peter, here is cut and paste from the XOMA site. I know the feeling of trying to make sense of a biotech that I have not followed. Think, those with a technical background do have an advantage. I loved SEPR from the start. I understood the business concept not the science. But I got worried out of the stock early on, and I had had a nice position.
<<<<<<<<<<<<<<<<Castellos comments>>>>>>>>>>>>>>>
Historically, what pharmaceutical companies did was try to find a cure for sepsis, the
area inside the center white circle. But if you look at sepsis in the context of the
underlying disease states, a couple of things become apparent. For many of these
diseases, there is a high percentage of underlying mortality. It's no surprise to
anybody that people die of heart disease, cancer or infections, whether or not they
progress to sepsis. So curing their sepsis will not necessarily demonstrate a mortality
benefit in a clinical trial. Sepsis patients are also a very heterogeneous patient
population with a lot of variables. So even with very large trials, it's hard to sort out
the effects of all this variability.
These are some of the reasons why we felt, in the early '90s, that doing another
sepsis trial, trying to cover the inner white circle, didn't make sense. At the same
time, we had a very exciting molecule, called BPI, and were trying to figure out how
to get our first BPI-derived product, NEUPREX®, to market without stumbling down
the same road that more than a dozen companies have now been down. I believe these
companies have enrolled a total of about 13,000 patients in sepsis trials and there
hasn't been any trial product that succeeded through phase III. And it isn't because
the drugs don't work, it's because they targeted too broad an indication.
So what did we do? We approached this market in a very focused way to target clean
patient populations. We started with a pediatric disease, meningococcemia. We picked
off little pieces of the pie. Why did we pick them? The idea is that in each case there
is a discrete patient population that allows us to do a clean clinical trial that hopefully
can give us a successful conclusion. And that's basically our clinical strategy.
It's a legitimate question to ask "How many little pieces of pie do we have to cut to
demonstrate the product works before it can be used for the whole circle?" That's yet
to be seen. But as you can see by the indications shown, we are gradually going
around the circle. Its a long process, but one that gives us a better possibility of
winning in the end, instead of trying to get it all in one bite. |
