AsianScientist (May 22, 2014) – NeoStem, Inc., a cellular therapy manufacturer, has signed an exclusive license agreement with China-based Cellular Biomedicine Group (CBMG) to begin a Phase II 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 NeoStem’s developmental patient-specific cancer immunotherapy, known as DC-TC, in patients with hepatocellular carcinoma (HCC).
NeoStem could receive up to US$30 million in licensing milestone fees over the life of the agreement, with US$1 million payable upon enrollment of the first patient in the currently planned Phase II trial.
The DC-TC therapy involves growing cancer stem cells that have been isolated from a patient’s resected tumor sample, and then enriching and inactivating them. This newly created cancer 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 II 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. 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. “Patients with this stage of disease are not eligible for curative resection or transplantation.”
“The planned Phase II 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 percent of the world’s HCC patients, being responsible for 395,000, or roughly 50 percent, of new cases in 2012.”
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Source: Takeda.
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