November 02, 2015
Kite Pharma Initiates ZUMA-1 Phase 2 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma (NHL) to Support Registration of KTE-C19
SANTA MONICA, Calif., Nov. 2, 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 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 email@example.com firstname.lastname@example.org