On 5th June 2019, RhoVac AB announced about advancing their clinical phase II-b study on the approval of Danish Medicines Agency with the compound RV001 ( drug candidate having strong therapeutic properties). They have now revealed that the company had their first patient screened for the RhoVac-002 (“BRaVac”), a prostate cancer-based study.
They got their first patient screened at Odense University Hospital. BRaVac is a study where neither the participants nor the experimenters are aware of who is getting the treatment.
The random placebo-controlled study’s main aim is to study and observe the extent and ability of the drug candidate RV001 in controlling and preventing the growth of prostate cancer. Researchers hope the drug will limit the development of prostate-specific antigens to a greater extent in treated participants than the placebo group.
The clinical phase II-b of BRaVac is an international study that targets 175 patients resting in the United States and six basic European countries (Finland, Belgium, Sweden, Germany, United Kingdom, and Denmark).
Since the first patient is now screened safely, it is expected that all the patients will be enlisted in Q3 2020. The results are expected to be shared in 2021. The study targets those participants who have passed radiotherapy and surgery steps but still show rising levels of prostate cancer.
Anders Ljungqvist, the chief operating officer at RhoVac, calls the clinical phase II-b study a challenge to start in the summer period. Thus, it is a matter of celebration that the company has screened its first patient at the Odense University Hospital, Denmark.
Other hospitals and clinics in Denmark are now open for the screening of the rest of the patients. The company’s next target for screening patients is in Finland.
Anders Mansson, CEO of the company, explains how hectic the last few months have been for the company since they got approval by the Danish authorities and a positive response by the FDA. The FDA appreciated the continuation of the clinical phase II-b study in pre-IND in the United States.
The biggest achievement of the study was the approval by Finland to continue screening. A few months back, Anders Mansson stood by the rights issue, which will now fund the BRaVac study. Also, upon applying for the funds at EU research and Innovation Fund Horizon 2020 they received a fund of EUR 2.5 million.
In July 2019, RhoVac AB shared the 12-month results of clinical phase I and II, both showing positive and stable results. The CEO described the study as a successful achievement for RhoVac.
Anders Mansson, CEO of RhaVoc says, “The fact that we have now screened our first patient for the clinical phase IIb trial is an extremely important milestone for RhoVac! I would also like to extend my gratitude to all employees and consultants who have worked tirelessly to take the project to the point where it is today.”
Clinical phase II-b is a well designed clinical study by RhoVac and is now at the last stage of its completion. Since the study is about to be completed, a step towards discussing the collaborations has moved forward.