“Our activities in this quarter demonstrate our continued drive to develop and commercialize cell therapy products that have the potential to help millions of patients facing unmet medical needs, while also generating value for our shareholders,” stated Pluristem Chairman and Co-CEO, Zami Aberman. “We have seen a burgeoning interest in our cell therapy products from external parties including key regulatory agencies, government bodies, business partners, physicians and patients around the world. We believe this interest shows broad confidence that Pluristem can fill a significant gap in the current global healthcare system. As we come closer to marketing approval and commercialization, we believe Pluristem maintains a significant advantage in the industry with our proprietary 3D manufacturing technology, strong intellectual property and business partnerships, and positive data from our completed studies.”
Clinical and Corporate Highlights:
PLX-PAD Leading Programs Receive a Vote of Confidence from Key Regulatory Agencies with Fast Track Designation Granted for Phase III CLI Study by the U.S. FDA and Positive Feedback from the FDA and EMA for Phase III Hip Fracture Trial
Pluristem’s multinational Phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) was granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) and is currently enrolling patients in the U.S. and Europe. Fast Track Designation increases the chance of a priority review by the FDA. This trial was recently awarded an $8 million grant from the European Horizon 2020 program.
The Company reported that in previous discussions with the FDA and the European Medicines Agency (EMA), it received positive feedback on the proposed study design and endpoints for its Phase III trial in the treatment of muscle recovery following arthroplasty for hip fracture. Pluristem plans to submit the Investigational New Drug (IND) and Clinical Trial Application (CTA) for the trial in the coming months. This trial was recently awarded an $8.7 million grant from the European Horizon 2020 program.
PLX-R18 Receives Orphan Drug Designation for the Treatment of ARS; Pluristem Extends its Trial in the Treatment of Insufficient Hematopoietic Recovery Following Bone Marrow Transplant and Opens Clinical Centers in Israel
Pluristem’s PLX-R18 was granted Orphan Drug Designation by the FDA as a treatment for Acute Radiation Syndrome (ARS), which may accelerate the path to potential marketing approval and includes a seven year grant market exclusivity upon marketing approval. Pluristem’s ARS trial is supported and conducted by the National Institutes of Health (NIH), the U.S. Department of Defense and Fukushima Medical University.
Pluristem reported that, following approval from Israel’s Ministry of Health, it will open clinical centers in Israel for its Phase I trial of PLX-R18 cell therapy as a treatment for insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT). The trial is already recruiting patients in the United States. Up to 30 patients will be recruited in total from the United States and Israel.
Pluristem Expands its Pipeline and Enters into Agreement for Investigator Initiated Study in Chronic GvHD
Pluristem signed an agreement with Tel Aviv Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II trial in PLX-PAD cell therapy for the treatment of Steroid-Refractory Chronic Graft-versus-Host-Disease (GvHD).
Pluristem Was Issued Three Patents in Support of its PLX Products
Pluristem was granted three significant patents. Two of the patents were issued by the Hong Kong Patents Registry for cell therapy products related to CLI and muscle regeneration. The third patent was granted to Pluristem by the European Patent Office for PLX-R18 to be used to treat a host of new indications, including ARS, genetic disorders, and autoimmune diseases, while also supporting chemotherapy treatments.