AIVITA Biomedical 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.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
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.