On April 4, 2019 RhoVac AB ("RhoVac") reported, 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 (Press release, RhoVac, APR 4, 2019, View Source [SID1234535005]). The application is for a permit to start a clinical phase IIb study with the drug candidate RV001 in prostate cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 – CEO, RhoVac AB
Telephone: +45 4083 2365
E-mail: [email protected]

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 4th April 2019.