Sotio, a Czech Republic-based biotechnology firm owned by the PPF Group, has enrolled the first patient in its global Phase III VIABLE trial for DCVAC/PCa, an active cellular immunotherapy, to treat patients with prostate cancer.
The randomised, double-blind, multicentre, parallel-group Phase III trial will evaluate the safety and efficacy of DCVAC/PCa as an add-on therapy to first line standard of care chemotherapy in men with metastatic castration resistant prostate cancer (mCRPC).
VIABLE is based on overall survival (OS) in mCRPC patients treated with DCVAC/PCa versus placebo with standard care chemotherapy.
The first patient in the trial was enrolled in Hungarian Army Medical Center, Department of Oncology.
Patient enrolment in the trial will be carried out through cooperation with medical centres in 20 countries, which are Belgium, Bulgaria, Croatia, the Czech Republic, France, Germany, Hungary, Italy, the Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Turkey, the UK and the US.
According to the company, initiations of individual countries have already been started and the first patients will be enrolled in the coming weeks.
A total of 1,170 prostate cancer patients are expected to be enrolled in the trial from Europe, Russia and the US.
Sotio chief scientific officer Radek Špíšek said the company believes that in order to be successful in treating advanced stages of the disease it is essential to understand if cancer immunotherapy should be combined with existing treatment modalities, such as chemotherapy.
"In accordance with this strategy, we have designed a combined chemo-immunotherapy clinical trial that explores the combination of standard care chemotherapy and dendritic cell based immunotherapy treatment with DCVAC/PCa," Špíšek said.
"Dendritic cells are separated from patients' monocytes and introduced to a prostate cancer cell line killed by high hydrostatic pressure.
"While the chemotherapy treatment decreases tumour cell load, the cancer immunotherapy treatment with DCVAC/PCa may induce an immune response directed against multiple tumor antigens and therefore control the growth of tumour cells.
"The VIABLE study will thus test the hypothesis that the combination of two treatment modalities synergises and leads to the prolonged survival of treated patients."
DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer, is the first product candidate of the company to enter clinical evaluations.
The product is produced individually for each patient and it uses a patient's dendritic cells, to induce an immune reaction against presented tumour antigens.
Image: Micrograph of prostate adenocarcinoma, acinar type, the most common type of prostate cancer. Photo: courtesy of Nephron.