SOTIO, a biotechnology company owned by the PPF Group, today
announced that the first patient has enrolled in its VIABLE study, the
global Phase III clinical trial for DCVAC/PCa, an active cellular
immunotherapy treatment for prostate cancer patients.
VIABLE is a randomized, double blind, multicenter, parallel-group, Phase
III study to evaluate the efficacy and safety of DCVAC/PCa as an add-on
therapy to 1st line standard of care chemotherapy in men with
metastatic Castration Resistant Prostate Cancer (mCRPC), which is based
on overall survival (OS) in mCRPC patients treated with DCVAC/PCa versus
placebo with standard of care chemotherapy.
The first patient was enrolled into the study in Hungarian Army Medical
Center (Magyar Honvédség Egészségügyi Központ), Department of Oncology.
The VIABLE study will recruit patients through cooperation with medical
centers in 20 countries: Belgium, Bulgaria, Croatia, the Czech Republic,
France, Germany, Hungary, Italy, the Netherlands, Poland, Portugal,
Romania, Russia, Serbia, Slovakia, Spain, Sweden, Turkey, the United
Kingdom and the United States. The initiations of individual countries
have already started and the first patients will be enrolled in the
coming weeks. SOTIO's aim is to enroll a total of about 1,170 prostate
cancer patients in the study from Europe, Russia and the United States.
Radek Špíšek, Chief Scientific Officer of SOTIO said: "We believe
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 wit 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. 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
tumor 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 tumor cells. The VIABLE study will thus
test the hypothesis that the combination of two treatment modalities
synergizes and leads to the prolonged survival of treated patients."
Ladislav Bartonícek, CEO of SOTIO added: "I am delighted to announce
that SOTIO is the first company from the CEE region to initiate a Phase
III clinical trial in the area of cellular immunotherapy. This milestone
is due to all the hard work and the cooperation of Charles University
and University Hospital in Motol in Prague as well as many years of
research by a dedicated group of scientists and we are now focused on
delivering the results of the trial in our efforts to further the
treatment of prostate cancer on a global scale."
SP005 VIABLE (Eudra CT: 2012-002814-38; IND:
015255): A Randomized, Double Blind, Multicenter, Parallel-Group,
Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus
Placebo in Men with Metastatic Castration Resistant Prostate Cancer
Eligible for 1st Line Chemotherapy.
DCVAC/PCa was the first SOTIO product candidate to enter clinical
evaluations. DCVAC/PCa is an active cellular immunotherapy treatment for
prostate cancer patients being evaluated in clinical studies; DCVAC/PCa
is produced individually for each patient; it uses a patient's dendritic
cells (that are part of the immune system), to induce an immune reaction
against presented tumor antigens. Phase I and Phase II clinical trials,
already involving several hundred patients with prostate cancer at
various stages, indicate promising preliminary results to support
SOTIO is an international biotechnology company developing new medical
therapies, focusing on the treatment of cancer and autoimmunity
diseases. The company conducts research concerning the actual platform
of active cellular immunotherapy on the basis of dendritic cells, with
the goal of significantly improving this treatment and making it
accessible to patients. In SOTIO's laboratory in Prague, equipped with
state-of-the-art technology, leading scientists research the role of
dendritic cells in the therapeutic activation of the immune system and
work to verify its safety and efficacy through clinical trials. SOTIO
has facilities in Europe, the United States, China and Russia. For more
information about the company visit the website www.sotio.com.
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