IRVINE, Calif.--(BUSINESS WIRE)--California Stem Cell, Inc. (“CSC”) announced today it has submitted a Phase II protocol to the U.S. Food and Drug Administration for a randomized, double-blind study to evaluate CSC’s patient-specific cancer immunotherapy in women with Stage III or IV ovarian, fallopian tube or primary peritoneal cancer.
Led by Chief Medical Officer Robert Dillman, M.D., the study design randomizes an estimated 99 adult female patients to two treatment arms. The treatment group will receive Ovapuldencel-T, which is a combination of autologous dendritic cells loaded with irradiated autologous tumor cells in GM-CSF. Ovapuldencel-T is created by first isolating cancer stem cells from the patient's resected tumor sample, then enriching, inactivating and combining these cells with dendritic cells – or antigen-presenting immune cells – which are harvested from the patient’s blood.
The control group will receive the “MC” treatment, which involves harvesting the patient’s blood (autologous peripheral blood mononuclear cells) and combining it with GM-CSF, granulocyte-macrophage colony-stimulating factor, a white blood cell growth factor.
The trial design calls for both groups to receive subcutaneous injections of their respective treatment weekly for three consecutive weeks, then monthly for the following five months. The trial, which will be conducted at Hoag Hospital Presbyterian in Newport Beach, CA, is expected to last approximately sixty months, including enrollment, treatment, and long-term patient follow-up.
“We were pleased with the FDA’s positive response to our initial discussions regarding this study, which enabled CSC to proceed directly to a Phase II submission. This suggests that application of this platform technology to other cancer indications may similarly begin at the Phase II clinical trial stage,” said Hans Keirstead, Ph.D., CEO of California Stem Cell.
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 neurological disorders.
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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