IRVINE, Calif., Dec. 20, 2017 — AIVITA Biomedical today announced that the first patient has been enrolled in its double-blind Phase II clinical study assessing the efficacy and safety of its autologous cancer immunotherapy in women with advanced epithelial ovarian carcinomas. This Root of Cancer trial, designated CL-OVA-P01 at the FDA, has been initiated at Newport Beach, California's leading hospital.
Ovarian cancer is the 8th most common cancer among women, fifth leading cause of cancer-related death among women, and is the deadliest of gynecologic cancers. A woman's lifetime risk of developing invasive ovarian cancer is 1 in 75.1
“The gynecologic oncologists we are working with have been strong clinical partners to AIVITA in bringing this promising cancer vaccine to patients from our local community,” said Dr. Robert Dillman, Chief Medical Officer of AIVITA. “I also would like to credit the AIVITA team for making novel advancements which were critical to enabling the safe and efficient manufacture of this promising treatment.”
AIVITA's treatment is the subject of international patent applications outlining the discovery of new ways to augment a patient's immune response to seek out and destroy tumors. The Company is planning to expand access to its Phase II trial by opening additional sites in the coming year.
1 American Cancer Society. Cancer Facts and Figures 2017. Atlanta, GA: American Cancer Society; 2017.
About the ROOT OF CANCER Trial
AIVITA's treatment consists of autologous dendritic cells loaded with tumor-associated antigens from autologous self-renewing tumor-initiating cells, which represent that root of cancer. The Phase II double-blind study will enroll approximately 99 patients who will be randomized in a 2:1 ratio to receive either treatment or a monocyte placebo comparator.
Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%).
For additional information about AIVITA's AVOVA-1 trial patients can visit www.clinicaltrials.gov/ct2/show/NCT02033616
About AIVITA Biomedical
AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its commercial line of skin care products and therapeutic pipeline. All proceeds from the sale of AIVITA's skin care products directly support its Phase II clinical trial for the treatment of ovarian cancer.
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SOURCE AIVITA Biomedical
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