[Cynthia]

Debbie,

Here is the response I just received from the PI, COL George Peoples, MD:

Valid questions….here’s the scoop…

HER2/neu negative as used in clinical practice today does not mean that HER2/neu isn’t expressed, just not over expressed. The actual distribution of HER2 expression by IHC staining is as follows: 25% - IHC 3+ or over-expressed (the vast majority of these are also FISH >2), 50% - IHC 1-2+ (called negative but actually low-expressors), and approx 25% - IHC 0 (true negatives).

The E75 vaccine trial presented at AACR worked in all patients but best in the low expressors (LE).

The actual rates as reported for the OE (over-expressors – 25% of all breast cancer patients) and LE (low –expressors – 50% of all breast cancer patients):

Recurrence rate OE-controls = 18% at 3 years vs 14% in the OE-vaccinated
<DIR><DIR>LE-controls = 18% at 3 years vs 11% in the LE-vaccinated

</DIR></DIR>Mortality rate OE-controls = 9% at 3 yrs vs 3% in the OE-vaccinated
LE-controls = 7% at 3 yrs vs 0% in the LE-vaccinated

Mortality among patients that recurred
OE-controls = 50% vs 25% in the OE-vaccinated
LE-controls = 38% vs 0% in the LE-vaccinated
<DIR><DIR>


</DIR></DIR>