January 20, 2015
NeoStem, Inc. (NASDAQ:NBS) a leader in the development and manufacturing of cell therapy products and regenerative medicine, announced today that the State of California’s Department of Public Health, Food and Drug Branch has completed its review of NeoStem’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.
“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.
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.
About the Intus Study
The Intus Study is a multi-national, randomized, double-blind Phase 3 clinical trial in which patients will be randomized in a 2:1 ratio to receive either eltrapuldencel-T or a control treatment (autologous mononuclear cells in GM-CSF). An expected 250 enrolled patients throughout the U.S., Canada, Australia and New Zealand will receive weekly injections for three consecutive weeks, and then once monthly for five months. This investigational treatment, planned to be evaluated in the Company’s Phase 3 Intus study, has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and will be conducted under a protocol that has been granted Special Protocol Assessment. For more information please visit www.theintusstudy.com
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