Lion Biotechnologies Provides Update on Phase II Results for Metastatic Melanoma
Patients have 22% Complete Response rate; 95% of those continue to be alive and disease free over 6-9 years
LOS ANGELES--(BUSINESS WIRE)-- 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.
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/.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including market conditions, risks associated with the cash requirements of the company's business and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission, and represent the company's views only as of the date they are made and should not be relied upon as representing the company's views as of any subsequent date. The Company is a development-stage company that will require significant capital and other resources to further develop and commercialize its technology. The Company does not currently have the capital or resources required to develop this technology into a revenue producing asset. Furthermore, the Company will need to expand its current management team and other personnel to achieve its technological and financial objectives. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
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