On July 4, 2019 RhoVac AB ("RhoVac") reported positive top-line results on safety and immune response in the long-term follow-up of the Company’s phase I/II clinical trial RhoVac-001 (Press release, RhoVac, JUL 4, 2019, View Source [SID1234555928]).

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In total 22 prostatectomised cancer patients received RV001 treatment over a period of approximately 30 weeks. Following completion of treatment, all patients were monitored over a 12 months follow-up period. At 3, 6, 9 and 12 months after completion of treatment with RV001, the patients were evaluated for treatment related reactions and for immunological response. In summary, the results from the long-term follow-up evaluation can be concluded as follows:

All 22 patients recruited to the study completed the follow-up phase and during this phase no treatment related adverse events were reported.
Of the 18 patients showing significant treatment related immunological response at completion of treatment, all 18 patients still showed significant response at 3-, 6- and 9-months follow-up. At the 12-months follow-up 17 out of the 18 responding patients showed significant immunological response.
The over-all conclusion of the RhoVac-001 study including the long-term follow-up phase is that that treatment with RV001 is safe and well tolerated by prostate cancer patients. It is also concluded that a product mediated, significant, robust and long-lasting immune response is established following treatment with RV001.

Comments from RhoVac´s CEO, Anders Ljungqvist

-Receiving the results from the long-term follow-up phase of our first-in-humans clinical trial and experiencing the excellent results is fantastic. The follow-up data confirms that our product has a very good safety profile and is well tolerated by prostate cancer patients. The results also show that the immune response, which we knew was significant and robust, is also long-lasting. I don’t think anyone could have asked for better results than this and it confirms that we took the right decision, when we decided to accelerate preparation for the next clinical study. The platform for the further development of RV001 has now been completed and I am looking forward to continuing this development. Again, I must thank everyone in the company and all our collaborators outside the company for the dedicated work. A special thanks, as always, to the patients for participating in this long clinical trial. Without your commitment to the project we would never have reached this point of progress where we now are starting the phase IIb study.