Pluristem Therapeutics

Pluristem Strengthens Its Position in Asia, Awarded Two New Patents in Hong Kong for Critical Limb Ischemia and Muscle Regeneration

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today that the company has been issued two new patents by Hong Kong Patents Registry for its cell therapy products relating to two of the company's leading indications, Critical Limb Ischemia (CLI) and muscle regeneration.

Pluristem Launches Co-CEO Structure and Appoints New CFO

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today two senior executive appointments to support the company's growth and ensure continued success as it enters advanced stages of clinical development for its PLX products.

Pluristem Receives Clearance from Germany to Initiate Its Multinational Phase III Trial in Critical Limb Ischemia Targeting Early Conditional Marketing Approval

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that Germany's health regulatory agency, the Paul Ehrlich Institute (PEI), has cleared Pluristem to begin enrollment in Germany for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia (CLI) in patients who are unsuitable for revascularization. The trial was recently cleared by the United States' Food and Drug Administration (FDA) and the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA).

Pluristem's Phase III Study of PLX-PAD Cells for the Treatment of Critical Limb Ischemia Cleared by U.S. FDA

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that the Company's Phase III study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI) was cleared by the U.S. Food and Drug Administration (FDA). Pluristem's strategy is to use this single multinational Phase III study to support the submission of a biologics license application (BLA) to the FDA for marketing approval. Pluristem expects to begin enrolling patients in its Phase III study in both the U.S. and Europe during the first half of 2017.

Pluristem Continues to Strengthen Its Position in China and Receives Key Cell Therapy Patent

LogoPluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, today announced that the State Intellectual Property Office of the People's Republic of China has issued an allowance to Pluristem for its patent application titled, "Adherent Cells From Adipose or Placenta Tissues and Use Thereof In Therapy". The patent addresses methods of treating Ischemic conditions such as CLI using placental cells. Additional patents of Pluristem in China cover methods of expending placental cells in a 3D apparatus, various therapeutic uses of placental cells and devices for a 3D culture of placental cells.

Pluristem's Pivotal Phase III Critical Limb Ischemia Trial Approved by UK Regulatory Agency

LogoPluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today announced that the United Kingdom's Medicines & Healthcare Products Regulatory Agency (MHRA) has cleared Pluristem's application to begin the pivotal Phase III trial of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) for patients who are unsuitable for revascularization. Pluristem's CLI program was previously selected by the European Medicines Agency (EMA) for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal Phase III trial.

Pluristem CEO Zami Aberman Re-Elected to Alliance for Regenerative Medicine's Board of Directors

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced its Chairman and CEO, Zami Aberman, has been re-elected as Member of the Board of Directors of the Alliance for Regenerative Medicine (ARM). This is Mr. Aberman's second year serving on the Board of the Washington, D.C.-based, international organization that represents the gene therapy, cell therapy and tissue engineering sector. Pluristem has been a member of ARM for 4 years and has actively supported the organization's goals.

Pluristem Advances Towards U.S. Clinical Trial in PLX-R18 and Announces Principal Investigator

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced the appointment of Dr. Hillard Lazarus of Case Western Reserve University as the Principal Investigator of the Company's Phase I trial of its PLacental eXpanded (PLX)-R18 cells to treat incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).

Pluristem's Phase III Critical Limb Ischemia Study Wins $8 Million Grant from Europe's Horizon 2020 Program

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that its critical limb ischemia (CLI) program in the European Union has been awarded an $8 million grant. The grant is part of the European Union's Horizon 2020 program, which is its largest Research and Innovation program. 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.

Pluristem Advances Towards Multinational Phase III Trial of PLX-PAD to Improve Recovery Following Surgery for Hip Fracture

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced recently that it intends to conduct a Phase III trial assessing its PLX-PAD cells in recovery following surgery for femoral neck fracture, which is the most common form of hip fracture. The trial protocol is now being designed by Pluristem and its Clinical Advisory Board (CAB), which is comprised of world-leading orthopedic surgeons, and experts in rehabilitation. Pluristem is planning to meet with the FDA later this year to discuss the Phase III protocol. The Company has already submitted this protocol to the European Medicines Agency (EMA) following consultation with the Adaptive Pathways Project Group. Pluristem's program in critical limb ischemia is already being developed via the Adaptive Pathways Project.