ThromboGenics NV (Euronext Brussels: THR), a biotechnology company
focused on novel therapies for eye disease, vascular disease and cancer,
announces positive results from its MITI IV Phase II trial to evaluate the
safety and preliminary efficacy of microplasmin when administered
intravenously to acute stroke patients. The trial showed that microplasmin
was generally well tolerated and also provided some interesting preliminary
efficacy data. The overall results of the study were presented by Dr.
Vincent Thijs on September 27 at a Late-Breaking Clinical Trial session at
the World Stroke Congress.
The MITI IV (Microplasmin In Treatment of Ischemic stroke -
IntraVenous) trial was a Phase II, multicentre, randomized, double-blinded,
placebo-controlled, ascending-dose clinical trial evaluating the safety and
preliminary efficacy of the intravenous administration of microplasmin in
40 patients, 4 to 12 hours after onset of acute ischemic stroke. The trial
investigated three dose regimens of microplasmin (2, 3, and 4 mg/kg total
dose) compared to placebo. Clinical outcomes were assessed at seven days
and 30 days post-treatment, and at each of these visits neurological
assessments were performed.
The study found that microplasmin was generally well tolerated with no
evidence of increased bleeding risk; there were no systemic bleeding events
reported and there was no evidence of increased rate of bleeding in
general, in those patients that had been treated with microplasmin compared
to those treated with placebo.
In addition, the study provided some interesting preliminary efficacy
results. Approximately 25% of patients treated with microplasmin had
reperfusion (restoration of blood flow) within eight hours of being
treated, this compares with 10% of placebo-treated patients. Moreover, of
the patients who had more severe vascular blockages, 33% of patients
treated with microplasmin achieved reperfusion compared with 14% of
placebo-treated patients. Due to the small number of patients in this
study, neither of these end points were statistically significant. However,
the study also showed that microplasmin-treated patients had a
statistically significant improvement in the level of damage to the blood
brain barrier compared to placebo-treated patients, measured using the
marker of matrix metalloproteinase (MMP). MMP activation plays a crucial
role in the pathogenesis of brain edema and hemorrhagic transformation
after ischemic stroke.
Professor Vincent Thijs, Lead Principal Investigator of the trial,
commenting on the results said, "I am delighted that we were able to
present these interesting results at the World Stroke Congress. The results
show that microplasmin is safe and generally well tolerated with no
evidence of increased bleeding risk. Moreover, the results also support
previous preclinical studies that have shown that microplasmin is able to
lyse clots and may also have certain vascular protective properties."
Dr. Patrik De Haes, CEO of ThromboGenics, commenting on today's
announcement said: "I am very pleased that we have been able to
successfully conclude this study of microplasmin in patients with stroke.
The results that have been reported show that the product is well tolerated
and could potentially be of benefit in this indication of high medical
need. However, as we have stated previously, our current view is that it
only makes sense for ThromboGenics to move forward with the development of
microplasmin for vascular indications in cooperation with a partner, given
the costs and risks involved. We believe that by focusing on the
development of microplasmin for eye disease, where we have already
generated encouraging clinical data, and carefully utilizing our resources
on the other opportunities in our pipeline, we will continue to generate a
high return for ThromboGenics' shareholders."
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 for
vascular occlusive diseases. 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
thrombogenics.
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.
ThromboGenics NV
thrombogenics