ThromboGenics - Positive Microplasmin Phase II Data Published in Ophthalmology
By Thrombogenics Nv, PRNEMonday, February 8, 2010
Paper Examines the Potential of Microplasmin to Improve the Treatment of a Range of Back of the Eye Diseases
LEUVEN, Belgium, February 9 - ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical
company focused on the discovery and development of innovative treatments for
eye disease, vascular disease and cancer, announces today that the positive
microplasmin Phase II trial results, evaluating the product's efficacy and
safety in patients who require vitrectomy, have been published in the
prestigious American Academy of Ophthalmology's Journal, Ophthalmology, the
leading journal for the vitreoretinal community.
A paper entitled "A Placebo-Controlled Trial of Microplasmin
Intravitreous Injection to Facilitate Posterior Vitreous Detachment Before
Vitrectomy" has been published online ahead of print in Ophthalmology. This
publication covers the Phase II trial (MIVI III) with microplasmin, with the
objective of evaluating the efficacy and safety of intravitreal microplasmin
in facilitating the separation of the vitreous from the retina. The
separation of the vitreous from the retina is used to treat a range of back
of the eye disorders and is achieved currently via a surgical procedure
called a vitrectomy.
The paper showed that the highest dose of microplasmin
(125microg) led to a greater likelihood of induction and progression of PVD
than placebo injection. Moreover, patients in this dose group had a
statistically significant improvement in visual acuity at the 35-day
timepoint when compared to placebo. Also, the trial showed that patients
receiving microplasmin were significantly more likely not to require
vitrectomy surgery to resolve their underlying disease.
The results outlined in the article highlight that
microplasmin could be a potential breakthrough for the treatment of certain
patients suffering from vitreoretinal pathologic conditions related to
vitreomacular adhesion. Vitreomacular adhesion is thought to play a key role
in numerous back of the eye conditions such as macular hole formation, and
some forms of macular edema. Vitreomacular adhesion is also associated with
much poorer prognosis in certain major eye conditions, including diabetic
retinopathy and Age-Related Macular Degeneration (AMD).
ThromboGenics is now conducting an extensive Phase III program
with microplasmin, referred to as MIVI-TRUST (Microplasmin IntraVitreous
Injection - Traction Release without Surgical Treatment), for the
non-surgical resolution of focal vitreomacular adhesion. The patient
enrollment for the two Phase III trials was completed in 2009 ahead of
schedule. The first results 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.[1] Further information
is also included in the ThromboGenics press release dated 30 June, 2008 (see
www.thrombogenics.com).
Steve Pakola, MD, Chief Medical Officer of ThromboGenics and
co-author of the Ophthalmology paper, commented, "We are very pleased to have
had these results with microplasmin published in such a prestigious journal.
The Phase II trial data discussed in the paper demonstrate the exciting
potential of microplasmin in treating a range of important back of the eye
diseases. We very much look forward to announcing the first results from our
Phase III program with microplasmin by mid 2010."
About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on the
discovery and development of innovative medicines for the treatment of eye
disease, vascular disease and cancer. The Company's lead product microplasmin
is in Phase III clinical development 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, and TB-403 (anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of
Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive
rights to certain therapeutics developed at these institutions. 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.
———————————
[1] "A Placebo-Controlled Trial of Microplasmin Intravitreous Injection
to Facilitate Posterior Vitreous Detachment Before Vitrectomy," Matthew S.
Benz, MD, Kirk H. Packo, MD, Victor Gonzalez, MD, Stephen Pakola, MD, Donna
Bezner, Julia A. Haller, MD, Steven D. Schwartz, MD, Ophthalmology, Abstract
available at www.ophsource.org/periodicals/ophtha/article/S0161-6420(
09)01293-7/abstract
(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)
For further information please contact: ThromboGenics Dr. Steve Pakola, CMO, Dr. Patrik De Haes, CEO, Tel: +1(212)201-0920, steve.pakola@thrombogenics.com , Tel: +32-16-75-13-10 , patrik.dehaes@thrombogenics.com; Citigate Dewe Rogerson Amber Bielecka/ David Dible/ Nina Enegren, Tel: +44(0)207-638-95-71, amber.bielecka@citigatedr.co.uk
For further information please contact: ThromboGenics, Dr. Steve Pakola, CMO, Dr. Patrik De Haes, CEO, Tel: +1(212)201-0920, steve.pakola at thrombogenics.com, 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
Tags: belgium, Leuven, ThromboGenics NV