IRVINE, Calif. (February 18, 2014) California Stem Cell, Inc. (CSC) announced today that the U.S. 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 Companys second cancer therapy approved for clinical trials by FDA, bolstering its platform approach to treating late stage solid-tumor cancers. The Companys 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 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 patients resected tumor sample, then enriching, inactivating and combining these cells with dendritic cells or antigen-presenting immune cells which are harvested from the patients blood. The control group will receive the MC treatment, harvested … Continue reading →

FDA weighs possibility of allowing research into three-parent babies By Dennis Sadowski Catholic News Service WASHINGTON (CNS) -- Fertilization techniques that would create babies from the DNA of three or four people to prevent the transmission of inheritable genetic diseases are being questioned by ethicists and others who say the procedures fail basic ethical and moral standards. Chief among the concerns is that the techniques, which involve replacing a mother's mitochondria with that of an egg donor, would pass on genetic alterations with unknown implications for future generations. The techniques are controversial because they involve altering an embryo's DNA, leading to questions about whether the government should approve the creation of, in effect, genetically modified humans. In addition, the techniques rely upon in vitro fertilization, which the Catholic Church has long opposed as immoral. In IVF, a woman's eggs are removed, united with sperm in a laboratory, and then implanted in the womb of the mother or a surrogate. The two forms of the technology to overcome mitochondrial disease -- maternal spindle transfer and pronuclear transfer -- were discussed during a hearing called by the Cellular, Tissue and Gene Therapies Advisory Committee of the Food and Drug Administration Feb. 25-26. … Continue reading →