October 04, 2017, ALAMEDA, Calif. — AllCells, LLC, a leading provider of hematologic primary cell products for global life science research and further manufacturing of allogeneic cell therapy products is pleased to announce the successful deployment of its new Oracle enterprise resource planning (ERP) system, effective October 2. [Read more…]
Will Glycostem Release 1st Allogeneic NK Cell Product with Off-the-Shelf Potential?
This interview comes shortly after Novartis became the first company to get a gene therapy approved in the United States, the CAR-T cell therapy, Kymriah®. The historic event demonstrates to investors, the public and funding providers alike that cell therapy is a sector that has emerged, no longer one that is evolving in the future. There are close to 40 companies developing redirected T cells or NK cells for therapeutic use. There are also 800+ cell therapy clinical trials underway around the world, and a considerable amount of research and preclinical work taking place across the cell therapy sector.
In the light of the recent Gilead takeover of Kite Pharma for $11 billion, the cellular immunotherapy sector is in focus among both investors and oncology and non-oncology companies. The search for the “next Kite” has begun!
Glycostem is a 10-year old clinical stage cellular immunotherapy company based in The Netherlands. The uniqueness around Glycostem, beyond that it is a privately funded company with strong phase I safety clinical trial data, is that it may become the first company with an allogeneic off-the- shelf product (oNKord®). This would potentially position NK cell technology to leapfrog CAR-T cell products, due to a safer profile, lower production costs, off-the- shelf status and positive clinical trial data. [Read more…]
VitaMine&Yours – Combining Private Health Care and Public Donation
Stem cells are a valuable resource for modern cell therapy. Newborn cord blood contains young, vital stem cells that can be obtained without invasive measures and are virtually free of any pathogens and environmental influences. These stem cell are cryogenically preserved in stem cell banks for decades and stored for medical health care.
Private stem cell banks store stem cells for a child and its family, with parents paying for this service. Public banks retain these stem cells for use by third-party recipients as a service for the general public. This service is funded by donations or public resources. Establishing a nationwide public donation system would be difficult and perhaps unfeasible due to costs, and based on a very high rejection rate of up to 80%, it would not make much sense, either.
Vita 34 in Germany, one of the ten most influential stem cell banks, has created a combination of both models. As part of this process, public registries will also have access to some of the privately stored cord blood. With VitaMine&Yours, Vita 34 has developed the first true hybrid product, combining private health care and public donation. [Read more…]
Genetically Modified Muscle Progenitor Cells with Stem Cell Medicine Ltd.
In the world of stem cells, there are a number of well-recognized market participants that receive a great deal of attention from the stem cell community.
At the same time, there are brilliant companies that quietly operate under the radar screen, building themselves up one intelligent and methodical step at a time. [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
• 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.
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…]
- « Previous Page
- 1
- …
- 255
- 256
- 257
- 258
- 259
- …
- 338
- Next Page »