Kite Pharma Initiates ZUMA-1 Phase 2 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma (NHL) to Support Registra...
November 02 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 opened enrollment for the Phase 2 portion of its ongoing
Phase 1/2 clinical trial (ZUMA-1) of KTE-C19 in patients with
refractory, aggressive NHL. 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.
"Kite has achieved a pivotal milestone with the initiation of
our Phase 2 KTE-C19 multi-center clinical trial in DLBCL. We are
deeply grateful to the patients and clinical researchers who have
participated in our program. We look forward to presenting top-line
data from the Phase 1 portion of the trial at ASH and anticipate
reporting interim results from the study next year," said Arie
Belldegrun, M.D., FACS, Chairman, President and Chief Executive
Officer.
Dr. Belldegrun continued, "With inputs from regulatory agencies,
we designed ZUMA-1 to enable market registration of KTE-C19
for refractory, aggressive NHL. Based on our progress and
current timelines, Kite remains on track towards potential launch
and commercialization of KTE-C19 in 2017."
Kite's ZUMA-1 trial of KTE-C19 is a single arm, open-label,
multi-center study, designed to determine the safety and efficacy
of KTE-C19 in patients with refractory diffuse large B-cell
lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or
transformed follicular lymphoma (TFL). Kite expects that the Phase
2 portion of the trial will include a total of approximately 112
patients. Additional information about Kite's Phase 1/2 study
may be found at ClinicalTrials.gov, using Identifier NCT:
02348216.
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 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 success and timing of the Phase 1/2 KTE-C19 clinical
trial for the treatment of DLBCL, PMBCL and TFL, obtaining results
from the trial, and obtaining regulatory approval and commercially
launching 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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