PFIZER'S ANTI-TNF-ALPHA NANOBODY (ATN-103) SUCCESSFULLY COMPLETES A PHASE II STUDY AND DEMONSTRATES CLINICAL PROOF-OF-CONCEPT (POC) IN PATIENTS WITH RA
(Thomson Reuters ONE) -
REGULATED INFORMATION
GHENT, Belgium, 17 May 2011 - Ablynx [Euronext Brussels: ABLX] today announced
top-line results from the recently completed POC Phase II clinical trial of
ozoralizumab (ATN-103), an anti-TNF-alpha Nanobody licensed to Pfizer, in
patients with active rheumatoid arthritis (RA). The study evaluated five
different dosing groups plus placebo, and preliminary analysis of the data
indicates that the study met its pre-defined primary efficacy endpoint with the
highest dose of ozoralizumab (80 mg every 4 weeks) resulting in a statistically
significant improvement of ACR20 responses compared with placebo at week 16. In
addition, an improvement over placebo was also observed for secondary endpoints
such as improvements of clinical scores, DAS28, ACR50, ACR70 and EULAR response
at this dose level at week 16. No dose limiting toxicities were observed, and
the adverse events and serious adverse events that did occur, did not show a
clinically significant increase on increased dosing.
Pfizer have now confirmed that clinical proof-of-concept has been achieved and
they are now engaged in a full technical, clinical and commercial evaluation to
determine whether and how to take ATN-103 forward.
Dr Edwin Moses, Chairman and CEO commented: "We are delighted to announce the
first clinical proof-of-concept for a Nanobody. This has extremely important
implications for Ablynx, the whole Nanobody technology platform and our R&D
pipeline containing more than 25 programmes. Our progress has been rapid and we
are excited to have passed this critical milestone in our development into a
potentially leading biopharmaceutical company. We look forward to the completion
of Pfizer's internal decision making process."
About the clinical development programme
Pfizer successfully completed Phase I studies with ATN-103 in the summer of
2009, and then initiated two randomized, double-blind Phase II trials in Japan,
US and Rest of the World in September 2009, which finished recruitment of a
total of 312 patients in September 2010.
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/1516627/452958.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(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#1516627]
Unternehmensinformation / Kurzprofil:
Datum: 17.05.2011 - 18:00 Uhr
Sprache: Deutsch
News-ID 54749
Anzahl Zeichen: 3392
contact information:
Town:
Ghent
Kategorie:
Business News
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"PFIZER'S ANTI-TNF-ALPHA NANOBODY (ATN-103) SUCCESSFULLY COMPLETES A PHASE II STUDY AND DEMONSTRATES CLINICAL PROOF-OF-CONCEPT (POC) IN PATIENTS WITH RA"
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