December 18, 2013

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December 18, 2013 09:00 AM Eastern Time

IRVINE, Calif.--(BUSINESS WIRE)--California Stem Cell, Inc. (CSC) announced today the successful completion of a Phase I clinical trial investigating the safety of a cancer stem cell-based therapy in patients with Stage IV hepatocellular carcinoma, a common form of advanced liver cancer. The trial, conducted in Shanghai, China in accordance with international standards, marks the second cancer type the Company has explored with its platform approach, the first being a Phase III treatment for melanoma in the United States.

“We were very encouraged by these early clinical and operational results”

Led by Global Medical Director Michael Bayer, M.D., Ph.D., the study called for 8 patients with Stage IV hepatocellular carcinoma to receive the Company’s patient-specific cancer immunotherapy, known as “DC-TC.” Study patients received weekly injections for three consecutive weeks and were evaluated over a two-month period.

CSC's "DC-TC" therapy begins with growing cancer stem cells that have been isolated from a patient's resected tumor sample, which are then enriched and inactivated. 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 introduced back into the patient via a series of subcutaneous injections.

This initial study sought to determine whether patients could safely receive the “DC-TC” product without experiencing adverse events, which could serve as an indication that the therapeutic product was safe for further research in human patients. The study also sought to explore whether the immune-activating process might create complications in trial patients who also had active hepatitis B.

“In China, a nation with the largest incidence rates for liver cancer in the world, many patients will co-present with hepatitis B,” said Dr. Bayer. “Initially there was some concern that these patients might experience flare-up of their hepatitis as the immune system was strengthened and directed to kill their cancer stem cells; however, those concerns proved to be unwarranted.”

In addition to demonstrating initial safety of the cell therapy product among the initial patient cohort, this trial demonstrated the successful transfer of CSC’s manufacturing technology to a remote manufacturing facility under its control, which the company considers a critical component in future trials using this approach. Manufacture of the patient-specific product for the trial was conducted by CSC under cGMP conditions.

“We were very encouraged by these early clinical and operational results,” said CEO Hans Keirstead, Ph.D. “Not only were the initial results promising, but the trial represented a successful first step in California Stem Cell’s goal of translating its platform cancer stem cell treatment to other cancer types. We expect this successful experience and the data collected will serve us well as we expand into other solid tumor cancers.”

About the DC-TC Treatment

CSC’s DC-TC treatment is based on recent clinical findings that the rapid proliferation and subsequent spreading of cancer throughout a patient’s body may be fueled by a small number of cancer stem cells. Through proprietary processes developed at CSC, researchers have refined isolation and expansion of these cancer stem cells to clinically useful numbers, which are then combined with autologous dendritic cells, and reintroduced into the patient with the intention of training and bolstering the patient’s immune system to target the cancer stem cells that have the ability to metastasize and create new tumors.

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA-based company focused on the development of stem cell-based therapies for metastatic cancers and neuromuscular disorders such as spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease) and spinal cord injury.

CSC has proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and cGMP processes.

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Contacts

California Stem Cell, Inc.
Matt Bayless, 949-725-1750
press@californiastemcell.com

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