http://www.reutershealth.com/archive/2002/01/22/eline/links/20020122elin022.html
Jan 22, 2002
Preliminary research into a type
of gene therapy for rheumatoid arthritis has yielded promising results,
indicating that it might be possible to develop anti-inflammatory injections
that need only be given once every few months, German researchers report.
Dr. Axel Baltzer, of the University
Hospital in Dusseldorf, told Reuters Health that phase I clinical trials
of the gene therapy confirmed that it has no serious side effects and is
a feasible approach for joint disease treatment.
"We can show that this is a method
(that) will enable us to give long-term treatment of rheumatoid arthritis
with just one injection," he said.
The developer of the treatment is
Dr. C. H. Evans of Harvard Medical School in Boston, Massachusetts. Evans
and colleagues in the US conducted phase I research on nine patients. Baltzer
and Dr. Peter Wehling, who is now operating a biotech company in Dusseldorf,
have completed phase I trials in Germany with three patients.
Baltzer said the 12 patients, all
with advanced rheumatoid arthritis, were treated with the same basic procedure.
Cells were drawn from an arthritic joint, cultured and genetically altered
so they would produce the anti-inflammatory protein interleukin-1 receptor
antagonist.
After a few weeks in culture, the
treated cells were injected into two joints. In the placebo-controlled
study, one additional joint was injected with non-treated cells and one
joint injected with a saline solution.
In the US, patients participating
in the study had already been slated for joint replacement. The injections
were given 4 weeks before replacement surgery, and were producing the desired
anti-inflammatory protein for at least 4 weeks, Baltzer said. In Germany,
the injection was shown to be effective for 6 weeks, until all the treated
tissues were surgically removed for joint replacement. In both the US and
Germany, the treatment resulted in pain relief lasting a few months for
some patients, he said.
Baltzer said the researchers will
publish study results within the next few months and hope to begin phase
II studies this year.
"This could be the first step in
finding a cure for rheumatoid arthritis, " he said. "But right now our
goal is to find a way to help people suffering from rheumatoid arthritis
for an extended period of time with just one injection."
Copyright © 2002 Reuters Limited
By Ned Stafford
FRANKFURT, Reuters Health