IRVINE, Calif., June 14, 2018 /PRNewswire/ -- AIVITA Biomedical announced today the randomization of its first patient in the Company's Phase II clinical trial for newly diagnosed advanced ovarian cancer. The double-blind study will enroll approximately 99 patients who will receive AIVITA's patient-specific ovarian cancer vaccine, or a control agent. This milestone achievement is the first application of AIVITA's new ROOT OF CANCER technology, a revolutionary immunotherapy that targets cancer-initiating cells.
AIVITA has received seven patient tumor specimens from a single clinical site, and has successfully generated a treatment for each patient, yielding a 100% manufacturing success rate. Given the success of patient recruitment and manufacturing, AIVITA will now expand the clinical study to multiple centers.
"I'm very proud that our AIVITA team has so clearly demonstrated feasibility and reproducibility in manufacturing these patient-specific treatments," said Dr. Robert Dillman, AIVITA's Chief Medical Officer. "Quick, reliable and cost-effective production is critical for the viability of both patient and company."
AIVITA's ROOT OF CANCER technology may soon be applied to both melanoma and glioblastoma multiforme patients. The Company is seeking approval to commercialize the treatment of melanoma patients in Japan and was recently approved to conduct a Phase 2 clinical study in glioblastoma multiforme by the US FDA.
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of female cancer deaths, with an estimated 22,240 new diagnoses in 2018 and 14,070 deaths. The median age at diagnosis is 63, with a 5-year survival rate of less than 50% for all, and about 35% for the two thirds who have advanced disease (stage III or IV) at the time of initial diagnosis. Current standard of care includes surgical debulking and several courses of chemotherapy.
About ROOT OF CANCER
AIVITA's treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.
The ovarian Phase II double-blind study will enroll approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine or autologous monocytes as a 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%).
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 support the treatment of women with ovarian cancer.