NEW YORK, Oct. 6, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today 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. 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.
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.
Melanoma, which originates in pigment-producing cells known as melanocytes, is the most lethal form of skin cancer. Melanoma is often caused by unrepaired DNA damage to skin cells from UV radiation. Patients who have progressed to Stage IV melanoma have a cancer that has metastasized, or spread to distant sites in the body which may include the lymph nodes, lungs, liver, or brain. As a result, advanced melanoma is exceedingly difficult to treat, with a 5-year survival rate of approximately 15%. For 2014 it was estimated there would be 76,100 new diagnoses of melanoma in the U.S., and 9,710 deaths.
Treatments for Stage IV melanoma are typically directed at slowing the growth of the cancer and prolonging survival. Current treatment options include radiation, chemotherapy, surgical resection, immunotherapy, or a combinatory approach. Unfortunately, most current approaches merely either halt the growth of tumors for an average of 6-10 months or eliminate all tumors in only 10-20% of patients. Administering certain anti-melanoma drugs at higher doses appears to be more effective, but often results in more severe side effects.
About NeoStem, Inc.
NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation. www.neostem.com
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Targeted Immunotherapy Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, the performance and planned expansion of the Company's contract development and manufacturing business. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 13, 2014, the Company's Current Report on Form 8-K filed with the SEC on May 8, 2014 and in the Company's other periodic filings with the SEC. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
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