On October 6, 2014 NeoStem reported that the United States Adopted Name Council (USAN) has approved the generic name "eltrapuldencel-T" for the Company’s patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma (Press release NeoStem, OCT 6, 2014, View Source [SID:1234500876]). 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 (SPA). NeoStem plans to begin the trial by the end of 2014.

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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.

"We welcome the receipt from USAN of the generic name for use in this important program and look forward to the launch of our pivotal Phase 3 trial to evaluate eltrapuldencel-T," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

Eltrapuldencel-T was developed by recent NeoStem acquisition California Stem Cell, Inc., based on a technology developed over the course of 10 years at Hoag Memorial Hospital Presbyterian in Newport Beach, California. Two previous Phase 2 clinical studies conducted at Hoag had resulted in a combined median 5-year survival of 50% in patients with Stage IV melanoma, double that of any current treatment.

Following on the success of those trials, 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.