- Results Continue to Support Microplasmin's Potential to Make a MajorContribution to the Treatment of Back of the eye Disease
Advertisement
ThromboGenics NV (Euronext Brussels: THR), a biotechnology companyfocused on eye disease, vascular disease and cancer, announces promising sixmonth follow-up results from its Phase IIb MIVI III trial, which was designedto evaluate the safety and efficacy of microplasmin in vitrectomy. Theresults were presented at the American Academy of Ophthalmology in Atlanta,USA, by Dr. Kirk Packo, Professor and Chairman at the Department ofOphthalmology, Rush University Medical Center in Chicago, Illinois.
Advertisement
The six month results from the MIVI III (MIVI III - Microplasmin forVitreous Injection) trial continue to support the one month data previouslyreported, namely that the most effective dose of microplasmin studied (125micrograms) was able to resolve the underlying disease in approximately 30%of patients without the need for vitrectomy. The six month data also showthat these patients continue to do well. As anticipated, all patients in thetrial who at 1 month had achieved complete resolution of vitreomaculartraction or macular hole without need for surgery did not have recurrence ofeither traction or macular hole during the full 6 month follow up period.
The six month results also show that these patients continue to see animprovement in their visual acuity. On average, the microplasmin treatedpatients who had resolution of their underlying condition without need forvitrectomy achieved a 9 letter improvement when reading a standard eye chart,in comparison to the baseline reading taken prior to treatment withmicroplasmin. Crucially, this improvement in visual acuity is at least asgood as the results seen in patients who had to undergo a surgical vitrectomyin order to resolve their underlying eye disease. These results, along withthe same findings observed in the MIVI II Traction trial, represent the firstever demonstration of a pharmacologic treatment option for these conditionsthat 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 forvitrectomy. The patients were recruited at 19 centers across the UnitedStates. The trial was designed to assess the safety and efficacy ofmicroplasmin intravitreal injection given 7 days prior to the patient'splanned vitrectomy. The detailed one month results from this study werepresented 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 clinicaltrial program for microplasmin in the treatment of back of the eye disease,following a successful "End of Phase II meeting" with the FDA. The initialindication planned for the program is the Nonsurgical Resolution ofVitreomacular Adhesion. Two placebo controlled trials are planned, one in theU.S. and one combined European and North American trial. Together it isanticipated that the two trials will recruit a total of approximately 640patients, with both trials expected to begin in Q1 2009. The Phase IIIdevelopment program will use the 125 micrograms dose of microplasmin.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting ontoday's announcement, said: "We are delighted with the encouraging six monthfollow up data from the Phase IIb MIVI III trial. These findings supportmicroplasmin's potential to significantly change the treatment of a range ofimportant back of the eye diseases. The maintained tolerability andnonsurgical benefit achieved in many of these patients highlights both thepotential medical and economic value of microplasmin therapy. We look forwardto confirming these important benefits in the forthcoming Phase IIIdevelopment program for this exciting product."
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery anddevelopment of biopharmaceuticals for the treatment of eye disease, vasculardisease and cancer. The Company has several programs in Phase II clinicaldevelopment including microplasmin, which is being evaluated as a treatmentfor vitreoretinal disorders and as a thrombolytic agent in stroke.ThromboGenics is also developing novel antibody therapeutics in collaborationwith BioInvent International; these include TB-402 (Anti-Factor VIII), a longacting anti-coagulant, and TB-403 for cancer.
ThromboGenics has built strong links with the University of Leuven andthe Flanders Institute for Biotechnology (VIB) and has exclusive rights tocertain therapeutics developed at these institutions. ThromboGenics isheadquartered in Leuven, Belgium and has subsidiaries in Dublin, Ireland andNew York, U.S. The Company is listed on Eurolist by Euronext Brussels underthe 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 currentexpectations, and, accordingly, entail and are influenced by various risksand uncertainties. The Company therefore cannot provide any assurance thatsuch forward-looking statements will materialize and does not assume anobligation to update or revise any forward-looking statement, whether as aresult of new information, future events or any other reason. Additionalinformation concerning risks and uncertainties affecting the business andother factors that could cause actual results to differ materially from anyforward-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 protected] Dr. Patrik De Haes, CEO Tel : +32-16-75-13-10 [email protected] Citigate Dewe Rogerson Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71 [email protected]
SOURCE ThromboGenics NV
