RhoVac has received and validated results from its 3-year follow-up of the patients who took part in its phase I/II study that was concluded in 2018.
The top-line results shows that the vast majority of patients still had undetectable PSA. Furthermore, the RhoC specific immune response has so far been assessed in 15 patients, and in these all but one patient who was a responder in the 1-year follow-up, still had RhoC specific immunity after 3 years. This exceeded expectations, states the company.
“To RhoVac the result of this study is truly excellent news. Though the number of patients in the follow-up study is of course small in comparison to the soon to conclude placebo-controlled clinical phase IIb study (BRaVac), we really could not have wished for better outcomes. The apparent lack of cancer progression in the long-term follow-up study, and especially the largely intact RhoC specific immune response, even after 3 years, are to us at least good indications of long-term effectiveness of our drug candidate, something which will be important for eventual phase III trials and commercialisation. Big kudos to the team behind this study,” says RhoVac CEO, Anders Månsson.
The 3-year follow-up study
A 3-year follow-up study on the phase I/II patients was conducted at Zelo Phase I Unit, Bispebjerg Hospital in Copenhagen, Denmark in collaboration with the University of Tübingen in Germany and with Professor Klaus Brasso, Rigshospitalet, as Principal Investigator.
19 out of the 21 patients who completed the 1-year-follow-up to the phase I/II study, was identified and consented to participate in the 3-year-follow-up study. Out of these 19 patients, none of the patients had progressed significantly in terms of PSA nor progressed to other therapy. Indeed, all but three patients had undetectable PSA values (<0.1 ng/ml), and the patients who had a measurable PSA, had a longer PSA doubling time than they did when to entering the original study, indicating a slower progression, describes the company.
“It should be noted that there was no placebo control group in the phase I/II study; therefore, we can not conclude with certainty that patients were doing better than they would have if they were not treated. We can only conclude that they are all doing well, in terms of non-progression of their cancers, considering the time that has passed since they had their surgery. We can also conclude that the PSA doubling time, a measurement of cancer progression, is very rarely extended in untreated patients,” states the company.
Furthermore, the RhoC specific immune response has so far been assessed in 15 patients and in these, all but one patient who was a responder in the 1-year follow-up, still had RhoC specific immunity after 3 years. Given these results, further details on the immunity data will be produced and analysed in the coming months, aiming for a scientific journal publication, states the company.
Photo of Anders Månsson