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November 28, 2017
Source: Press Release
SOTIO, a biotechnology company owned by the PPF Group, today announced the enrollment of the first patient to a Phase II study testing DCVAC/OvCa in combination with standard of care chemotherapy for patients with ovarian cancer after first relapse. Based on positive signals from ongoing trials, SOTIO is also expanding its ongoing study testing DCVAC/OvCa as a maintenance therapy in first line treatment of patients with ovarian cancer.
The newly initiated clinical trial SOV06 (Eudra CT: 2017-002196-26) is an open-label, single-group, multicenter Phase II clinical trial evaluating DCVAC/OvCa in combination with standard of care chemotherapy in women with first relapse of platinum-sensitive epithelial ovarian carcinoma.
The SOV06 study will enroll 30 patients in seven oncogynecological centers. The clinical trial is conducted in collaboration with CEEGOG (Central and Eastern European Gynecological Oncology Group), which brings together centers dedicated to patients with malignant gynecological tumors in eight countries in Central and Eastern Europe.
The first patient was enrolled in the clinical trial at the General University Hospital in Prague at the department of Professor David Cibula. "For CEEGOG this is an exceptional study for several reasons. The active substance was developed in the Czech Republic, where the sponsor, biotechnology company SOTIO, is headquartered, the mechanism of action is innovative and the results of studies conducted so far are promising in the area, which still has the worst results in our field of gynecological oncology,” commented Professor Cibula.
In addition, SOTIO is expanding its ongoing trial SOV01 (Eudra CT: 2013-001322-26) by including additional 30 patients in the Czech Republic. SOV01 is a randomized, open-label, three-arm multicenter Phase II clinical trial evaluating DCVAC/OvCa in combination with first-line standard chemotherapy in women with newly diagnosed epithelial ovarian cancer following radical debulking surgery. The trial launched in November 2013 and the recruitment was completed in March 2016. The first part of SOV01 enrolled 99 patients at clinical sites in the Czech Republic, Poland and Germany.
Ladislav Bartonicek, CEO of SOTIO, said: “Positive signals from the clinical trials with DCVAC/OvCa encourage us to launch an additional Phase II trial with larger numbers of patients to confirm its efficacy. The expansion of the clinical trials represent an important step in the development of this innovative treatment for ovarian cancer. We have also started discussions with key opinion leaders in order to define the path towards the setup of the registration trials.”
“SOV06 and the expansion of SOV01 represent a significant broadening of our Phase II program for ovarian cancer”, Radek Spisek, Chief Scientific Officer of SOTIO added. “From ongoing clinical trials we see indications that DCVAC/OvCa in combination with the first line chemotherapy could be beneficial for patients. Expanding the program and testing of DCVAC/OvCa in combination with standard of care chemotherapy in patients with platinum sensitive relapse of the disease is a logical step to do.”
DCVAC is an active cellular immunotherapy treatment which 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. SOTIO is developing three product candidates using the DCVAC platform to affect multiple different cancers in various stages of disease - DCVAC/PCa for patients with prostate cancer, DCVAC/OvCa for patients with ovarian cancer and DCVAC/LuCa for patients with lung cancer.
The company is currently testing the safety and efficacy of investigational medicinal treatment DCVAC through multiple Phase I to Phase III clinical trials. SOTIO has been sponsoring four Phase II clinical trials in patients with ovarian cancer (DCVAC/OvCa treatment).