Kite Pharma Initiates the ZUMA-3 Study to Support Registration of KTE-C19 for Relapsed or Refractory (r/r) Acute Lymphoblasti...
December 02 2015 - 8:00AM
Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical
company focused on developing engineered autologous cell therapy
(eACT™) products for the treatment of cancer, today announced that
it has initiated a phase 1/2 clinical study of KTE-C19 (ZUMA-3) for
the treatment of adult patients with r/r ALL. 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 an important milestone this year, with the
initiation of our third company-sponsored clinical trial for our
lead product candidate, KTE-C19," said Arie Belldegrun, M.D., FACS,
Chairman, President and Chief Executive Officer. "The breadth of
our KTE-C19 registration program underscores our commitment to
addressing critical unmet needs in cancer treatment. We are
grateful to all the patients, caregivers, and members of the
medical community who have participated in our clinical
programs."
ZUMA-3 will proceed as a single-arm, open-label, multi-center
study in patients with ALL whose disease is refractory to or has
relapsed following standard chemotherapy or hematopoietic stem cell
transplantation. The phase 1 portion of ZUMA-3 will assess the
safety of KTE-C19, and the phase 2 portion will assess
efficacy and safety. The study will target to enroll a
total of 75 patients. Additional details about this study can be
found on ClinicalTrials.gov, using Identifier NCT: 02614066.
About Kite's ZUMA Clinical Programs
Kite is advancing three single-arm, multi-center clinical trials
to support registration of KTE-C19:
- ZUMA-1 is a phase 2 study in patients with
refractory, aggressive non-Hodgkin's lymphoma (NHL), including
refractory diffuse large B-cell lymphoma (DLBCL), primary
mediastinal B-cell lymphoma (PMBCL), and transformed follicular
lymphoma (TFL).
- ZUMA-2 is a phase 2 study in patients with r/r
mantle cell lymphoma.
- ZUMA-3 is a phase 1/2 study in adult patients
with r/r ALL.
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 ability to advance multiple clinical trials of KTE-C19
and 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 September 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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