RhoVac AB participates in a discussion meeting with the European Medicines Agency
25 April, 2018
RhoVac AB (publ) (“RhoVac”) announced today, 25th April 2018, that the company has received an invitation to meet with the European Medicines Agency (EMA) to further discuss a phase IIb clinical trial.
RhoVac initiated a Scientific Advice procedure with EMA immediately after completion of a pre-submission meeting end of February 2018; the procedure was originally estimated to be completed end of April 2018. Following invitation to participate at the EMA’s Scientific Advice Working Party’s meeting in London the entire procedure is, according to standard regulatory procedures, extended by approximately one month and completion is now estimated to be at the end of May 2018.
Invitation to a discussion meeting with the Working Party is not standard in a Scientific Advice procedure; however, EMA can provide this opportunity to a company to ensure that the development strategy of the company is fully understood and thereby to ensure that the most accurate advice is provided to the company for the design of the coming clinical phase IIb study.
Comments from RhoVac´s CEO, Anders Ljungqvist
-We are delighted for the opportunity to further discuss RhoVac’s development project for the coming phase IIb study with the relevant experts at EMA. The company’s drug candidate RV001 aims to target treatment of metastatic cancer in an earlier phase of disease progression than existing treatments applied today. Thus, it is important that the regulatory authorities and RhoVac have a common understanding of the treatment concept developed. It is valuable for the continuation of the project that RhoVac will be able to participate in this discussion meeting with several of EMA’s clinical phase IIb and III experts.
For more information, please contact:
Anders Ljungqvist – CEO, 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 25 April 2018.
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 phase and clinical phase I/II study has started spring 2017. 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 Stock Market, Sweden, a Multilateral Trading Facility (MTF), since March 2016. The share is traded under the ticker RHOVAC. Read more at www.rhovac.com.