December 22, 2014
Kite Pharma Submits Investigational New Drug Application for Phase 1/2 Trial of KTE-C19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, for the Treatment of Refractory Aggressive Non-Hodgkin Lymphoma
SANTA MONICA, Calif., Dec. 22, 2014 (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 the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 1/2 study of KTE-C19, the Company's investigational anti-CD19 CAR T cell therapy, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL).
KTE-C19 is Kite Pharma's lead product candidate in which a patient's T cells are genetically modified using a gammaretroviral vector to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. As previously reported, a Phase 1/2 clinical study of anti-CD19 CAR T cell therapy at the National Cancer Institute has shown broad anti-tumor activity across a range of advanced B cell malignancies. More information on Kite's CAR technology can be found at this link.
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 eACT™ designed to restore the immune system's ability to recognize and eradicate tumors. In partnership with the NCI Surgery Branch through a Cooperative Research and Development Agreement (CRADA), Kite is advancing a pipeline of proprietary eACT™ product candidates, both CAR and TCR (T cell receptor) products, directed to a wide range of cancer indications. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
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 ongoing and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation of our clinical trial of KTE-C19; the ability and willingness of the NCI to continue research and development activities relating to eACT™ pursuant to the CRADA; our expectations regarding the clinical effectiveness and safety of our product candidates and results of the NCI's clinical trials; and the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates and advancing a clinical trial 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, 2014. 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 Contacts: Cynthia M. Butitta Chief Financial Officer and Chief Operating Officer 310-824-9999 For Media: Justin Jackson For Investor Inquiries: Nancy Yu Burns McClellan (212) 213-0006 firstname.lastname@example.org email@example.com