Cellular Biomedicine Group Releases Positive Results From Phase I Clinical Trial for Hepatocellular Carcinoma
- Category: Vaccines
- Published on Tuesday, 25 March 2014 09:05
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PALO ALTO, CA, USA I March 24, 2014 I Cellular Biomedicine Group, Inc. (CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, is pleased to announce positive results from its Phase I clinical trial, which evaluated the safety of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer.
The last patient in the trial received treatment in December 2013, and a 2-month follow-up and clinical observation has been completed and data has been analyzed for all patients.
Safety data to date from the trial has shown:
- No adverse events related to the injection site;
- A few mild, transient adverse events related to the therapy, which were mitigated with drug treatment;
- One serious adverse event, which was deemed by the Investigators to be pre-treatment tumor recurrence; and
- No laboratory abnormalities.
"We are very pleased with the positive results of this trial, which show the TC-DC therapy to be safe, and are now in a position to plan a Phase II trial to further test its safety and efficacy," said Dr. Wei (William) Cao, Chief Executive Officer of Cellular Biomedicine Group, Inc.
The Principal Investigator of the trial and director of the Liver Disease Center at Shanghai's PLA 85 Hospital, Professor Chengwei Chen, commented, "Our team is encouraged by the safety profile of this therapy which may have the potential to not only extend life but improve quality of life for many people."
About the Trial and Therapy
The Phase I clinical trial for TC-DC therapy for HCC is an open-label single center clinical trial conducted with Shanghai's PLA 85 Hospital, one of China's largest liver disease centers. The trial evaluated the safety of TC-DC therapy aimed at lowering the incidence of tumor recurrence and metastasis by means of autologous immune cell therapy in primary HCC patients following standard tumor resection and TACE chemotherapy.
The TC-DC therapy isolates cancer stem cells from a patient's resected tumor sample. These cancer stem cells are enriched and inactivated, forming a new cancer stem cell line which is then combined in vitro with dendritic cells, a type of antigen-presenting immune cell that is derived from the same patient's blood. The resulting product is introduced back into the patient via a series of subcutaneous injections, where it can "train" the immune system to fight and destroy the cancer stem cells, which are the root cause of tumor recurrence and metastasis.
The trial consisted of eight primary hepatocellular carcinoma patients following resection. Each patient received patient-specific TC-DC therapy. Patients received weekly injections for three consecutive weeks and were evaluated over a two-month period for the therapy's safety.
Hepatocellular Carcinoma in China
With over five million patients, China holds 55% of the world's HCC patients, and there are more than 340,000 new patients diagnosed per year in China. (Source: Chinese Clinical Oncology, Mar 2009, Vol. 14, No. 3). Currently, the most common therapies used to treat most HCC patients are surgery and local chemotherapy, with a 2-year recurrence rate of 51%.
About Cellular Biomedicine Group, Inc.:
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases and cancers. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility, consisting of eight independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com.
SOURCE: Cellular Biomedicine