Lisata Therapeutics Inc (LSTA)

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" Caladrius Biosciences Receives Award from the National Cancer Institute  

Leverages Company Expertise in Cell Therapy Manufacturing to Support Process Improvements for Platform Cancer TechnologyBasking Ridge, NJ (September 24, 2015) – Caladrius Biosciences, Inc. (“Caladrius” or the “Company”, NASDAQ:CLBS), a cell therapy company combining an industry-leading external development and manufacturing provider with a development pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and ischemic repair, announces that it has received a $300,000 contract from the National Institutes of Health’s (NIH) National Cancer Institute (NCI) to wholly fund the first phase of a project for process optimization of its therapeutic agent targeting tumor-initiating cells (often referred to as cancer stem cells). The contract anticipates an additional $2 million in funding for the project should both the government and Caladrius agree to proceed at the conclusion of the first phase which is expected in June 2016. Hans Keirstead, PhD, Chief Science Officer of Caladrius, is the principal investigator for the project.The goal of the government-funded project is to investigate the use of technology to improve the efficiency of the Company’s tumor cell/dendritic cell incubation process to reduce the number of tumor-initiating cells required as an antigen source and, therefore, reduce the duration of ex-vivo culture required to produce the treatment. The project will also look at potential optimizations through the elimination of process steps and the enhancement of antigen processing and presentation.“We are excited to receive this prestigious award to support our immuno-oncology program and thank the NCI for their review and consideration. This grant underscores the value of our unique capability to leverage PCT, our world-class cell therapy processing and manufacturing subsidiary, to enhance our proprietary product development efforts,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “Importantly, this project supports our continued commitment to the optimization of our technologies, and we expect the project will have a direct impact on both feasibility and cost of our product candidates.” The Company’s technology platform is currently under investigation in a Phase 3 study (the Intus Study) for the treatment of stage III recurrent or stage IV metastatic melanoma. Compelling and consistent results from two Phase 2 trials for metastatic melanoma, as well as data from a Phase 1 trial for hepatocellular carcinoma and patient data from investigations in renal cell carcinoma, provide evidence supporting the application of the platform to additional solid tumor types, including ovarian cancer, lung cancer, colon cancer and glioblastoma multiforme. The Company has previously received FDA clearance on the protocol for a Phase 2 clinical trial for CLBS23 in ovarian cancer and will continue to pursue partnership opportunities to enable the launch of that trial."