New York, October 1, 2014 — NeoStem, Inc. (“NeoStem” or the “Company,” Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today its establishment of a melanoma scientific advisory board consisting of internationally renowned experts in oncology and in the development of novel therapeutics for melanoma. The group of six experts, including medical oncologists, a basic scientist, and a surgical oncologist specializing in melanoma, will advise and provide support to NeoStem in the area of melanoma research and clinical development. Each of the consultants contributes a breadth of experience in the oncology field intended to enable the successful design and execution of the Company’s upcoming Intus Phase 3 clinical trial investigating the use of its DC/TC (dendritic cell/tumor cell) technology in patients with metastatic melanoma.
The members of this advisory board include:
- Michael B. Atkins, M.D., of the Georgetown-Lombardi Comprehensive Cancer Center in Washington D.C.;
- Lisa H. Butterfield, Ph.D., of the University of Pittsburgh in Pittsburgh, Pennsylvania;
- Kim Margolin, M.D, of Stanford University in Palo Alto, California;
- Steven J. O’Day, M.D., of the Beverly Hills Cancer Center in Beverly Hills, California;
- Merrick I. Ross, M.D., of the University of Texas M.D. Anderson Cancer Center in Houston, Texas;
- Jedd D. Wolchok, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center in New York City
“This impressive group of physicians and researchers will serve as an excellent source of external input in areas such as clinical strategy, anticipated trends in the management of melanoma and medical practice, identification of other opinion leaders in the field, and correlative studies, such as sensitive assays for detecting the extent of anti-tumor response,” said Dr. Robert Dillman, Vice President of Oncology of NeoStem.
“With our Intus Phase 3 melanoma clinical trial investigating the use of our DC/TC technology expected to begin by year’s end, we are thrilled to be receiving the guidance of such notable specialists,” said Dr. Robin L. Smith, Chairman and CEO of NeoStem. “Their collective experience in melanoma research and the clinical development of cancer immunotherapies will be invaluable as we move forward the development of this therapy.”
The Company’s DC/TC (dendritic cell/tumor cell) product candidate is an autologous immunotherapy intended to eliminate cancer-initiating (stem) cells capable of causing disease recurrence. The therapy employs the patient’s own tumor cells and dendritic cells (a type of immune cell), along with granulocyte-macrophage colony stimulating factor (GM-CSF, a natural growth factor that stimulates white blood cells in the body). The patient’s dendritic cells are mixed with the patient’s tumor cells to create the therapeutic agent, which is then suspended in GM-CSF for injection into the patient. DC/TC was developed by California Stem Cell, Inc., which was acquired by NeoStem in May 2014. NeoStem plans to begin the Intus study of DC/TC later this year and has been granted fast track and orphan designation by the Food and Drug Administration (“FDA”). The trial has a Phase 3 protocol that is the subject of a Special Protocol Assessment (“SPA”).
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%. There are 76,100 new cases per year in the U.S. and melanoma kills an estimated 8,790 in the U.S. annually.
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 provide only temporary relief, either halting the growth of tumors for an average of 6-10 months or eliminating 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 Cancer Immunotherapy Program (including whether or not NBS20 will successfully be developed to treat metastatic melanoma or any other cancer indications), 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 and 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.