LEUVEN, Belgium, February 9
- Paper Examines the Potential of Microplasmin to Improve the Treatmentof a Range of Back of the Eye Diseases
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical companyfocused on the discovery and development of innovative treatments for eyedisease, vascular disease and cancer, announces today that the positivemicroplasmin Phase II trial results, evaluating the product's efficacy andsafety in patients who require vitrectomy, have been published in theprestigious American Academy of Ophthalmology's Journal, Ophthalmology, theleading journal for the vitreoretinal community.
A paper entitled "A Placebo-Controlled Trial of MicroplasminIntravitreous Injection to Facilitate Posterior Vitreous Detachment BeforeVitrectomy" has been published online ahead of print in Ophthalmology. Thispublication covers the Phase II trial (MIVI III) with microplasmin, with theobjective of evaluating the efficacy and safety of intravitreal microplasminin facilitating the separation of the vitreous from the retina. Theseparation of the vitreous from the retina is used to treat a range of backof the eye disorders and is achieved currently via a surgical procedurecalled a vitrectomy.
The paper showed that the highest dose of microplasmin (125microg) led toa greater likelihood of induction and progression of PVD than placeboinjection. Moreover, patients in this dose group had a statisticallysignificant improvement in visual acuity at the 35-day timepoint whencompared to placebo. Also, the trial showed that patients receivingmicroplasmin were significantly more likely not to require vitrectomy surgeryto resolve their underlying disease.
The results outlined in the article highlight that microplasmin could bea potential breakthrough for the treatment of certain patients suffering fromvitreoretinal pathologic conditions related to vitreomacular adhesion.Vitreomacular adhesion is thought to play a key role in numerous back of theeye conditions such as macular hole formation, and some forms of macularedema. Vitreomacular adhesion is also associated with much poorer prognosisin certain major eye conditions, including diabetic retinopathy andAge-Related Macular Degeneration (AMD).
ThromboGenics is now conducting an extensive Phase III program withmicroplasmin, referred to as MIVI-TRUST (Microplasmin IntraVitreous Injection- Traction Release without Surgical Treatment), for the non-surgicalresolution of focal vitreomacular adhesion. The patient enrollment for thetwo Phase III trials was completed in 2009 ahead of schedule. The firstresults from this Phase III program are due in Q2 2010.
For a full discussion of the results from the Phase II trial (MIVI III),please refer to the Ophthalmology article. Further information is alsoincluded in the ThromboGenics press release dated 30 June, 2008 (seehttp://www.thrombogenics.com).
Steve Pakola, MD, Chief Medical Officer of ThromboGenics and co-author ofthe Ophthalmology paper, commented, "We are very pleased to have had theseresults with microplasmin published in such a prestigious journal. The PhaseII trial data discussed in the paper demonstrate the exciting potential ofmicroplasmin in treating a range of important back of the eye diseases. Wevery much look forward to announcing the first results from our Phase IIIprogram with microplasmin by mid 2010."
ThromboGenics is a biopharmaceutical company focused on the discovery anddevelopment of innovative medicines for the treatment of eye disease,vascular disease and cancer. The Company's lead product microplasmin is inPhase III clinical development for the non-surgical treatment of back of theeye diseases. Microplasmin is also being evaluated in Phase II clinicaldevelopment for additional vitreoretinal conditions. In addition,ThromboGenics is developing novel antibody therapeutics in collaboration withBioInvent International; these include TB-402 (Anti-Factor VIII), a longacting anti-coagulant, and TB-403 (anti-PlGF) 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. The Company is listed on Eurolist byEuronext Brussels under the symbol THR. More information is available athttp://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.
 "A Placebo-Controlled Trial of Microplasmin Intravitreous Injectionto Facilitate Posterior Vitreous Detachment Before Vitrectomy," Matthew S.Benz, MD, Kirk H. Packo, MD, Victor Gonzalez, MD, Stephen Pakola, MD, DonnaBezner, Julia A. Haller, MD, Steven D. Schwartz, MD, Ophthalmology, Abstractavailable at http://www.ophsource.org/periodicals/ophtha/article/S0161-6420(09)01293-7/abstract
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SOURCE ThromboGenics NV