California Stem Cell Announces U.S. FDA Approval of Phase III Cancer Stem Cell Clinical Trial for Metastatic Melanoma

– Go-Ahead Received for Stem Cell-Based Therapy to Explore its Potential to Treat the Deadliest Form of Skin Cancer –
December 03, 2013 08:30 AM Eastern Standard Time
IRVINE, Calif.--(BUSINESS WIRE)--California Stem Cell, Inc. (CSC) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's application to begin a Phase III clinical trial exploring the potential of a cancer stem cell-based platform therapy to treat advanced metastatic melanoma. The protocol has received Special Protocol Assessment (SPA), indicating that FDA is in agreement that the design, clinical endpoints, and planned clinical analyses of the Phase III trial address regulatory objectives sufficient for market approval. The therapy has also been granted fast track status by FDA, a designation given to therapies which show promise in treating life-threatening medical conditions, which accelerates the approval of investigational new drugs undergoing clinical trials.
"We are very excited to continue this landmark work through the commencement of our Phase III trial"
The study, to be led by Robert Dillman, M.D., F.A.C.P., medical oncologist at the Hoag Family Cancer Institute of Hoag Memorial Hospital Presbyterian, calls for enrolling 250 patients with recurrent Stage III or Stage IV metastatic melanoma in a multi-centered, randomized, double-blind study that compares overall survival of patients who receive CSC's patient-specific cancer immunotherapy, known as "DC-TC," against patients receiving a control treatment.
CSC's "DC-TC" therapy begins with cancer stem cells that have been isolated from a patient's resected tumor sample, enriched and inactivated. This newly created cancer stem cell line is then combined with dendritic cells, or antigen-presenting immune cells, that are derived from the same patient's blood. The product is then introduced back into the patient via a series of subcutaneous injections.
In the planned Phase III trial, patients will receive weekly DC-TC injections for three consecutive weeks, and then once monthly for five months. CSC is expecting to begin enrollment in the first quarter of 2014.
"We are very excited to continue this landmark work through the commencement of our Phase III trial," said Dr. Dillman, noting that in two earlier Phase II clinical studies, the combined median 5-year survival in patients with metastatic melanoma was observed to be a remarkable 51%, double that of any current treatments. "We look forward to furthering our exploration of this cancer stem cell therapy's possible role in the successful treatment of this devastating disease, and to bringing this promising therapeutic approach to even more patients," he said.
About the DC-TC Treatment
The DC-TC treatment is based on findings in recent years 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 their ability to isolate and expand these cancer stem cells to clinically useful numbers, combine them with autologous dendritic cells, and reintroduce them into the patient with the intention of training and bolstering the patient's immune system to target the cells that have ability to form new tumors.
About Melanoma
According to an October 2012 article authored by Dr. Dillman, metastatic melanoma is usually lethal within 1-2 years, with only 10% of patients surviving five years. In 2012, there were approximately 20,000 new cases of metastatic melanoma diagnosed in the U.S., and about 10,000 deaths.*
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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* Journal of Immunotherapy, Vol. 35, No. 8, October 2012, "Tumor Stem Cell Antigens as Consolidative Active Specific Immunotherapy: A Randomized Phase II Trial of Dendritic Cells Versus Tumor Cells in Patients With Metastatic Melanoma" Robert O. Dillman, et. al.
California Stem Cell, Inc.
Matt Bayless, 949-725-1750