NEW YORK, May 13, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, announced today that the Company has signed an exclusive license agreement with China-based Cellular Biomedicine Group (OTCQB:CBMG) ("CBMG") to begin a Phase 2 clinical trial in patients with late stage liver cancer. The trial, to be conducted in China in accordance with international standards, will investigate the use of the Company's developmental patient-specific cancer immunotherapy known as "DC-TC", in patients with hepatocellular carcinoma ("HCC").
Pursuant to the terms of the license agreement, the cost of the Phase 2 trial will be borne by CBMG, and CBMG will also be responsible for all clinical, marketing, and, should a product be approved, commercialization activities in China. NeoStem will be responsible for all regulatory filings and will directly control and manage all manufacturing processes and procedures relating to the development of its DC-TC product. NeoStem could receive up to $30 million in licensing milestone fees over the life of the agreement, with $1 million payable upon enrollment of the first patient in the currently planned Phase 2 trial. Royalties and sublicense fees may also be payable.
The Company's DC-TC therapy involves growing cancer initiating (stem) cells that have been isolated from a patient's resected tumor sample, and then enriching and inactivating them. This newly created cancer initiating (stem) cell line is then combined with dendritic cells, a type of antigen-presenting immune cell that is derived from the same patient's blood. The product is then reintroduced to the patient via a series of subcutaneous injections.
The planned study follows a Phase 1 trial which demonstrated safety in HCC patients. There were no serious adverse events related to the treatment in patients who co-presented with active hepatitis B and underlying cirrhosis, commonly associated with liver cancer in China, and patients were not charged for treatment. "We were very pleased to have concluded a Phase 1 trial with positive safety outcomes and look forward to continuing to work to develop this treatment in a country where so many people are greatly affected by this disease," said Dr. Hans Keirstead, President of NeoStem Oncology, LLC, the Company's wholly-owned subsidiary developing targeted immunotherapies for cancer treatment. "Patients with this stage of disease are not eligible for curative resection or transplantation."
"The planned Phase 2 study in China is seeking to assess the efficacy and safety of our new DC-TC platform technology in treating hepatocellular carcinoma, and we look forward to working with CBMG to develop this indication in Asia," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "China holds more than 45% of the world's HCC patients, being responsible for 395,000, or roughly 50%, of new cases in 2012."
The Company has also recently reached agreement with the U.S. Food and Drug Administration to begin a Phase 3 clinical trial for its lead product candidate, Melapuldencel- T, in metastatic melanoma, expected to begin in 2014. Melapuldencel-T's Phase 3 protocol has been granted Special Protocol Assessment ("SPA") and the product candidate has received Fast Track designation for metastatic melanoma, as well as Orphan Drug designation. Five year survival data from the Phase 2 clinical trial in metastatic melanoma has been accepted for a poster presentation at The American Society of Clinical Oncology's 2014 annual meeting in June.
About the DC-TC Treatment
The Company's DC-TC treatment is based on recent clinical findings that the rapid proliferation and subsequent spreading of cancer throughout a patient's body may be fueled by a small number of cancer initiating (stem) cells. Through proprietary processes, our researchers have refined isolation and expansion of these cancer initiating (stem) cells to clinically useful numbers, which are then combined with autologous dendritic cells, and reintroduced into the patient with the intention of training and bolstering the patient's immune system to target the cancer stem cells that have the ability to metastasize and create new tumors.
About NeoStem
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
Forward-Looking Statements
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, including with respect to the Company's ability to consummate the CSC acquisition and the Company's ability to develop and grow its business, the successful development of cellular therapies (including in hepatocellular carcinoma) with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Targeted Immunotherapy Program, CD34 Cell Program and T Regulatory Cell 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.