PRNewswire
LEUVEN, Belgium, November 14, 2008 /PRNewswire-FirstCall via COMTEX/ --
- Results Continue to Support Microplasmin's Potential to Make a Major
Contribution to the Treatment of Back of the eye Disease
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company
focused on eye disease, vascular disease and cancer, announces promising six
month follow-up results from its Phase IIb MIVI III trial, which was designed
to evaluate the safety and efficacy of microplasmin in vitrectomy. The
results were presented at the American Academy of Ophthalmology in Atlanta,
USA, by Dr. Kirk Packo, Professor and Chairman at the Department of
Ophthalmology, Rush University Medical Center in Chicago, Illinois.
The six month results from the MIVI III (MIVI III - Microplasmin for
Vitreous Injection) trial continue to support the one month data previously
reported, namely that the most effective dose of microplasmin studied (125
micrograms) was able to resolve the underlying disease in approximately 30%
of patients without the need for vitrectomy. The six month data also show
that these patients continue to do well. As anticipated, all patients in the
trial who at 1 month had achieved complete resolution of vitreomacular
traction or macular hole without need for surgery did not have recurrence of
either traction or macular hole during the full 6 month follow up period.
The six month results also show that these patients continue to see an
improvement in their visual acuity. On average, the microplasmin treated
patients who had resolution of their underlying condition without need for
vitrectomy achieved a 9 letter improvement when reading a standard eye chart,
in comparison to the baseline reading taken prior to treatment with
microplasmin. Crucially, this improvement in visual acuity is at least as
good as the results seen in patients who had to undergo a surgical vitrectomy
in order to resolve their underlying eye disease. These results, along with
the same findings observed in the MIVI II Traction trial, represent the first
ever demonstration of a pharmacologic treatment option for these conditions
that would otherwise have required major eye surgery.
The MIVI III trial was a Phase IIb, randomized, double-masked,
placebo-controlled, dose-ranging trial evaluating three doses of microplasmin
(25, 75 and 125 micrograms) versus placebo in 125 patients scheduled for
vitrectomy. The patients were recruited at 19 centers across the United
States. The trial was designed to assess the safety and efficacy of
microplasmin intravitreal injection given 7 days prior to the patient's
planned vitrectomy. The detailed one month results from this study were
presented in June by Dr. George Williams (Beaumont Hospital, Michigan, USA)
at the World Ophthalmology Congress in Hong Kong.
ThromboGenics is currently working to finalise the Phase III clinical
trial program for microplasmin in the treatment of back of the eye disease,
following a successful "End of Phase II meeting" with the FDA. The initial
indication planned for the program is the Nonsurgical Resolution of
Vitreomacular Adhesion. Two placebo controlled trials are planned, one in the
U.S. and one combined European and North American trial. Together it is
anticipated that the two trials will recruit a total of approximately 640
patients, with both trials expected to begin in Q1 2009. The Phase III
development program will use the 125 micrograms dose of microplasmin.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on
today's announcement, said: "We are delighted with the encouraging six month
follow up data from the Phase IIb MIVI III trial. These findings support
microplasmin's potential to significantly change the treatment of a range of
important back of the eye diseases. The maintained tolerability and
nonsurgical benefit achieved in many of these patients highlights both the
potential medical and economic value of microplasmin therapy. We look forward
to confirming these important benefits in the forthcoming Phase III
development program for this exciting product."
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery and
development of biopharmaceuticals for the treatment of eye disease, vascular
disease and cancer. The Company has several programs in Phase II clinical
development including microplasmin, which is being evaluated as a treatment
for vitreoretinal disorders and as a thrombolytic agent in stroke.
ThromboGenics is also developing novel antibody therapeutics in collaboration
with BioInvent International; these include TB-402 (Anti-Factor VIII), a long
acting anti-coagulant, and TB-403 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 and has subsidiaries in Dublin, Ireland and
New York, U.S. 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
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.