October
29, 2003 Updated
data from the 20-patient, randomized,
placebo-controlled, phase IIa trial of Isis’s (NASDAQ:
ISIS) ISIS 104838 in patients with rheumatoid arthritis
(RA) further support the construct’s advancement to
more mature clinical investigation. A 160-patient,
placebo-controlled, phase II, dose-ranging trial of ISIS
104838 in RA is ongoing, and Isis plans to report
results from the trial “by the end of the year.”
Further evidence of the following were found, and were
presented at the recently concluded American College of
Rheumatology Annual Scientific Meeting in Orlando:
- ISIS
104838’s ability to accumulate in synovial tissue
in a dose-dependant manner
- subcutaneous
rote of administration as effective as
intravenous route
- enhanced
possibility for self-administration
- ISIS
104838’s capacity to reduce TNF-alpha mRNA in what
is likely to be a clinically significant fashion
- 300
mg recipients experienced a greater reduction in
swollen and tender joints compared to placebo
recipients
- 35%
decrease in mean number of swollen joints at the
end of the 29-day treatment period
- 28%
decrease in mean number of swollen joints at the
end of the 85-day treatment period
- placebo
recipients’ analogous response rates were 25%
and 16%, respectively
- 26%
decrease in mean number of tender joints at the
end of the treatment period
- 18%
decrease in mean number of tender joints at the
end of the follow-up period
- placebo
recipients’ analogous response rates were 19%
and 1%
- ISIS
104838 was well tolerated.
ISIS
104838 is an antisense inhibitor that blocks production
of TNF-alpha, a cytokine (small hormone-like protein
that transmits signals between cells) important in
immune responses and inflammation. Several marketed
products, such as Amgen’s (NASDAQ: AMGN) Enbrel and
Johnson & Johnson’s (NYSE: JNJ) Remicade, target
TNF-alpha. |
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