Kura Oncology Presents Preliminary Clinical and Preclinical Data for Tipifarnib in the Treatment of Relapsed or Refractory Pe...
June 14 2017 - 7:30AM
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.
CONTACT INFORMATION
INVESTOR CONTACT:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com
CORPORATE COMMUNICATIONS CONTACT:
Mark Corbae
Vice President
Canale Communications
(619) 849-5375
mark@canalecomm.com
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