jgusl 7. 1998 * Jaast o u t 1 3
mil I.I 7 TU news
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N ew D rug P romises
B etter V ision for
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FDA approval of fomivirsen is likely, despite some scientists' criticism
of its small-scale clinical trials by Bob Roehr
B
y a 5-2 vote, an advisory committee
of the federal Food and Drug
Administration
recommended
approval of fomivirsen, trade name
Vitravene, for the treatm ent o f
cytomegalovirus retinitis, an opportunistic
infection sometimes found in those with
advanced-stage AIDS.
T he vote occurred July 22.
Cytomegalovirus retinitis is an eye disease
that causes progressive scarring
of the retina and loss of sight. It
cannot be reversed, but suc
cessful therapy may hold the
infection in check and prevent
further deterioration of vision.
A few drugs have already
been approved for treatment of
the disease, but each has disad
vantages in terms of side
effects, and some patients have
developed viral resistance to
one or more of those therapies.
Dr. Daniel L. Kisner is pres
ident of Isis Pharmaceuticals,
the company that developed
the drug. He says it works one
step further back in the process
of inhibiting viral reproduction
than do existing therapies. It
binds to messenger RN A of the
cytomegalovirus
when
it
divides and prevents its reproduction.
Fomivirsen is injected directly into the eyeball
to prevent development of the infection.
Thanks to protease inhibitor therapy, fewer
people are suffering from opportunistic infec
tions like cytomegalovirus retinitis. A t the same
time, the pool of potential patients to enroll in
clinical trials has grown markedly smaller.
T he FDA initially recommended the compa
ny not submit fomivirsen for approval, accord
ing to FDA medical officer Dr. Wiley Chambers.
“But with the inability to recruit additional
patients, additional progress was not being
made,” he admits.
T h e agency acknowledged that reality,
though it would have liked a
larger patient sample.
Chambers conceded the
product showed efficacy, but
he was not as convinced of its
magnitude. Because the stud
ies were “underpowered,”
with smaller than desired
numbers of participants, he
said it only takes a couple of
patients to have a tremendous
impact on the interpretation
of data.
T he committee grappled with
this fact.
Dr. Christopher Mathews
from the University of
California at San Diego
Medical Center concluded, “I
don’t think you will ever see a
comparison trial with num
bers that will be convincing”
because of the decline in cases of opportunistic
infections.
T he FDA will likely follow the committee’s
recommendation, and Vitravene should become
available in the fall.
Associate Broker
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sstandarddavis@msn.com
S U E S T A N D A R D D A V I S , w/“ F R E D ”
Cytomegalovirus
retinitis is an eye
disease that causes
progressive scarring of
the retina and loss
of sight. It cannot be
reversed, but successful
therapy may hold the
infection in check
and prevent
further deterioration
of vision.
How
the
D rug W orks
omivirsen is part of a new class of drugs
called antisense oligonucleotides.
Antisense drugs work at the genetic
level to interrupt the process by which dis
ease-causing proteins are produced. Proteins
play a central role in virtually every aspect
of human metabolism. Almost all human
diseases are the result of inappropriate pro
tein production or disordered protein per-
F
DNA
mRNA
formance. This is true of both host diseases,
such as cancer, and infectious diseases, such
as HIV.
Traditional drugs are designed to interact
with protein molecules throughout the body
that support or cause diseases. Antisense
drugs, on the other hand, are designed to
inhibit the production of disease-causing
proteins. They are designed to be more
selective and, as a result, more effective and
less toxic than traditional drugs.
: lomq
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