ThromboGenics to Present Results of Second Phase III Trial of Microplasmin at the 28th Annual Meeting of the American Society of Retina Specialists (ASRS) and the 10th EURETINA CongressBy Thrombogenics Nv, PRNE
Wednesday, June 30, 2010
LEUVEN, Belgium, July 1, 2010 - 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
ASRS (American Society of Retina Specialists)
Congress to be held 28 August - 1 September in Vancouver, BC,
- 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. Details of these results can be found in
the press release dated 6 June 2010, available at
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
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 125Î¼g 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.
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 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 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.
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
ThromboGenics, Dr. Steve Pakola, CMO, Tel: +1(212)201-0920, steve.pakola at thrombogenics.com, Dr. Patrik De Haes, CEO, Tel: + 32-16-75-13-10, patrik.dehaes at thrombogenics.com, Citigate Dewe Rogerson, Amber Bielecka/ David Dible/ Nina Enegren, Tel: +44(0)207-638-95-71, amber.bielecka at citigatedr.co.uk
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