Kura Oncology, JUN 16, 2016, View Source [SID:1234513434]). Schedule your 30 min Free 1stOncology Demo! "We believe there is a significant unmet need for therapies targeting MDS," said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura Oncology. "We were encouraged by data from a previous Phase 2 trial of tipifarnib conducted by Johnson & Johnson that showed modest activity of this agent in the overall population of patients with intermediate to high risk MDS. Using translational medicine methodologies, we identified potential predictive biomarkers of this activity, and one key goal of this study is to validate the ability of those biomarkers to identify the patients most likely to benefit from tipifarnib."
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Patients with MDS, a group of diverse bone marrow disorders, suffer from a dearth of treatment options and the development of new drugs is vital to combat the disease," said Joseph G. Jurcic, M.D., Professor of Medicine and principal investigator at Columbia University Medical Center. "The analyses from previous studies provide a strong rationale for evaluating tipifarnib in this indication."
MDS is a group of hematopoietic stem cell malignancies with significant morbidity and mortality. MDS is characterized by ineffective blood cell production, or hematopoiesis, leading to low blood cell counts, or cytopenias, and a high risk of progression to acute myeloid leukemia. MDS is estimated to have an annual incidence of approximately 13,000 patients in the United States. These patients generally have a poor prognosis due to the low response rate to available treatment options.
The trial is designed to enroll approximately 58 patients and will evaluate tipifarnib as a treatment for patients with lower risk myelodysplastic syndromes. 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: NCT02779777.
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 will seek to identify patients most likely to benefit from tipifarnib. Kura Oncology holds an exclusive license to develop and commercialize tipifarnib in the field of oncology, under an agreement with Janssen Pharmaceutica NV.