On March 20, 2019 RhoVac AB (publ) ("RhoVac") reported that FDA (US Food and Drug Administration) has accepted RhoVac’s application for a pre-IND meeting, which is focused on the clinical development program with the drug candidate RV001 (Press release, RhoVac, MAR 20, 2019, View Source [SID1234534503]).

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RhoVac’s next step in the clinical development of the drug candidate RV001 is expected to start in mid-2019. Clinical development is going to be run primarily in Europe, but part of the company’s strategy is to run some of the clinical development in the US.

Therefore, RhoVac has submitted an application for a pre-IND meeting with the FDA to get answers and recommendations on specific issues related to the continued clinical development. A pre-IND meeting with the FDA is very similar to EMA’s Scientific Advice procedure, which was conducted by RhoVac in spring of 2018.

FDA has now confirmed RhoVac’s application following which the company has submitted the required Briefing Package. The evaluation of the FDA will be based on this package. RhoVac is expected to receive FDA’s comments on RV001 project by end of April 2019.

CEO Anders Ljungqvist comments
-It is very exciting that we now have the opportunity to receive FDA’s feedback and comments on RV001 project. The company’s drug candidate, RV001, is aimed at treating metastatic cancer in an earlier phase of prostate cancer development than existing treatments currently do. Therefore, it is important that both FDA and RhoVac have a common understanding of the concept of the treatment under development.

For more information, please contact:
Anders Ljungqvist – CEO, RhoVac AB
Phone: +45 4083 2365
E-mail: [email protected]