LEUVEN, Belgium, September 29 ThromboGenics-NV
LEUVEN, Belgium, September 29 /PRNewswire-FirstCall/ --
- Results Presented at World Stroke Congress in Vienna
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 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.
For further information please contact:
ThromboGenics
Patrik De Haes, CEO Tel : +32-16-75-13-10
patrik.dehaes@thrombogenics.com
Desire Collen, Chairman Tel : +32-16-75-13-10
desire.collen@thrombogenics.com
Citigate Dewe Rogerson
Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71
amber.bielecka@citigatedr.co.uk
SOURCE ThromboGenics NV
