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November 20, 2014
Source: Press Release Boston
SOTIO, a biotechnology company owned by the PPF Group, today announced that the first US patient has been enrolled in its VIABLE study, the global Phase III clinical trial for DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer patients. Initial patients were also recently enrolled into the study in Italy, UK, the Netherlands and Slovakia.
The first US patient was enrolled into this Phase III global study in Rockville, MD. SOTIO is targeting the enrollment of around 250 US patients, collaborating with physicians from more than 80 US medical centers. The VIABLE study plans to recruit patients through cooperation with medical centers in the United States, Canada and 25 European countries. SOTIO’s aim is to enroll approximately 1,170 prostate cancer patients globally. The first patient was enrolled into the VIABLE study in Hungary in May 2014.
Niels Borgstein, Chief Medical Officer of SOTIO US commented: “Commencing the VIABLE study in the US is a crucial next step in our global clinical strategy to help develop a new immunotherapy for the treatment of prostate cancer patients.”
Professor Radek Špíšek, Chief Scientific Officer of SOTIO explained: “We believe that in order to be successful in treating advanced stages of prostate cancer it is essential to understand if cancer immunotherapy should be combined with existing treatments, such as chemotherapy. In accordance with this strategy, we have designed a chemo-immunotherapy clinical trial that explores the combination of both standard care chemotherapy and a new dendritic cell-based immunotherapy known as DCVAC/PCa.”
SP005 VIABLE: 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.
More information on the study is available on the website www.viablestudy.com.
DCVAC/PCa was the first SOTIO product 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 using the patient’s own dendritic cells (that are part of the immune system), to induce an immune reaction against tumor antigens. Phase I and Phase II clinical trials, already involving several hundred patients with prostate cancer at various stages of the disease, indicate promising preliminary results to support the further clinical development of DCVAC.
Besides the VIABLE study, SOTIO is currently sponsoring five Phase II clinical trials in prostate cancer patients and three Phase II clinical trials in patients with ovarian cancer (DCVAC/OvCa treatment). Clinical testing of DCVAC/LuCa treatment in patients with lung cancer will start soon.