Pressmeddelande

RhoVac announces the completion of patient recruitment for the BRaVac clinical phase IIb study of RV001 in prostate cancer

Sep 20, 2021

RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, announces today on Sep 20th , 2021, that its clinical phase IIb study of lead drug candidate RV001 in prostate cancer, BRaVac, is deemed fully recruited and that no additional patients will be screened after this week. Top-line results of the study are estimated to be at hand in the first half of 2022.

RhoVac started the clinical phase IIb trial (BRaVac) of RV001 in late 2019, targeting 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. 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 currently available. As planned, an interim safety review was conducted in July 2021 by the Safety Monitoring Committee, and no unexpected adverse events were identified, confirming excellent safety, in concurrence with the previous clinical phase I/II findings.

RhoVac CEO, Anders Månsson, comments: “We are extremely happy to have concluded the recruitment of this important study as per the forecast of Q1 of this year. It should be noted that we have carried out this study through in the midst of the covid pandemic, in which many companies have been forced to pause or completely discontinue their studies. Also, recently published data (IQVIA – Oncology Trends) reveals a devasting 25-50% drop in patient flow through oncology clinics in the US and main European countries in 2020 and the start of 2021. These are the circumstances in which we have succeeded in bringing this study to its full recruitment, and the team in charge of clinical operations should be lauded for their achievement. We are particularly happy with our decision to expand the study in the US to partly compensate for delays. This US initiative has also raised RhoVac’s profile and reputation significantly in our most important market. With full recruitment reached, operational risks going forward are greatly reduced for RhoVac, and we now look forward to the conclusion of the trial and to the unveiling of the results next year.”


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 20-09-2021 11:57 CET.

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 RV001 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 RV001 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 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

 

On BRaVac

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.

.