Kite Pharma Initiates Phase 2 Clinical Study of KTE-C19 (ZUMA-2) in Patients With Relapsed or Refractory Mantle Cell Lymphoma...
November 09 2015 - 8:00AM
Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical
company focused on developing engineered autologous T cell therapy
(eACT™) products for the treatment of cancer, today announced that
it has initiated a phase 2 clinical study of KTE-C19 (ZUMA-2) for
the treatment of r/r MCL. KTE-C19 is an investigational therapy in
which a patient's T cells are genetically modified to express a
chimeric antigen receptor designed to target the antigen CD19, a
protein expressed on the cell surface of B-cell lymphomas and
leukemias. In addition to ZUMA-2, Kite recently initiated a phase 2
clinical study of KTE-C19 (ZUMA-1) in patients with refractory,
aggressive non-Hodgkin's lymphoma (NHL).
"This phase 2 study in r/r MCL will address an unmet need in
patients who have failed prior therapies," said Arie Belldegrun,
M.D., FACS, Chairman, President and Chief Executive Officer. "In
addition to ZUMA-1 in refractory, aggressive NHL and ZUMA-2 in r/r
MCL, we expect to initiate two additional pivotal KTE-C19 studies
in acute lymphoblastic leukemia by the end of this year."
ZUMA-2 will proceed as a single arm, open-label, multi-center
study, designed to determine the efficacy and safety of KTE-C19 in
patients with MCL whose disease is refractory to or has relapsed
following anthracycline- or bendamustine-containing chemotherapy
and anti-CD20 monoclonal antibody therapy and ibrutinib. This study
plans to enroll 70 subjects. Additional details about this
study will soon be posted to ClinicalTrials.gov.
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company
engaged in the development of novel cancer immunotherapy products,
with a primary focus on engineered autologous T cell therapy
(eACT™) designed to restore the immune system's ability to
recognize and eradicate tumors. Kite is based in Santa Monica, CA.
For more information on Kite Pharma, please visit
www.kitepharma.com. Sign up to follow @KitePharma on Twitter at
www.twitter.com/kitepharma.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. We may, in some cases, use terms
such as "predicts," "believes," "potential," "proposed,"
"continue," "estimates," "anticipates," "expects," "plans,"
"intends," "may," "could," "might," "will," "should" or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Forward-looking statements
include statements regarding our intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: the timing of initiating two additional pivotal KTE-C19
studies in acute lymphoblastic leukemia (ALL), and the ability to
obtain regulatory approval based on the studies of KTE-C19. Various
factors may cause differences between Kite's expectations and
actual results as discussed in greater detail in Kite's filings
with the Securities and Exchange Commission, including without
limitation in its Form 10-Q for the quarter ended June 30, 2015.
Any forward-looking statements that we make in this press release
speak only as of the date of this press release. We assume no
obligation to update our forward-looking statements whether as a
result of new information, future events or otherwise, after the
date of this press release.
CONTACT: Kite Pharma
Cynthia M. Butitta
Chief Financial Officer and Chief Operating Officer
310-824-9999
For Media: Justin Jackson
For Investor Inquiries: Lisa Burns
Burns McClellan
212-213-0006
jjackson@burnsmc.com
lburns@burnsmc.com
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