Cellular Biomedicine Group Releases Positive Results From Phase I Clinical
Trial for Hepatocellular Carcinoma
PALO ALTO, Calif., March 24, 2014 (GLOBE NEWSWIRE) -- Cellular Biomedicine
Group, Inc. (OTCQB: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
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
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.
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.
CONTACT: Sarah Kelly
Director of Corporate Communications, CBMG
+1 650 566 5064
Managing Director Investor Relations, Grayling
+1 646 284 9427
Director Investor Relations, Grayling
+1 646 284-9426
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