ThromboGenics To Present Results Of Second Phase III Trial Of Microplasmin At The 28th Annual Meeting Of The American Society Of Retina Specialists

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 14 Jul 2010 - 2:00 PDT

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ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, announces that data from the second Phase III trial of microplasmin (TG-MV-007) for the non-surgical treatment of vitreomacular adhesion (VMA), are to be presented at the 28th Annual Meeting of the American Society of Retina Specialists (ASRS) and the 10th EURETINA Congress. Positive data from the first Phase III trial of microplasmin (TG-MV-006), previously disclosed at the World Ophthalmology Congress in June, will also be presented at both conferences.

The schedule of presentations for both upcoming conferences is as follows:

ASRS (American Society of Retina Specialists)

Congress to be held 28 August - 1 September in Vancouver, BC, Canada

August 31: Dr. J. Michael Jumper of West Coast Retina and U.C. San Francisco (California, USA) will present results from the TG-MV-007 trial.

August 31: Dr. Kirk Packo of Rush University Medical Center, Chicago, Illinois, USA, will present data from the TG-MV-006 trial.

The Annual Meeting of ASRS is the largest gathering of retina specialists in the United States. The acceptance of these two presentations demonstrates the growing interest amongst the retina community in microplasmin's potential to offer an effective, convenient, non-surgical treatment option for a range of retinal diseases.

EURETINA (European Society of Retina Specialists) Congress to be held 2-5 September in Paris, France

September 4: Professor Peter Stalmans of University Hospitals Leuven, Belgium, lead investigator of the TG-MV-007 trial, will present results of this trial at the main session of the Congress.

September 3: Dr. Victor Gonzalez of Valley Retina Institute, Texas, USA, will present data from the TG-MV-006 trial.

The EURETINA congress is one of the largest gatherings of retina specialists in Europe and an excellent platform to raise awareness of the potential of microplasmin.

The full results of the TG-MV-006 study were presented at the World Ophthalmology Congress in Berlin on 6 June 2010 by Dr. Matthew Benz of The Methodist Hospital, Texas, USA.

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).

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 125μg of microplasmin versus placebo in the 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.

About ThromboGenics

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.

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.

Source: ThromboGenics NV

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