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Kura Oncology to unveil data presentation on Tipifarnib at the upcoming ASH meeting

Published: 09:27 03 Dec 2015 EST

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Kura shares have lost 47% this year.

Kura Oncology (NASDAQ:KURA), a clinical stage biopharmaceutical company, unveiled that new data from a Phase 3 trial of tipifarnib, the company's lead product candidate, will be presented at the 57th American Society of Hematology (ASH) annual meeting and exposition to be held in Orlando, December 5-8.

Tipifarnib as maintenance therapy in Acute Myeloid Leukemia (AML) improves survival in a subgroup of patients with high risk disease, the La Jolla, California-based company said in a statement on Thursday.

Results of the Phase 3 Intergroup Trial E2902 is described in abstract # 1308.

The abstract describes results from the ECOG-ACRIN Cancer Research Group's (ECOG-ACRIN) Phase 3 trial E2902, which compared tipifarnib as maintenance therapy to observation only with respect to disease-free survival in patients with AML in second or subsequent complete remission, in complete remission following primary induction failure, or patients 60 years of age or older in first complete remission.

Researchers in these groups designed and conducted trial E2902 independent of Kura Oncology and with sole sponsorship from the National Cancer Institute, part of the National Institutes of Health.

Between August 2004 and December 2009, 144 patients with AML were enrolled in the study at multiple medical facilities (sites) across the United States, as well as one site in Israel and one site in Peru, through ECOG-ACRIN, the Alliance for Clinical Trials in Oncology and SWOG.

The median age of patients was 69 years (range 28-86), 73 patients (51%) were male and 135 patients (94%) were white.

Ninety-one percent of patients were 60 years of age or older. A majority of patients enrolled on the study (70%) were in first complete remission (CR).

Eighty patients (56%) had post remission chemotherapy prior to randomization.

"The results are exciting and suggest that tipifarnib, when administered in this fashion, provides a survival benefit to a significant group of patients with AML who otherwise have a high risk of relapse," said lead investigator Selina M. Luger, MD from the University of Pennsylvania.

"We are encouraged by the outcomes of this study," said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura Oncology.

The ECOG-ACRIN Cancer Research Group is a membership-based scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer. Its research is supported primarily by federal funding through the National Cancer Institute.

Kura shares closed at $7.99 on Wednesday, down 47% this year.

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