RhoVac submits application for the start of clinical phase IIb study with the drug candidate RV001
Apr 04, 2019
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.