On September 30, 2015 Kura Oncology, Inc. (OTCQB:KURO), a clinical stage biopharmaceutical company advancing a pipeline of precision medicines for the treatment of solid tumors and blood cancers, reported it has initiated a Phase 2 clinical trial of tipifarnib in patients with peripheral T-cell lymphoma (PTCL) (Press release, Kura Oncology, SEP 30, 2015, View Source [SID:1234507618]). Schedule your 30 min Free 1stOncology Demo! "I’m delighted that the second of our two planned company sponsored Phase 2 trials for tipifarnib is now underway," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "This study, along with the Phase 2 trial we initiated in May in advanced cancers with HRAS mutations, is an important part of our strategy to identify patients most likely to benefit from tipifarnib, a compound that has previously demonstrated durable responses in subsets of cancer patients."
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PTCL consists of a group of rare and usually aggressive forms of non-Hodgkin’s lymphoma (NHL) that develop from mature T-cells. PTCL is estimated to have an annual incidence in the U.S of 2,800-7,200 patients. These patients generally have a poor prognosis with a low response rate to available treatment options and commonly experience repeated treatment failures.
A previous Phase 2 trial of tipifarnib, sponsored by the National Cancer Institute, was conducted at the Mayo Clinic and University of Iowa in adult patients with relapsed or refractory lymphoma (Blood. 2011 Nov 3; 118(18): 4882-4889). That study demonstrated that tipifarnib can be administered for prolonged periods and may produce durable responses as a single agent in relapsed lymphoma in a group of patients who were heavily pretreated, including those with PTCL.
The primary objective of the current Phase 2 study sponsored by Kura Oncology is to evaluate the efficacy of tipifarnib as a treatment for patients with relapsed or refractory PTCL. The Phase 2 trial is designed to enroll up to 18 patients to test the primary study objective, and the study includes a potential extension of up to 30 patients in total. Additional information about this clinical trial is available at clinicaltrials.gov using identifier: NCT02464228.
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 compelling and durable anti-cancer activity in certain patient subsets and a well-established safety profile. Preclinical and clinical data suggest that, in the right genetic 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, 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.