ThromboGenics Announces Publication of Positive Microplasmin Phase II Data in the Journal Retina
LEUVEN, Belgium, July 15, 2010/PRNewswire-FirstCall/
--
- Paper Highlights the Potential of Microplasmin for Nonsurgical
Treatment of Vitreomacular Adhesion
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 positive microplasmin Phase II trial results, evaluating
the product for the nonsurgical treatment of vitreomacular
adhesion, have been published in the July/August issue of the
journal Retina.
The paper is entitled "Intravitreal Injection of Microplasmin
for Treatment of Vitreomacular Adhesion - Results of a Prospective,
Randomized, Sham-Controlled Phase II Trial (The MIVI-IIT Trial)."
The results show that microplasmin was generally well tolerated,
and support its potential for nonsurgical resolution of
vitreomacular adhesion. For a full discussion of the results from
this Phase II trial, please refer to the Retina article.[1]
Based on these positive results, along with the positive results
of the MIVI III trial (previously published in the journal
Ophthalmology), the Phase III program MIVI-TRUST[2] was performed.
The MIVI-TRUST program included two trials, the TG-MV-006 and
TG-MV-007 studies. Positive data from the first Phase III trial of
microplasmin (TG-MV-006) were previously disclosed at the World
Ophthalmology Congress in June. Details of these results can be
found in the press release dated 7 June 2010, available at
http://www.thrombogenics.com.
Results from the second Phase III trial (TG-MV-007) for the
non-surgical treatment of vitreomacular adhesion (VMA) are to be
presented at the Annual Meeting of the American Society of Retina
Specialists (ASRS) and the European Society of Retina Specialists
(EURETINA Congress).
The schedule of presentations for both upcoming conferences is
as follows:
ASRS (28 August - 1 September in Vancouver, BC, Canada).
- TG-MV-007 results presented by Dr. J. Michael Jumper of West
Coast Retina and U.C. San Francisco (California, USA) on August 31.
- TG-MV-006 data presented by Dr. Kirk Packo of Rush
University Medical Center, Chicago, Illinois, USA on August 31.
EURETINA (2-5 September in Paris, France).
- TG-MV-007 results presented at the main session of the Congress by
Professor Peter Stalmans of University Hospitals Leuven, Belgium,
lead investigator of the TG-MV-007 trial on September 4.
- TG-MV-006 data presented by Dr. Victor Gonzalez of Valley Retina
Institute, Texas, USA on September 3.
Professor Peter Stalmans, lead investigator of the MIVI IIT
study and lead author of the Retina publication, commented, "I am
very pleased that these highly interesting Phase II results with
microplasmin have been published in such an important journal as
Retina. The excitement that microplasmin generated at the time of
the Phase II results has continued, with the positive data reported
in the first study of the Phase III trial program. I very much look
forward to presenting the upcoming results of the second Phase III
trial at EURETINA in September, a study which I hope will again
show microplasmin's potential to offer an effective, convenient,
non-surgical treatment option for a range of retinal
diseases."
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 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
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.
---------------------------------
[1] "Intravitreal Injection of Microplasmin for Treatment of
Vitreomacular Adhesion. Results of a Prospective, Randomized,
Sham-Controlled Phase II Trial (The MIVI-IIT Trial).", Stalmans P;
Delaey C; de Smet, M; van Dijkman E; Pakola S. Retina, 30(7):
1122-1127, July/August 2010. Abstract available at:
http://journals.lww.com/retinajournal/Abstract/2010/07000/INTRAVITREAL
_INJECTION_OF_MICROPLASMIN_FOR.19.aspx.
(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.)
[2] MIVI Trust = Microplasmin IntraVitreous Injection - Traction Release
without Surgical Treatment
For further information please contact:
ThromboGenics
Dr. Steve Pakola, CMO Tel: +1-212-201-0920
steve.pakola@thrombogenics.com
Dr. Patrik De Haes, CEO 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
Source: ThromboGenics NV
For further information please contact: ThromboGenics, Dr. Steve
Pakola, CMO, Tel: +1-212-201-0920, steve.pakola@thrombogenics.com;
Dr. Patrik De Haes, CEO, 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
Posted: July 2010
