Florida Biologix Enters Manufacturing Agreement with America Stem Cell

Florida Biologix (Alachua, FL) has signed a development and manufacturing contract with America Stem Cell (Helotes, TX) for a Phase 1 cell therapy product, ASC-101. ASC-101 is a human recombinant enzyme technology that increases the efficiency of engraftment in transplantation of cord blood derived stem cells.

ASC-101 has been proven to accelerate hematopoietic and immune system recovery, reducing the treatment-related mortality rate associated with infections during the patient’s immune-compromised period. ASC-101 also may 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. The company also will conduct a formulation and fill-and-finish of the substrate that will be used, along with the enzyme, for the Phase 1 clinical trial targeted to start at University of Texas MD Anderson Cancer Center in early 2010.