Pluristem, Charité Expand Collaboration

Pluristem Therapeutics Inc. and the Berlin-Brandenburg Center for Regenerative Therapy at Charité – University Medicine Berlin have agreed to expand their five-year Collaborative Research Agreement. Both parties will work toward the identification of orthopedic indications that may be eligible for development under Europe’s Adaptive Pathways and conditional marketing approval in the European Union. Pluristem’s program to develop PLX cells in critical limb ischemia is already under discussion with the European Medicines Agency (EMA) and others under the Adaptive Pathways.

According to the October 12, 2015 news release, “Pluristem and Charité have jointly completed a successful orthopedic Phase I/II study using PLacental eXpanded (PLX) cells in muscle injury…”

Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité, who served as senior scientist on the completed Phase I/II orthopedic study, commented, “In our studies PLX cells demonstrated the potential to improve overall muscle functionality, with an impressive magnitude of effect. An additional orthopedic PLX indication has a promising potential.”

“Pluristem has enjoyed a very productive relationship with European regulators and our PLX cells have already been selected for the Adaptive Pathways in critical limb ischemia. Working with the prestigious Charité, we look forward to advancing an orthopedic indication through Adaptive Pathways as well, ” stated Pluristem Chairman and CEO Zami Aberman.

Asked how they will go about identifying the orthopedic indications, Aberman told OTW, “We are looking for indications in the field that meet the criteria for selection into the Adaptive Pathways Project in Europe. The Adaptive Pathways provides guidance as a company develops a Phase II trial that can lead to conditional marketing approval. To be eligible for these pathways an indication must have limited treatment options. Therapies developed through this pathway are intended to bring innovative treatments to patients with a significant unmet need. Our Phase II trial in muscle injury provided evidence that our PLX-PAD (peripheral arterial disease) cell product can stimulate the healing of soft tissue. In the past we published data showing that injecting our PLX-PAD cells improves recovery of traumatized tendon.”

As for what indications might be appropriate, Aberman added, “The positive results we presented from a Phase II trial of our cells for the treatment of muscle injury after hip replacement surgery point to the potential of placenta-derived cells to treat soft tissues such as muscles, tendons and ligaments.”‫

Aberman also commented to OTW, “Placenta-derived cells such as ours can be off-the-shelf products that do not require any tissue matching. In the context of clinical trials our PLX-PAD cells have been administered to patients in the U.S., Germany, Israel, Australia and South Korea without any matching. This makes them potentially practical and accessible for use in a variety of orthopedic indications and settings.”