Kite Pharma, Inc., (KITE), today announced that the first patient in its Phase 1/2 clinical trial of KTE-C19 in patients with refractory aggressive NHL has been treated. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
“This is a very exciting time for Kite, and we’re grateful to the patients and clinical researchers who greatly contribute to the progress of our KTE-C19 program,” said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer. “We are at a pivotal moment for our Company and for the industry as a whole as we initiate the first company-sponsored clinical trial of CAR T-cell therapy in patients with refractory diffuse large B-cell lymphoma (DLBCL).”
Dr. Belldegrun continued, “Kite has met its goal of initiating the first company-sponsored clinical trial of KTE-C19 in the first half of this year and plans to commence an additional three trials of KTE-C19 before year-end. Our first study is expected to provide pivotal results in 2016, leading to the potential launch and commercialization of KTE-C19 in 2017.”
Kite’s Phase 1/2 clinical 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 DLBCL, primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL). Upon completion of the Phase 1 portion of the study, Kite expects to proceed with the Phase 2 portion that 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 T-cell therapy (eACT(TM)) designed to restore the immune system’s ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA.
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. Kite 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 Kite’s 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, commercially launching KTE-C19, and conducting additional clinical trials of KTE-C19. Various factors may cause differences between Kite’s expectations and actual results as discussed in greater detail under the heading “Risk Factors” in the Form 10-Q for the quarter ended March 31, 2015. Any forward-looking statements that Kite makes in this press release speak only as of the date of this press release. Kite assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.