In this study, a single injection of CBLB612 was given in combination with the current standard methodology for stem cell donor isolation, which is four daily injections of G-CSF followed by one injection of AMD3100. The addition of CBLB612 to the protocol yielded eight to ten times higher concentrations of short-term and long-term HSC in peripheral blood, respectively, compared to the standard protocol. Even a single administration of CBLB612 in combination with AMD3100 yielded twice as many mobilized HSC compared with that of the standard regimen. Furthermore, CBLB612 mobilized all major classes of HSC to peripheral blood, suggesting that no HSC classes would be lost in the enrichment process.
Protectan CBLB612 has been shown to be highly efficacious as a stand-alone treatment in stimulating proliferation and mobilization of hematopoietic stem cells into peripheral blood in both mice and primates. In addition, Protectan CBLB612 has demonstrated both radiation protection and mitigation properties over a very broad time window of use.
Michael Fonstein, president and CEO of Cleveland BioLabs, said: “This study represents a potential paradigm shift in the methodology for HSC mobilization and collection.”