LEUVEN, Belgium, November 14 /PRNewswire/ --
- Results Continue to Support Microplasmin's Potential to Make a Major Contribution to the Treatment of Back of the eye Disease
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on eye disease, vascular disease and cancer, announces promising six month follow-up results from its Phase IIb MIVI III trial, which was designed to evaluate the safety and efficacy of microplasmin in vitrectomy. The results were presented at the American Academy of Ophthalmology in Atlanta, USA, by Dr. Kirk Packo, Professor and Chairman at the Department of Ophthalmology, Rush University Medical Center in Chicago, Illinois.
The six month results from the MIVI III (MIVI III - Microplasmin for Vitreous Injection) trial continue to support the one month data previously reported, namely that the most effective dose of microplasmin studied (125 micrograms) was able to resolve the underlying disease in approximately 30% of patients without the need for vitrectomy. The six month data also show that these patients continue to do well. As anticipated, all patients in the trial who at 1 month had achieved complete resolution of vitreomacular traction or macular hole without need for surgery did not have recurrence of either traction or macular hole during the full 6 month follow up period.
The six month results also show that these patients continue to see an improvement in their visual acuity. On average, the microplasmin treated patients who had resolution of their underlying condition without need for vitrectomy achieved a 9 letter improvement when reading a standard eye chart, in comparison to the baseline reading taken prior to treatment with microplasmin. Crucially, this improvement in visual acuity is at least as good as the results seen in patients who had to undergo a surgical vitrectomy in order to resolve their underlying eye disease. These results, along with the same findings observed in the MIVI II Traction trial, represent the first ever demonstration of a pharmacologic treatment option for these conditions that would otherwise have required major eye surgery.
The MIVI III trial was a Phase IIb, randomized, double-masked, placebo-controlled, dose-ranging trial evaluating three doses of microplasmin (25, 75 and 125 micrograms) 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 detailed one month results from this study were presented in June by Dr. George Williams (Beaumont Hospital, Michigan, USA) at the World Ophthalmology Congress in Hong Kong.
ThromboGenics is currently working to finalise the Phase III clinical trial program for microplasmin in the treatment of back of the eye disease, following a successful End of Phase II meeting with the FDA. The initial indication planned for the program is the Nonsurgical Resolution of Vitreomacular Adhesion. Two placebo controlled trials are planned, one in the U.S. and one combined European and North American trial. Together it is anticipated that the two trials will recruit a total of approximately 640 patients, with both trials expected to begin in Q1 2009. The Phase III development program will use the 125 micrograms dose of microplasmin.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on today's announcement, said: We are delighted with the encouraging six month follow up data from the Phase IIb MIVI III trial. These findings support microplasmin's potential to significantly change the treatment of a range of important back of the eye diseases. The maintained tolerability and nonsurgical benefit achieved in many of these patients highlights both the potential medical and economic value of microplasmin therapy. We look forward to confirming these important benefits in the forthcoming Phase III development program for this exciting product.
ThromboGenics is a biotechnology company focused on the discovery and development of biopharmaceuticals for the treatment of eye disease, vascular disease and cancer. 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 in stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 for 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 http://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 Dr. Steve Pakola, CMO Tel : +1-212-201-0920 email@example.com Dr. Patrik De Haes, CEO Tel : +32-16-75-13-10 firstname.lastname@example.org Citigate Dewe Rogerson Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71 email@example.com
For further information please contact: ThromboGenics, Dr. Steve Pakola, CMO, Tel : +1-212-201-0920, firstname.lastname@example.org; Dr. Patrik De Haes, CEO, Tel : +32-16-75-13-10, email@example.com; Citigate Dewe Rogerson, Amber Bielecka/ David Dible/ Nina Enegren, Tel: +44(0)207-638-95-71, firstname.lastname@example.org