RhoVac’s reports positive and constructive response from the European Medicines Agency in the now completed Scientific Advice Procedure
RhoVac AB (“RhoVac”) announced today, June 19, 2018, that the company has received response from the European Medicines Agency (EMA) on the Scientific Advice Procedure. EMA has stated that there are no further preclinical studies needed to be conducted to support the development of the proposed Phase IIb trial and that there is a clear window for early prostate cancer treatment with RhoVac's drug candidate RV001.
In alignment with company’s original schedule, RhoVac initiated a Scientific Advice Procedure with EMA in March 2018, to discuss progression of company’s RV001 project into a clinical phase IIb development, and to ensure that RhoVac’s approach was in line with EMA’s guidelines and expectations. Following this, in May, RhoVac was invited to participate at the EMA’s Scientific Advice Working Party's (SAWP) meeting in London to further discuss the project. Now RhoVac has received the response which was adopted by The Committee for Medicinal Products for Human Use (CHMP) at their meeting 28 – 31 May 2018. The response given by SAWP is based on the questions and supporting documentation RhoVac submitted at the initiation of the procedure.
In summary, EMA has agreed that no further pre-clinical studies are needed to support the proposed phase IIb clinical trial development. EMA has also agreed that the company’s approach in development of a quality specification for RV001 drug candidate was in compliance with relevant regulatory guidelines.
In the response relating to the proposed clinical trial, which targets the early stage of prostate cancer, immediately after radical prostatectomy, EMA agreed that there is a clear window to treat in this stage of the disease using RhoVac’s RV001 drug candidate. Finally, EMA provided valuable advice to further definition of the patient population and on inclusion criteria for the patients to be enrolled in the proposed clinical study.
Comments from RhoVac´s CEO, Anders Ljungqvist
-The Scientific Advice Procedure including the face to face meetings with relevant experts at EMA have been extremely valuable for RhoVac assuring us that we are now in a position to refine and progress our plans for our clinical phase IIb development. To our knowledge, there are no other drugs in development targeting this very early stage of disease progression in prostate cancer while relevant regulatory guidelines for adjuvant treatment in this stage are scarce. The comments and advice from EMA are therefore crucial for the further development of our drug candidate RV001.
For more information, please contact:
Anders Ljungqvist – VD, RhoVac AB
Phone: +45 4083 2365
E-mail: alj@rhovac.com
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 19 June 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 AktieTorget, Sweden, a Multilateral Trading Facility (MTF), since March 2016. The share is traded under the ticker RHOVAC. Read more at www.rhovac.com