Odense University Hospital Screens First Patient for Phase IIb Prostate Cancer ‘BRaVac’ Study Assessing RV001

Odense University Hospital Screens First Patient for Phase IIb Prostate Cancer ‘BRaVac’ Study Assessing RV001

Odense University Hospital screen first patient for phase IIb prostate cancer “BRaVac” study assessing drug candidate RV001. The lead investigator there is Mads Hvid Aaberg Poulsen, MD.

The Study

The study will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostate adenocarcinoma and biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo controlled double-blind study of peptide cancer vaccine (RV001).

The study commenced October 2019 and is planned to run till September, 2022.  Research sites include:

  • Aalborg University, Department of Urology, Niels Christian Langkilde, MD
  • Aarhus University Hospital, Department of Urology, Michael Borre, MD
  • Rigshospitalet, Copenhagen Prostate Cancer Center, Klaus Brasso, MD
  • Herlev & Gentofte Hospital, Department of Urology, Lisa Andersen, MD
  • Odense University Hospital, Department of Urology, Mads Hvid Aaberg Poulsen, MD

The recent RhoVac press release notes that other sites in Europe and the U.S. would be involved.  Known as the “BRaVac” study we cross-reference with Clincialtrials.gov and found the same study with some slightly different data (for example less sites).

Who is 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 here.