| October
28, 2003 At
the American College of Rheumatology (ACR) Annual Scientific
Meeting, Furie et al published kinetic and dynamic data
highlighting the progress of Human Genome Sciences’ (NASDAQ:
HGSI) LymphoStat-B in clinical trial development, confirming
data reviewed in our April
21, 2003 BT News.
A
preliminary efficacy profile showed, “no change in SLE
[systemic lupus erythematosus] disease activity was observed
over this short exposure [a single infusion or 2 infusions 21
days apart with 84 to 105 days follow-up]. ” The lack of
observed benefit in this type of phase I effort should not, by
itself, be taken as detracting from LymphoStat-B’s
potential. Ongoing phase II efforts remain supported by the
literature.
Further
support presented at ACR included LymphoStat-B’s reassuring
preclinical pharmacologic activity and tolerability profiles
in Cynomolgus monkeys. Human investigation showed that BLyS
(the target of LymphoStat-B) is elevated in the blood of
20-40% of SLE, rheumatoid arthritis, and Sjogren syndrome
patients. BLyS levels, at least in SLE patients, correlate
with increased disease activity at multiple clinical and
molecular levels.
Also
notable from ACR was a presentation by Amgen (NASDAQ: AMGN)
investigators suggesting that the company may be developing a
small molecule BLyS inhibitor that could eventually compete
with LymphoStat-B, a monoclonal antibody. |
|
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