Ablynx (BE) - Initial Observations of Ablynx's Phase II Ttp Programme Presented at Isth Congress
GHENT, Belgium, 28 July 2011 - Ablynx [Euronext Brussels: ABLX] today announced that initial observations of the on-going Phase II study with the anti-von Willebrand factor (vWF) Nanobody ALX-0081/ALX-0681 in patients with thrombotic thrombocytopenic purpura (TTP) were presented at the 13th Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Kyoto, Japan.
The presentation only includes initial findings and the data should not be extrapolated for the overall study.
The data were presented by principal investigator, Dr. Flora Peyvandi (IRCCS Maggiore Hospital Foundation, University of Milan), and included the study design and goal, and the initial observations from the first five patients that were enrolled in the trial. These were two men and three women, aged 31 to 60 years. Four patients experienced their first episode of TTP and one patient had a history of recurrent TTP.
Three patients received Nanobody treatment, the other two received placebo treatment. Four patients have completed the study treatment. Biological activity of the Nanobody was confirmed by a decrease of the biomarker RICO compared with placebo. Two serious adverse events occurred, but were resolved, with one subject discontinuing treatment.
Recruitment of the Phase II study is currently ongoing and final data are expected during the course of 2013 with a Marketing Authorisation Application (MAA) filing in Europe planned end 2013, if the Phase II study is accepted as pivotal.
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
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
Complete version of the press release<http://hugin.info/137912/R/1533110/466968.pdf>
Posted: July 2011