recruitment for can003 trial phase, page-32

People are just trying to make sense of what has been announced, and determine what it means.

ICS - this determines if CVAC is indeed producing a response within the dendritic cells. Becuase it is only presented in 6 subjects could be for 2 reasons:
1. They only performed in the first 6 subjects, to determine if the dosage was producing a biological response after the 1st and/or 2nd dose

2. If ICS is performed after the last dose is administered, then it is probably because they only have data on the first 6 people randomized into the treatment arm. remember that people are also randomised into standard of care.

I'm no expert regarding if it is assessed after the initial or final dose, but i'm sure management can confirm why it is only 6 people.

PFS - lets look at the definition of PFS:
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.

Now, lets look at the design of the study:
"Clinical assessments will be performed every four weeks, and imaging with computed tomography (CT) or magnetic resonance imaging (MRI) will be performed every 12 weeks
until progression or removal of the subject from study"

So, they can choose to present data in any way they want, but we have clinical data at 4week intervals, until patients "progress". According to the definition, patients can progress during administration of the drug. as such, we will data on the rate of progression, from both groups, as well as changes in CA125, or imaging (this is unlikely as these take time).

How is PFS evaluated?

EVALuAtIon crItErIA:
Efficacy: Progression Free Survival will be the measure of efficacy for the purpose of this clinical trial. Both first and second responding subjects will be judged as having
developed Progression of Disease (PD) on the basis of:
Two serum values of CA-125 =2x Upper Normal Limits performed at least one week apart, regardless of CT scan results, based on Gynecologic Cancer Intergroup (GCIG) criteria, or
Clinical or radiological evidence of disease since study entry regardless of serum CA-125


Now, they can choose to present it a couple of ways.

1. Take the last data point from the last patient, and report all data in all patients up until that point
2. Report data in all patients that have completed the dosing
3. Report the rate of PFS so far

Its anyones guess, but data is essentially available for PFS, a primary outcome in this study, if they choose to present it.

Just do some reading

http://www.asx.com.au/asxpdf/20120730/pdf/427ntntwrr9r0j.pdf

http://www.primabiomed.com.au/announcements/pdf/2010/PBM_Study.pdf