$8 Million Grant for Pluristem Therapeutics

A major effort is underway in Europe to further our understanding of critical limb ischemia (CLI). Pluristem Therapeutics Inc. has announced that its CLI program in the European Union has been awarded an $8 million grant.

As indicated in the August 9, 2016 news release, “The Phase III study of PLX-PAD in CLI will be a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies (BCRT) under the leadership of Prof. Hans-Dieter Volk and Prof. Petra Reinke together with Pluristem.”

“The pivotal study for Pluristem’s PLacental eXpanded (PLX) PAD cells in the treatment of CLI is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), with the second dose administered two months after the first. The primary endpoint will be time to amputation and death.”

“We are honored to have been awarded this Horizon 2020 grant designed to support the manufacturing and development of our cell products for potential commercialization. This grant is a vote of confidence and an expression of hope by the European Union that we may be able to provide a regenerative therapy for millions of CLI patients around the world. Pluristem is committed to developing PLX-PAD for patients with peripheral artery disease, and this grant will help us move towards our goal of rapid entry into the European and U.S. markets, given positive results, ” stated Pluristem Chairman and CEO Zami Aberman.

Asked about how they would enter the European and U.S. markets, Aberman told OTW, “We would plan to partner with a pharmaceutical company to achieve commercialization. With the large and growing number of patients around the world undergoing surgery for hip fracture, it would be most effective to partner with a company that already has extensive experience and resources in place in the orthopedic space, rather than build out our own sales force and capabilities at this time.

“Orthopedic surgeons are very skilled in repairing femoral neck fractures, but unfortunately challenges in post-operative rehabilitation can negatively impact the long term outcome for their patients. There is a strong need to reduce the significant morbidity and mortality that can follow surgery by improving patient muscle strength and time to recovery of mobility and function. We believe, based on data from our earlier studies, that our PLX-PAD cells may trigger improved regeneration and healing of tissue damaged by the trauma of a fracture and subsequent surgery, which could lead to reduced mortality and an increase in the percent of patients undergoing a faster and more successful rehabilitation, giving them a better quality of life.”