BOSTON, MA, USA I November 19, 2014 I 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.
The first US patient was enrolled into this Phase III global study in Rockville, MD. SOTIO is targeting to enroll around 250 US patients, collaborating with physicians from more than 80 US medical centers. Initial patients were also recently enrolled into the study in Italy, UK, the Netherlands and Slovakia. 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 novel 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 treatment modalities, such as chemotherapy. In accordance with this strategy, we have designed a chemo-immunotherapy clinical trial that explores the combination of both standard of care chemotherapy including a novel dendritic cell based immunotherapy known as DCVAC/PCa.”
About VIABLE:
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.
About DCVAC/PCa:
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 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 clinical trials in Phase II 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.
SOTIO
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.
SOURCE: Sotio
Post Views: 75
BOSTON, MA, USA I November 19, 2014 I 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.
The first US patient was enrolled into this Phase III global study in Rockville, MD. SOTIO is targeting to enroll around 250 US patients, collaborating with physicians from more than 80 US medical centers. Initial patients were also recently enrolled into the study in Italy, UK, the Netherlands and Slovakia. 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 novel 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 treatment modalities, such as chemotherapy. In accordance with this strategy, we have designed a chemo-immunotherapy clinical trial that explores the combination of both standard of care chemotherapy including a novel dendritic cell based immunotherapy known as DCVAC/PCa.”
About VIABLE:
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.
About DCVAC/PCa:
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 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 clinical trials in Phase II 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.
SOTIO
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.
SOURCE: Sotio
Post Views: 75
