Advanced Viral Research Corporation Waits for
Results of AVR118's Cacehxia Trial
By Chael Needle
LifeGuide
[Treatment Horizons]
Advanced Viral Research Corporation (ADVR) has released a
forward-looking preliminary sketch of forthcoming results of
a clinical trial in Israel studying the safety of AVR118
(formerly called Product R), an immunomodulator, in its
treatment of body wasting. The results have not been
published yet and cannot be reviewed, but ADVR decided to
send out a press release claiming that the first fifteen
patients in the study, all of whom were experiencing body
wasting as well as failing HAART regimens, showed
improvement in appetite, weight gain or stability, and
enhanced quality of life; none reported significant side
effects. Readers should note the smallness of the
sample—not because it’s unusual for a Phase I trial, but
because it’s too early to tell if these results can be
replicated and if the other fifteen patients that will
complete the results will make good on the theorized safety
and efficacy. The only FDA-approved treatment for body
wasting in individuals with HIV/AIDS so far is the
recombinant human growth hormone, somatropin.
I had interviewed Dr. Shalom Z. Hirschman, then-President
and CEO of ADVR, in November 2002 for this column. At the
time, Dr. Hirschman was excited about the Israeli studies,
which would look at the immunomodulator as a possible
salvage therapy for patients failing HAART, as well as a
treatment that could reverse body wasting and mitigate the
toxicities of HAART drugs. I was expecting to hear results
about AVR118 as a salvage-therapy candidate. As it turns
out, the only results offered so far concern body wasting.
An important quality-of-life issue, to be sure, but the
absence of news about other trial goals is disappointing.
“When we looked the raw data that was published—or,
rather, put out into the press release—what we found was
that virtually every patient had a response. In other words,
all patients had a response, “ says Dr. James D’Olimpio,
M.D., Director of the North Shore University Hospital’s
Supportive Oncology and Palliative Care Service in Manhasset
New York, and a member of ADVR’s Scientific Advisory Board
as well the company’s spokesperson. “All fifteen
patients responded in the kind of parameters [one needs] to
publish with. I can’t get into that right now because the
database isn’t complete.” Though he is not participating
as a researcher in the trial, he has treated body wasting in
patients with cancer as well as those with HIV/AIDS since
the mid-eighties and has researched body wasting for the
past five years. He sees this trial as part of new
scientific attention being devoted to understanding body
wasting. Any drug that is eventually developed, however,
won’t be a “magic bullet, or monotherapy. It’s going
to be a number of things. We’re building pieces of the
puzzle,” he says. “AVR118 could be something we can use
to reverse the process of body wasting.”
Dr. D’Olimpio has found that treating body
wasting, or cachexia, in patients with cancer dovetails with
patients with HIV disease. Body wasting is caused
by different things in each but they do have similar models
in the sense that “both have a number of different
inflammatory pathways that become activated” in common.
Says Dr. D’Olimpio: “The key feature in both situations
is that skeletal muscle, what’s called lean body mass, is
significantly affected. Once skeletal muscle is affected,
then the body cannot fight it off from the standpoint of
immune response or from the standpoint of being able to
tolerate therapy.” The organs cannot support themselves as
a result and eventually deteriorate, he says, as evidenced
by the “20,000 individuals who ultimately die of HIV
disease each year who lose weight as the key feature of why
they get infections or why infections lead to weight
loss.” He continues: “The weight loss itself is a
reflection of this inflammatory process by which patients
cannot muster an effective response and/or tolerate their
treatments.”
One present goal for treatment research in general is to
find drugs that down-regulate or interrupt these pathways.
The targets are the signals that tell the body to siphon off
protein from muscle and, in effect, keep aberrant
inflammatory processes going. EPA, a fatty acid, and amino
acids have been found to dampen signals, according to
D’Olimpio. “It also seems that AVR118 does this. The
information coming out is worthy of scientific
publication.” At this point, however, all we can do is
wait and see if a new treatment for body wasting is indeed
on the way.
Chael Needle reported on cardiovascular disease and HIV
for the December 2003 issue.
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