PUBLIC RELEASE DATE:
25-Aug-2014
Contact: Justin Jackson jjackson@burnsmc.com 212-213-0006 x327 Burns McClellan
Santa Monica, CA August 25, 2014 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. Kite's most advanced product candidate, KTE-C19, is an anti-CD19 CAR T cell therapy that involves genetically modifying a patient's T cells to express a CAR that is designed to target CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.
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
Continued here:
Kite Pharma announces positive results in patients with aggressive non-Hodgkin's lymphoma
- Goodie Mob - Cell Therapy Instrumental - April 2nd, 2011 [April 2nd, 2011]
- Dogged by pain -- stem cell therapy for dogs - April 3rd, 2011 [April 3rd, 2011]
- SIRA: Could Stem Cell Therapy Renew Your Body Cells? – Affordable ... - April 22nd, 2011 [April 22nd, 2011]
- SIRA: Could Stem Cell Therapy Renew Your Body Cells? - April 22nd, 2011 [April 22nd, 2011]
- Stem Cell Therapy for Kidney Failure - May 13th, 2011 [May 13th, 2011]
- Dogs now getting stem cell therapy - May 19th, 2011 [May 19th, 2011]
- Goodie Mob - Cell Therapy Official Music Video (VJ CodyDietz.com ReMiX) - May 20th, 2011 [May 20th, 2011]
- Stem Cell Therapy for Autism - May 20th, 2011 [May 20th, 2011]
- Dog Undergoes Stem Cell Therapy - May 20th, 2011 [May 20th, 2011]
- Stem Cell Therapy for Cerebral Palsy - May 22nd, 2011 [May 22nd, 2011]
- Stem Cell Therapy for Type II Diabetes - May 31st, 2011 [May 31st, 2011]
- Stem Cell Therapy Success - May 31st, 2011 [May 31st, 2011]
- Heart Failure Patient After Adult Stem Cell Therapy - June 1st, 2011 [June 1st, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis - June 3rd, 2011 [June 3rd, 2011]
- Stem Cell Therapy for Critical Limb Ischemia - June 12th, 2011 [June 12th, 2011]
- Stem Cell Therapy Cream: Less Wrinkles In 30 Days or Less Anti-Wrinkle Cream That Works - June 12th, 2011 [June 12th, 2011]
- Stem Cell Therapy for Multiple Sclerosis - June 13th, 2011 [June 13th, 2011]
- Clinical Advances in Adult Stem Cell Therapy: Dr. Jorge Paz - June 17th, 2011 [June 17th, 2011]
- Stem Cell Injection Treatment - Stem Cell Therapy - June 21st, 2011 [June 21st, 2011]
- Stem Cell Therapy for Spinal Cord Injury - Injured Airline Pilot Flies Again - July 1st, 2011 [July 1st, 2011]
- Documentary: Stem Cell Therapy for Muscular Dystrophy - Ryan Benton's Story - July 1st, 2011 [July 1st, 2011]
- Documentary: Stem Cell Therapy for Muscular Dystrophy - Ryan Benton's Story - July 1st, 2011 [July 1st, 2011]
- XCell-Center Stem Cell Therapy Christmas Video 2010 - July 2nd, 2011 [July 2nd, 2011]
- Stem Cell Therapy for Stroke - Gary Steinberg, Stanford University - July 9th, 2011 [July 9th, 2011]
- Stem Cell Therapy Injections - July 9th, 2011 [July 9th, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl - July 13th, 2011 [July 13th, 2011]
- Adult Stem Cell Therapy Clinical Advances - Dr. Jorge Paz in San Diego, CA March 2011 - July 14th, 2011 [July 14th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Rationale - July 15th, 2011 [July 15th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Rationale - July 15th, 2011 [July 15th, 2011]
- Stem Cell Therapy--Hillcrest Animal Hospital - July 18th, 2011 [July 18th, 2011]
- Regenerative Medicine With Stem Cell Therapy Injections at an Arizona pain clinic (602) 507-6550 - July 19th, 2011 [July 19th, 2011]
- Bone Marrow Aspiration - Stem Cell Therapy - July 19th, 2011 [July 19th, 2011]
- The New World of Medicine: Stem Cell Therapy - July 29th, 2011 [July 29th, 2011]
- Post Stem Cell Therapy Video for Cerebral Palsy - August 3rd, 2011 [August 3rd, 2011]
- Lou Gehrig's Disease (ALS): Stem Cell Therapy - A Patient's Perspective - August 5th, 2011 [August 5th, 2011]
- Lou Gehrig's Disease (ALS): Stem Cell Therapy - A Patient's Perspective - August 5th, 2011 [August 5th, 2011]
- Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com - August 9th, 2011 [August 9th, 2011]
- WAVE3 News Adipose Stem Cell Therapy - August 14th, 2011 [August 14th, 2011]
- Embryonic stem cell therapy in China (www.esctherapy.com) - August 17th, 2011 [August 17th, 2011]
- Ying Liu discusses IPS cell therapy for ALS - August 17th, 2011 [August 17th, 2011]
- KO Clancy - August 24th, 2011 [August 24th, 2011]
- Stem cell therapy in Guatemala - (closer than China) - August 26th, 2011 [August 26th, 2011]
- ATP Cell Therapy - August 27th, 2011 [August 27th, 2011]
- Dr. Craig Saunders Adult Stem Cell Therapy - August 28th, 2011 [August 28th, 2011]
- Spinal Cord Injury - Stem Cell Therapy - August 29th, 2011 [August 29th, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia - September 13th, 2011 [September 13th, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia - September 13th, 2011 [September 13th, 2011]
- Stem Cell Therapy (Regenerative Medicine) in New Jersey - September 17th, 2011 [September 17th, 2011]
- Clinical Advances in Adult Stem Cell Therapy - Dr. Jorge Paz Rodriguez (Miami) - September 23rd, 2011 [September 23rd, 2011]
- Stem Cell Therapy Skin Repair and Anti-Wrinkle Cream - September 25th, 2011 [September 25th, 2011]
- Cardiac Stem Cell Therapy - September 26th, 2011 [September 26th, 2011]
- Adult Stem Cell Therapy for Multiple Sclerosis - September 26th, 2011 [September 26th, 2011]
- SENS5 - Cellular Therapy for Intestinal Regeneration - September 29th, 2011 [September 29th, 2011]
- channel 10 news stem cell therapy for hair loss part 2.flv - October 4th, 2011 [October 4th, 2011]
- Multiple Sclerosis Stem Cell Therapy News Coverage - October 4th, 2011 [October 4th, 2011]
- Stem-Cell-Therapy-in-China.wmv - October 5th, 2011 [October 5th, 2011]
- Adickes: Stem cell therapy - October 5th, 2011 [October 5th, 2011]
- Don Reed: Why we need new stem cell therapies and how you can help - October 5th, 2011 [October 5th, 2011]
- Repair Your Joint Injuries With Stem Cell Therapy | Los Angeles | Beverly Hills | Hollywood - October 6th, 2011 [October 6th, 2011]
- Repair Your Joint Injuries With Stem Cell Therapy | Los Angeles | Beverly Hills | Hollywood - October 6th, 2011 [October 6th, 2011]
- Ovation Cell Therapy Review (request) - October 6th, 2011 [October 6th, 2011]
- Glazer's Edge: Peyton's Stem Cells - October 6th, 2011 [October 6th, 2011]
- Glazer's Edge: Peyton's Stem Cells - October 6th, 2011 [October 6th, 2011]
- The Spinal Cord Journey - Stem cell therapy stories from three spinal cord injury patients - October 6th, 2011 [October 6th, 2011]
- Goodie Mob - Cell Therapy - Video - October 13th, 2011 [October 13th, 2011]
- Randolph veterinarian uses new stem cell therapy on ailing pets - Video - October 13th, 2011 [October 13th, 2011]
- Stem Cell Therapy for Autism - Video - October 13th, 2011 [October 13th, 2011]
- 1 month after using Ovation Hair Cell Therapy and the results are...... - Video - October 13th, 2011 [October 13th, 2011]
- Stem Cell Series: Part 1 - Video - October 15th, 2011 [October 15th, 2011]
- Stem Cell Therapy for Multiple Sclerosis (MS patient) - Video - October 15th, 2011 [October 15th, 2011]
- Affordable Stem Cell Therapy in Guatemala (2hrs from Miami) - Video - October 16th, 2011 [October 16th, 2011]
- Duffy Update, Post Stem Cell Therapy - Video - October 18th, 2011 [October 18th, 2011]
- Duffy Gets Stem Cell Therapy - Video - October 18th, 2011 [October 18th, 2011]
- Adult Stem Cell Therapy for Congestive Heart Failure - October 20th, 2011 [October 20th, 2011]
- CELL THERAPY - Video - October 23rd, 2011 [October 23rd, 2011]
- Stem Cell Therapy in Cardiac Disease - Video - October 25th, 2011 [October 25th, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis - Community Outreach Dallas - Darnell Morris - Video - October 25th, 2011 [October 25th, 2011]
- UMBILICAL CORD STEM CELL THERAPY - Video - October 27th, 2011 [October 27th, 2011]
- Stem Cell Therapy for Multiple Sclerosis Stimulates IDO - Video - October 27th, 2011 [October 27th, 2011]
- Goodie Mob - Cell Therapy ( Killuminati Music ) - Video - October 27th, 2011 [October 27th, 2011]