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Kite Pharma Initiates the ZUMA-3 Study to Support Registration of KTE-C19 for Relapsed or Refractory (r/r) Acute Lymphoblastic Leukemia (ALL) in Adult Subjects

SANTA MONICA, Calif., Dec. 2, 2015 (GLOBE NEWSWIRE) -- 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

Source:Kite Pharma, Inc.