ABLYNX PROVIDES UPDATE ON ITS ONGOING PHASE I STUDY FOR ALX-0141
(Thomson Reuters ONE) -
GHENT, Belgium, 9 January 2011 - Ablynx [Euronext Brussels: ABLX] announces an
update on its ongoing Phase I study in 42 healthy post-menopausal women treated
with ALX-0141, a Nanobody(®) targeting Receptor Activator of Nuclear Factor
kappa B Ligand (RANKL).
In September 2010, at 120 days follow-up, positive safety data were reported, as
well as data on the pharmacokinetics (PK) of ALX-0141. The double-blind,
placebo-controlled Phase I study was designed to assess safety, tolerability and
PK of a subcutaneous injection of ALX-0141. In addition, serum levels of certain
bone biomarkers were measured, to provide an early indication of efficacy. ALX-
0141 was administered in 6 dose levels as a single subcutaneous injection
ranging from 0.003 mg/kg to 1 mg/kg.
At the 9 month follow-up time point, statistically significant suppression of
the bone biomarker CTX-1 was noted. Following a single dose of 1mg/kg, 4 out of
6 subjects (67%), in this highest dose group, showed statistically significant
suppression of CTX-1 at 9 months and will be followed-up until their biomarker
normalizes. As a comparison, published Phase I data for denosumab (a monoclonal
antibody also targeting RANKL and developed by Amgen which some analysts predict
will reach peak sales of $3 billion) also showed statistically significant
suppression of another bone biomarker, serum NTX-1, for 9 months at the highest
dose level of 3mg/kg.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: "The prolongation of
biomarker suppression beyond the expected endpoint confirms the high biological
activity of ALX-0141. We are delighted with the positive safety data and the
drug's PK/PD profile and we are assessing the importance of these results for
the future development of the drug. We expect to have the final biomarker data
available by the second quarter of 2011."
For more information, please contact Ablynx:
Dr Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
+32 (0)473 39 50 68
e: edwin.moses(at)ablynx.com
Marieke Vermeersch
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e:marieke.vermeersch(at)ablynx.com
Complete version of the press release:
http://hugin.info/137912/R/1478138/414028.pdf
This announcement is distributed by Thomson Reuters on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Ablynx via Thomson Reuters ONE
[HUG#1478138]
Unternehmensinformation / Kurzprofil:
Datum: 09.01.2011 - 18:01 Uhr
Sprache: Deutsch
News-ID 50288
Anzahl Zeichen: 3170
contact information:
Town:
Ghent
Kategorie:
Business News
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