On December 9, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on December 9th, 2021, that its Data & Safety Monitoring Committee (DSMC) has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac (Press release, RhoVac, DEC 9, 2021, View Source [SID1234596725]). All patients have now been recruited into the study. The safety profile of RV001 (onilcamotide) was considered excellent, and the DSMC concluded that the trial can continue without modifications.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, (onilcamotide) 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 its drug candidate in this cancer indication. RhoVac currently estimates finalising the study and presenting results in the first half of the 2022. The objective of the study is to show that RV001 (onilcamotide) 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 by the DSMC last week, and no unexpected adverse events have been identified, confirming excellent safety, in concurrence with the previous DSMC conclusions on BRaVac, as well as with the findings of the phase I/II study, including follow-up studies. And therefore, the study continues without modifications.
RhoVac CEO, Anders Månsson, comments: "RhoVac has handled its study recruitment well in spite of the difficulties circumstances brought about by the covid pandemic. We had no reason to anticipate 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 and metastatic disease. An effective cancer vaccine with this profile could fulfil a huge unmet medical need in prostate cancer as well as in on other common cancers".
This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-12-2021 08:42 CET.