STOCKHOLM, Sweden I October 29, 2019 I RhoVac AB (“RhoVac”) announces today, on 29th October, 2019, that the company has received approval from FIMEA (Finnish Medicines Agency) for starting the clinical phase IIb study in prostate cancer, a multicenter study entitled RhoVac-002 (“BRaVac”). The phase IIb study is an international, multicenter study, which is expected to recruit more than 175 patients in six European countries (Denmark, Finland, Sweden, the UK, Belgium and Germany), as well as in the United States.

BRaVac is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if and to what extent treatment with the drug candidate RV001 can prevent or limit the development of cancer measured as a limited development of PSA (Prostate Specific Antigene) in prostate cancer patients compared to the control group (placebo group). The Phase IIb study is an international multicenter study, which is expected to recruit more than 175 patients in six European countries (Denmark, Finland, Sweden, the United Kingdom, Belgium and Germany), as well as in the United States. The ambition is for all patients to be recruited by end Q3 2020. The results reporting on the primary objective of the study is expected during H2 2021. RhoVac has, after obtaining approval, received it in two countries, Denmark and Finland. 

SOURCE: RhoVac