LEUVEN, Belgium, December 11 /PRNewswire-FirstCall/ --
- TB-402 Shows Clear Promise as a Stable Long-acting Anticoagulant for the Prevention of Thromboembolic Disorders.
ThromboGenics NV (Euronext Brussels:THR), a biotechnology company focused on vascular and eye disease, announced that the results of the first Phase I trial of TB-402 were presented yesterday at the prestigious American Society of Hematology (ASH) 49th Annual Meeting in Atlanta, Georgia, USA. TB-402 is being co-developed in collaboration with BioInvent International (Nordic Exchange: BINV).
TB-402 is a recombinant human monoclonal antibody which has shown a beneficial partial inhibition of the blood coagulation Factor VIII. Its long half life of approximately three weeks enables it to produce a stable and long-acting inhibition. This indicates well-controlled inhibition of Factor VIII activity with low risk of spontaneous bleeding, thus avoiding the possibility of overdose and the need for patient monitoring.
These unique features may be of major clinical significance, as it suggests that a product with an excellent safety profile, with ease of administration and compliance superior to alternative anticoagulants, can be developed. The preliminary results of the initial Phase I study were previously communicated in a Press Release issued September 7, 2007.
The Phase I trial presented at ASH was a randomized, single-dose, placebo-controlled, dose escalation trial in healthy male volunteers. 56 subjects were enrolled into the trial, including both younger age (18-45) and older age (55-76) volunteers. Results of the trial show that TB-402 is both safe and well-tolerated. No serious adverse events related to TB-402 were reported. In addition, there were no major bleeding complications, with the overall incidence being similar in both the TB-402 treated group and the patients who received placebo.
The pharmacokinetic analysis undertaken as part of the study
|SOURCE ThromboGenics NV|
Copyright©2007 PR Newswire.
All rights reserved