Global Covid-19 Vaccination Roll-out causes delay to RhoVac’s Phase IIb study
RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, announces today, March 8th , 2021, that its clinical phase IIb study, “BRaVac”, in prostate cancer, will be somewhat further delayed as Covid-19 vaccinations are rolled out to the study population.
As Covid-19 vaccinations are presently being rolled out in the age brackets of our study, some patients will have their RV001 treatment initiation deferred until after vaccination. The delay caused by these deferrals is difficult to estimate presently. However, the previous target of having full recruitment by Q2 no longer seems realistic. This tentatively pushes the target for full recruitment to Q3 and the company will communicate a more precise recruitment forecast later in the spring when more data on the handling of the vaccinations is available. RhoVac does not anticipate that his delay will necessitate the need for further financing. The company is doing all it can to ensure that the study progresses as fast as possible, while obviously respecting public health concerns related to the pandemic as a first priority. The first out of four new US clinics in the study was just initiated, further increasing recruitment capacity, compensating to the extent possible for delays related to the pandemic.
RhoVac CEO, Anders Månsson, comments: “The unexpectedly speedy roll-out of highly effective Covid-19-vaccines is a great win for health and a blessing in that it will significantly reduce the devastating impacts of the pandemic. The fact that the vaccination roll-out causes a delay to our study, must be seen in this light. Our focus is to make sure that each patient in our study is handled professionally and with respect, allowing for individual circumstances to be considered when ensuring optimal planning of both RV001 and Covid-19 vaccinations. Our first loyalty is always to patient safety.”
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 08-03-2021 19:00 CET.
For further information, please contact:
Anders Månsson – CEO, RhoVac AB
Phone number: +46 73-751 72 78
BRaVac is a clinical trial phase IIb-study 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, multicenter study, which will recruit over 175 patients in six European countries (Denmark, Finland, Sweden, Belgium, Germany and United Kingdom) and the US.
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 is launching a clinical phase IIb trial that will include at least 175 prostate cancer patients. The study 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 tumor. 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