AIVITA Biomedical Announces Treatment of First Two Patients in Phase 2 Glioblastoma Trial

IRVINE, Calif., Nov. 16, 2018 /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

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 therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of women with ovarian cancer.

SOURCE AIVITA Biomedical