Cytovac has tested the ALECSAT therapy in a number of clinical trials.
The clinical development program comprises studies in prostate and pancreatic cancer as well as glioblastoma brain cancer. All studies show a good safety profile and many examples of positive clinical efficacy is seen.
Currently, the main focus of the company is targeted at brain cancer, as the brain-cancer studies have demonstrated good tolerance and safety as well as several distinct examples of reduced tumor sizes and indications of longer life expectancies. Furthermore, CytoVac has been granted Orphan drug designation from both EMA and FDA for the brain cancer project.
For technical and strategic reasons, Cytovac decided to discontinue their first phase II brain cancer study in 2015 and commence a new and re-designed trial. This decision was based on advice from EMA, as they recommended a different clinical strategy when aiming at obtaining regulatory drug approval in Europe.
The primary end point should be survival, the control group should be different, and it was further suggested to administer ALECSAT earlier in the course of disease preferably together with and in addition to usual standard therapies. Furthermore, in the first phase II study, it had already been observed that for many of the patients their disease developed before the therapeutic effect of the ALECSAT treatment could take effect.
The now ongoing redesigned phase II study closely follows all EMA recommendations, and the patients receive treatment very early in the course of their disease – shortly after their diagnosis.
In future clinical trials the ALECSAT treatment’s therapeutic effect will be tested on other types of cancer.