ThromboGenics Announces Publication of Positive Microplasmin Phase II Data in the Journal Retina
By Thrombogenics Nv, PRNEWednesday, July 14, 2010
Paper Highlights the Potential of Microplasmin for Nonsurgical Treatment of Vitreomacular Adhesion
LEUVEN, Belgium, July 15, 2010 - 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 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 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:
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
For further information please contact: ThromboGenics, Dr. Steve Pakola, CMO, Tel: +1-212-201-0920, steve.pakola at thrombogenics.com; Dr. Patrik De Haes, CEO, 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
Tags: belgium, July 15, Leuven, ThromboGenics NV