In 2018 a clinical phase I/IIa project with ca. 20 prostate cancer patients was concluded, and results show that RC001 was safe and well-tolerated, which is of particular importance as the drug candidate’s intended us is after curative intent surgery or radiation to the primary tumour, when the patient is essentially symptom free and the all identified cancer has been removed. The study also showed a strong and lasting immune response from the use of RV001.
With these excellent results achieved, RhoVac will in 2019 start a large clinical phase IIb prostate cancer study, engaging some 30 clinics presumably both in Europe and in the USA, and enrolling some 175 patients. This study will conclude in the 2nd half of 2021 and then we project to have statistically significant results demonstrating the efficacy of RC001 in preventing and treating disease progression after surgery or radiation to the primary tumour. In addition, we plan a smaller explorative study aiming to provide at least indicative evidence for the “preventing metastases” effect of RV001 also in other types of cancer.