SANTA MONICA, CA, USA I November 2, 2015 I Kite Pharma, Inc. (KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) 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(TM)) 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.
SOURCE: Kite Pharma
Post Views: 98
SANTA MONICA, CA, USA I November 2, 2015 I Kite Pharma, Inc. (KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) 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(TM)) 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.
SOURCE: Kite Pharma
Post Views: 98
