ThromboGenics and BioInvent Complete Enrollment of Phase IIb Trial With TB-402 Ahead of Schedule
LEUVEN, Belgium and LUND, Sweden, December 16, 2011 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce today that they have completed the enrolment of a 632-patient Phase IIb trial with their novel long-acting anticoagulant TB-402 (factor VIII inhibitor) for the prophylaxis of venous thromboembolism (VTE) after total hip surgery. The trial has recruited patients from 36 centers across Europe.
It is anticipated that the swift inclusion of patients in the final recruitment phase of the study will allow the Companies to report the outcome in the second quarter of 2012. This is ahead of previous guidance, which was the second half of 2012.
This double blind, randomized controlled trial is comparing two doses of TB-402 (25mg and 50mg), given as a single intravenous infusion after total hip replacement, with the recently approved factor Xa inhibitor rivaroxaban, which is given orally (10mg) once a day for 35 days.
TB-402 is a recombinant human monoclonal antibody that has a novel mode of action. It partially inhibits factor VIII, a key component of the coagulation cascade. An important potential benefit of TB-402 is that a single injection provides safe, stable, long-term anticoagulation for approximately one month, depending on the dose. This is expected to lead to reduced nursing time and improved patient compliance.
In 2010, a 316-patient Phase IIa trial comparing TB-402 with enoxaparin for VTE prophylaxis after total knee replacement reported positive results. Patients treated with one of three doses of TB-402 had a significantly lower incidence of total VTE (22%) compared with patients treated with enoxaparin (39%). In this study, TB-402 was well tolerated and demonstrated comparable safety to enoxaparin.
Dr Patrik De Haes , CEO of ThromboGenics, commenting on the announcement said: "Completing enrolment, ahead of schedule, of this important Phase IIb study with TB-402 in patients after total hip replacement, is a key step in our development of this potentially improved prophylactic option for VTE. VTE remains a significant unmet need in many clinical settings despite the introduction of a number of new anticoagulants. We believe that a single dose of TB-402, with its consistent, stable and long-term anticoagulant effect could improve compliance and convenience for patients who have undergone surgery."
Svein Mathisen , CEO of BioInvent, added: "At BioInvent we are proud to have maintained the excellent momentum of this Phase IIb study of TB-402, which is on track to be completed ahead of schedule. By measuring TB-402 against one of the newer agents in the anticoagulant market, we expect decisive information that will allow us to shape the future development of our drug. "
TB-402 has the potential to be an important new entrant into the anticoagulant market. TB-402 is a long-acting agent, which means it could be given as a single dose to prevent the development of VTE, both in patients undergoing surgery and in immobilized medical patients at increased risk of VTE. This could lead to better patient compliance. This simple approach to prophylaxis would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks. TB-402 does not require anticoagulation monitoring, and importantly, the anticoagulant effect can immediately be reversed with recombinant human factor VIII in case of bleeding or if surgery is required, overcoming a main shortcoming of current anticoagulant therapy.
About Venous Thromboembolism (VTE)
VTE includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is caused when a blood clot forms in a deep vein, most commonly in the deep veins of the lower leg. PE occurs when a blood clot dislodges from the leg and then travels to block the main artery of the lung or one of its branches.
It is estimated that by 2015, 1.4 million patients will undergo knee replacement and 600,000 patients will undergo hip replacement in the US if current trends persist. In Europe, it is estimated that VTE causes more than 500,000 deaths each year. Patients undergoing knee or hip replacement are at high risk of developing VTE and are therefore treated with anticoagulants prophylactically. Nevertheless, available anticoagulants are still inconvenient and associated with an increased risk of bleeding. Improved anticoagulants are therefore required. In particular, agents that allow for improved ease of administration (without requirement for daily dosing and frequent dose adjustment) would fill a significant unmet need.
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative ophthalmic medicines. The Company's lead product ocriplasmin has completed two successful Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (VMA). The Marketing Authorisation Application for ocriplasmin has been accepted for review in Europe and the BLA is expected to be filed in the U.S. by the end of 2011. Ocriplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions.
ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF) in Phase Ib/II for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on NYSE Euronext Brussels under the symbol THR. More information is available at http://www.thrombogenics.com.
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances to strengthen the product pipeline and increase the likelihood of success. These partners include Genentech, Human Genome Sciences, Roche and ThromboGenics.
The company's competitive position is underpinned by an in substance patented antibody development platform. The scope and strength of this platform is also utilised by partners, such as Bayer HealthCare, Daiichi Sankyo, Mitsubishi Tanabe, UCB and XOMA.
More information is available at http://www.bioinvent.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
1. "Changes in Surgical Loads and Economic Burden of Hip and Knee Replacements in the US: 1997-2004," Sunny Kim , Arthritis & Rheumatism (Arthritis Care & Research), April 15, 2008; 59:4, pp. 481-488.
2. "VTE Impact Assessment Group in Europe (VITAE). Venous Thromboembolism (VTE) in Europe. The number of VTE Events and Associated Morbidity and Mortality," Cohen AT, Agnelli G, Anderson FA, et al. Thromb Haemost 2007; 98(4): 756-764
For further information please contact:
Dr. Steve Pakola , CMO
Dr. Patrik De Haes , CEO
Citigate Dewe Rogerson
David Dible / Nina Enegren /Sita Shah
BioInvent International AB
Svein Mathisen , President & CEO
Cristina Glad , Executive Vice President
College Hill (media enquiries)
Melanie Toyne Sewell , Anastasios Koutsos
Rebecca Skye Dietrich
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