AMERICA STEM CELL, INC. RECEIVES FDA CLEARANCE FOR ITS MULTI-CENTER NATIONWIDE TRIAL
San Antonio, TX SEPTEMBER 4, 2012. America Stem Cell, Inc. (ASC) announced today it has received clearance from FDA for its Phase I/IIa nationwide multi-center dual-umbilical cord transplantation study evaluating ASC-101 in in patients with hematologic malignancies and myelodysplastic syndrome.
ASC-101 is currently undergoing evaluation in a single-center study at The University of Texas MD Anderson Cancer. To date, 12 patients have been enrolled in the study with 9 patients evaluable. On the basis of data obtained in the single-center study, FDA has given approval to proceed with a multi-center trial.
“Enhancing umbilical cord stem cell engraftment into bone marrow in the dual cord transplant setting will improve clinical outcomes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell transplant is prescribed,” said, Dr. Elizabeth Shpall, MD, Medical Director, Cell Therapy Laboratory and Director, Cord Blood Bank at M.D. Anderson Cancer Center and Study Chair on the ASC-101 Phase I/IIa clinical trial. Dr. Shpall has submitted an abstract to the upcoming American Society of Hematology (ASH) meeting in December describing the clinical results to date with ASC-101.
“There is a significant unmet medical need to improve stem cell engraftment into bone marrow for patients undergoing umbilical cord transplantation, and America Stem Cell is committed to filling that need,” said Dr. Linda Paradiso, Chief Development Officer at ASC. ASC-101 is a novel enzyme treatment that will potentially transform hematopoietic stem cell transplantation by accelerating patient immune system and platelet recovery, reducing opportunistic infections and other co-morbidities, and improving patient survival.
“ASC was founded with the vision to make stem cell transplants safer and more efficacious for patients undergoing cell therapy. The expansion of this trial using ASC-101 in cancer patients undergoing stem cell transplantation is a major step forward in advancing the ASC clinical pipeline,” said Lynnet Koh-LeMaire, Chief Executive Officer/Founder of America Stem Cell.
America Stem Cell is commercializing breakthrough platform technologies and products that enable cell-based therapies and immunotherapies across a wide range of indications. ASC’s technologies target homing and engraftment of therapeutic cells to sites of ischemia, inflammation and disease for improved clinical efficacy and patient outcomes. The most advanced product (ASC-101), manufactured at Florida Biologix, is currently in PhI/IIa clinical trials for cord blood transplantation. ASC’s second wave of products will expand the platform technology to a broad range of cell types and diseases.
About America Stem Cell, Inc.
America Stem Cell is a privately-held biotechnology company based in San Antonio, TX, with offices in San Diego, CA, and is dedicated to the development and commercialization of enabling technologies to enhance and expand the therapeutic potential of stem cell therapies. The key technology platforms (ASC-101 and ASC-102) are designed to improve the homing and engraftment of stem cells to target organs and increase their therapeutic potential for patients in need of hematopoietic stem cell transplantation. Additionally, these technologies have the potential to enhance efficacy in stem cell treatment of inflammation from chemotherapy/radiation, solid tumors, autoimmune diseases, and ischemic diseases including myocardial infarction and stroke. ASC has partnerships and collaborations with Kyowa Hakko Kirin, Spectrum Health Innovations, Florida Biologix, various medical research institutions including The University of Texas M.D. Anderson Cancer Center, Oklahoma Medical Research Foundation, Fred Hutchinson Cancer Center, University of California San Diego, the Sanford-Burnham Institute, Indiana University, Juvenile Diabetes Research Foundation, as well as corporate partnerships. For additional information, please contact Lynnet Koh at 760-612-6277, or view www.americastemcell.com.Lynnet Koh email@example.com Telephone 760-612-6277 www.americastemcell.com