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Pluristem Partners with Tel Aviv Sourasky Medical Center for Phase I/II Trial in Steroid-Refractory Chronic GvHD

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  • Tel Aviv Sourasky Medical Center will act as the sponsor of the study
  • PLX-PAD cells have demonstrated efficacy in preclinical models of GvHD             

HAIFA, Israel, Nov. 06, 2017 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that it has 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 Tel Aviv Sourasky Medical CenterThe trial will be an investigator initiated study.  As such, Tel Aviv Sourasky Medical Center will support the study and will be responsible for its design and implementation. Dr. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit for the Tel Aviv Sourasky Medical Center will act as principal investigator.

GvHD is a potentially lethal complication of hematopoietic cell transplantation (HCT) from a donor. When a patient receives a donor’s stem cells, the transplanted cells identify the patient’s body as foreign and attack it. The chronic form of GvHD occurs at least 100 days following the transplantation. The GvHD market is predicted to exceed $500 million by 2023. [Read more…]

$7.9M Granted to nTRACK Collaborative Project to Study Pluristem’s PLX-PAD Cells

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  • Grant from European Union’s Horizon 2020 program to nTRACK project designed to study nanoparticle effects on PLX-PAD cell viability and functionality
  • Grant brings total to approximately $25 Million (€21.8 million) in funding from Horizon 2020 program to cover clinical and research activity for PLX-PAD

HAIFA, Israel, Oct. 02, 2017 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that a $7.9 million (€6.8 million) non-dilutive grant from the European Union’s Horizon 2020 program has been awarded to nTRACK, a collaborative project carried out by an international consortium led by LEITAT. [Read more…]

Pluristem Receives Positive Feedback from FDA and EMA as Company Prepares for Phase III Trial of PLX-PAD to Support Recovery from Hip Fracture

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• Trial was recently awarded $8.7 million grant from the European Horizon 2020 program
• Pluristem plans to use results of trial to achieve marketing approval in both the U.S and
Europe

HAIFA, Israel, Sept. 26, 2017 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, has today reported the status of its planned Phase III hip fracture study. In previous discussions held with the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), the company received positive feedback on the proposed study design and endpoints of its Phase III trial in PLX-PAD cells as a treatment for muscle recovery following arthroplasty for hip fracture. This trial was recently awarded an $8.7 million grant by the Horizon 2020 program, the European Union’s largest research and innovation program.

Pluristem Prepares for Phase III Trial of PLX-PAD The proposed Phase III trial is intended to support marketing authorization and will be a double-blind, randomized, placebo-controlled trial with approximately 180 patients enrolled in clinical sites across the U.S. and Europe. Patients will be injected intramuscularly with 150 million PLX-PAD cells during arthroplasty for hip fracture. The primary endpoint for the trial will be the change of Short Physical Performance Battery (SPPB) from baseline to six months after surgery. Additional endpoints may include objective measurements of muscle strength and muscle volume.

This Phase III trial follows positive results from a Phase I/II trial which demonstrated significant muscle regeneration when PLX-PAD cells were injected following arthroplasty, including a 300% improvement in muscle volume (p=0.004) and a 500% (p=0.0067) boost in muscle force when observed six months after surgery compared to the control group. [Read more…]

Celularity Accelerates Breakthrough Placental Discovery & Therapeutic Platform

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New Biotechnology Company Accelerates the Delivery of Transformative Innovations in Treatments of Cancer, Inflammatory & Degenerative Diseases, and Functional Regeneration

Ceularity IncWARREN, New Jersey, Aug. 21, 2017 /PRNewswire/ — Celularity, Inc., a newly formed biotechnology company, today announced its acceleration of cell and tissue regenerative therapies to address unmet medical needs in cancer and chronic and degenerative disease. Celularity completed their Series A financing with contributions from several biopharma companies, including Sorrento Therapeutics, United Therapeutics Corporation and Human Longevity, Inc., and entrepreneurial investors.

Celularity has been created through the contributions of extensive intellectual property, clinical-stage assets, basic and clinical research, and development expertise including:

  • Several clinical-stage immuno-oncology and regenerative medicine assets and a pipeline of pre-clinical assets
  • Proprietary allogeneic (“readily accessible”) immunotherapy platform
  • 200+ issued and pending patents in cell therapy; robust IP for placental stem cells
  • Broad fully human antibody-CAR constructs
  • IND-ready joint CD38 immuno-oncology programs
  • Commercial-stage functional regeneration products Biovance® and Interfyl®* and pipeline assets
  • LifeBankUSA stem cell biorepository with two decades operating expertise

Founded on the pioneering work of Robert Hariri, MD, PhD, in human placenta-derived cellular therapeutics and biomaterials, Celularity’s ability to procure placental stem cells, engineer potential therapies, and deploy potential treatments, positions it to harness the potential of the human placenta and operate along the entire value chain.
[Read more…]

Dr. Kleinhaus of Pluristem Therapeutics on Immune-Advantaged Placental-Derived PLX-Cells

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Pluristem TherapeuticsPluristem Therapeutics is a clinical-stage biotherapy company using placental cells and an advanced 3D manufacturing platform to develop cell therapies for conditions that include inflammation, ischemia, muscle trauma, hematological disorders, or exposure to radiation. Their two lead cell products are entering late-stage clinical trials. Based in Haifa, Israel, Pluristem’s propriety bioreactor technology provides full-scale cell manufacturing capabilities that allow it to expand trillions of cells and create a commercial-grade product. [Read more…]

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