Home » Health

Microplasmin Meets Primary Endpoint in Second Phase III Trial in VMA, Confirms Positive Findings of First Trial

6 September 2010 38 No Comment

Data Presented at ASRS Confirm Previous Phase III Findings and
Microplasmin’s Potential to Transform the Treatment of Retinal Disorders

Leuven, Belgium –-– 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 that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint. Importantly, the trial also confirmed the positive results
seen in the first Phase III trial with microplasmin. The results of the second Phase III trial (TG-MV-007) were presented for the first time at the American Society of Retina Specialists (ASRS) Annual Meeting by Dr. J. Michael Jumper (West Coast Retina and Medical Group and California Pacific Medical Center, California, USA). The trial recruited 326 patients at 48
centers in Europe and the U.S.

The detailed positive results from the first Phase III trial in the microplasmin MIVI-TRUST program (TG-MV-006) were presented at the World Ophthalmology Congress in Berlin in June 2010. The pooled results of both trials will be presented at the upcoming EURETINA (European Society of Retina Specialists) Congress in Paris, France, on September 4 by Prof. Peter Stalmans (University Hospitals Leuven, Belgium).

In his presentation at ASRS, Dr. Jumper highlighted that the TG-MV-007 study had met its primary endpoint, with 25.3% of the 245 microplasmin treated patients achieving resolution of their VMA at 28 days, compared to 6.2% of the 81 patients who received a placebo injection, a highly statistically significant result (p=0.001). In patients without epiretinal
membrane, microplasmin was shown to be even more effective with 34.5% of patients seeing resolution of their VMA at 28 days, compared to 6.4% of placebo treated patients. Epiretinal membrane is a layer of scar tissue which builds up on the macula, making it more difficult to achieve resolution of VMA without surgical intervention. Epiretinal membrane can
be easily identified using Optical Coherence Tomography (OCT).

The TG-MV-007 trial also showed that microplasmin was highly effective in treating patients who had been diagnosed with full thickness macular hole (FTMH). In this group, 36.7% of the 49 patients saw closure of their FTMH at 28 days following a single 125?g injection of microplasmin, without the need for a vitrectomy. This compares with 6.7% of the 15 patients in the placebo group (p= 0.028). These positive results are in line with what was achieved in this patient group in the TG-MV-006 study.

The TG-MV-007 study also evaluated the visual acuity (VA) of patients. This analysis showed that at the end of the study 22.0% of the microplasmin treated patients had achieved at least a 10 letter (2 lines) improvement in VA without the need for vitrectomy. This compares to only 11.1% of the patients who received a placebo injection (p

Share

Related posts:

  1. ThromboGenics Presents Positive Pooled Results from the MIVITRUST Phase III Program, Confirming Microplasmin’s Potential to Transform the Treatment of Retinal Disorders
  2. GlaxoSmithKline and Tolerx announce phase III DEFEND-1 study of otelixizumab in type 1 diabetes did not meet its primary endpoint
  3. Reata and Abbott Announce Positive Phase 2b Study Results for Bardoxolone Methyl
  4. Pfizer Announces Primary Endpoints Met In Second Phase 3 Clinical Trial Of Tofacitinib (CP-690,550) In Patients With Active Rheumatoid Arthritis
  5. Pfizer Announces Primary Endpoints Met In Second Phase 3 Clinical Trial Of Tofacitinib (CP-690,550) In Patients With Active Rheumatoid Arthritis

Leave your response!

Add your comment below, or trackback from your own site. You can also subscribe to these comments via RSS.

Be nice. Keep it clean. Stay on topic. No spam.

You can use these tags:
<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

This is a Gravatar-enabled weblog. To get your own globally-recognized-avatar, please register at Gravatar.