Alachua, FL: America Stem Cell and Florida Biologix team up to get an important cancer therapy to the clinic that can potentially making a life-changing difference for patients with blood-related cancers such as Leukemia, Lymphoma and Myeloma.
Florida Biologix is pleased to announce that they have signed a development and manufacturing contract for a Phase I cell therapy product, ASC-101, with America Stem Cell. ASC-101 is a breakthrough human recombinant enzyme technology that increases the efficiency of engraftment in transplantation of cord blood derived stem cells. Exciting in vitro and in vivo experimental results attest to the potential for ASC-101 to accelerate hematopoietic/immune system recovery, reducing the treatment-related mortality rate associated with infections during the patient’s immune-compromised period. ASC-101 may also enable adult cancer patients requiring bone marrow transplants to be treated quickly with cord blood derived stem cells from a single cord blood unit, avoiding the long and often futile wait for matching bone marrow or peripheral blood derived stem cells.
Florida Biologix will conduct process and assay development, an engineering run, final cGMP manufacturing and purification of the enzyme. They will also conduct a formulation, fill and finish of the substrate which will be used, along with the enzyme, for the Phase I clinical trial targeted to start at University of Texas MD Anderson Cancer Center in early 2010.
America Stem Cell CEO Lynnet Koh explained “we chose to work with an experienced biologics manufacturing team that we believe will deliver a high-quality product within our budget and within aggressive development timelines. We are confident that the team at Florida Biologix will deliver on all fronts. We are incredibly excited to be underway for our first human trials to make life-changing difference for cancer patients and their families!”
About Florida Biologix
Florida Biologix® is a Phase I/II biologics contract development, manufacturing & testing organization that offers a wide range of biopharmaceutical services to the biotechnology industry and research institutes. They provide exceptional customer service, close project collaboration, and clear and honest communication.
Florida Biologix staff are not only experts in a variety of aspects of pharmaceutical and biological manufacturing backed by science, but are also approachable, trustworthy, and believe that the best way to build long-term relationships with our clients is through open communication and delivering on-time. This ensures that either technical or business issues, if they arise, will be resolved quickly and smoothly.
Florida Biologix’ in-house quality department provides a full range of analytical services, facility and systems monitoring, product review and disposition and regulatory support including CMC and DMF preparation. Our new, 23,000 square foot, state-of-the-art facility was designed for multi-product manufacturing and testing; an adjacent building houses our 5,000 square foot, fully-equipped, process development laboratories.
About America Stem Cell
Founded in 2005, America Stem Cell, Inc. (ASC) is a privately held biotechnology company dedicated to the development and commercialization of stem cell-enabling technologies to enhance the clinical success and the therapeutic potential of stem cell transplants. Their key technology platforms — ASC-101 and ASC-201 — are designed transform the homing and engraftment of stem cells to target organs and increase their therapeutic potential.
ASC is led by an experienced management team and has established a prominent board of advisors to guide its technology development programs. The Company has established a number of strategic partnerships with medical research institutions including the University of Texas M.D. Anderson Cancer Center, the Oklahoma Medical Research Foundation, Indiana University, Rush Presbyterian, Fred Hutchinson Cancer Center, National Institute of Health, Burnham Institute, University of California, Baylor College of Medicine and University of Texas San Antonio.