positive announcement, page-19

Funny how PRR spiked in the US and then got shaken down too.




Last: $0.165 / Price Target (risk adjusted): $0.53



Event: PRR has released interim trial results for a 63 patient Phase IIb study (known as CAN-003).



Details: The data released today focused on three main areas – safety, efficacy and biological activity.



Safety – This is being measured by adverse events (AE), which can range from a mild headache to death, whether related to CVac, the disease, or otherwise. While a large proportion of the participants experienced a mild AE, there were only 7 serious AE. All but one of these were considered unrelated to treatment. There was also one death in the observational standard of care group (ie: not receiving CVac).



Efficacy – This is being measured by progression free survival (PFS), or the length of time before the disease begins to progress again after being treated either by CVac or standard of care. Of the data available to date, for the first 7 patients who received CVac in a non-randomised format, the average PFS is 421 days, for patients in the randomised CVac cohort 365 days and 321 days in the observational standard of care group. The data is showing the right signs in terms of survival advantage but note the interim stage of the data. Observation will continue for another 12 months.



Biological Activity – Immune response is being measured by intracellular cytokine staining (ICS). Tests were undertaken on 2 healthy volunteers, 5 untreated patients and 3 patients who had received 3 CVac doses. There is clear and marked improvement in two specific markers that indicate a very robust response from the immune system, but more specifically in markers which suggest it is specific to mucin-1, the target of CVac.