IRVINE, C.A., June 21, 2016 – AIVITA Biomedical, a therapeutic development company focused on regenerative and curative medicines, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application to begin a Phase 2 clinical study. The study will investigate the efficacy of AIVITA’s novel immunotherapy in patients with ovarian cancer, an indication with a high unmet medical need.

AIVITA has signed an agreement with a renowned hospital to conduct a Phase 2 clinical trial. AIVITA expects to begin the Phase 2 clinical trial using its novel immune approach by the end of the year.

“While our stand-alone therapy targets the engine of cancer, the cancer stem cell, it may also be used in combination with immune checkpoint inhibitors such as antibodies to CTLA4, PD-1 and PD-L1. Data suggest that the benefits may be synergistic,” said Dr. Hans S. Keirstead, CEO of AIVITA.

AIVITA’s treatment consists of autologous dendritic cells loaded with antigens derived from the patient’s own cancer stem cells, or tumor-initiating cells. AIVITA is the only company in the world with the ability to isolate and expand a patient’s cancer stem cells and specifically target them, with a product that is both reliable and inexpensive to produce. By educating dendritic cells isolated from the patient’s own blood with antigens isolated from the patient’s own tumor-initiating cells, the patient’s immune system is thereby exposed to the full antigenic signature of the patient’s specific cancer. As a result, the treatment has the potential to seek out and destroy the very cells responsible for the growth of the disease wherever they have spread.

About AIVITA Biomedical

AiVita Biomedical is advancing commercial and clinical-stage programs utilizing curative and regenerative medicines. Built upon expertise in stem cell growth and directed, high-purity differentiation, AiVita Biomedical has engineered safe, efficient and economical manufacturing systems to support the development and commercialization of curative and regenerative medicines