Clean interim safety review of RhoVac's clinical phase IIb study in prostate cancer

RhoVac AB, a Swedish cancer immunotherapy company, announces on July 9th 2021, that its Safety Monitoring Committee has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac. The safety profile of RV001 was excellent and the Safety Monitoring Committee concluded the trial can continue without modifications.

RhoVac started the clinical phase IIb trial (BRaVac) with the company's drug candidate, RV001, late 2019, in 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. RhoVac currently estimates finalizing the patient recruitment for the study no later than September this year, and after that the study will run to completion, which is estimated to take 9-12 months after the closing of the recruitment. 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 available today. As planned, an interim safety review was conducted today by the Safety Monitoring Committee, and no unexpected adverse events have been identified, confirming excellent safety, in concurrence with the previous clinical phase I/II findings.

RhoVac CEO, Anders Mansson, comments: "We had never anticipated anything but a clean safety review. Nevertheless, it is great to get further confirmation that our drug has a safety profile that makes it suitable for treating symptomless cancer patients who have already undergone local curative intent therapy, with an aim to prevent cancer recurrence. Also, the fact that we have excellent patient compliance in the study in spite of the pandemic circumstances, is a sign of how motivated these patients are to receive the treatment. This will add to the interest we already experience in our drug candidate".