RhoVac reports a positive meeting with the European Medicines Agency
26 October, 2017
RhoVac AB (“RhoVac”) announced today, 26 October 2017 that the company has had a positive meeting with the European Medicines Agency (“EMA”) regarding the regulatory development of the company’s cancer vaccine RV001.
RhoVac’s therapeutic cancer vaccine RV001 is currently in clinical phase I/II focusing on patients with diagnosed prostate cancer. RV001 is developed with the goal of preventing or limiting the spread of cancer metastasis. Treatment with cancer vaccine RV001 is a targeted therapy against the RhoC protein. RhoC is over-expressed in almost all cancer cells that can metastasize – no matter what type of cancer the spread originates from. This means that the RV001 can potentially be used in the treatment of many different cancer indications. This feature also means that the regulatory development of RV001 does not necessarily follow a standard procedure, and there are currently limited guidelines available for the implementation of such development plan. RhoVac has therefore contacted EMA to discuss the regulatory development of RV001, following which the company completed a so-called SME briefing meeting with EMA. The meeting has been singinficantly positive and RhoVac has received valuable and constructive advices for continution of the development plan. The main conclusion of the meeting was that EMA recommends that RhoVac has reached a point where it should go directly to the Scientific Advice procedure to discuss more detailed plans for the next clinical phase – a Phase IIb study. Based on EMA´s recommendation, RhoVac is planning to initiate the Scientific Advice procedure early 2018.
Comments from RhoVac´s CEO, Anders Ljungqvist
-Meetings with EMA are always interesting. It is motivating to sit with well-prepared representatives from almost all relevant sections of the EMA and discuss drug development. We received the guidance we needed and we are now ready to take the regulatory development process forward. EMA recommendations on the regulatory process and on the next clinical phase IIb study in conjunction with the Scientific Advice procedure, together with results of the ongoing Phase I/II study, will help visualize the potential of the cancer vaccine RV001 for the treatment of metastatic cancer and be important information in our further discussions with potential partners.
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 26 October 2017.
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.