May 26, 2015
Source: Press release, Prague / Boston
SOTIO, a biotechnology company owned by the PPF Group, today announced that it will present an abstract highlighting the design, methods and objectives of its VIABLE study, the global Phase III clinical trial of DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer patients, in the poster session at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
SOTIO is developing new medical therapies, focusing on the treatment of cancer and autoimmune diseases. The company’s current focus is predominantly on development of its Active Cellular Immunotherapy (ACI) treatment for prostate cancer patients (DCVAC/PCa), patients with ovarian cancer (DCVAC/OvCa), and patients with lung cancer (DCVAC/LuCa). In addition, SOTIO’s in-house research and clinical development teams are investigating potential uses in patients with other indications.
SOTIO will be attending the 2015 ASCO annual meeting with its own exhibition booth and will also present an abstract from the following study evaluating its autologous dendritic cell immunotherapy at:
- Autologous dendritic cell vaccination (DCVAC/PCa) added to docetaxel chemotherapy in a double-blind, randomized Phase III trial (VIABLE) in men with advanced (mCRPC) prostate cancer (Genitourinary (Prostate) Cancer Session: S Hall A, Saturday, May 30, 1:15 PM to 4:45 PM, Poster Board #63b, Abstract No. TPS5070)
Nicholas J. Vogelzang, Medical Director of the Genitourinary Research program US Oncology Research and a coordinating principal investigator for the study, highlighted: “Docetaxel chemotherapy has been the standard of care since 2003 for mCRPC. In spite of over a dozen Phase III trials no agent has been able to improve upon it. Given the power of immunotherapy, we are optimistic that autologous dendritic cell vaccination will improve upon docetaxel therapy. The trial is rapidly accruing patients and the patient community is excited at this new opportunity.”
Professor Radek Špíšek, Chief Scientific Officer of SOTIO explained: “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 standard of care chemotherapy and a new dendritic cell-based immunotherapy known as DCVAC/PCa. We believe that the results of our VIABLE clinical trial will prove our expectations on the benefits of such a combination and our innovative method will broaden treatment possibilities for patients suffering from this devastating disease.”
SOTIO will have an exhibition booth at ASCO for those seeking further information (booth number 20141).
With over 30,000 attendees, the ASCO annual meeting (May 29-June 2, 2015) is one of the largest and most prestigious educational and scientific events in the oncology community. The five-day event provides a venue for physicians and scientists to present research results to a global audience of oncology professionals. Clinical trial results and updates presented at ASCO's annual meeting represent the extent of progress globally made each year in the fight against cancer.
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 research. 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 has been launched at the end of 2014.