AIDS Treatment New, no. 183

Statistician Ousted As Waxman Enters gp 160 Fray," Nature, July 29, 1993.
Fortunately the Army has already obligated the $20
million to the Jackson Foundation, so the money will not
be lost to AIDS research at the end ofthe current fiscal year
(end of September) if the plan for the VaxSyn-only trial is
changed.
It is not hard to see why MicroGeneSys has an incentive
for testing only its vaccine. The first AIDS therapeutic
vaccine to get FDA approval could be worth a billion
dollars or more. If only one vaccine starts phase III testing,
no other will have enough data to be a candidate for
approval at the time the Army test ends; the FDA will have
to approve VaxSyn or nothing. But if the other vaccines
were tested, one or more of them might prove significantly
better, and then VaxSyn might not be approved at all.
The public loss from this result is equally clear. First,
thousands of people with HIV will receive a vaccine which
many experts believe is less promising than other available
candidates, in a trial which a panel of leading vaccine
experts concluded should not be run as currently planned.
And the way MicroGeneSys could benefit from having its
vaccine tested alone would be through the loss or delay of
other vaccines which are as good or better, which is likely
to adversely affect hundreds of thousands of people.
What You Can Do
This article only sketches some of the elements of the
gpl60 treatment-vaccine controversy. Much more information has been published in Science, Nature, New Scientist, and major newspapers.
Three AIDS organizations (Treatment Action Group
[TAG], ACT UP/New York Treatment + Data Committee,
and the AIDS Action Council) are now investigating both
administrative and legislative alternatives to letting the
VaxSyn-only trial go forward as now planned. But time is
very short, and they need to know what people think
should be done. They have distributed the following survey, asking people which of the following options are
acceptable, and in which order, as well as which are
unacceptable:
1. Allow the Army to proceed with a comparison of
gp160 vs. placebo in a phase III trial with clinical
endpoints.
2. Implement the NIHI/FDA panel's recommended
multi-product, placebo-controlled large trial with clinical endpoints, mandating that sponsors provide vaccine free.

2a. If MicroGeneSys remains unwilling to guarantee free drug for the full duration of the trial,
instruct trial organizers to consider Immuno AG's

mammalian-cell based gp160, safety data on which
will be in by January.
3. Allow the Army to redirect the $20 million to other
AIDS research programs:
3a. Mandate ad hoc external peer review for the
disbursement of AIDS awards by the Army with
this $20 million, as will be done with the Army's
$210 million breast cancer appropriation.
3b. Specify that the money be spent on therapeutic research.
3c. Specify that it be spent on vaccine research.
3d. Specify that it be spent on basic research.
4. Other (please specify).
Fax your answers (or any other comments) to TAG at
212/260-8561. Or leave them a phone message at 212/260 -0300.
Cosalane: New Approach
to HIV Drug
Cosalane, developed by researchers at Purdue University and the U.S. National Cancer Institute, is not yet ready
for human testing, but is interesting because it represents
a new class of drugs and new ideas for developing an HIV
treatment. The work is supported by the U.S. National
Cancer Institute.
Cosalane was developed from a chemical known as
ATA (aurintricarboxylic acid), which has long been known
to have anti-HIV activity. ATA has not been developed as
a drug because it is difficult to work with. It is not a single
chemical, but a mixture of many different polymers - and
every batch tends to be different. This creates problems for
quality control, and makes it almost impossible to get FDA
approval for marketing.
The first attempt to overcome this problem was to
separate out the smaller molecules (lower molecular weight)
in the mixture, to look for a single molecule which could
be made uniformly. But, unfortunately, the low molecular
weight molecules have the least anti-HIV activity.
Chemists then took one of these low molecular weight
components of ATA, and attached it to a steroid molecule
(in addition to making other chemical changes). The
purpose was to target the substance more effectively to the
surface of viruses and of cells. The result, cosalane, has a
relatively low molecular weight but works as well as any
of the ATA fractions.

Cosalane is believed to inhibit binding of HIV to the
cell, and also to inhibit viral entry (the fusion of the virus
and the cell, after binding). In laboratory tests, it is active
415/255-0588

AIDS Treatment News #183