The New York Blood Center and Pluristem Therapeutics are to collaborate on preclinical studies evaluating whether Pluristem’s Placental eXpanded (PLX)-R18 cells can speed the engraftment of umbilical cord blood (UBC) stem cells in UBC transplants. The project has been granted a conditional award of $900,000 by the Israel–U.S. Binational Industrial Research and Development Foundation. Under terms of the collaboration Pluristem will provide its PLX-R18 cells and the NYBC will carry out the studies.
Pluristem says prior preclinical research has already suggested that administering PLX-R18 cells in combination with UBC cells can help the cord blood stem cells to engraft faster and more effectively. “Based on previous data, we believe that PLX-R18 cells might contribute to a significant improvement in the success rate of UCB transplants,” commented Dr. Beth H. Shaz, svp and chief medical and scientific officer of NYBC. “PLX-R18 is emerging as a promising multifactorial treatment for hematologic conditions,” added Pluristem chairman and CEO Zami Aberman. “It can potentially speed engraftment of UCB cells and stimulate the production of all three types of blood cells: white and red blood cells, as well as platelets. We believe this offers a clear advantage over current therapies.”
PLX-R18 is in development for treating bone marrow that is unable to produce enough blood cells due to causes including certain cancers or cancer therapy, immune-mediated bone marrow failure, or acute radiation syndrome (ARS). Use of PLX-R18 cells to support UBC transplantation represents the third potential hematologic indication for the cells, Pluristem notes. The FDA has separately approved a Phase I clinical trial evaluating PLX-R18 cells for the treatment of insufficient hematopoietic recovery following hematopoietic stem cell transplantation. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is also conducting a dose-evaluation study of PLX-R18 in large animals, prior to a pivotal animal trial evaluating PLX-R18 in the treatment of ARS. The pivotal animal study could feasibly be enough for subsequent filing for regulatory approval under FDA’s Animal Rule regulatory pathway.
The NYBC deal comes just a week after Pluristem announced setting up a Japanese company with Sosei Corporate Venture Capital to develop and commercialize Pluristem’s placental-derived adherent stromal cell (PLX-PAD) therapy in Japan. In November the U.K. regulator gave Pluristem the go-ahead to start a Phase III study evaluating PLX-PAD in the treatment of critical limb ischemia. The single trial may be enough to gain conditional marketing approval of PLX-PAD in Europe, under the European Medicines Agency's (EMA’s) Adaptive Pathways pilot project.