January 6, 2015
Source: Press release
SOTIO, a biotechnology company owned by the PPF Group, today 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).
Ladislav Bartoníček, CEO of SOTIO and a PPF shareholder, said: “Almost two million people throughout the world are diagnosed with lung cancer every year. According to expert estimates, this horrifying figure will increase by a further 50 per cent by 2030. We believe that our newly launched clinical trial will confirm the efficacy of the new treatment method developed by our company, and we will then be able to contribute to the battle against this treacherous disease.”
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.
Radek Špíšek, SOTIO’s Chief Scientific Officer, explained the new clinical trial in further detail: “DCVAC/LuCa is a treatment composed of dendritic cells, which have the ability to activate an immune response, and from proteins which are present in the lung carcinoma cells, the so called tumour antigens. Thus the objective of administering the DCVAC/LuCa is to induce an immune response against the tumour cells, and therefore slow down the disease’s progression. As with SOTIO’s clinical trials for other diseases in patients in an advanced stage of cancer, we have designed a clinical trial combined with chemo-immunotherapy which tests the combination of the standard treatment of chemotherapy with immunotherapy. Lung carcinoma is a rapidly progressing disease and in this clinical programme we will be monitoring whether adding the anti-tumour immunotherapy to standard chemotherapy treatment will improve the prognosis of this aggressive illness.”
About SOTIO’s Phase I/II clinical trial:
SLU01 (Eudra CT: 2014-003084-37) 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.
The DCVAC/LuCa is another treatment that SOTIO has added to its portfolio of clinical trials. The DCVAC/LuCa is an active autologous cellular immunotherapy treatment for patients with lung carcinoma being evaluated in this Phase I/II clinical trial. In each case, the DCVAC/LuCa is produced individually for each patient using the patient’s own dendritic cells (which are part of the immune system) cultivated from monocytes obtained from the patient’s blood, to induce an immune reaction against tumor antigens present.
Alongside this clinical trial assessing DCVAC in Lung Cancer, five further Phase II clinical trials are already currently underway for patients with prostate cancer (DCVAC/PCa treatment) as well as three Phase II clinical trials for patients with ovarian cancer (DCVAC/OvCa treatment). The most advanced trial in SOTIO’s portolio is the clinical development of the treatment focused on prostate cancer (DCVAC/PCa), and in May 2014 the Phase III international clinical trial (known as VIABLE) was launched, in which SOTIO plans to enrol around 1170 patients from more than 20 countries in Europe and the U.S.