Phase II trial results of TB-402 presented at International Congress on Thrombosis

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BioInvent International AB (OMXS: BINV) and ThromboGenics NV (Euronext Brussels: THR) announce that the positive results from a Phase II trial of TB-402 (Anti-Factor VIII antibody) were presented at the 21st International Congress on Thrombosis (ICT) in Milan, Italy yesterday. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism (VTE) following orthopaedic surgery.

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The data were presented by Professor Peter Verhamme (University of Leuven, Belgium) in a presentation entitled, "Single intravenous administration of TB-402 for the prophylaxis of VTE after total knee replacement surgery." The Phase II results showed the superior antithrombotic activity of TB-402, when compared to enoxaparin (Lovenox®: sanofi-aventis). The study showed that the two drugs had comparable safety. Enoxaparin is currently the standard treatment to prevent VTE in this setting. VTE encompasses both deep venous thrombosis (DVT) and pulmonary embolism (PE).

The Phase II trial was a multicenter, dose-escalating, randomised, open-label trial, evaluating TB-402 against enoxaparin for the prophylaxis of VTE after knee surgery. All patients received enoxaparin 40mg pre-operatively. Post operatively, patients were randomized in a sequential cohort design to one of three doses of TB-402 (0.3mg/kg, 0.6mg/kg or 1.2mg/kg) or enoxaparin 40mg (3:1;>

TB-402 was administered as a single intravenous bolus injection 18-24 hours after orthopaedic surgery, whereas enoxaparin was given as a 40mg subcutaneous injection every day for a period of at least 10 days. The primary efficacy endpoint was based on measuring all occurrences of VTE in patients by Day 7-11, whether they were symptomatic or asymptomatic. The primary safety endpoint was the number of patients with major or clinically relevant non-major bleeding from randomisation until the end of the study at 3 months.

Professor Verhamme presented the pooled data for the TB-402 treated group, which showed that 47 out of 218 (or 22%) patients experienced VTE; this compares to the enoxaparin treated group, where 30 out of 77 (or 39%) patients experienced VTE (p<0.05). The difference of reduction in VTE between the two groups is statistically significant. The study also showed that TB-402 and enoxaparin had a similar safety profile.

Svein Mathisen, CEO of BioInvent, commented, "We are pleased to have Phase II results for TB-402 presented at this internationally recognized event, reinforcing the unique profile of this drug candidate which we expect to generate interest from pharmaceutical partners. We are excited by the opportunity that TB-402 provides in the anticoagulation marketplace due to its attractive dosing opportunities and half life and the potential benefits this will provide for patients and healthcare providers alike."

Patrik De Haes, CEO of ThromboGenics, also commented, "We are very pleased by Professor Verhamme's presentation of the exciting TB-402 Phase II data at this important conference. VTE is a major clinical problem that carries considerable costs both to patients and healthcare providers, and we are very encouraged that TB-402 has demonstrated such an attractive profile compared to the current gold standard. These data have reinforced our view that a product that is able to reduce the incidence of VTE significantly in just a single post-operative injection could represent an exciting opportunity for a potential partner and allow us to bring TB-402 to market."

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