RhoVac reports positive interim immune-results in the follow-up phase of company’s phase I/II clinical study
RhoVac AB (“RhoVac”) reported today, 17th January 2019, positive interim immune-results on 3- and 6-month’s follow-up testing in their phase I/II clinical study RhoVac-001 in prostate cancer patients.
In the clinical study RhoVac-001 all patients treated are monitored for duration of immune response over a 12-month period following completion of treatment. At this time RhoVac can present interim results after 3- and 6-month’s follow-up analysis. The result show that 18 of 21 of the patients (86%) still have a robust immune response to RV001. In other words, all 18 patients measured as Confirmed Immune Responders following completion of treatment, still show comparable response after 3- and 6-month’s follow-up.
The clinical study RhoVac-001
The study RhoVac-001 (ClinicalTrials.gov identifier: NCT03199872) is a first-in-man trial studying the cancer vaccine RV001. Twenty-two prostatectomised patients were enrolled in the study. The primary endpoint of the study was to evaluate the safety and tolerability of the RV001 cancer vaccine. The primary end-point was met and the results reported in August 2018 confirmed that treatment with RV001 is safe and well tolerated by the prostate cancer patients.
The secondary endpoint was to investigate the RV001-specific immunological response to treatment. The immune response was analysed before -, two time during - and once, one month after completion of treatment. The result reported in August 2018 was that 86% (18 of 21 of the eligible patients) showed a significant immune response to RV001 in the three samples taken during or after treatment. All 18 responding patients also qualified as Confirmed Immune Responders as they showed a significant response in two of the three samples taken during or after treatment. The conclusion on the immune monitoring during treatment was that a vaccine mediated immune response was established following treatment with RV001 and the dose administered in the study was biologically active.
Final results, including 9- and 12 month’s follow-up immunological analysis, is expected to be reported mid-2019.
Comments from RhoVac´s CEO, Anders Ljungqvist
-The interim results at 3- and 6 month’s follow-ups are exciting data and the results confirm that the RV001 mediated immune response is maintained in the patients. Again, the data shows that the response is very consistent over time as already indicated at completion of treatment. The T-cell monitoring group, Department of Immunology at the University of Tübingen, has again performed a timely and dedicated work enabling us to report the interim results as planned. We are now looking forward to completing the follow-up phase and after this, focus on the phase IIb clinical study.
For more information, please contact:
Anders Ljungqvist – VD, RhoVac AB
Phone: +45 4083 2365
E-mail: alj@rhovac.com
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 17th January 2019.
About RhoVac AB
RhoVac AB conducts research and development of immunotherapeutic drugs. The Company’s main focus is the development of a therapeutic cancer vaccine with the potential to prevent or limit metastasis in cancer. RhoVac’s first drug candidate has completed pre-clinical and clinical phase I/II. RhoVac has its headquarters at Medicon Village in Lund, Sweden. Since 2007, research is conducted primarily at the University Hospital in Herlev, Denmark and at University of Tübingen by research teams of world-class in their field. RhoVac is listed on Spotlight Stock Market, Sweden, a Multilateral Trading Facility (MTF), since March 2016. The share is traded under the ticker RHOVAC. Learn more at www.rhovac.com.