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May 29, 2014
07:35 EDTNBSNeoStem presents five-year survival data for autologous melanoma Immunotherapy
NeoStem announced results of a pooled analysis indicating that Melapuldencel-T, an investigational patient-specific immunotherapy for metastatic melanoma, may increase survival rates significantly for patients at the most advanced stages of the disease. The findings will be presented on Sunday, June 1 in a poster by Robert O. Dillman, MD, study author and Vice-President, NeoStem Oncology, at the 50th Annual Meeting of the American Society of Clinical Oncology, or ASCO. The analysis to be presented at ASCO includes a subset of pooled data from three melanoma clinical trials, conducted successively from 1990-2011. Two of these trials, one of which was controlled and one of which was not, studied Melapuldencel-T. The new pooled analysis indicates significantly better five-year overall survival rates in patients treated with Melapuldencel-T than those treated with the comparator therapy for the subset of patients who still had evidence of disease after prior treatment with one or more standard therapies. "This subset analysis lends further support to the view that tumor-initiating cells are viable targets for therapeutic interventions like Melapuldencel-T, aiming for better overall survival, even for patients in the most advanced stages of malignant melanoma. In addition, the product may have significant safety and tolerability advantages over existing therapies," said Dr. Dillman. Chief Medical Officer Douglas Losordo, said, "NeoStem is excited to continue investigating this promising therapy in a large-scale Phase 3 study beginning this year." Melapuldencel-T was developed by California Stem Cell, Inc., which was acquired by NeoStem in May. NeoStem is initiating a Phase 3 study of Melapuldencel-T later this year under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration, and the therapy has been granted fast-track designation by the agency as well.
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