Published data indicates that bone marrow-derived stem cells injected directly into injured myocardium provides improvement in left ventricular function post-myocardial infarction. Our collaborator, Dr. Randy Lee at UCSF, has developed an alternative proprietary approach using targeted cells delivered peripherally. This approach is less invasive, more specific and expected to be more efficacious. Using a rodent model of ischemia-reperfusion, this lab demonstrated that stem cells derived from human peripheral blood can be antibody-targeted to injured myocardium when injected intravenously. A pair of antibodies is linked to guide the stems cells: a CD45 or CD34 antibody recognizes the stem cells and troponin I or myosin light chain antibodies recognize injured cardiac tissue. Phase I will support a proof-of-concept study to demonstrate that the bispecific (BiMab) antibody-targeted stem cells can repair injured cardiac tissue. Based on the successful outcome of this work, Phase II studies will focus on the humanization, genetic construction, production and purification of the best bispecific antibody pair. More detailed proof of concept and toxicology studies will precede preparation of an IND for human clinical trials of this novel therapy.
