AGM transcript third section Dr. McPherson: We have also moved this program forward into phase III
trials in colon cancer and we're currently looking at, I'm sorry phase
II, clinical trial program in colorectal cancer and this study was
done by Margaret Tempero and reported in ASCO, in May. The data would
indicate that, in this setting, there is clear evidence of a dose
response relationship at the 1, 10 and 100 ug or unit dose, in terms
of antibody response. But what's more important is that if you look at
these patients and there were 45 patients with 15 at each of those
dose regimens, you can see that these patients, for all 45 patients
had a total of 14.2 months for the 45 patients and 12.5 months for the
27 colon cancer patients. Now these are all people with colon cancer
who have been treated with first-line chemotherapy, 5-FU, leucovorin,
something of that nature and have progressed. Now the median survival
for that group of patients is something in the order of 9 to 12 months
on chemotherapy so if they have a median survival of 9 to 12 months
then they are going to progress at something of the order of a median
of 6 months and if you take a look at these people and say 'OK well
they've progressed', the 27 progressed at six months, they got another
12.5 months. So they got 18.5, 19 months of survival from the time
they first were shown to have metastatic disease in their colon, which
is, you know, a very important and quite impressive, small number
increase. And this is certainly an area that we will be looking at
with our collaborator Merck and EMD. And certainly does suggest that
there's possible justification for a randomized trial in this
massively difficult disease. And as I've said we're discussing moving
this indication into a registration program also with Merck and EMD.
Our follow on product is the BLP25, the 25 amino acid sequence that's
encapsulated, as shown here, in the yellow globule which is a
liposome, is the product that we've taken into non-small cell lung
cancer and our phase I trial, which was done with different doses
established safety and immunogenicity and, in particular, induced
T-cell responses. However, we found that the T-cell responses that we
got with that regimen were not as good as we wanted them to be. And
remembering that we need to get some pretty good T-cell responses here
fairly quickly because these people only have a median survival of
9-10 months with stage IIIb and IV smoker's cancer. So if you've got
sort of a three-month period during which they are being treated and
then followed, they're well down the road, 33% of the way down the
road to death, before you have the first follow up. So, we moved that
to a more aggressive program and with this more aggressive program and
a higher dose, we found that we got a better T-cell response in six of
the first eight patients that we treated. We then added to that
liposomal IL-2, in an attempt to see if we could enhance the immune
response and that data, to date, indicates that it hasn't, at those
doses, increased the immune response. The enrollment's complete and
we've looked at the immunogenicity and so we've moved forward with a
166 patient randomized trial in patients who receive BLP25, after
chemotherapy, and one group, 83 of them, receives the BLP25, 1000ug
subcutaneously, weekly for eight weeks, followed by best standard of
care and the second group receives best standard of care after they
have received the chemotherapy program. So, both groups have received
chemotherapy, shown some indication of usefulness and then are
randomly allocated to the two groups, much as the Theratope in the
Theratope trial. And we are looking at hopefully completing the
enrollment of this trial, unless we move it forward more aggressively
and that will be part of our discussion with our collaborator, at the
moment it's enrolling rather slowly, we have ten sites in Canada, four
in the U.K. The ramp up has been somewhat encouraging in the last
month or so but nevertheless if this is going to enroll at an
acceptable rate we're going to move more aggressively in this
particular area.
Patents are the essence, the crown jewels, of bio-pharmaceutical and
biotech companies. We have a very solid patent portfolio. One of the
things that our collaborators noticed when they did what's called due
diligence, prior to signing a collaboration agreement, was to go
through our patent portfolio with a fine toothed comb. We've added
two, I think, very important patents. One which we've licensed from
the Imperial Cancer Research Technology, which is a composition of
matter patent, the best kind of patent, and this will be in
relationship to our MUC1, BLP25 peptide, which is used in our
liposomal cancer vaccine. We've also had another patent issue, which
also is a composition of matter patent, and it is a cost effective way
of extracting autologous vaccines, patient specific vaccines that can
be used in B-cell lymphoma, for instance. And we expect to be moving
forward with that, under the protection of that autologous vaccine
patent. That trial will begin in 2001 with the National Cancer
Institute in the United States under the supervision of Dr. Larry
Kwak, a literally world famous hemo-oncologist at the NCI US.
Now, it's important to recognize that these one's that I've been
talking about are the lead product candidates but if you are going to
be investing in a company that's going to have any strength, in terms
of staying power, it has to be more than a one trick or a two trick
pony. And so Theratope and BLP25 I've talked about but in addition we
do have that BLP25/Interleukin-2 program, that product we need to go
further with it because we clearly don't have the right dose and the
right scheduling for that or maybe the right indication. We have to
move forward with the autologous vaccine and we're looking at using
this liposomal IL-2 as a single agent, for instance, in renal cell
cancer and possibly malignant melanoma. And then beneath that product
pipeline, all of which is in clinical settings, we have a fairly
strong product portfolio at a pre-clinical level and we're
aggressively looking at in-licensing as well as internally developing
a product portfolio that will allow us to have staying power and move
ahead capability as we go forward.
Our financial position, as of now, indicates that as of the end of
March we had $49.6 million or $31.2 million US in the bank and we've
drawn down on the $100 million equity line financing $67.6 Canadian
with still 3.9 million shares available for this equity line financing
drawdown. In addition to that, of course, we also have the money,
which is in the bank today, in a large measure, from the upfront
payments from Merck KGaA. So under those circumstances we feel we are
in a reasonable circumstance for having something in excess of two
years of cash available to us, with the upfront payments plus the cash
and not including the additional drawdown.
To finally conclude I want to just leave up for your attention the
fact that we have eight particular milestones which we believe we
accomplished in 2000 and 2001 and thank you very much for listening to
the Biomira story. And, actually, particularly, thank you Pat.
End of Presentation. Q and A to follow.