Pluristem therapeutics and the Charité Berlin-Brandenburg Center for Regenerative Therapy (BCRT) have expanded for a second five-year term their collaboration to develop Pluristem’s placental expanded (PLX) cells. The partnership is working to generate placental cell-derived regenerative therapies for neurological and cardiovascular indications including multiple sclerosis and inflammatory cardiomyopathy, and for Pluristem’s peripheral artery disease clinical programs, which have now progressed to the Phase II clinical trials stage. The firm says the collaboration, originally signed in 2007, has in addition significantly contributed to the progress of its cardiovascular programs, including ischemic heart disease and diastolic heart failure, both of which have not completed preclinical trials.
“As a result of our cooperation to date, we have enhanced and expanded our product pipeline,” comments Pluristem chairman and CEO, Zami Aberman. “Our PLX cells may hold the key to a number of regenerative therapies, and working with one of the leading institutions in the world in the field of regenerative medicine is extremely important to us.”
Pluristem’s PLX cells are mesenchymal-like adherent stromal cells derived from full-term placenta, which release a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. Grown in a bioreactor system that provides a 3D micro-environment, the expanded cells are being developed as an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. Data from two Phase I clinical trials have indicated that Pluristem’s first PLX product, PLX-PAD, is safe and potentially effective for the treatment of end-stage peripheral artery disease.
Earlier this month Pluristem reported that the life of a second patient with bone marrow failure had been saved using PLX cells administered on a compassionate-use basis. The lymphoma patient had already received an unsuccessful bone marrow transplant and was suffering from life-threatening pancytopenia. Also this month, the firm received regulatory clearance in Germany to start a placebo-controlled Phase I/II study evaluating intramuscular injections of PLX cells in the regeneration of injured gluteal musculature following total hip replacement, and approval from Indian regulators to carry out a Phase II clinical trial with PLX cells as a treatment for thromboangiitis obliterans, or Buerger's disease.
Just last month Pluristem reported that the National Institute of Allergy and Infectious Diseases had offered to support the evaluation of PLX cells in models of the acute radiation syndrome. Prior preclinical in vivo studies carried out in collaboration with the Hadassah University Medical Center had shown that treating irradiated animals with PLX-RAD cells was associated with a fourfold increase in the survival rate compared with treatment using placebo.