RhoVac’s clinical phase IIb study of lead drug candidate RV001 in prostate cancer, BRaVac, is deemed fully recruited and no additional patients will be screened after this week.
Top-line results of the study are estimated to be at hand in the first half of 2022, the company states.
RhoVac started the clinical phase IIb trial (BRaVac) of RV001 in late 2019, targeting prostate cancer patients with a biochemical recurrence (a rise in PSA) after curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for RV001 in this cancer indication.
“This US initiative has also raised RhoVac’s profile and reputation significantly in our most important market.”
The objective of the study is to show that RV001 can significantly prevent or delay disease progression in these patients, something for which no standard therapy is currently available. As planned, an interim safety review was conducted in July 2021 by the Safety Monitoring Committee, and no unexpected adverse events were identified, confirming excellent safety, in concurrence with the previous clinical phase I/II findings.
“It should be noted that we have carried out this study through in the midst of the covid pandemic, in which many companies have been forced to pause or completely discontinue their studies. Also, recently published data (IQVIA – Oncology Trends) reveals a devasting 25-50% drop in patient flow through oncology clinics in the US and main European countries in 2020 and the start of 2021. These are the circumstances in which we have succeeded in bringing this study to its full recruitment, and the team in charge of clinical operations should be lauded for their achievement. We are particularly happy with our decision to expand the study in the US to partly compensate for delays. This US initiative has also raised RhoVac’s profile and reputation significantly in our most important market. With full recruitment reached, operational risks going forward are greatly reduced for RhoVac, and we now look forward to the conclusion of the trial and to the unveiling of the results next year,” says RhoVac CEO, Anders Månsson.
Photo of Anders Månsson: RhoVac