Date: 2015-01-06
Type of information: Recruitment of the first patient
phase: 1-2
Announcement: recruitment of the first patient
Company: Sotio (Czech Republic)
Product: DCVAC/LuCa
Action
mechanism: immunotherapy product/cell therapy. immunotherapy product/cell therapy. The DCVAC/LuCa is an active autologous cellular immunotherapy treatment for patients with lung carcinoma. In each case, the DCVAC/LuCa is produced individually for each patient using the patient’s own dendritic cells cultivated from monocytes obtained from the patient’s blood, to induce an immune reaction against tumor antigens present.
Disease: stage IV non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Czech Republic, Slovakia
Trial
details: SLU01 is a Phase I/II clinical trial assessing the safety and efficacy of the DCVAC/LuCa treatment administered in addition to standard chemotherapy (carboplatinum and paclitaxel) in the first line (to some patients, immunomodulating drugs are added to the DCVAC/LuCa). The primary objective is to compare the efficacy of DCVAC/LuCa (with or without added immunomodulating drugs), administered together with standard chemotherapy, versus standard chemotherapy on its own, in patients with stage IV NSCLC, which is based on overall survival without the disease’s progression. (NCT02470468)
Latest
news: * On January 6, 2015, Sotio, a biotechnology company owned by the PPF Group, announced that the first patient has been enrolled into its recently launched international study in lung cancer a Phase I/II clinical trial using its Dendritic Cell Vaccine (DCVAC/LuCa), an active cellular immunotherapy treatment. Lung cancer has become the most common newly diagnosed tumour disease globally and is also the most frequent cause of death among patients suffering from cancer. The clinical trial will focus on determining the safety and efficacy of the DCVAC/LuCa in combination with standard chemotherapy treatment for patients with advanced metastasis of non-small cell lung carcinoma (NSCLC). Preliminary recruiting sites were initiated into the study in late November 2014 and the first patient was enrolled at the Oncology Clinic of the General University Hospital in Prague last week. Sotio plans to enrol a total of 105 patients with NSCLC into the clinical trial in collaboration with almost 20 medical facilities across the Czech Republic and Slovakia and potentially another European Union country.
