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May 13, 2014
07:33 EDTNBSNeoStem announces licensing agreement, plans to begin Phase 2 HCC trial in China
NeoStem announced that the company has signed an exclusive license agreement with China-based Cellular Biomedicine Group 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, or 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 $30M in licensing milestone fees over the life of the agreement, with $1M 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 cells that have been isolated from a patient's resected tumor sample, and then enriching and inactivating them. This newly created cancer initiating 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.
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