NeoStem Receives Manufacturing License
NeoStem, Inc., a biopharmaceutical company developing cell therapy products and regenerative medicines, reports that the State of California's Department of Public Health, Food and Drug Branch has completed its review of the company’s manufacturing and control processes at its Irvine, California cGMP facility for the production of eltrapuldencel-T (also known as NBS20) and has issued NeoStem a manufacturing license permitting NeoStem to manufacture drugs from this facility, including the manufacture of eltrapuldencel-T for clinical trial use. Eltrapuldencel-T is the company's patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma.
Eltrapuldencel-T is an autologous immunotherapy intended to eliminate cancer-initiating (stem) cells capable of causing disease recurrence and progression. Creation of the therapy begins with cancer-initiating (stem) cells that have been isolated from the patient's resected tumor sample, enriched and inactivated. These newly created cancer-initiating (stem) cells are then combined with dendritic cells (antigen-presenting immune cells) derived from the patient's own blood, and granulocyte-macrophage colony stimulating factor (GM-CSF), a natural growth factor that stimulates white blood cells in the body. The product is then introduced back into the patient via a series of subcutaneous injections.