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NeoStem Announces Licensing Agreement And Plans To Begin Phase 2 Hepatocellular Carcinoma Trial In China

Stocks in this article: NBS

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."

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