ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on innovative medicines for eye disease, vascular disease and cancer, is today issuing a business update for the period ending 30 September, 2009.
Patrik De Haes, CEO of ThromboGenics, said:
"ThromboGenics' clinical development programs have continued to make significant progress. We are very happy to have completed patient enrolment for the US Phase III study with microplasmin and recruitment in our second Phase III trial is continuing to make excellent progress. Microplasmin is central to our aim of building a successful integrated company focused on cutting edge ophthalmic medicines, that is positioned to deliver significant shareholder value.
We have also recently completed patient recruitment of a Phase II study with TB-402, assessing it as a DVT prophylactic in patients undergoing knee replacement, ahead of schedule. Our experience with TB-402 suggests that this long acting product has the potential to be an important new entrant into the anticoagulant market making it an attractive out-licensing opportunity. Our partnership with Roche for the novel anti-cancer antibody TB-403 continues to make good progress, with results from the Phase Ib trial to be presented later this month at the American Association for Cancer Research conference."
Financial Update - ThromboGenics achieved revenues of EUR3.7 million in the third quarter of 2009, the majority of which came from out-licensing. R&D expenses were EUR12.6 million during this nine month period. In Addition EUR10.4 million of expenses related to the microplasmin Phase III clinical program have been capitalized over the first nine months of this year. - As of September 30, 2009, ThromboGenics had EUR43.1 million in cash and cash equivalents. This compares to EUR60.9 million on September 30, 2008 and EUR58.9 million on December 31, 2008. Business Highlights Clinical Highlights
Microplasmin - Back of the Eye Disease: Phase III clinical program to evaluate non-surgical treatment of patients with vitreomacular adhesion.
- Phase III program continues to progress well, with enrolment
completed for TG-MV 006 and on track for TG-MV 007
In September, ThromboGenics announced the completion of patient recruitment in the US trial (TG-MV-006) of the Phase III program with microplasmin for the non-surgical treatment of vitreomacular adhesion (a back of the eye condition). The trial recruited a total of 326 patients ahead of schedule and we anticipate reporting the results from this study by mid 2010, after a 6 month follow up period.
The second Phase III study with microplasmin, TG-MV-007, which is recruiting 320 patients in Europe and the US, is progressing well and we expect complete enrolment within the first quarter of 2010 and results of this study near the end of 2010.
This Phase III program, referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program, comprises two clinical trials, taking place in the United States (TG-MV-006 trial) and a second combined European and US study (TG-MV-007 trial). The indication for both of these Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Vitreomacular adhesion is a condition in which the vitreous has an abnormally strong adhesion to the retina at the back of the eye. These adhesions can cause vessel and retinal distortion, which results in deterioration in the patient's vision. Both of these trials use the 125micro g dose of microplasmin.
Microplasmin - Diabetic Retinopathy: Phase II trial to evaluate microplasmin for the treatment of Diabetic Macular Edema (DME).
- Results from the Phase IIa trial presented at the American
Society of Retina Specialists (ASRS) Conference in New York
In October 2009, ThromboGenics announced results from the Phase II trial of microplasmin intravitreal injection for treatment of DME (MIVI II DME). The trial showed that microplasmin was safe and well tolerated and that microplasmin is able to non-surgically resolve vitreomacular adhesion in some DME patients. The data from this trial were presented at the ASRS Conference in New York on 3 October, 2009 by Professor Peter Stalmans, University Hospitals Leuven, Belgium.
The MIVI II DME trial was designed to be the initial step in evaluating microplasmin in patients with diabetes, a group which is more prone to eye disease, and specifically diabetic retinopathy. ThromboGenics will finalize the next step in the development plan for microplasmin in this patient population once the results from the first Phase III trial (TG-MV-006) are reported. These results will provide significant additional data that will help ThromboGenics to refine the development plans for microplasmin in patients with diabetic retinopathy.
TB-402 - Phase II trial assessing the long-acting anticoagulant TB-402 for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopedic surgery.