May 22, 2013
Milestone for Liver Cancer Trial
Cellular Biomedicine Group Announces Enrollment Milestone for Phase I Clinical Trial for Liver Cancer
PALO ALTO, Calif., May 22, 2013/PRNewswire/ Cellular Biomedicine Group (OTCQB: CBMG) today announced that it has achieved half of the enrollment of the total projected enrollment required for its Phase I trial to evaluate the safety and preliminary efficacy of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer. To date the trial has had no Severe Adverse Effect (SAE) reported.
The Phase I clinical trial for TC-DC therapy for HCC, registered with NIHunder number NCT01828762(click here to view)is an open label clinical trial conducted with Shanghai’s PLA 85 Hospital, one of the Liver Disease Centers of People’s Liberation Army. The trial will evaluate the safety and efficacy in lowering the incidence of tumor recurrence and metastasisby means ofautologous immune cell therapy in primary HCCpatients following standard tumor resection and TACE chemotherapy.
Cellular Biomedicine Group’s VP and GM of the Autologous Products Business Unit, Cheng Xiang (Chase) Dai, MD, commented,“We expect that enrollment will progress quickly and this study is on schedule to complete Phase I clinical trials.”
Forty-five percent of the world’s HCC patients are in China, with over 300,000 new patients diagnosed every year. Currently the therapies commonly offered to most patients are surgery and local chemotherapy, with a 2-year recurrence rate of 51% and median survival time of 13 months.
The TC-DC therapy that CBMG is developing has had extraordinary US phase II metastatic melanoma trial results, with a 5 year overall survival of 54% in the TC-DC group versus 10% in the control group, and a median survival time of 4.5 years for the TC-DC group, versus 1.3 years for the control group with standard therapies.
“TC-DC therapy takes a sample of the patient’s own dendritic cells, the ‘trainer’ cells of effecter immune cells,and a sample of the patient’s tumor stem cells,and co-culturesthem together in the lab. The dendritic cellswill learn the characteristics of the patient’s owntumor stem cells, and are reintroduced to the patient’s bodyas a vaccine, where they can ‘train’ the immune system to fight and destroy the tumor stem cells, which are the root cause of tumor recurrence and metastasis”, explained Dr. William Cao, President of CBMG, “We are excited about the potential of this therapy to not only extend life but to maintain a high quality of life by not subjecting the patient to dramatic chemotherapy and its adverse effects”.
About Cellular Biomedicine Group
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
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.
Director of Corporate Communications, CBMG
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