11 May 2022 | Wednesday | News
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This means that all data from the trial is now finally reported, cleaned and "locked" in the data base. The next step will be analysis to produce the results. As previously stated, RhoVac anticipates having its primary results no later than at the beginning of June.
RhoVac started the clinical phase IIb trial (BRaVac) with the company's drug candidate, RV001, (onilcamotide) late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after local curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. Patient recruitment was conducted in six European countries (Finland, Sweden, Denmark, the United Kingdom, Belgium and Germany) and in the United States. Recruitment ended in September 2021, when 180 patients had been included. The objective of the study is to show that onilcamotide can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. Interim safety reviews have been conducted and no unexpected adverse reactions have been identified, confirming the anticipated safety of the drug. Now, the study has reached "Database Lock" with only a few weeks to go until the primary results are known. All results, including subgroup analyses, will be available in the summer.
CEO, Anders Månsson, comments: "BRaVac started at the end of 2019, and much of the study has been run in pandemic conditions, which it has taken extraordinary efforts to overcome. We are happy to conclude that we have overcome all obstacles, that our intermediary safety reviews have all been positive, and now, after database lock, we await with excitement and anticipation what the primary results will bring in terms of efficacy."