- TB-402 Demonstrates Superior Antithrombotic Activity to Enoxaparin
ThromboGenics NV (Euronext Brussels: THR) and co-development partnerBioInvent International (OMXS: BINV) announce today positive results fromtheir Phase II trial of TB-402. TB-402 is a novel, long acting anticoagulantthat is being developed as a single injection for the prevention of venousthromboembolism (VTE) following orthopaedic surgery. The Phase II resultsdemonstrate that TB-402 has superior antithrombotic activity to enoxaparin(Lovenox(R): sanofi-aventis) with comparable safety. Enoxaparin is currentlythe standard treatment to prevent VTE in this setting. Venous thromboembolismencompasses both deep venous thrombosis (DVT) and pulmonary embolism (PE).
Advertisement
The Phase II trial was a multicenter, dose-escalating, randomised,open-label trial, evaluating TB-402 against enoxaparin for the prophylaxis ofVTE after knee surgery. All patients received enoxaparin 40mgpre-operatively. Post operatively, patients were randomized in a sequentialcohort design to one of three doses of TB-402 (0.3mg/kg, 0.6mg/kg or1.2mg/kg) or enoxaparin 40mg (3:1; n=75 per group).
Advertisement
TB-402 was administered as a single intravenous bolus injection 18-24hours after orthopaedic surgery, whereas enoxaparin was given as a 40mgsubcutaneous injection once daily for a period of at least 10 days. Theprimary efficacy endpoint was based on measuring all occurrences of VTE inpatients by Day 7-11, whether they were symptomatic or asymptomatic. Theprimary safety endpoint was the number of patients with major or clinicallyrelevant non-major bleeding from randomisation until the end of the study at3 months. The study enrolled a total of 316 patients across 30 centers inEurope.
For the pooled TB-402 treated group, 47 out of 218 (or 22%) patientsexperienced VTE; for the enoxaparin treated group, 30 out of 77 (or 39%)patients experienced VTE (p<0.05). The difference of reduction between thetwo groups is statistically significant.The study also showed that TB-402 andenoxaparin had a similar safety profile.
The results of this trial ("Single intravenous administration of TB-402for the prophylaxis of VTE after total knee replacement surgery") will bepresented by Prof. Peter Verhamme (University of Leuven, Belgium) at the 21stInternational Congress on Thrombosis in July in Milan, Italy.
Patrik De Haes, CEO of ThromboGenics, commented, "It is very clear thatVTE is a major clinical problem that carries considerable costs both topatients and healthcare providers. These exciting results show that TB-402when given as a single post-operative injection could dramatically reduce theincidence of VTE. This would clearly be a major step forward in preventingthis potentially life threatening condition. These results also reinforce ourconfidence that we can secure a significant partnership deal that will allowus to bring TB-402 to market and deliver its significant potential."
Svein Mathisen, CEO of BioInvent, also commented, "We are delighted withthe progress of TB-402 and are excited about the product's demonstratedsuccess over current treatments in preventing VTE in post-operative patientsand the associated advantages of this being delivered as a single dose. Theseresults underpin our belief that this novel approach will find a solid placein the anticoagulation market."
About TB-402
TB-402 has the potential to be a very important new entrant into theanticoagulant market. TB-402 is a recombinant human monoclonal antibody thatpartially inhibits Factor VIII, a key component of the coagulation cascade.This novel mode of action is expected to reduce the risk of undesirablebleeding events, even at high doses, as well as the need for patientmonitoring. These are the two main drawbacks associated with currentanticoagulant therapy. In addition, TB-402 is a long-acting agent, whichmeans it could be given as a single dose to prevent the development of DVT inpatients undergoing surgery. This simple approach to prophylaxis would be anattractive option, as all current anticoagulant treatment options requiredaily treatment for up to several weeks.
About Deep Vein Thrombosis (DVT)
DVT is caused when a blood clot forms in a deep vein, most commonly inthe deep veins of the lower leg. DVT is a major public health issue and it isestimated that in the U.S. alone, more than 600,000 patients are treated forvenous thromboembolisms (VTE) such as DVT or pulmonary embolism (PE) eachyear.[1] Moreover, DVT and PE together may be responsible for more than100,000 deaths in the U.S. each year.[2]
It is estimated that by 2015, 1.4 million patients will undergo kneereplacement and 600,000 patients will undergo hip replacement in the U.S. ifcurrent trends persist.[3] Patients undergoing hip replacement or kneesurgery are particularly at risk of developing DVT and all patients aretherefore treated with anticoagulants prophylactically in order to reduce therisks of blood clots. The annual sales of anticoagulants worldwide are over$5 billion. Nevertheless, available anticoagulants are still inconvenient andassociated with an increased risk of bleeding. Improved anticoagulants aretherefore required. In particular, agents that allow for improved ease ofadministration (without requirement for daily dosing and frequent doseadjustment) would fill a significant unmet need.
Legal disclaimer
This press release contains statements about the future, consisting ofsubjective assumptions and forecasts for future scenarios. Predictions forthe future only apply as of the date they are made and are, by their verynature, in the same way as research and development work in the biotechsegment, associated with risk and uncertainty. With this in mind, the actualoutcome may deviate significantly from the scenarios described in this pressrelease.
Notes to Editors:
About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on the discovery anddevelopment of innovative medicines for the treatment of eye disease,vascular disease and cancer. The Company's lead product microplasmin is inPhase III clinical development for the non-surgical treatment of back of theeye diseases. Microplasmin is also being evaluated in Phase II clinicaldevelopment for additional vitreoretinal conditions. In addition,ThromboGenics is developing novel antibody therapeutics in collaboration withBioInvent International; these include TB-402 (anti-Factor VIII), a longacting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listedon Eurolist by Euronext Brussels under the symbol THR. More information isavailable at http://www.thrombogenics.com.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), isa research-based pharmaceutical company that focuses on developing antibodydrugs. The Company currently has four clinical development projects withinthe areas of thrombosis, cancer and atherosclerosis. The Company has signedvarious strategic alliances around these product candidates and is developingthem in collaboration with partners including Genentech, Roche andThromboGenics.
These projects are based around a competitive and in substance patentedantibody development platform. The scope and strength of this platform isalso utilised by partners, such as ALK-Abello, Bayer HealthCare, DaiichiSankyo, ImmunoGen, Mitsubishi Tanabe Pharma Corporation, OrbusNeich, UCB andXOMA. More information is available at http://www.bioinvent.com.
---------------------------------
[1] Barclays Capital Equity Research Report on New Anticoagulants, August5, 2009
[2] "The Surgeon General's Call to Action to Prevent Deep Vein Thrombosisand Pulmonary Embolism," September 15, 2008, p.1.
[3] "Changes in Surgical Loads and Economic Burden of Hip and KneeReplacements in the US: 1997-2004," Sunny Kim, Arthritis & Rheumatism(Arthritis Care & Research), April 15, 2008; 59:4, pp. 481-488.For further information, please contact: ThromboGenics NV Patrik De Haes, MD Chief Executive Officer Tel : +32(0)16-75-13-10 E-mail: [email protected] Andy De Deene, MD Clinical Director Europe Tel: +32(0)16-75-13-10 E-mail: [email protected] Citigate Dewe Rogerson Amber Bielecka, David Dible, Nina Enegren Tel: +44(0)207-638-95-71 E-mail: [email protected] BioInvent International AB Svein Mathisen President & CEO Tel: +46(0)46-286-85-67 Mobile: +46(0)708-97-82-13 E-mail: [email protected] Cristina Glad Executive Vice President Tel: +46(0)46-286-85-51 Mobile: +46(0)708-16-85-70 E-mail: [email protected] College Hill (media enquiries) Holly Griffiths, Sue Charles, John McIntyre Tel: +44(0)20-7866-7856 E-mail: [email protected] ThromboGenics NV Gaston Geenslaan 1 B-3001 Leuven Belgium Tel: +32(0)16-75-13-10 http://www.thrombogenics.com BioInvent International AB (publ) Co. reg. No. 556537-7263, Address: Solvegatan 41 Mailing address: SE-223 70 LUND Tel: +46(0)46-286-85-50 [email protected] http://www.bioinvent.com
SOURCE ThromboGenics NV
