NeoStem’s Irvine Site Receives Manufacturing License

NeoStem, Inc. has received a drug manufacturing license following a successful review of its Irvine, CA cGMP facility by the State of California’s Department of Public Health, Food and Drug Branch. NeoStem will produce eltrapuldencel-T (also known as NBS20) 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, combined with dendritic cells (antigen-presenting immune cells), and then introduced back into the patient via a series of subcutaneous injections.
 
“We are pleased to have reached another critical milestone in the development of NBS20. With this step, we remain on track to begin patient enrollment in our pivotal Phase 3 trial, the Intus Study, to evaluate eltrapuldencel-T in metastatic melanoma, during the first quarter of 2015,” said Dr. David J. Mazzo, chief executive officer of NeoStem.