IRVINE, Calif. /PRNewswire/ -- AIVITA Biomedical announced today that it has dosed the first two patients in its Phase 2 clinical trial in patients with newly diagnosed glioblastoma. The trial is designed to investigate AIVITA Biomedical's next-generation patient-specific cancer treatment, uniquely targeting the patient's tumor-initiating cells.
The first two patients were treated at the University of California Irvine (UCI) Comprehensive Brain Tumor Program under the direction of UCI Health neuro-oncologist and Principal Investigator Daniela Bota, MD, PhD.
AIVITA will enroll approximately 55 patients in its ROOT OF CANCER Glioblastoma trial to receive the Company's patient-specific cancer treatment, which is administered in a series of subcutaneous injections alongside standard care. AIVITA is also expanding access to the trial, having recently adding the University of California San Diego and John Wayne Cancer Institute as clinical sites.
"I am very proud of the AIVITA team for so effectively running three clinical programs in two countries," said Dr. Bob Dillman, Chief Medical Officer at AIVITA. "This is enabled by a quick, reliable and inexpensive manufacturing process and a treatment protocol that truly complements the regime of cancer care."
AIVITA's ROOT OF CANCER technology is also the subject of an ongoing multi-center Phase 2 clinical trial treating ovarian cancer in the USA, and an application to commercialize the treatment of melanoma patients in Japan. Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. These clinical studies demonstrated a 72% 2-year survival rate and a 54% 5-year survival rate, supporting AIVITA's conditional commercial approval application in Japan. The Company is considering Japanese strategic partners for this program.
About the ROOT OF CANCER Glioblastoma trial
AIVITA's treatment is a platform technology applicable to any solid tumor type and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.
Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established by AIVITA, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).
For additional information about AIVITA's AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917