Kura Oncology Initiates Phase 2 Study of Tipifarnib in Peripheral T-cell Lymphoma

September 30, 2015 at 7:31 AM EDT
Second of Two Planned Company Sponsored Phase 2 Trials for Tipifarnib

LA JOLLA, Calif., Sept. 30, 2015 (GLOBE NEWSWIRE) -- 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, today announced it has initiated a Phase 2 clinical trial of tipifarnib in patients with peripheral T-cell lymphoma (PTCL).

"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."

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.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines for the treatment of solid tumors and blood cancers. Kura's pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. The company's lead drug candidate is tipifarnib, a farnesyl transferase inhibitor that is currently in two Phase 2 clinical studies: the first in patients with locally advanced tumors that carry HRAS mutations and the second in patients with peripheral T-cell lymphoma. The company's preclinical pipeline includes KO-947, an ERK inhibitor, and a menin-MLL inhibitor program. More information about Kura Oncology may be found at www.kuraoncology.com.

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 and Kura Oncology's other compounds and product candidates, the conduct and results 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 pre-clinical studies or clinical trials, the risk that Kura Oncology may not obtain approval to market its product candidates, uncertainties associated with regulatory filings and applications, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further research, clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," " "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

         Robert H. Uhl
         Managing Director
         Westwicke Partners, LLC
         (858) 356-5932

         Mark Corbae
         Vice President
         Canale Communications
         (619) 849 5375

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