According to a story from PR Newswire, the drug development company AIVITA Biomedical recently announced that the first patient in its Phase II clinical trial has been randomized. This is a double-blind study that will involve the participation of 99 ovarian cancer patients.
Each patient will receive an individually customized ovarian cancer control agent, or vaccine. The treatment incorporates AIVITA’s proprietary ROOT OF CANCER immunotherapy that is meant to target cells that start cancer.
Ovarian cancer can originate inside or on the ovaries. In its early stages, the abnormal cancer cells multiplying in the ovary rarely cause symptoms, leading to late detection and diagnosis, which increases the risk of mortality. Risk factors for ovarian cancer include a longer period of ovulation over the life span, not having children, genetic factors (BRCA mutations) obesity, hormone therapy, and fertility medication. Symptoms of ovarian cancer include back pain, irregular menstruation, bloating, abdominal/pelvic pain, fatigue, diarrhea, indigestion, pain and bleeding during sex, and changes to urinary habits. Treatment includes a variety of approaches, such as surgery, radiation therapy, chemo, and immunotherapy. Five year survival rates for ovarian cancer are relatively poor, at only 45 percent. This is mainly due to the fact that it is difficult to detect until it has reached an advanced stage. To learn more about ovarian cancer, click here.
So far, AIVITA has manufactured custom vaccination for seven patients so far without issue. Part of the goal for the treatment approach is a manufacturing process that is fast-paced, consistent, and cost-effective. This success will allow the trial to begin to expand to different localities. The company eventually hopes to test its ROOT OF CANCER technology on other cancer types as well, such as melanoma and glioblastoma. In theory, the approach could be applicable to all solid tumors.
ROOT OF CANCER is an immunotherapy approach that harnesses autologous dendritic cells that are then loaded with tumor antigens that are derived from self-renewing tumor growth cells. The Phase II trial will be the first to test the effectiveness of the technology in human patients.
Hopefully, this trial will demonstrate the effectiveness of this experimental immunotherapy technology.
