LA JOLLA, Calif., June 14, 2017 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced that clinical and preclinical data for tipifarnib in the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) was presented at the International Conference on Malignant Lymphoma (ICML) being held June 14-17, 2017 in Lugano, Switzerland.
Kura Oncology is conducting preclinical and clinical development studies in clinical indications where tipifarnib has previously shown signs of activity with the goal to identify and validate biomarkers associated with the observed clinical activity of tipifarnib. The preliminary Phase 2 clinical data presented at ICML indicate that tipifarnib has antitumor activity in PTCL, particularly in patients with angioimmunoblastic T-cell lymphoma (AITL) histology and PTCL-NOS (Not Otherwise Specified) histology with high levels of CXCL12 gene expression and absence of single nucleotide gene variations in the 3'-untranslated region of the CXCL12 gene.
“Patients with PTCL have a poor overall survival of about 40%. Effective options for relapsed patients are limited and new drugs with novel mechanisms of action are needed,” said Thomas Witzig, M.D., Professor of Medicine at the Mayo Clinic and a lead investigator on the study. “The preliminary results of this study are exciting because they may define a molecular mechanism of action and characterize a subgroup of patients that derive significantly greater clinical benefit from a targeted therapy such as tipifarnib.”
“These results identify the CXCL12/CXCR4 pathway as a potential target of tipifarnib. CXCL12 is secreted in large amounts by lymph nodes, bone marrow stroma, liver, and lung, and plays key roles in tumor invasion, bone marrow homing and site of metastasis. Its receptor, CXCR4, signals in part through HRAS, a protein that is uniquely farnesylated, and it is one of the most frequently over-expressed chemokine receptors in malignant cells,” said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer at Kura Oncology. “Based on our preliminary data, we believe CXCL12/CXCR4 may have the potential to unlock the therapeutic value of farnesyl transferase inhibition in a number of tumor indications.”
Patients in the Phase 2 study received tipifarnib 600 mg orally twice daily on days 1-7 and 15-21 in 28-day cycles. Among the 18 patients in stages 1 and 2 of this trial, 3 achieved a partial response (PR), and two of the PRs occurred in the two patients on study with AITL. An additional 4 patients had meaningful tumor size reductions and prolonged disease stabilization. In addition, tipifarnib was generally well-tolerated with adverse events consistent with its known safety profile and no patient discontinued due to adverse events. The Phase 2 study has been extended to enroll an additional 12 patients with AITL histology aimed at confirming the preliminary observations and validating CXCL12 as a biomarker of tipifarnib activity.
The preliminary results from the Phase 2 study in PTCL were also selected for a poster presentation at the 22nd Congress of the European Hematology Association (EHA) taking place June 22-25, 2017 in Madrid, Spain.
About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The company’s pipeline consists of small molecule drug candidates 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. Kura Oncology’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple Phase 2 clinical trials. Kura’s pipeline also includes KO-947, an ERK inhibitor, currently in a Phase 1 trial, and KO-539, an inhibitor of the menin-MLL protein-protein interaction, currently in preclinical testing. For additional information about Kura Oncology, please visit the company’s website 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 activity, tolerability and utility of tipifarnib, the conduct, results and timing of pre-clinical studies and clinical trials and plans regarding future research and development activities. 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 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 third parties to successfully conduct clinical trials within and outside the United States and for development and commercialization of product candidates. You are urged to consider statements that include the words "may," "might," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "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.