LEUVEN, Belgium, June 7, 2010 /PRNewswire-FirstCall/ --
- Data Presented Show Microplasmin Cures Approximately 50% of Patients With Macular Hole
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, announces that further data from the first successful Phase III trial with microplasmin (TG-MV-006) for the non-surgical treatment of vitreomacular adhesion (VMA) were presented at the World Ophthalmology Congress by Dr. Matthew Benz, MD (The Methodist Hospital, Houston, Texas, U.S.) The trial recruited 326 patients at 42 centers in the U.S. The second Phase III trial in the microplasmin MIVI-TRUST program (TG-MV-007) is due to report in the third quarter of 2010.
In his presentation, Dr. Benz highlighted that the TG-MV-006 study had met its primary endpoint with 27.7% of the 220 microplasmin treated patients achieving resolution of their VMA at 1 month, compared to 13.2% of the 106 patients who received a placebo injection, a highly statistically significant result (p=0.003). He also presented data on a Per Protocol analysis of the microplasmin treated patient population, all of whom met the study's inclusion criteria, that showed that 30.7% achieved resolution of their VMA (p=0.004). These top-line results had previously been announced in April.
The trial evaluated the visual acuity (VA) of patients. This analysis showed that at the end of the study 25.5% of the microplasmin treated patients had achieved at least a 10 letter improvement in VA without the need for vitrectomy. This compares to only 11.3% of the patients who received a placebo injection (p<0.005).
The TG-MV-006 study also confirmed that microplasmin was generally safe and well tolerated with no increase in the rate of retinal tear or detachment in comparison to placebo.
A key finding from the TG-MV-006 study that was presented in Berlin related to patients who had been diagnosed with full thickness macular hole (FTMH), a severe condition which can lead to irreversible vision impairment, including central blindness, if not treated by eye surgery (vitrectomy). In this group, 45.6% of the 52 patients were cured by a single 125 micro g injection of microplasmin without the need for a vitrectomy in the 6 months post treatment. This compares with 15.6% of the 32 patients in the placebo group (p= 0.005). A Per Protocol analysis of the microplasmin treated patients showed that 54.3% of patients achieved FTMH closure after 6 months without the need for surgery.
The closure of FTMH also resulted in these patients experiencing a significant improvement in their VA compared to baseline. These results show that microplasmin could represent a major breakthrough, as it has the potential to cure approximately 50% of patients with FTMH without the need for major eye surgery.
Dr. Patrik De Haes, CEO of ThromboGenics, commented, "The more detailed results from the TG-MV-006 study that we have announced today clearly show that microplasmin has the potential to make a significant impact on the treatment of retinal disorders linked to adhesion. In addition, I am particularly excited that we have shown that microplasmin has the ability to cure approximately 50% of patients with macular hole, a very severe condition which can lead to central blindness. Given these results, I am confident that microplasmin could provide both patients and retinal specialists with an alternative to surgery. We are looking forward to announcing the results from our second Phase III study with microplasmin, which is due to report in the third quarter of 2010."
Dr. Matthew Benz, commenting on his presentation today, said, "I am sure that the results of this important study, which is part of the largest interventional clinical program ever performed to specifically evaluate the vitreoretinal interface, will create great excitement in the retinal community. The ability to cure a significant proportion of patients with a range of retinal disorders, including macular hole, with a simple injection of microplasmin is clearly an attractive alternative to the current option of surgery."
Notes to Editors
About Focal Vitreomacular Adhesion (VMA)
Focal vitreomacular adhesion is a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the macula, the center of the retina at the back of the eye. Vitreomacular adhesion is thought to play a key role in numerous back of the eye conditions, such as macular hole and some forms of macular edema. Vitreomacular adhesion is also associated with a poorer prognosis in certain major eye conditions, including Diabetic Retinopathy and Age-related Macular Degeneration (AMD).
About Macular Hole
Focal vitreomacular adhesion can lead to macular hole, where the traction from the vitreomacular adhesion actually pulls off a piece of the macula (the part of the retina responsible for central vision). If not treated with major eye surgery called a vitrectomy, which involves using suction to completely remove the vitreous from the eye, macular hole can lead to irreversible, central blindness. While vitrectomy is generally effective in closing macular holes, the invasive procedure is costly and a proportion of patients experience side-effects. These include alteration of vision, bleeding, retinal detachment and development of glaucoma and cataracts. Therefore, a nonsurgical treatment option for such patients could be a very important breakthrough in the way macular hole patients are treated.
The MIVI-TRUST Program
The microplasmin Phase III program, referred to as MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment), consists of two multi-center, randomized, placebo controlled, double-masked trials. These trials are designed to evaluate 125 micro g of microplasmin versus placebo in the intravitreal treatment of patients with symptomatic focal vitreomacular adhesion (VMA). The MIVI-TRUST program is the largest interventional clinical program ever performed to specifically evaluate the vitreoretinal interface in patients with retinal disorders. In total, over 650 patients were enrolled in these trials, which were held across 90 centers in 7 countries.
The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion one month after a single injection of microplasmin. This endpoint is being measured and recorded using optical coherence tomography (OCT), the standard method of assessment for this condition, which provides images that can clearly show the separation of the vitreous from the retina.
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease. The Company's lead product microplasmin has completed its first Phase III clinical trial for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (anti-Factor VIII), a long acting anti-coagulant in Phase II, and TB-403 (anti-PlGF) in Phase I for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. 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
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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
SOURCE ThromboGenics NV