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Thrombogenics

 
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biscia



Registrato: 24/09/07 08:30
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MessaggioInviato: Ven 12 Set, 2008 22:34    Oggetto: Thrombogenics Rispondi citando

Ho contattato i ricercatori della thrombogenics (autori degli studi sulla microplasmina) presentandomi come membro dell'associazione (fornendogli anche il link al nostro sito inglese) e chiedendogli se i loro studi fossero anche indirizzati alla cura delle miodesopsie. Ho ricevuto una risposta molto celere che vi riporto:

Hello Mr. XXXX,
Thank you for your email, which was forwarded to me by Dr. XXX. I reviewed your website with great interest. What you are doing is of great value, since while floaters are a very big problem (ophthalmologists tell me this repeatedly) there is virtually nothing in the literature on this problem. If you know of any source of data regarding number of patients that have floaters, I would love to know this, as this information can help in terms of getting others to see the potential benefit that treatments aimed at this condition might have for these patients.
Regarding microplasmin: Microplasmin is an experimental drug curently in clinical development for treatment of various vitreoretinal diseases. You can look on our website www.thrombogenics.com , as well as www.clinicaltrials.gov and type in keyword microplasmin in order to learn more about these trials. We have been told by ophthalmologists/retina specialists that they believe microplasmin would be a good nonsurgical option for treatment of visually significant non-clearing vitreous floaters based on its mechanism of action; however, microplasmin has of yet not been used in clinical trials for treatment of this condition. We in future may expand the development program to look at other conditions (potentially including floaters).
I hope this information is helpful.

Traduzione per i non anglofoni:

Grazie per la tua mail, che mi è stata girata dal dottor XXX. Ho visionato il vostro sito web con grande interesse. Quello che state facendo ha un grande valore, dal momento che sebbene le miodesopsie siano un grosso problema (gli oculisti me lo hanno ribadito più volte) non esiste praticamente nulla in letteratura riguardo questo problema. Se sei a conoscenza di fonti informative riguardo il numero di pazienti affetti da questo problema mi piacerebbe esserne informato dal momento che tale informazione aiuterebbe il mondo scientifico a capire i benefici che una cura avrebbe nei pazienti affetti da tale problema.
Riguardo la microplasmina: La Microplasmina è un farmaco al momento in fase di studio per il trattamento di numerose patologie vitreo-retiniche. Puoi visitare il nostro sito web www.thrombogenics.com , o www.clinicaltrials.gov avendo cura di ricercare la parola microplasmina per saperne di più sullo stadio delle nostre sperimentazioni.

Ci è stato detto dagli oculisti e dagli specialisti vitreo-retinici che la microplasmina potrebbe essere un'ottima opzione non chirurgica per il trattamento di miodesosie invalidanti gtazie al suo meccanismo di azione; Comunque la microplasmina non è stata ancora usata per trattare questo tipo di problema. In futuro potremmo allargare il programma di sperimentazione per valutare gli effetti della microplasmina anche su altre patologie (potenzialmente includendo anche le miodesopsie).

Spero che questa informazione ti sia utile.

XXX

A questo punto ho capito la grande importanza del primo studio epidemiologico che l'associazione ha fatto (è esattamente quello che il riceecatore aspira ad avere, anche se probabilmente su un campione statistico più elevato) e ho provveduto a tradurlo in inglese e ad inviarlo al ricercatore.

Qualcosa come vedete si muove.....

Fabrizio
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Giorgio
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Registrato: 11/08/05 08:09
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MessaggioInviato: Sab 13 Set, 2008 15:26    Oggetto: Rispondi citando

Ottima iniziativa, Fabrizio.
Complimenti!

Giorgio
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studentebohemien



Registrato: 11/11/08 12:58
Messaggi: 7

MessaggioInviato: Mar 30 Dic, 2008 11:36    Oggetto: Rispondi citando

e poi? Ci sono novità?
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GIL75



Registrato: 08/12/08 13:18
Messaggi: 144

MessaggioInviato: Dom 04 Gen, 2009 21:34    Oggetto: Novità sul sito Thrombogenics Rispondi citando

Ciao a tutti,

volevo avvisarvi che sul sito Thrombogenics c'è una
novità al 14.11.08, non so possa essere importante
per noi. Sembra di sì.
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biscia



Registrato: 24/09/07 08:30
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Località: Roma

MessaggioInviato: Lun 05 Gen, 2009 0:08    Oggetto: Rispondi citando

In sostanza sembra che gli studi sulla microplasmina (Fase tre) hanno dato esiti positivi....ma ancora non si parla di un uso per curare i floaters:

Leuven, Belgium – November 14, 2008 - ThromboGenics NV (Euronext Brussels: THR), a
biotechnology company focused on eye disease, vascular disease and cancer, announces
promising six month follow-up results from its Phase IIb MIVI III trial, which was designed to
evaluate the safety and efficacy of microplasmin in vitrectomy. The results were presented
at the American Academy of Ophthalmology in Atlanta, USA, by Dr. Kirk Packo, Professor
and Chairman at the Department of Ophthalmology, Rush University Medical Center in
Chicago, Illinois.
The six month results from the MIVI III (MIVI III - Microplasmin for Vitreous Injection) trial
continue to support the one month data previously reported, namely that the most effective
dose of microplasmin studied (125 ìg) was able to resolve the underlying disease in
approximately 30% of patients without the need for vitrectomy. The six month data also
show that these patients continue to do well. As anticipated, all patients in the trial who at 1
month had achieved complete resolution of vitreomacular traction or macular hole without
need for surgery did not have recurrence of either traction or macular hole during the full 6
month follow-up period.
The six month results also show that these patients continue to see an improvement in their
visual acuity. On average, the microplasmin treated patients who had resolution of their
underlying condition without need for vitrectomy achieved a 9 letter improvement when
reading a standard eye chart, in comparison to the baseline reading taken prior to treatment
with microplasmin. Crucially, this improvement in visual acuity is at least as good as the
results seen in patients who had to undergo a surgical vitrectomy in order to resolve their
underlying eye disease. These results, along with the same findings observed in the MIVI II
Traction trial, represent the first ever demonstration of a pharmacologic treatment option for
these conditions that would otherwise have required major eye surgery.
The MIVI III trial was a Phase IIb, randomized, double-masked, placebo-controlled, doseranging
trial evaluating three doses of microplasmin (25, 75 and 125 ìg) versus placebo in
125 patients scheduled for vitrectomy. The patients were recruited at 19 centers across the
United States. The trial was designed to assess the safety and efficacy of microplasmin
intravitreal injection given 7 days prior to the patient’s planned vitrectomy. The detailed one
month results from this study were presented in June by Dr. George Williams (Beaumont
Hospital, Michigan, USA) at the World Ophthalmology Congress in Hong Kong.
ThromboGenics is currently working to finalise the Phase III clinical trial program for
microplasmin in the treatment of back of the eye disease, following a successful “End of
Phase II meeting” with the FDA. The initial indication planned for the program is the
Nonsurgical Resolution of Vitreomacular Adhesion. Two placebo controlled trials are
planned, one in the U.S. and one combined European and North American trial. Together it
is anticipated that the two trials will recruit a total of approximately 640 patients, with both
trials expected to begin in Q1 2009. The Phase III development program will use the 125 ìg
dose of microplasmin.
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studentebohemien



Registrato: 11/11/08 12:58
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MessaggioInviato: Mer 07 Gen, 2009 14:23    Oggetto: Rispondi citando

una domanda!
se ho ben inteso la microplasmina (che sta dando esiti molto positivi) viene studiata per tarttare i pazienti afflitti da una eccessiva trazione vitreale sulla retina (che produce spesso foro maculare..). Grz a questa sostanza la trazione sulla retina dovrebbe cessare poichè il vitreo viene indotto a distaccarsi posteriormente.
Ma poi il vitreo distaccato che fine fa ? si scioglie ulteriormente... o tutto questo è solo un preliminare per rendere più semplici le vitrectomie?
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GIL75



Registrato: 08/12/08 13:18
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MessaggioInviato: Dom 11 Gen, 2009 15:36    Oggetto: Aggiornamento Thrombogenics Rispondi citando

Ciao,

vedete sul sito Thrombogenics al 09.01.09 ulteriore
aggiornamento.

Smile
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biscia



Registrato: 24/09/07 08:30
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MessaggioInviato: Dom 11 Gen, 2009 20:45    Oggetto: Rispondi citando

Microplasmin’s pivotal Phase III program is referred to as the MIVI-TRUST (Microplasmin for
IntraVitreous Injection-Traction Release without Surgical Treatment) program.
The initial indication for both of the Phase III microplasmin trials is the non-surgical treatment
of focal vitreomacular adhesion. Focal vitreomacular adhesion is a condition in which the
vitreous gel, in the center of the eye, has an abnormally strong adhesion to the retina at the
back of the eye. These adhesions can cause vessel and retinal distortion which results in
deterioration in the patient’s vision. Moreover, vitreomacular adhesion is thought to play a
key role in numerous back of the eye conditions such as macular hole formation, and some
forms of macular edema. Vitreomacular adhesion is also potentially associated with a much
poorer prognosis in certain major eye indications, including diabetic retinopathy and Agerelated
Macular Degeneration (AMD).
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on the
announcement said, “Intravitreal injection of microplasmin is a unique approach to treating
back of the eye disease. Microplasmin may represent an important clinical advance as
earlier clinical studies have shown that it could potentially resolve vitreomacular adhesion in
a simple one-off procedure, removing the need for major eye surgery with its associated
risks and costs in such cases. In addition, we believe microplasmin has potential for
treatment of other conditions such as diabetic retinopathy and AMD, given the increasing
evidence that vitreomacular adhesion plays an important part in these sight-threatening
conditions."
Both trials are multi-centre, randomized, placebo controlled, double-masked trials which will
evaluate 125μg of microplasmin versus placebo in the intravitreal treatment of patients with
focal vitreomacular adhesion. The trials will enrol approximately 320 patients each across
approximately 40 centres in the United States (TG-MV-006) and 40 centres in Europe and
North America (TG-MV-007).
The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular
adhesion after one month. Additional measures of efficacy and safety will also be assessed
at various intervals over six months in both studies. It is estimated that these two studies will
be completed by the end of 2010.
Dr. Patrik De Haes, CEO of ThromboGenics, commenting on the announcement said,
ThromboGenics NV • Leuven, Belgium • tel +32 (16) 75 13 10 • www.thrombogenics.com
“I am very pleased to announce the start of the Phase III trials of microplasmin for the nonsurgical
treatment of vitreomacular adhesion. We have been very encouraged by the results
we have seen in our Phase II program, and believe that microplasmin has the potential to
make a significant difference to the treatment of back of the eye diseases. During the last
twelve months, ThromboGenics made considerable progress in maximising the value of the
Company’s pipeline, and the start of these trials represent another important milestone in our
corporate development. We look forward to advancing these two important studies and
ensuring that ThromboGenics continues to enjoy further success in 2009.”
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TEXWILLER72



Registrato: 30/07/09 09:44
Messaggi: 1724

MessaggioInviato: Lun 24 Mag, 2010 18:17    Oggetto: Rispondi citando

20/04/2010 (testo in inglese):

http://www.thrombogenics.com/html/documents/10_THR_04_006Results_final_EN.pdf
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