Kite Pharma Initiates Phase II Clinical Study Of KTE-C19 (ZUMA-2) In Patients With Relapsed Or Refractory Mantle Cell Lymphoma (R/R MCL) To Support Registration For A Second Indication
SANTA MONICA, Calif., Nov. 9, 2015 (GLOBE NEWSWIRE) -- 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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