On April 2, 2019 RhoVac AB ("RhoVac") reported that all prostate cancer patients who participated in the clinical phase I / II study with RhoVac’s drug candidate RV001, have completed their 9- and 12-month’s follow-ups (Press release, RhoVac, APR 4, 2019, View Source [SID1234555932]). This marks the completion of the clinical phase I / II study for the participating patients.
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RhoVac’s clinical phase I / II study was conducted during the period of Q1 2017 to Q1 2019. The 22 patients recruited for this study had been diagnosed with prostate cancer and been treated with prostatectomy. Blood samples were drawn before, during and after the study to analyze the product-mediated immune response to the treatments. The results, reported in August 2018, showed a significant immune response in 86% of patients. The patients also participated in 3-, 6-, 9- and 12-month’s follow-ups to study the duration of the immune response. This follow-up phase is now completed as all 22 patients have had their final follow-up visit at the clinical site.
The last samples from the 9- and 12-month’s follow-up phase have now been sent to the University of Tübingen for immunological analysis. RhoVac expects to report these results mid-2019.
CEO Anders Ljungqvist comments:
– The company’s first clinical study, RhoVac-001, is now completed and only analyzes and final reporting of the follow-up phase remain. I am proud that RhoVac has completed this study within the set timeframe. A result we have largely achieved thanks to the highly dedicated patients who have participated in the study. This combined with an outstanding collaboration with Copenhagen Prostate Cancer Center at University Hospital, Copenhagen; Phase I unit Zelo at Bispebjerg and Frederiksberg Hospital, DanTrials ApS and T-cell Monitoring Group, the Department of Immunology at the University of Tübingen, Germany have all ensured that we have been able to communicate conclusive results according to time frame. Thank you very much to all the participants.