On February 28, 2020 RhoVac AB ("RhoVac") reported 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 (Press release, RhoVac, FEB 28, 2020, View Source [SID1234555924]). 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.
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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."