Another clean interim safety review of RhoVac’s clinical phase IIb study in prostate cancer
RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, announces today 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. 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.
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.
For more information, please contact:
Anders Månsson – CEO, RhoVac AB
Phone: +46 73 751 7278
On RhoVac AB
RhoVac was established as a private company in Denmark in 2007. Under this company, the basic development steps for the drug candidate onilcamotide were undertaken. In 2015 the Swedish RhoVac AB was formed, which is now headquartered and in 2016 the company was listed on the then Aktietorget in Sweden (now Spotlight Stock Market). RhoVac has passed the early stages of development. In 2018, the first clinical trial (phase I / II) was completed in prostate cancer, demonstrating that onilcamotide has good safety and is well tolerated, and that the drug provides the expected immune response that will exert its effect on the cancer cells. The strong immune response has also been shown to last over time. Therefore, RhoVac has launched a clinical phase IIb trial that will include at least 180 prostate cancer patients. The study will close in the first half of 2022, and it is designed to show, with statistical significance, the effect of RV001 in preventing disease progression in prostate cancer after surgery or radiation to the primary tumour. RhoVac is listed on Spotlight, Sweden, a Multilateral Trading Facility (MTF) since March 2016. The share is traded under the ticker RHOVAC. Read more at www.rhovac.com
BRaVac is a randomized, placebo controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative intent treatment. The clinical phase IIb study is an international, multi-centre study, which will recruit over 180 patients in six European countries (Denmark, Finland, Sweden, Belgium, Germany, and United Kingdom) and the US.