AIVITA Completes Treatment of First Patient in Phase 2 Ovarian Cancer Trial

AIVITA Biomedical announced its first patient has completed treatment in its multi-center Phase 2 ROOT OF CANCER ovarian cancer trial. The patient has received the eighth and final dose of the study therapy under the guidance of Principal Investigator Dr. Lisa Abaid of Gynecologic Oncology Associates in Newport Beach, CA.

AIVITA's trial calls for approximately 99 patients to be randomized in a 2:1 ratio to receive either the Company's patient-specific cancer-stem cell targeting treatment or a control agent consisting of autologous monocytes. Eight subjects have been randomized to receive the study therapy, which is administered in a series of eight injections along with standard care. 11 subjects are currently enrolled in the study across five clinical sites, with three additional sites opening soon.

"Interest amongst oncologists has been extremely high, as our therapy complements standard of care and has such a high efficacy rate," said Dr. Robert Dillman, Chief Medical Officer at AIVITA. "Of the eight subjects currently randomized in our trial we have been successful in manufacturing treatments for all eight, further evidencing that this technology can be quickly and reliably produced for the treatment of multiple cancer types."

AIVITA is currently conducting three clinical studies investigating its platform ROOT OF CANCER therapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skin care line to support the treatment of women with 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.

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 purified autologous self-renewing tumor-initiating cells.

AIVITA's ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy 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, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy.

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