MALVERN, Pa., Sept. 7, 2011 /PRNewswire/ — Auxilium
Pharmaceuticals, Inc. (NASDAQ:
AUXL), a specialty biopharmaceutical company, today announced
positive top-line results from a pilot clinical study to assess
safety, tolerability, and multiple-dose pharmacokinetics of
XIAFLEX® (collagenase clostridium histolyticum) in adult
Dupuytren’s contracture subjects with multiple palpable
cords. The tolerability profile following concurrent
injection of two doses of XIAFLEX into palpable cords in the same
hand is consistent with that demonstrated in pivotal clinical
trials following a XIAFLEX injection into a single palpable cord.
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“We were encouraged that multiple injections of XIAFLEX into the
same hand concurrently have demonstrated a preliminary tolerability
profile clinically similar to that of a single injection,” said Dr.
James P. Tursi, Chief Medical Officer at Auxilium.
“Concurrent multiple injections of XIAFLEX would offer hand
surgeons the ability to treat several joints in the same hand at
the same time, which would be similar to historical surgical
interventions.”
In this phase IIIb study, 12 adult subjects with 36 palpable
cords were enrolled at a single site in Australia. All
subjects were required to have Dupuytren’s disease with at least
three fixed-flexion contractures, excluding the thumb. Each
subject was given a single injection of XIAFLEX and, if no severe
local or systemic reaction was observed, concurrent injections of
two doses of XIAFLEX were given into two palpable cords in the same
hand. In the pivotal phase III clinical trials, only a
single joint was treated with XIAFLEX and additional joints were
required to be treated sequentially every 30 days. Following
the multiple concurrent injections in the pilot study,
patient
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