On June 5, 2019 RhoVac AB ("RhoVac") reported that the Danish Medicines Agency (DMA) has approved RhoVac’s clinical trial application (CTA) on the clinical phase IIb study with the drug candidate RV001 (Press release, RhoVac, JUN 19, 2019, View Source [SID1234555929]). The approval from the DMA is conditioned final approval by the Ethics Committee, which has not yet finalized the review of the application.

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Clinical Phase IIb study

The study, named RhoVac-002 ("BRAVAC") for which RhoVac has received approval to start, targets prostate cancer patients who have completed primary treatment (surgery or radiotherapy) and who show rising values ​​in the prostate cancer marker PSA. It is a randomized, placebo controlled and double blinded study, where the primary goal of the study is to evaluate whether treatment with the drug candidate RV001 can reduce or prevent PSA increase compared to the control group (placebo group).

The study will enrol 150 evaluable patients who will be recruited in at least six countries, of which Denmark is the first. The clinical trial application will now be submitted in the remaining countries and, according to schedule, recruitment of patients to the study will be completed in Q3 2020. Reporting on the primary end-point of the study is expected Q3 2021.

CEO Anders Ljungqvist comments

-In the beginning of April 2019, RhoVac announced that the application to start the clinical phase IIb study, with RV001 had been submitted to the Danish Medicines Agency in Denmark. The fact that RhoVac has now received approval from the DMA means that the study can be initiated, in accordance with the communicated schedule, in the beginning of H2 2019. The first patients will be recruited at the University Hospital in Copenhagen.

Thanks to the rights issue on approximately SEK 181 million (before issue costs), which is currently ongoing, we secure that the study can start without delay. With this issue, we will have funding for the coming three years and can now focus on optimal clinical development and on finding the best possible exit partner, a partner we expect to have in final stage of negotiations when phase IIb study results becomes available.

The combination of advanced preparation for the phase IIb study and financing secured for the coming three years, puts RhoVac in a unique situation, and I am pleased to now continue the journey of the drug candidate RV001 into the next development phase.