Auxillium's "Positive" Data For Xiaflex Not So Positive Given Severe Side Effects
(Thomson Reuters ONE) -
Auxilium Pharmaceuticals (NASDAQ:AUXL) announced top-line data from a Phase IIIb
trial evaluating treatment with Xiaflex for multiple Dupuytren's Contracture
cords at one time. The company called the data "positive", as the 60-patient
trial demonstrated response rates of 76% at the knuckle joint in the hand (MCP
joint - 60% of all joints requiring treatment), but just 33% at the finger joint
above (the PIP joint - next most common joint). The company plans to begin a
larger trial for the treatment of multiple cords in the third quarter.
Importantly, adverse events, including bruising, pain, itching, and
lymphadenopathy were higher than observed in previous trials, which could make
the FDA more cautious in approving the treatment for multiple cords at one time.
Also adding to the safety concern there was one pulley rupture/ligament injury
of a middle finger and a 24 hour hospitalization for pain control after 2
injections into a little finger. While AUXL states in its press release that the
incidence of tendon/ligament injury with 2 concurrent injections is not
different from the overall experience with Xiaflex to date (0.1%), the incidence
in this trial calculates to 1.67%. These data could give physicians further
pause in using Xiaflex, especially when considering for multiple cords. Stock
could sell off on this news.
See the original at PropThink.com
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Source: PropThink via Thomson Reuters ONE
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Unternehmensinformation / Kurzprofil:
Datum: 30.07.2012 - 16:32 Uhr
Sprache: Deutsch
News-ID 169876
Anzahl Zeichen: 2557
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Town:
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