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

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