Home Interviews Completed recruitment in RhoVac’s phase IIb trial

Completed recruitment in RhoVac’s phase IIb trial

Completed recruitment in RhoVac's phase IIb trial

Completed recruitment in RhoVac’s phase IIb trial

21 September, 2021

The Covid-19 pandemic came as an unwelcome guest for many drug developers around the world, resulting in delayed and discontinued studies. Lund-based RhoVac is one of the companies that has managed to parry the pandemic reasonably well and can now report that the recruitment for the phase IIb study BRaVac has been completed. The study results are expected by the middle of next year.

Biotechnology company RhoVac develops its drug candidate RV001 for the treatment of prostate cancer. The phase IIb study BRaVac, that is currently ongoing, aims to evaluate the extent to which treatment with RV001 can prevent or limit further development of prostate cancer after surgery or radiation treatment.

Full recruitment in BRaVac

Where many other drug developers have been forced to pause or even discontinue their studies, RhoVac has managed to continue, which should also be seen in the light of the fact that patient flow in oncology in hospitals around the Western world during the pandemic has decreased by between 25 and 50 per cent, according to IQVIAS’ report “Global Oncology Trends.” This Monday, the company announced that it has reached full recruitment in the study and that no more patients will be included. This means that the next major milestone in the project will be the readout of topline results, which the company estimates will take place no later than the middle of next year.

Analysis concludes that the study is safe

This summer, the company’s patient safety committee conducted an interim analysis to ensure patient safety in BRaVac. The analysis concluded that safety is excellent and that the study was able to proceed according to plan, further confirming the good safety profile demonstrated during the previously conducted Danish phase I/II study. Learn more about the interim analysis here.

In parallel with BRaVac, RhoVac is also in full swing with a long-term follow-up of patients who participated in the Danish phase I/II study. Patients underwent treatment three years ago and the aim is to investigate to what extent they still have a relevant RhoC-specific immune response, what their PSA development looks like, and whether they have had to supplement with other therapy since then. Results from this follow-up are expected in the autumn.

CEO comments

BioStock spoke to RhoVac’s CEO Anders Månsson to get his view on the fact that recruitment is now completed in BRaVac.

Anders Månsson, CEO RhoVac
Anders Månsson, CEO RhoVac

Looking back on the period since the pandemic began, what are your thoughts on the fact that you now stand here with a fully recruited study?

– It is of course a great relief that we have managed to carry out the study in these difficult circumstances. Now we are at the last lap and are excitedly looking forward to the result.

What does it mean for RhoVac that recruitment to BRaVac is now complete and next year’s important efficacy results are getting closer and closer?

– This means, of course, that an operational risk has now been eliminated and that we can focus on preparing for what will happen when we have the results. We expect them to arrive no later than the summer, but they may also come sooner. After all, we include patients who have a PSA duplication time between 3 and 12 months. If we have more patients with shorter PSA duplication time, the study will also be completed faster because we measure the time to duplication, among other things, and half of the patients receive placebo, so there is no reason to believe that their disease progression would be significantly affected.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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