- Highly Significant Trial Result (p=0.003) Demonstrates the Potential ofMicroplasmin in the Treatment of Retinal Disease
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ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical companyfocused on the discovery and development of innovative treatments for eyedisease, vascular disease and cancer, announces that its first Phase IIItrial with microplasmin for the non-surgical treatment of eye disease has metits primary endpoint (p=0.003). The trial, TG-MV-006, recruited a total of326 patients in the U.S. A second Phase III study with microplasmin,TG-MV-007, which recruited a similar number of patients in the U.S. andEurope, is due to report in the third quarter of 2010.
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The microplasmin Phase III program, referred to as MIVI-TRUST(Microplasmin for IntraVitreous Injection-Traction Release without SurgicalTreatment), consists of two multi-center, randomized, placebo controlled,double-masked trials. These trials are designed to evaluate 125μg ofmicroplasmin versus placebo in the intravitreal treatment of patients withsymptomatic focal vitreomacular adhesion (VMA). The MIVI-TRUST program is thelargest interventional clinical program ever performed to specificallyevaluate the vitreoretinal interface in patients with retinal disorders.
The primary endpoint of both trials is the non-surgical resolution offocal vitreomacular adhesion one month after a single injection ofmicroplasmin. This endpoint is being measured and recorded using opticalcoherence tomography (OCT), the standard method of assessment for thiscondition, which provides images that can clearly show the separation of thevitreous from the retina.
The results of the first trial, TG-MV-006, confirmed that it had met itsprimary endpoint with 27.7% of microplasmin treated patients achievingresolution of their VMA compared to 13.2% of patients treated with placeboinjection (p=0.003). A Per Protocol analysis of the microplasmin treatedpatient population showed that 30.7% achieved resolution of their VMA(p=0.004).
In addition to the primary endpoint, the Phase III trials will evaluateadditional measures of efficacy as well as safety, assessed at various timeperiods over the six month study period. These data will be presented at theWorld Ophthalmology Congress (WOC) in Berlin by Dr. Matthew Benz, MD (BaylorCollege of Medicine, Houston, Texas, U.S.).
Dr. Patrik De Haes, CEO of ThromboGenics, commented, "This is the mostimportant milestone in ThromboGenics' history. Microplasmin is key to thesuccess of our ophthalmic focused strategy, and we are very pleased to beable to announce these positive results. The fact that microplasmin resolvedVMA without surgery in approximately 30% of patients is a clinicallyimportant development. These results reaffirm our confidence in the potentialof this innovative approach to the treatment of a range of retinal disorders.We are moving ahead with our pre-commercialization activities formicroplasmin, so that we are well-positioned to launch this unique productsuccessfully."
About Focal Vitreomacular Adhesion (VMA)
Focal vitreomacular adhesion is a condition in which the vitreous gel, inthe center of the eye, has an abnormally strong adhesion to the macula, thecenter of the retina at the back of the eye. Vitreomacular adhesion isthought to play a key role in numerous back of the eye conditions, such asmacular hole and some forms of macular edema. Vitreomacular adhesion is alsoassociated with a poorer prognosis in certain major eye conditions, includingDiabetic Retinopathy and Age-related Macular Degeneration (AMD).
About ThromboGenics
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 hascompleted its first Phase III clinical trial for the non-surgical treatmentof back of the eye diseases. Microplasmin is also being evaluated in Phase IIclinical development 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 in Phase II, and TB-403 (anti-PlGF) in Phase I forcancer.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listedon Eurolist by Euronext Brussels under the symbol THR. More information isavailable 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: ThromboGenic 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
