Published 18 February 2014 California Stem Cell has announced that the US Food and Drug Administration (FDA) has approved the companys 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 randomized, double-blind study is the company's second cancer therapy approved for clinical trials by the 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. Led by chief medical officer Dr Robert Dillman, 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, harvested … Continue reading
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