For Release February 12, 2004
AuRx announced today that it has completed a series of tests in
nude mice showing that its recombinant therapy does not cause disease
in immune compromised animals. Nude mice injected with the therapy
lived 10 times longer than normal mice injected with HSV-2. No infections
were seen at the injection site and no symptoms were seen. Mice
receiving a dose of HSV-2 at the level given normally die in three
days. At the end of the 30 test period, the nude mice given 5 X
106 pfu of the AuRx therapeutic vaccine showed no ill effects.
The AuRx therapy is a live recombinant virus which has had one
gene deleted. The latest series of tests combined with earlier published
evidence is believed to show that the recombinant virus does not
grow in animals. This leads to hope that the recombinant therapy
could be tested and ultimately approved for use in immunosuppressed
humans.
This study also increases the confidence in the safety of the recombinant
therapy. Clinical trials in Mexico have shown no side effects greater
than placebo and the side effects experienced were mild. The recombinant
virus used in the therapy does not grow as well as HSV-2 in animal
cells and could not be recovered from mice or guinea pigs injected
with the therapy. In neuronal tissues in guinea pigs the amount
of virus was 100 fold lower where present and occurred five times
less frequently in surgically removed neurons.
One immediate target for the AuRx therapy could be persons infected
with HIV. HIV infection results in suppression of the immune system.
It is thought that HSV-2 infection stimulates the progression of
HIV to AIDS. Prevention of this progression would be a major step
in halting many of the life threatening consequences of AIDS.
AuRx, Inc. is a private biotechnology company located near Baltimore,
MD.
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