- ThromboGenics' Lead Product to be Studied in the Treatment ofVitreomacular Adhesion in the US and Europe
ThromboGenics NV (Euronext Brussels: THR), a biotechnology companyfocused on innovative treatments for eye disease, vascular disease andcancer, announces today that it has started the Phase III clinical program ofmicroplasmin for the non-surgical treatment of back of the eye disease, thefinal step in the clinical development of this potential new therapy. Thisprogram involves two clinical trials, taking place in the United States (TGMV-006 trial) and Europe and North America (TG-MV-007 trial). The start ofthese pivotal clinical trials represents an important step in potentiallyimproving the treatment of back of the eye disease, and is a major milestonein ThromboGenics' corporate development.
Advertisement
Microplasmin's pivotal Phase III program is referred to as the MIVI-TRUST(Microplasmin for IntraVitreous Injection-Traction Release without SurgicalTreatment) program.
Advertisement
The initial indication for both of the Phase III microplasmin trials isthe non-surgical treatment of focal vitreomacular adhesion. Focalvitreomacular adhesion is a condition in which the vitreous gel, in thecenter of the eye, has an abnormally strong adhesion to the retina at theback of the eye. These adhesions can cause vessel and retinal distortionwhich results in deterioration in the patient's vision. Moreover,vitreomacular adhesion is thought to play a key role in numerous back of theeye conditions such as macular hole formation, and some forms of macularedema. Vitreomacular adhesion is also potentially associated with a muchpoorer prognosis in certain major eye indications, including diabeticretinopathy and Age-related Macular Degeneration (AMD).
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting onthe announcement said, "Intravitreal injection of microplasmin is a uniqueapproach to treating back of the eye disease. Microplasmin may represent animportant clinical advance as earlier clinical studies have shown that itcould potentially resolve vitreomacular adhesion in a simple one-offprocedure, removing the need for major eye surgery with its associated risksand costs in such cases. In addition, we believe microplasmin has potentialfor treatment of other conditions such as diabetic retinopathy and AMD, giventhe increasing evidence that vitreomacular adhesion plays an important partin these sight-threatening conditions."
Both trials are multi-centre, randomized, placebo controlled,double-masked trials which will evaluate 125 micrograms of microplasminversus placebo in the intravitreal treatment of patients with focalvitreomacular adhesion. The trials will enrol approximately 320 patients eachacross approximately 40 centres in the United States (TG-MV-006) and 40centres in Europe and North America (TG-MV-007).
The primary endpoint of both trials is the non-surgical resolution offocal vitreomacular adhesion after one month. Additional measures of efficacyand safety will also be assessed at various intervals over six months in bothstudies. It is estimated that these two studies will be completed by the endof 2010.
Dr. Patrik De Haes, CEO of ThromboGenics, commenting on the announcementsaid,
"I am very pleased to announce the start of the Phase III trials ofmicroplasmin for the non-surgical treatment of vitreomacular adhesion. Wehave been very encouraged by the results we have seen in our Phase IIprogram, and believe that microplasmin has the potential to make asignificant difference to the treatment of back of the eye diseases. Duringthe last twelve months, ThromboGenics made considerable progress inmaximising the value of the Company's pipeline, and the start of these trialsrepresent another important milestone in our corporate development. We lookforward to advancing these two important studies and ensuring thatThromboGenics continues to enjoy further success in 2009."
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery anddevelopment of biopharmaceuticals for the treatment of eye disease, vasculardisease and cancer. The Company's lead product Microplasmin is in Phase IIIclinical development for the non-surgical treatment of back of the eyediseases. Microplasmin is also being evaluated in Phase II clinicaldevelopment for additional vitreoretinal indications and as a potentialtherapy for stroke. ThromboGenics is also developing novel antibodytherapeutics in collaboration with BioInvent International; these includeTB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403(anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of Leuven andthe Flanders Institute for Biotechnology (VIB) and has exclusive rights tocertain therapeutics developed at these institutions. ThromboGenics isheadquartered in Leuven, Belgium and has subsidiaries in Dublin, Ireland andNew York, U.S. The Company is listed on Eurolist by Euronext Brussels underthe 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 currentexpectations, and, accordingly, entail and are influenced by various risksand uncertainties. The Company therefore cannot provide any assurance thatsuch forward-looking statements will materialize and does not assume anobligation to update or revise any forward-looking statement, whether as aresult of new information, future events or any other reason. Additionalinformation concerning risks and uncertainties affecting the business andother factors that could cause actual results to differ materially from anyforward-looking statement is contained in the Company's Annual Report.For further information please contact: ThromboGenics Dr. Steve Pakola, CMO Tel: +1-212-201-0920 [email protected] Dr. Patrik De Haes, CEO Tel: +32-16-75-13-10 [email protected] Citigate Dewe Rogerson Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71 [email protected]
SOURCE ThromboGenics NV
