Many governments, including the U.S. and Japan, are well aware of the dangers to their populations of exposure to high levels of radiation from nuclear accidents or dirty bomb attacks. Whereas Japan’s population was recently exposed at Fukushima following the tsunami of 2011, the U.S. Department of Defense has been stockpiling acute radiation syndrome (ARS) countermeasures as a precaution for many years. [Read more…]
Pluristem’s PLX Cells Significantly Inhibit Cancer Cell Growth in Newly Published Study
- PLX cells exhibit anti-proliferative effect on a wide range of human cancer cell types
- Pre-clinical study results show statistically significant reduction in tumor size as well as complete tumor remission in 30% of treated recipients
HAIFA, Israel, Jan. 12, 2018 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced the publication of a peer-reviewed article in the journal Scientific Reports, from the publisher of Nature, titled, “Human Placental-Derived Adherent Stromal Cells Co-Induced with TNF‑α and IFN‑γ Inhibit Triple-Negative Breast Cancer in Nude Mouse Xenograft Models.”
The article is based on studies which examined the effect of PLX cells that had been induced with tumor necrosis factor alpha (TNF-α) and interferon-gamma (IFN-γ), on the proliferation of over 50 lines of human cancerous cells. The induction of the cells was carried out by adjusting their manufacturing process in order to transiently alter their secretion profile. [Read more…]
Pluristem Gets Accelerated Approval Pathways in Top 3 Healthcare Markets – U.S., Europe, Japan
Cell therapy was recently described as “One of the most promising new fields of science and medicine,” by FDA Commissioner Scott Gottlieb. He went on to state that cell therapy and regenerative medicine “…hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies.” In the FDA statement issued August 28th, Gottlieb also revealed that the U.S. regulator is looking improve upon its approval process for cell therapies. [Read more…]
Pluristem Granted Key U.S. Patent for Skeletal Muscle Regeneration – a Meaningful Asset Ahead of Upcoming Phase III Femoral Neck Fracture Study
- Patent relates to the use of Mesenchymal Stem Cells (MSCs) for muscle regeneration following muscle injury
- Pivotal Phase III study to take place in U.S. and Europe to support recovery from hip fracture
HAIFA, Israel, Nov. 22, 2017 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Patent and Trademark Office (USPTO) has issued a patent titled, “Skeletal muscle regeneration using mesenchymal system cells.” This key patent, which has already been granted in Europe, Hong Kong and Israel, addresses the use of MSCs for skeletal muscle regeneration used either directly after, or shortly after, post-surgical muscle injury.
The Company received positive feedback from the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) for the proposed study design and endpoints of its Phase III trial for the treatment of muscle recovery following arthroplasty for hip fracture. This planned study was recently awarded an $8.7 million grant by the Horizon 2020 program, the European Union’s largest research and innovation program. If successful, Pluristem plans to use the study results to achieve marketing approval in both the U.S. and Europe. [Read more…]
Pluristem Partners with Tel Aviv Sourasky Medical Center for Phase I/II Trial in Steroid-Refractory Chronic GvHD
- 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).
The 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…]
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