2/21/2001 CEOCast InterviewFebruary 21st, 2001 CEOCast Interview with Dr. McPherson
Announcer: Good day, this is Michael Wax with CeoCast. We are here
today with Alex McPherson M.D.
Dr. McPherson is President and Chief Executive Officer of Biomira Inc.
A company that trades on the NASDAQ under BIOM and also on the Toronto
Exchange under the symbol BRA
and one that continues to make progress in the clinic in its phase III
trial of Theratope.
Thanks for joining CeoCast today, Dr. McPherson.
Dr. McPherson: You're welcome, Michael.
Announcer: I thought perhaps you could begin with an overview of the
company and
then we could get into Theratope.
Dr. McPherson: Sure, as you know we are focused on therapeutic cancer
vaccines and the
core technology that differentiates Biomira from other companies in
that area is that
we're working with synthetic vaccines. The two particular vaccines
that we're working with
relate to a carbohydrate vaccine called STn, for sialyated Tn, and
another one called BLP25,
for Biomira Lipo Peptide. These are both synthetic components of the
MUC1 molecule,
which is a molecule that is present on virtually all solid tumor
malignancies and is quite unique,
in that respect. So really, overall the basis of the company is the
immunology of the MUC1 molecule
in humans with solid tumor malignancies and our capacity through very
sophisticated chemistry to
synthesize these products so that when we go to a regulatory agency we
have a very homogeneous
population. And then finally the clinical steps that are necessary to
go through the regulatory process.
We have a very solid pipeline of other products but I don't think we
have time to get into that.
We're well financed, we have probably about $60 million in the bank
and we have a PIPE, which is current,
and we are continuing to draw down on that and we have additional
about $80 million available for draw down
on a total of 8.8 million shares. So we're moving along and we're
very, very happy with what is happening
as we speak.
Announcer: As you look at, now, the opportunity here, you're in phase
III with Theratope.
Now this trial, I believe, is generally a survival study.
What kind of results are you hoping to achieve here?
Dr. McPherson: Yes, this is the largest immunotherapy trial, using
therapeutic cancer vaccines,
ever held in the world. We have 120 sites in 11 countries that are
looking at patients with
metastatic breast cancer who have been treated for first-line
treatment by the investigator with
the treatment of their choice and have gone into either a complete or
a partial response or substantial
stable disease and then they are broken down into two groups of
patients, one group gets the
Theratope product, which in phase II demonstrated substantial survival
advantage over sub-optimal
formulations and historical controls, and the second arm in the
therapeutic trial is non-specific
immunotherapy, which contains everything except the active molecule
STn, which is the active component of
Theratope. This is a designer trial, from a regulatory perspective,
because it is a survival trial.
We do have two endpoints, in relation to this trial, the first
endpoint, which we will be opening and
looking at, in the third quarter of this year, relates to time to
progression of disease and we'll probably
have that data cleansed and available, if appropriate, and reviewed by
our data safety monitoring board to
submit a BLA, again I say if appropriate, by the first part of 2002.
The next analysis begins in mid-2002 and
will probably take, by the time the data is appropriately cleansed and
formulated and reviewed to
the end of 2002 and the possible BLA submission related to survival.
So it's critically important to recognize
that this is a trial that what's called event driven and the two
events that we're looking at are time to
progression and survival, but the critical endpoint relates to survival.
Announcer: As you look at, of course, recruitments efforts here,
what's been involved in recruiting the
populace and has it been difficult to find a sufficient number of
patients for the study?
Dr. McPherson: It's always difficult. As a former, well, still
practicing medical oncologist, I can tell
you that recruitment to clinical trials is always about 1/10th what we
oncologists suggest is possible. We
moved from about 70 sites to 120 sites and we moved from about 4
countries to about 11 countries and we
substantially increased our spend in relationship to trying to meet
full enrollment by the end of the first
quarter of 2001. We expect to have enrolled 950 patients or
thereabouts, in order to have 900 evaluable
patients, which will be broken down into 450 in each of the two
treatment and control arms.
Announcer: As you look at the opportunity here Dr. McPherson, if you
do get positive results in the
preliminary data what might be some of the interim steps that you
would initiate?
Dr. McPherson: Well, one of the things that's important to recognize,
Michael, is that we're currently in very
aggressive partnering discussions with a potential worldwide partner
and we probably will rely
predominantly upon the partner for marketing, sales and distribution
advice and certainly advice and
assistance in relation to the regulatory steps that are necessary, but
it's our expectation to file probably
in the United States first and probably fairly closely thereafter in
Europe, although that exact definition or
development is not yet finalized. The sort of numbers of patients that
we're talking about with metastatic
breast cancer are basically the annual deaths throughout the world
from metastatic breast cancer and
so we're looking at about a population of 135,000, which represents
the boundaries of the market that we
would be looking at. And if we get that population of patients and we
look at penetration of an industrial
norm, which is say 30%, in a peak year, fourth or fifth year after
launch and reasonable pricing against
competitive molecules, such as say HER2/Neu, as an example, we're
probably looking at a market that's
somewhere in the range of, at peak, about $400 million worldwide. So
it's a very attractive possibility and
it's particularly attractive because it's a product that has very
little in the way of adverse events and
seems to have, at least on the basis of phase II data, very strong
survival trends. So it has a very useful
therapeutic index and, certainly, most people who listen to this story
say 'Well I can't imagine if
you've got a product that has virtually no safety concerns and has
strong survival indications that it
will only penetrate 30% of the market', so the numbers I'm talking
about, related to breast cancer, are
probably conservative.
Announcer: You also have BLP25, which is a candidate in phase IIb
study, how does this address the non-small
cell lung cancer problem?
Dr. McPherson: Yes, this is another component of what's called the MUC
or Mucin-1 molecule, which is the
molecule that is unique to a wide variety of solid tumor malignancies.
This is a 25 amino acid sequence,
which we've synthesized and we've encapsulated in a liposome or a fat
droplet about the size of a red cell
and this particular product induces a very strong T-cell response and
we have done phase I and two phase
II studies prior to the one that you just mentioned to demonstrate
that we get very effective T-cell responses
and these T-cell responses in pre-clinical models cause clear
regression of tumors in mouse models. So
we're hopeful that we'll see some clear evidence of clinical benefit
that's associated with these
immunological T-cell responses. The product also in phase I and in
phase II studies, to date, appears also
to be very safe and, the study that you just referred to, is a study
that is still, I must say, in the
development phases. We have expectations, on the basis of powering the
study, of entering approximately 166
patients. Currently we're working on entering these patients in 10
sites in Canada and recruitment is very
slow. It's very slow for a couple of reasons; the first is we think
the eligibility criteria of the trial are
too rigorous and secondly there has, since we started looking at this
program, there's become a very major
competitive environment in non-small cell lung cancer. So we're
reworking the study, as we speak, and,
although, as it currently stands, the study is going forward in Canada
and probably in the UK, it has every
possibility of being rejigged over time, especially as we bring a
partner on board.
Announcer: Dr. McPherson, the company, of course, learned some things
in terms of the enrollment issues
with your phase III trial, how might you now apply what you learned to
solve the slow enrollment for the BLP25
program?
Dr. McPherson: I really think that the critical issue, aside from good
luck and prayer, is really to work on
recruiting serious numbers of sites and being very rigorous with
respect to the investigators that are
associated with the trial, cutting the ones that don't meet benchmark
standards that we establish and
enhancing the program through additional resources for investigators
that are doing a good job. There is an
enormous amount of competition out there, at the present time, for
clinical trial programs in good sites
and we certainly learned you have to have a large number of sites, you
want to have sites in a wide
variety of different locations, so it's a community based trial and
you need to have very, very dedicated
and committed investigators and most importantly committed and
dedicated clinical research nurses in the
institutions that you are working with.
Announcer: What should investors now look for in the coming quarters,
in terms of news out of both the phase
III and the phase IIb trials?
Dr. McPherson: Well, we will be announcing, as a matter of fact, at
the BIO Conference that I'm at here in New
York, we announced that as of Monday we had 928 patients enrolled in
this particular study. So we're
very close to the 950 patients that we wish to have in order to ensure
that we have a minimum of 900 evaluable
patients. So that information will come out probably towards the end
of the first quarter. The second thing
that will happen is that our Data Safety Monitoring Board does a
review of the first 800 patients, they've
already reviewed the first 300 and the first 600, and they will be
doing a review in the second quarter of
the first 800 patients and give us an idea as to whether or not the
numbers of events that are occurring
in the trial are according to the forecast. And then the next thing
that is important is that we will be
starting the interim analysis, through the Data Safety Monitoring
Board, and depending upon the results of
that, we will either go forward without submitting a BLA, if we do not
have very solid statistically
significant differences in time to progression and robust survival
trends on the first interim analysis
and that will be something that we'll be talking about as well. The
other, of course, major issue is going to
be a corporate alliance, which we hope to finalize by the end of this
quarter or probably, because of my
friends the lawyers, slipping into the second quarter.
End of Interview