AIVITA Biomedical has enrolled the first patient in a Phase II clinical study to evaluate the efficacy and safety of its autologous cancer immunotherapy in women with advanced epithelial ovarian carcinomas.
The double-blind ‘Root of Cancer’ trial was launched at Newport Beach hospital in California, US.
The trial will enrol roughly 99 patients who will be randomised in a 2:1 ratio to receive either treatment or a monocyte placebo comparator.
Patients who have undergone debulking surgery and leukapheresis that sufficient monocytes were obtained from will be eligible for randomisation and treatment in the cancer trial.
In addition, the patients with a cell line established and who have an ECOG performance grade of zero or one will be able to take part in the trial.
AIVITA Biomedical chief medical officer Dr Robert Dillman said: “The gynecologic oncologists we are working with have been strong clinical partners to AIVITA in bringing this promising cancer vaccine to patients from our local community.”
AIVITA is planning to expand its Phase II trial by opening new sites next year.
The company’s cancer immunotherapy treatment features autologous dendritic cells loaded with tumour-associated antigens from autologous self-renewing tumour-initiating cells, which represent that root of cancer.
The treatment has been included in the international patent applications outlining the discovery of new ways to enhance a patient’s immune response to locate and destroy tumours.