SOTIO’s clinical development team is working to confirm its promising research results in multiple-clinical trials with the objective of demonstrating safety and efficacy of its Active Cellular Immunotherapies.
SOTIO is sponsoring five multi-center Phase II trials focused on using Active Cellular Immunotherapy in the treatment of patients with prostate cancer at various stages.
In 2014 SOTIO launched its Global Phase III clinical trial called the VIABLE study to investigate the safety and efficacy of DCVAC/PCa in patients with metastatic castrate resistant prostate cancer. The name VIABLE is derived from the description of this clinical trial : "actiVe ImmunotherApy using dendritic cell-Based treatment for Late stage prostatE cancer".
In 2013 SOTIO also launched three Phase II clinical trials of DCVAC/OvCa to assess the safety and efficacy of its investigational Active Cellular Immunotherapy when combined with the standard of care treatments in patients with epithelial ovarian cancer.
At the end of 2014 SOTIO also launched the Phase I/II clinical trial of ACI focusing 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).
SOTIO Product Pipeline
| ||Preclinical testing||Phase I||Phase I/II||Phase II||Phase III|
|Prostate cancer (DCVAC/PCa)|
|Ovarian cancer (DCVAC/OvCa)|
|Lung cancer (DCVAC/LuCa)
In progress Completed
Researching, carrying out clinical trials, and registering a drug is a very time-consuming process, subject to stringent supervision by domestic and international regulatory institutions.
The primary purpose of clinical trials is to test the following properties of the drug:
- Compare the efficacy of the new drug with available standard treatments (i.e. influence on patient lifespan without signs of relapse; and with regard to serious cancers, influence on the total life expectancy and the quality of life of the patient);
- Assess potential combinations with medicines currently in use;
- Assess the new drug’s safety and identify potential undesirable side-effects;
- Identify the new drug’s economic impact on health care systems.
Upon completion of preclinical research, drugs then go through four phases of clinical trials.
Phases of clinical trials:
Phase I: This involves a small number of patients and is mainly aimed at confirming the safety of the drug being tested, verifying its pharmacological properties, and determining its appropriate dosage.
Phase II: During this stage, attention is focused on demonstrating the efficiency of the treatment and specifying the appropriate dosage. This phase involves more patients from different treatment centres.
SOTIO’s Phase II clinical trials are multi-center (involving multiple medical centers) and randomized (patients are divided into two randomly-selected groups). One group of patients is treated with the drug being tested while the other group undergoes standard treatment, and the results for predetermined parameters are then compared.
Phase III: The new drug is administered to between hundreds and thousands of patients. During this phase, the safety and efficiency of the drug being tested is observed in comparison to standard treatments. Typically, this phase takes place at many treatment centres in various countries. Its results are crucial for the decision regarding the new drug’s registration, and for making it available for routine clinical use.
Phase IV: The registered drug will continue to be evaluated in order to obtain as much information as possible about the drug during long-term use.