|Kite Pharma's Anti-CD19 Patients Experience Positive Results; Kips Bay Medical Receives Updated CE Mark Approval|
|By Staff and Wire Reports|
|Monday, 25 August 2014 18:47|
The findings from an ongoing Phase 1-2a clinical trial funded by Kite and conducted by the Surgery Branch of the National Cancer Institute (NCI) demonstrated that in 12 out of 13 evaluable patients with advanced B-cell malignancies, administration of anti-CD19 CAR T cells resulted in complete remission in eight patients and partial remission in four patients, representing an overall objective response rate of 92%. Of seven evaluable patients with chemotherapy-refractory DLBCL, four achieved complete remission, three of which are ongoing with durations ranging from 9 to 22 months. These findings are being published in an article titled, "Chemotherapy-refractory Diffuse Large B-cell Lymphoma and Indolent B-cell Malignancies Can Be Effectively Treated with Autologous T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor," DOI: 10.1200/JCO.2014.56.2025, which is appearing in the August 25, 2014 issue of the American Society of Clinical Oncology's Journal of Clinical Oncology.
Kite and the Surgery Branch of the NCI, led by Steven A. Rosenberg, M.D., Ph.D., are collaborating under a Cooperative Research and Development Agreement (CRADA) for the research and development of eACT™ based product candidates for the treatment of multiple cancer indications. The reported Phase 1-2a clinical trial is being conducted at the NCI with Dr. Rosenberg serving as principal investigator. Additional authors of the published study include James N. Kochenderfer, M.D., who presented earlier data for the NCI from the trial at the 55th American Society of Hematology (ASH) Annual Meeting in December 2013.
David Chang, M.D., Ph.D., Kite Pharma's Executive Vice President, Research and Development, and Chief Medical Officer, commented, "To date, Kite and the NCI have conducted an extensive program to investigate personalized T cell immunotherapies for blood cancers and solid tumors, including in patients with refractory DLBCL. Both the high overall response rate and the durability of the complete remissions are noteworthy, and we believe our anti-CD19-CAR T cell approach holds great potential for the treatment of B cell malignancies, including those with aggressive, resistant disease for which there are no viable treatment options."
Ronald Levy, M.D., Professor of Medicine, Director of the Lymphoma Program and Former Chief of the Division of Oncology at Stanford University and member of Kite's Scientific Advisory Board, commented, "I have been impressed by the results reported and updated from Dr. Rosenberg's group at the NCI. Particularly compelling are the frequency and the duration of the responses obtained in the difficult-to-treat patient population with relapsed, refractory lymphomas." Dr. Levy serves as a consultant to Kite and is helping to guide the Company in their upcoming clinical trials.
"We are greatly encouraged by the strong results we have seen from our joint lead clinical program with the NCI," commented Arie Belldegrun, M.D., FACS, Kite's President and Chief Executive Officer. "Based on this substantial progress, Kite plans to file an IND in the fourth quarter of this year to initiate a Phase 1-2 single-arm multicenter clinical trial of KTE-C19 in patients with DLBCL who have failed two or more lines of therapy. We are excited to advance this promising therapy and anticipate commencing patient enrollment in our DLBCL clinical trial in the first half of 2015."
Key Study Findings: The published clinical trial results relate to patients in the second cohort in the NCI's Phase 1-2a clinical trial of anti-CD19 CAR T cell therapy. The second cohort consists of 15 patients, including two retreated patients from a prior cohort, with advanced B cell malignancies, of which 13 were evaluable for responses, including seven with chemotherapy-refractory DLBCL.
Patients received a conditioning regimen of chemotherapy (cyclophosphamide and fludarabine) followed one day later by a single infusion of anti-CD19-CAR T cells. The CAR-expressing T cells were produced from each patient's own peripheral blood mononuclear cells (PBMCs), modified using a gammaretroviral vector encoding the CAR, as well as a CD28 costimulatory moiety.
Of the seven evaluable chemotherapy-refractory DLBCL patients, six showed a response (four complete remissions and two partial remissions), and one had stable disease.
Kips Bay Medical, Inc. (Nasdaq: KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting, or CABG, surgery, announced it has received an updated CE Mark approving use of a new surgical implant technique for its eSVS Mesh.
Feasibility Study Update: On August 20, 2014, the Company received an updated CE Mark approval from its notified body. This updated approval will allow the Company's European study sites to enroll patients in the Company's eMESH I clinical feasibility trial using the changes in the application of the eSVS Mesh to the saphenous vein graft and to the surgical implant technique that were approved by the United States Food and Drug Administration (FDA) in March of this year.
These changes were based upon the Company's consultations with medical advisors and several of the cardiac surgeons participating in the eMESH I clinical feasibility trial and the Company's initial review of early results from the eMESH I trial. The changes are intended to reduce the variables in the study and the risk of early graft occlusion. Kips Bay also believes these changes will simplify the process of applying and implanting the eSVS Mesh thereby reducing procedural costs.
With this updated CE Mark approval, seven European study sites are now able to enroll study patients in the eMESH I clinical feasibility study using the new implant technique. Three additional international sites have received ethics committee approval and are in the process of finalizing clinical trial agreements in order to begin enrollment, which is expected to commence during the third quarter.
Kips Bay currently has five study sites in the United States, which include the Mayo Clinic, the Cleveland Clinic, Emory University, the Lenox Hill Hospital and the Northeast Georgia Medical Center, that are recruiting patients for the trial, and one additional site is expected to be recruiting within the next 60 days.
The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein graft (SVG) support using the Company's eSVS Mesh in coronary artery bypass grafting surgery. The objective of the eMESH I clinical feasibility trial is to demonstrate to the FDA the initial safety and performance of the eSVS Mesh for use as an external SVG support device during CABG surgery. If the feasibility trial is successful, the Company intends to use the data from this study as the basis for the filing of a request for an investigational device exemption, or IDE, to perform a larger pivotal study. The pivotal study is required to demonstrate clinical effectiveness and support a premarket approval application filing with the FDA seeking approval to sell the eSVS Mesh in the United States.
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Kips Bay Medical, Inc. (Nasdaq:KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting, or CABG, surgery, today announced that it has received an updated CE Mark approving use of a new surgical implant technique for its eSVS Mesh.
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 publication of clinical results in a cohort of patients demonstrating the potential to treat aggressive non-Hodgkin's lymphoma with an anti-CD19 chimeric antigen receptor (CAR) T cell therapy.
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