Leuven, Belgium – June 30, 2008 - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on eye disease, vascular disease and cancer, today announces positive results from its Phase IIb MIVI III trial that was designed to evaluate the safety and efficacy of microplasmin in vitrectomy. The MIVI III (MIVI III - Microplasmin for Vitreous Injection) trial showed that the most effective dose of microplasmin studied (125 µg) was able to resolve the underlying disease in approximately 30% of patients without the need for a vitrectomy. The encouraging results from this study were presented by Dr. George Williams (Beaumont Hospital, Michigan, USA) on June 28 at the World Ophthalmology Congress in Hong Kong.
A vitrectomy is a surgical procedure carried out in the treatment of many important back of the eye diseases such as retinal detachment, diabetic vitreous hemorrhage and macular hole. A vitrectomy is used to induce a posterior vitreous detachment (PVD), which involves removing the vitreous via suction so that it is no longer attached to the retina.
Microplasmin is an enzyme that cleaves important protein molecules which link the vitreous to the retina and therefore has the potential to facilitate vitrectomy and pharmacologically induce PVD, without the risks inherent in detaching the vitreous by surgical intervention.
The MIVI III trial is a Phase IIb, randomized, double-masked, placebo-controlled, dose-ranging trial evaluating three doses of microplasmin (25, 75 and 125 µg) versus placebo in 125 patients scheduled for vitrectomy. The patients were recruited at 19 centers across the United States. The trial was designed to assess the safety and efficacy of microplasmin intravitreal injection given 7 days prior to the patient’s planned vitrectomy.
The study showed that microplasmin was well tolerated. The trial also showed a clear dose response curve with the highest 125 µg dose of microplasmin delivering the best results. In this group, 10 of the 32 patients receiving this dose of microplasmin had resolution of their underlying disease and therefore did not need a vitrectomy (surgical intervention) for the indication for which they were being treated. This compares very favourably with the placebo group, where only 1 patient out of 31 achieved the same positive outcome, and the 75 µg microplasmin treated group, where 5 patients out of 33 did not need a vitrectomy. In addition, use of microplasmin was associated with a reduced amount and duration of suction needed to achieve a PVD in patients who progressed to surgical intervention, compared to placebo.
The visual acuity of all of the patients recruited into the study was also measured at day 35 after the injection of microplasmin or placebo, whether they had a vitrectomy or not. In patients who received the highest 125 µg dose of microplasmin there was an improvement in vision (6.9 more letters read on a standard eye chart compared to a baseline reading prior to treatment); this compares with a 4.7 letter improvement for all microplasmin treated patients and a 0.1 letter improvement for the placebo group.
ThromboGenics has decided to proceed into Phase III clinical development of microplasmin based on these encouraging results. The microplasmin Phase III development program is expected to begin in late 2008/early 2009 following an End of Phase II Meeting with the FDA later this year. It is anticipated that this Phase III development program will use 125 µg dose of microplasmin.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on today’s announcement, said: “We are very pleased with the confirmatory results obtained in the Phase IIb MIVI III trial. The ability of the highest 125 µg dose of microplasmin to safely induce a PVD in approximately 30% of patients, without the need for surgical intervention, confirms its potential to significantly change the treatment of a range of important back of the eye diseases. The results build on the encouraging safety and efficacy results that we obtained from both the MIVI I and MIVI II Traction Phase II trials, and we feel that we are now well positioned to commence our Phase III development program with microplasmin.”
About Vitrectomy
Approximately 600,000 surgical vitrectomies are performed annually worldwide. The U.S. market accounts for more than 40% of treatments, and is growing at 6-8% per year. During a vitrectomy, three incisions are made through the white of the eye; the surgeon then inserts small instruments into the eye, cuts the vitreous gel, and suctions it out. There are certain risks inherent to this surgery including bleeding, infection, increased eye pressure, retinal detachment, and development of cataracts.
Other major eye diseases that may benefit from nonsurgical PVD induction include diabetic retinopathy and age-related macular degeneration (AMD). Diabetic retinopathy is the leading cause of blindness among working-age adults, while AMD is the leading cause of blindness among the elderly.
About ThromboGenics
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuticals for the treatment of a range of vascular diseases. The Company has several programs in Phase II clinical development including microplasmin, which is being evaluated as a treatment for vitreoretinal disorders and as a thrombolytic agent for vascular occlusive diseases. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), scheduled to enter Phase II clinical development by the end of 2008, and TB-403 (Anti-PlGF). ThromboGenics and its development partner BioInvent, have recently signed a license agreement with Roche for TB-403 worth up to €500 million plus royalties. A Phase Ib clinical trial with TB-403 has recently begun in patients with late stage cancer.
ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium and has subsidiaries in Dublin, Ireland and New York, U.S. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at www.thrombogenics.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.
For further information please contact:
ThromboGenics
Steve Pakola, MD, Chief Medical Officer
Tel.: +1 212 201 0920
steve.pakola@thrombogenics.com
Patrik De Haes, MD, COO
Tel : + 32 16 34 61 94
patrik.dehaes@thrombogenics.com
Citigate Dewe Rogerson
Amber Bielecka/Sylvie Berrebi/David Dible
Tel.: +44 (0) 207 638 95 71
amber.bielecka@citigatedr.co.uk
