RhoVac submits application for the start of clinical phase IIb study with the drug candidate RV001
RhoVac AB ("RhoVac") announced today, 4th April 2019, that the company has submitted the application for clinical trial (CTA, Clinical Trial Application) to the Danish Medicines Agency (Laegemiddelstyrelsen) and to the Scientific Ethics Committee. The application is for a permit to start a clinical phase IIb study with the drug candidate RV001 in prostate cancer patients.
The drug candidate RV001 is targeting early metastasis in cancer patients. The proposed study focuses on prostate cancer patients, who have completed primary treatment (prostatectomy or radiation therapy) and show increasing level of prostate cancer marker PSA. It is a randomized, placebo-controlled and double-blind study. The primary goal of the study, designated RhoVac-002 ("BRAVAC"), is to evaluate whether treatment with the drug candidate RV001 can reduce PSA progression compared to the control group (placebo group).
Application for the forthcoming phase IIb study has been submitted to the Danish Medicines Agency and to the Scientific Ethics Committee. Assuming approval from these authorities, the study is expected to be initiated, in accordance with the communicated schedule, at mid-2019.
CEO Anders Ljungqvist comments:
-The very extensive work on preparing and completing the documentation and the application of the clinical Phase IIb study has now been completed. It has been a productive and close collaboration between employees and partners. It is with pleasure that we are now looking forward to the next clinical development phase of the company's drug candidate RV001. We have completed the first clinical phase and have documented that RV001 is well tolerated by the patients with a very good safety profile. In addition, we have documented that treatment with the drug candidate provides a very significant and robust immunological response - a response that is also significant 6 months after the end of treatment. Based on this positive background, we look forward to the next coming clinical trial of the drug candidate RV001.
For more information, please contact:
Anders Ljungqvist – VD, RhoVac AB
Phone: +45 4083 2365
This is an English version of an original Swedish press release communicated by RhoVac AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that RhoVac AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 4th April 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 top-line results from the clinical phase I / II study has been published I August 2018. RhoVac has its head office at Medicon Village in Lund, Sweden. The research has been conducted since 2007 primarily at the University Hospital in Herlev, Denmark, by a world-class research team in its niche. RhoVac is listed on Spotlight Trade Market, Sweden, a Multilateral Trading Facility (MTF), since March 2016. The share is traded under the ticker RHOVAC. Read more at www.rhovac.com.