i spoke to martin today

Just to clarify a few important points:

I spoke to Martin Rogers today about the purpose and time line for the trials so far.

1. In the first 12 years of work, PRR undertook phase 1 and 2a trials which was on a small number of quite sick patients where it showed even with these that CVac worked in extending life to varying degrees.

2. Then PRR decided it would undertake 2b trials with the view of confirming the manufacturing comparability of multiple sites, potency assay, safety of CVac and compare disease progression (PFS) between CVac and the control group. However, since only 60 patients were involved, statistically sig data was not possible as an outcome of these trials but rather phase 2b was designed to suit the requirements of the FDA (as well as Australia). However since more healthy patients were selected (in first or second remission)PRR is expecting better PFS outcomes than phase 1 or 2a.
Not only this but the success of the potency assays and safety data etc in phase 2b will make the process of CVac immunotherapy appeal to a wider patient base once the whole trial process is complete and phase 3 outcomes are known. This of course is very good news for patients, carers, scientists and investors.


3. In phase 3 trials due to begin in November this year the goal is to seek a statistically significant outcome which requires a minimum of 192 patients but since PRR has raised more capital it is much more worthwhile making it a larger size of 800 patients which will meet the desired 90% confidence level statistically. These will be FIRST LINE( SECOND LINE?)patients whose cancer has not yet been treated. This, Martin said, was the best time to take the immune cells from the patients since there will be the most present and healthy then. The patients will then receive chemo before being given their treated immune cells ie the CVac.


In terms of time lines it seems that 2012 and 2013/4 are the years when important data will be released including at the ASCO conferences in June each year.

I hope this helps clarify some of the trials' complexities and helps us to understand that PRR has the best interests of all at heart-something that we would expect from such a professionally competent and trustworthy team of leaders.


Cheers
Birdseye