My AGM impressions The power of the Internet: I was struck on several levels just how
powerful and useful the Internet has become in a very short period of
time. Most of the people that I met knew immediately who I am and what
I do here. But that's not important to me, what is important is what
Pat Pangburn was saying about how she found Biomira and the Theratope
trial. Also how she recruited trial participants from all over America
through her Internet connection. I think in the future it won't be
quite as hard to get the clinical trial message out to patients. Dr.
McPherson made a comment at the beginning of his presentation where he
said that he preferred using chalk but even the good Dr. has adopted
modern Internet technology: slideshows, webcasts and the like.
The advantages of a community based trial like the Theratope phase III
trial. I was discussing this point with the Dr.'s from the Midwest.
They made the point that with 120 sites Biomira already has built the
framework of a marketing structure. Many of the major oncology centers
know about Theratope, they have experience with it and it won't be a
new and unknown product to them. Also, if they want to do other
trials, in say colorectal cancer, they already have made the contacts.
It won't be quite as hard to recruit centers. Patients maybe but not
centers.
The partnership with Merck KGaA. The partnership is a superior deal,
IMO, because of the control it gives Biomira over its own destiny.
I've talked about this point before but I feel that it is important.
Lukewitte55 made the point very well the other day when he said that
no big US pharma would even have considered a deal like this. The
leadership of Biomira is working to create a new entity, not just a R
& D company but a fully integrated bio-pharma. It's a difficult step
but a necessary one. Now that they've reached this point in
development how could they even consider a deal that would cede
control to another company? Of course they couldn't do that and they
didn't. I'm sure we will be discussing this point in the future.
Theratope trial design and chance of success at first look. I believe
that the DSMB reviews have not been given the attention that they
deserve. When Biomira first designed the phase III trial they made
certain assumptions about the number of events that would occur at
certain points in the trial. They have communicated these assumptions
and numbers to the DSMB. They have said that at time X (X can be the
300, 600 or 800 patient level) we expect that there will be this
number of patients who will have progressed and that there will be
this number of patients who have died. If there are too many events at
this time X, then Biomira's assumptions concerning the efficacy of
Theratope could be called into question. Alternatively if there not
enough events at these times then the assumptions concerning the
control group could be called into question. It could mean that more
time would be needed to show an effect. However the DSMB has not said
either of these things. They have said, not once but three times that:
"Having reviewed the safety data, the DSMB feels the trial should
continue without any modifications." In other words Biomira's initial
assumptions have been correct.
BLP25 phase IIb trial. After attending the meeting and reading other
reports I am convinced that the phase IIb trial will shortly be put on
a faster track to full enrollment by Biomira and Merck KGaA by
expanding the trial into the US. It is also possible (likely) that the
number of patients will be increased in order to increase the
possibility of the trial being potentially pivotal. Dr. McPherson
himself said that the answer was obvious when answering Futurist2050's
question. Merck has expressed the desire to introduce at least one new
oncology product every year starting next year. Why partner with
Biomira for Theratope and BLP25 if they were going to put BLP25 on the
shelf because of slow enrollment in a large indication? That just
doesn't make sense.
Your fellow investor,
DC Arnold