The randomized, double-blind study is the Company’s second cancer therapy approved for clinical trials by FDA, bolstering its platform approach to treating late stage solid-tumor cancers. The Company’s patient-specific approach to treating metastatic melanoma, recently approved to begin a Phase III trial, provided sufficient safety data to proceed directly to a Phase II study in ovarian cancer.
US regenerative medicine company California Stem Cell Inc. reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s application to begin a Phase II clinical trial exploring the potential of a patient-specific cancer immunotherapy in women with Stage III or IV ovarian, fallopian tube or primary peritoneal cancer.
The treatment group will receive Ovapuldencel-T, which is a combination of autologous dendritic cells loaded with irradiated autologous tumor cells in GM-CSF.
The control group will receive the “MC” treatment, harvested from the patient’s blood (autologous peripheral blood mononuclear cells) combined with GM-CSF, granulocyte-macrophage colony-stimulating factor, a white blood cell growth factor.
Both groups will receive subcutaneous injections of cell-based medicine for three consecutive weeks, then monthly for the following five months. The trial is expected to last approximately sixty months, including enrollment, treatment, and long-term patient follow-up.
ClinicalTrials.gov Identifier: NCT02033616