AIVITA Biomedical announced has dosed its first of 10 patients currently enrolled as part of its Phase 2 trial in patients with advanced ovarian cancer. The trial is designed to investigate AIVITA Biomedical's patient-specific cancer treatment consisting of autologous dendritic cells loaded with autologous antigens from the patient's tumor-initiating cells.
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AIVITA is enrolling approximately 99 patients in the company's ROOT OF CANCER ovarian cancer trial to be randomized in a 2:1 ratio to receive either the company's patient-specific cancer treatment or a control agent consisting of autologous monocytes. The treatment will be administered in a series of injections along with standard care. "We're proud of the manufacturing team here at AIVITA who have made this important moment possible," said Dr. Bob Dillman, Chief Medical Officer at AIVITA. "The team has contributed manufacturing efficiencies which have greatly improved the success rate and speed of creating this treatment, allowing us to treat more patients more reliably. We've since randomized several additional patients in this trial and activity is accelerating as we sign on more hospitals and receive additional tumors." Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. The first Phase 2 trial demonstrated a 54% 5-year survival rate compared to a 29% 5-year survival rate for an active control arm. The second randomized Phase 2 trial demonstrated similar results, with a significantly longer median survival compared to the control arm. AIVITA's ROOT OF CANCER technology is also the subject of an ongoing Phase 2 clinical trial treating glioblastoma in the USA. The company is also currently applying for conditional approval to commercialize the treatment for melanoma in Japan and is considering Japanese strategic partners for this program.