RhoVac receives approval in Germany and Belgium to start clinical phase IIb study in prostate cancer
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.
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