LOS ANGELES--(EON: Enhanced Online News)--Lion Biotechnologies, Inc. (OTCBB: GNBPD) is providing updated results from a Phase II trial for metastatic melanoma conducted by the National Cancer Institute (NCI) utilizing the tumor-infiltrating lymphocyte (TIL) technology currently licensed by the Company and being developed under a Cooperative Research and Development Agreement (CRADA) with the NCI. Steven A. Rosenberg, M.D., Ph.D., Chief of the NCI Surgery Branch, is the Principal Investigator on this study. The single-site trial included 93 patients in three cohorts.
“We believe the results achieved in the NCI trial warrant moving the program into a Phase III clinical trial for product approval, and we are currently developing the resources to initiate that process.”
The long-term follow-up data reported by the NCI show an Objective Response (OR) rate of 49% for patients treated with TILs alone. Objective Response is Partial Response (PR) plus Complete Response (CR), with Partial Response defined as a reduction in tumor volume of greater than 50%. Of the 43 patients in this cohort, 12% showed Complete Response, and these patients continue to live more than seven years following treatment, with no measurable disease.
Two additional cohorts of 25 patients each were treated with a combination of TILs and Total Body Irradiation (TBI). The cohort receiving TILs and 200 Gy TBI showed a 52% OR and 20% CR; the patients in the latter group continue to live more than seven years following treatment, with no measurable disease. A cohort receiving TILs therapy and 1200 Gy TBI showed 72% OR and 40% CR. Nine of the 10 patients in this cohort showing Complete Response continue to live more than six years following treatment, with no measurable disease.
Overall, patients in the three cohorts showed 22% CR, and 95% of those patients continue to live with no measurable disease 6-to-9 years following treatment.
Manish Singh, Ph.D., President and Chief Executive Officer of Lion Biotechnologies stated, “We believe the results achieved in the NCI trial warrant moving the program into a Phase III clinical trial for product approval, and we are currently developing the resources to initiate that process.”
About Lion Biotechnologies
Lion Biotechnologies, Inc., formerly Genesis Biopharma, Inc., is engaged in the development of T-cells and engineered T-cells for the treatment of various cancers. The company's lead product candidate is a ready-to-infuse autologous T-cell therapy utilizing tumor-infiltrating lymphocytes (TILs) for the treatment of patients with Stage IV metastatic melanoma, and is based on a clinical CRADA with the National Cancer Institute along with physician-sponsored investigational therapy at the MD Anderson Cancer Center and the H. Lee Moffitt Cancer & Research Institute. For more information, please visit http://www.genesis-biopharma.com/.
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