It is #7698 as follows:
Today's DSMB Report – My Analysis
by: Country_Doctor
7698 of 7755
Today's DSMB Report – My Analysis
Today's press release from IMNR announcing the Data Safety Monitoring
Board's (DSMB) meeting is very positive and exciting. Most regulars on this
thread may find this brief discourse repetitive, but this information is all relevant.
Some background information:
When the Phase III trial was first implemented over 3 years ago, 2500 patients
were planned to be enrolled with the clinical endpoints being: 1) progression to
AIDS (this is not the same as simply being HIV positive, it is the dreaded,
inexorable outcome of HIV infection, with opportunistic infections eventually
leading to death) and 2) mortality (ie death). At that time it was not possible to
measure viral loads in the manner now possible, and the understanding of immune
function related to HIV was comparatively in its infancy. The now widely accepted
goal of long term nonprogressor (LTNP) was then unknown.
Much has been learned in the past three years. We now recognize HAART is
highly effective in slowing the progression to AIDS and death, but that these drugs
are not a panacea, that they are expensive and have side effects, and their use can
lead to resistant strains of HIV. We now recognize that immune reconstitution
simply must be part of the treatment regimen in battling HIV, and that while we
may not be able to totally eradicate HIV from all tissues in the body, we can
achieve a clinical state as a LTNP. A LTNP lives with the virus in the body, but is
not overwhelmed by it and maintains a high state of health. Virtually all humans live
with Herpes Simplex virus and Herpes Zoster virus (chickenpox) in this manner,
but our immune systems keep these viruses in check.
The ongoing Phase III trial has collected enormous quantities of clinical data on
2500 HIV+ patients for 3 years. This is an amazing amount of scientific information
that is highly valuable and could probably never be obtained again. We have the
data, but what the DSMB has told us is that they want to look at it a bit differently.
Going forward, they had originally planned to look at progression to AIDS and
death, but retrospectively, they now need to look at more “modern” parameters,
such as viral loads and other surrogate markers. Dr. Valentine's Phase II study did
exactly that, with favorable results that were highly statistically significant.
Unfortunately he had only 43 patients in his study. It is certain that if he had a
larger cohort of patients giving the same results, he would have taken his data to
the FDA!
Question: Will this group of 2500 patients show the same significant reductions in
viral load as did Dr. Valentine's patients? I am convinced that it will. The DSMB
will look at that exact numbers over the next several weeks, and if these findings
corroborate those of Dr. Valentine, then IMNR will have a very strong NDA to
present to the FDA. This process will take several weeks to collect and analyze
the data. There are 2500 patients, and each one has to be evaluated in terms of
their viral load, immune status, and clinical endpoints (AIDS, death).
The DSMB did not terminate the study due to failure, and they did not simply say
continue the study.
What they did say was the data are available, the data are important, and they
need a little more analysis time in order to make a very major decision that will
affect the treatment of HIV around the world. They carry an ethical obligation to
end this clinical trial as early as possible. In my opinion, after several weeks of
analysis time, the DSMB will report back to IMNR to submit a NDA to the FDA
ASAP.
This press release combined with the recent news from Thailand is extraordinarily
good news, not just for IMNR shareholders, but for all patients with HIV infection
and for the health care delivery systems charged with their care. |
