Home News Rhovac’s phase II study passes safety review

Rhovac’s phase II study passes safety review

Rhovac’s phase II study passes safety review

12 July, 2021

Lund-based RhoVac recently conducted an interim safety review for the ongoing BRaVac study with the drug candidate RV001. The review, carried out by the company’s Safety Monitoring Committee, stated that patient safety is excellent, which means that the study can continue without alterations. The company further predicts that full recruitment will be achieved by September at the latest.

RhoVac is conducting the phase IIb study BRaVac in order to explore the efficacy and safety of the drug candidate RV001 in the treatment of prostate cancer. The idea behind the candidate is to attack the cancer when is at its weakest, after the primary tumour has been removed and before secondary tumours have formed. Read more about the treatment concept here.

The study was launched at the end of 2019 and is specifically aimed at prostate cancer patients with a biochemical recurrence, i.e. an increase in PSA. BRaVac is carried out at several sites in Europe and the USA, with the goal of treating a total of more than 180 patients. RhoVac estimates that full recruitment will be achieved by September this year. Thereafter, the study will run for another nine to twelve months before a readout is done.

RhoVac’s Safety Monitoring Committee recently conducted a planned interim review of the study with the aim of ensuring patient safety. The review concluded that the safety is excellent and that the study can continue according to plan.

RhoVac’s CEO Anders Månsson commented on the result in a press release:

»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.«


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