RhoVac receives FDA approval in the US for the start of its Phase IIb clinical trial
RhoVac AB ("RhoVac") announces today, February 28th 2020, that the US Food and Drug Administration (FDA) has approved RhoVac to initiate its clinical phase IIb study in prostate cancer in the United States, and the FDA has thus accepted the company's Investigational New Drug (IND) application. The study, titled RhoVac-002 ("BRaVac") is an international multicenter study, which is expected to recruit at least 175 patients in the EU as well as in the United States. RhoVac has previously received approval for the start of the clinical phase IIb trial in Denmark, Finland, Germany and Belgium.
The FDA has approved RhoVac to initiate its clinical study in prostate cancer and the FDA has thus accepted the company's IND application. 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 treatment. The Phase IIb study is an international multicenter study, which is expected to recruit at least 175 patients in the EU and the US. The ambition is to recruit all patients by the end of Q3 2020. The results report on active treatment part of the study is expected in H2 2021. RhoVac has already received approval in Denmark, Finland, Germany and Belgium. Rhovac is also awaiting final approval from the ethics committees in Sweden and the UK.
RhoVac's CEO Anders Månsson comments: “The FDA's approval for the start the clinical trial in prostate cancer in the United States is an important milestone for RhoVac. The purpose of the development of RV001 is to eventually be able to offer patients with prostate cancer a drug that minimizes the risk of the cancer returning in metastatic form after curative intent treatment of the primary tumor.”
For further information, please contact:
Anders Månsson – CEO, RhoVac AB
Phone number: +46 73-751 72 78
E-mail: info@rhovac.com
This 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 28th February 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