On April 26, 2019 RhoVac AB ("RhoVac") reported that the company has received a written response from the Food and Drug Administration (FDA), USA regarding to the recently completed pre-IND meeting on development of the company’s drug candidate RV001 (Press release, RhoVac, APR 26, 2019, View Source [SID1234555931]). The subject of the meeting was to obtain agreement with the Agency regarding the scope of currently available data and the necessary data to support an IND submission for the clinical phase 2 trial in prostate cancer patients. Furthermore, the purpose of the meeting was to discuss with the agency and reach concurrence regarding the initial IND study protocol in the identified study population, the proposed endpoints along with the proposed safety monitoring. The FDA has confirmed that no further preclinical studies are required to support clinical development of the company’s clinical phase II trial in USA and that the design and the defined end-points in the study are relevant to document clinical proof of concept in treatment of prostate cancer patients with the company’s drug candidate RV001.

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In alignment with the company’s original development schedule, RhoVac contacted the FDA in early 2019, and in March the company announced that FDA had accepted RhoVac’s request for a pre-IND meeting. A pre-IND meeting is comparable to a Scientific Advice Procedure in the EU, which RhoVac concluded in mid-2018. Following confirmation of the pre-IND meeting, the company submitted a Briefing Package which FDA has now evaluated and the response to our questions is based on this background information.

In conclusion, the FDA agrees that, in relation to USA, no further preclinical studies are required in support of a clinical phase II trial in prostate cancer patients. The identical study protocol is currently under review in Denmark with subsequent review in other European countries. The FDA also commented that the company’s approach in developing the quality specification for the drug candidate RV001 complies with relevant regulatory guidelines. In the response relating to the proposed clinical trial, the FDA agrees that the definition of the patient population, which we plan to recruit for the clinical study, is well-defined and that the clinical end-points set in the study are relevant in order to document clinical proof on concept.

Comments from RhoVac´s CEO, Anders Ljungqvist

-A pre-IND meeting may be a face-to-face meeting at FDA in Washington DC, a telephone conference or a written response. Based on the questions and the background information we forwarded the FDA, FDA assessed to have adequate background to be able to respond in writing. It is gratifying that the FDA confirms that we have correctly interpreted the regulatory guidelines in USA enabling us to continue our clinical development of RV001 based on the same strategy as used within the EU. A big thank you to employees and external consultants for a very professional and valuable work.