Ann: Admedus Releases Results of HSV-2 Phase IIa Study, page-150

Why me?

I think most people are aware that the total participants were low which makes this quite inconclusive. There are encouraging signs but the market likes certainty (as can be seen in the SP). This obvious problem may have been slightly overlooked if the result from this small amount of patients was outstanding, however, given the low number I understand the scepticism.

1. The vaccine clearly stimulates an immune T-CELL response, even with a small sample size you expect this trend to continue. This is great - although it doesn't prove efficacy. The safety profile appears to be good, which is the primary end point. The reduction in viral shedding appears to be most effective with COR-1 in Arm 1, although the data in Arm 2 is quite different. There are two things to consider here:

1.1 - The method of delivery is significant to the result
1.2 - There simply isn't enough people in the trial to make any strong case either way
1.3 - Both of the above

2. Covered above. A larger trial, which may involve some changes in how the trial is conducted in terms of dosage is required as we know. These changes may or may not change the efficacy of the treatment, although you would expect it wouldn't make things worse, knowing what they know now.

3. Wayne has mentioned that the funding of this program going forward is going to be "External Funding" we can all speculate what form this may take, but at the end of the day it isn't possible to find this on our own through 2B and P3. A 2B may be possible, but a P3 requires significantly higher patient numbers to pave the way for a NDA for the FDA. Keep in mind this isn't a rare disease so the FDA won't accept lower numbers in the trial design.

Given this is a platform technology a partner may not be interested in the HSV-2 program on its own, however, if they see value in the entire platform and the underlying technology maybe they will stump up funding for the entire lot assuming they get the majority of the earnings from any products that make it to market, where would would get a lower fixed percentage.

Again we won't know the details for this until further information is put the market.

So as other posters have said, it isn't positive, nor is it dead and buried. Funnily enough the market is probably most spooked out in fear that we will continue to fund a program that may never go anywhere. I think our new management would only progress under terms favourable to us, but that's my own opinion.