RhoVac Receives Approval in Germany and Belgium to Start Clinical Phase IIb Study in Prostate Cancer
STOCKHOLM, Jan. 10, 2020 /PRNewswire/ -- RhoVac AB ("RhoVac") announces today, on 10th January 2020, that the company has received approval from Beligian FAMHP (Federal Agency for Medicines and Health Products) and German Federal Institute for Vaccines and Biomedicines for starting the clinical phase IIb study in prostate cancer, a multicenter study entitled RhoVac-002 ("BRaVac"). The phase IIb study is an international, multicenter study, which is expected to recruit more than 175 patients in EU, as well as in the United States. RhoVac has previously received approval Denmark and Finland.
BRaVac is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if and to what extent treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative intent therapy measured as a limited development of PSA (Prostate Specific Antigen) in actively treated patients compared to the control group (placebo group). The Phase IIb study is an international multicenter study, which is expected to recruit more than 175 patients in EU, as well as in the United States. The ambition is for all patients to be recruited by end Q3 2020. The results reporting on the primary objective of the study is expected during H2 2021. RhoVac has previously received CTA approval in Denmark and Finland.
For further information, please contact:
Anders Månsson – CEO, RhoVac AB
Phone number: +46-73-751-72-78
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 29th October 2019.
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