20.01.2015 13:46:20

NeoStem Gets Drug Manufacture License For Irvine Facility - Quick Facts

(RTTNews) - NeoStem, Inc. (NBS), a developer of cell therapy products and regenerative medicine, said 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.

NeoStem has been issued a manufacturing license permitting the company 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. It is an autologous immunotherapy intended to eliminate cancer-initiating cells capable of causing disease recurrence and progression.

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