RhoVac receives approval in Sweden to start clinical phase IIb trial

RhoVac AB ("RhoVac") announces today, on June 22nd, 2020, that the company has received approval from all regulatory authorities in Sweden, which means that the clinical IIb study in prostate cancer ("BRaVac") can also be started in Sweden. The clinical phase IIb trial is an international study that is expected to recruit at least 175 patients in six European countries (Denmark, Finland, Sweden, the United Kingdom, Belgium and Germany) as well as in the United States.

BRaVac is a randomized, placebo-controlled and double-blind study, with the primary study aim to evaluate whether treatment with the drug candidate RV001 can prevent or limit the development of metastatic cancer after surgery or radiation of the prostate. The clinical phase IIb study is an international multicenter study, which is expected to recruit at least 175 patients in six European countries (Denmark, Finland, Sweden, the UK, Belgium and Germany), as well as the United States.

CEO Anders Månsson comments: “The fact that we have now also received a go-ahead from all authorities concerned, allowing us to begin our clinical study in prostate cancer in Sweden, is a very important milestone for the project. We look forward with optimism to starting the recruitment and treatment of prostate cancer patients also in our home market of Sweden."

For further information, please contact:

Anders Månsson – CEO, RhoVac AB

Phone number: +46 73-751 72 78

E-mail: info@rhovac.comThis information is such that RhoVac AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 22nd June 2020.

About 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 now 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 immediately launching a major Phase IIb clinical trial that will include at least 175 prostate cancer patients. The study, which is expected to be completed in 2021, 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


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