May 21, 2015
Kite Pharma Announces That the First Patient in Its Phase 1/2 Clinical Trial Has Been Treated With KTE-C19, Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, for Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
"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.
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
Kite Pharma Cynthia M. ButittaChief Financial Officer and Chief Operating Officer 310-824-9999 For Media: Justin JacksonFor Investor Inquiries: Lisa Burnsand Carol Werther Burns McClellan212-213-0006 firstname.lastname@example.org email@example.com firstname.lastname@example.org
News Provided by Acquire Media