Cell therapy weekly: First stem cell drug application approved in China for Phase II clinical trial
This week: Gamida Cell (Jerusalem, Israel) and Be The Match BioTherapies (MN, USA) will collaborate to improve patient outcomes for those undergoing bone marrow transplants and Athersys (OH, USA) announces positive results from expletory clinical study of MultiStem® cell therapy.
The news highlights:
China approves first stem cell drug Phase II clinical trial
Collaboration to expand the use of bone marrow transplants
Positive results from expletory clinical study of Athersys’ MultiStem® cell therapy
China approves first stem cell drug Phase II clinical trial
Following a 60 day priority review of the IND application, AlloJoin® has been approved as the first stem cell drug application in China for a Phase II clinical trial. From Cellular Biomedicine Group (NY, USA), the allogeneic adipose-derived mesenchymal progenitor cell (haMPC) AlloJoin® therapy will be tested for the treatment of knee osteoarthritis.
“We are pleased with this unprecedented milestone,” stated Tony (Bizuo) Liu, CEO of Cellular Biomedicine Group. “The Phase I trial for our proprietary AlloJoin® product demonstrated good safety and early efficacy for the prevention of cartilage deterioration and this new approval from the CDE brings us closer to helping address the unmet medical needs of 57 million knee osteoarthritis patients in China.”
Collaboration to expand the use of bone marrow transplants
Gamida Cell (Jerusalem, Israel) and Be The Match BioTherapies (MN, USA) have announced a partnership, aiming to improve the outcomes of patients undergoing allogenic hematopoietic stem cell (bone marrow) transplantation. The terms of the collaboration include development of NiCord® from Gamida Cell, which has the potential to serve as a universal bone marrow source for a variety of patients.
“Gamida Cell’s work to bring a new therapeutic option to patients in need of a bone marrow transplant aligns with our core mission to help organizations deliver cellular therapies that save more lives and improve the quality of life for patients,” commented Amy Ronneberg, President of Be The Match BioTherapies. “This collaboration is designed to leverage our expertise in cellular therapy to support the advancement of Gamida Cell’s clinical development and product delivery efforts.”
Positive results from expletory clinical study of Athersys’ MultiStem® cell therapy
Results from the clinical study of MultiStem® cell therapy has shown the treatment to be associated with lower mortality and a greater number of ventilator-free and intensive care unit-free days in the first month following diagnosis, compared to patients receiving a placebo. MutliStem, developed by Athersys, Inc. (OH, USA), is Indicated for the treatment of patients suffering from acute respiratory distress syndrome.
“We believe this exploratory study met all of its key objectives and view it as an important indication of the potential relevance of MultiStem in another critical care area where there is substantial unmet medical need,” commented Gil Van Bokkelen, Chairman and CEO, Athersys. “The consistent pattern of results suggesting a beneficial effect on mortality and key clinical parameters provides us with confidence that this is another condition where administration of MultiStem can have a meaningful therapeutic impact.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.