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Patrik De Haes, CEO of ThromboGenics, said:
"ThromboGenics' clinical development programs have continued to makesignificant progress. We are very happy to have completed patient enrolmentfor the US Phase III study with microplasmin and recruitment in our secondPhase III trial is continuing to make excellent progress. Microplasmin iscentral to our aim of building a successful integrated company focused oncutting edge ophthalmic medicines, that is positioned to deliver significantshareholder value.
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We have also recently completed patient recruitment of a Phase II studywith TB-402, assessing it as a DVT prophylactic in patients undergoing kneereplacement, ahead of schedule. Our experience with TB-402 suggests that thislong acting product has the potential to be an important new entrant into theanticoagulant market making it an attractive out-licensing opportunity. Ourpartnership with Roche for the novel anti-cancer antibody TB-403 continues tomake good progress, with results from the Phase Ib trial to be presentedlater this month at the American Association for Cancer Research conference."
Microplasmin - Back of the Eye Disease: Phase III clinical program toevaluate non-surgical treatment of patients with vitreomacular adhesion.
- Phase III program continues to progress well, with enrolment
completed for TG-MV 006 and on track for TG-MV 007
In September, ThromboGenics announced the completion of patientrecruitment in the US trial (TG-MV-006) of the Phase III program withmicroplasmin for the non-surgical treatment of vitreomacular adhesion (a backof the eye condition). The trial recruited a total of 326 patients ahead ofschedule and we anticipate reporting the results from this study by mid 2010,after a 6 month follow up period.
The second Phase III study with microplasmin, TG-MV-007, which isrecruiting 320 patients in Europe and the US, is progressing well and weexpect complete enrolment within the first quarter of 2010 and results ofthis study near the end of 2010.
This Phase III program, referred to as the MIVI-TRUST (Microplasmin forIntraVitreous Injection-Traction Release without Surgical Treatment) program,comprises two clinical trials, taking place in the United States (TG-MV-006trial) and a second combined European and US study (TG-MV-007 trial). Theindication for both of these Phase III microplasmin trials is thenon-surgical treatment of focal vitreomacular adhesion. Vitreomacularadhesion is a condition in which the vitreous has an abnormally strongadhesion to the retina at the back of the eye. These adhesions can causevessel and retinal distortion, which results in deterioration in thepatient's vision. Both of these trials use the 125micro g dose ofmicroplasmin.
Microplasmin - Diabetic Retinopathy: Phase II trial to evaluatemicroplasmin for the treatment of Diabetic Macular Edema (DME).
- Results from the Phase IIa trial presented at the American
Society of Retina Specialists (ASRS) Conference in New York
In October 2009, ThromboGenics announced results from the Phase II trialof microplasmin intravitreal injection for treatment of DME (MIVI II DME).The trial showed that microplasmin was safe and well tolerated and thatmicroplasmin is able to non-surgically resolve vitreomacular adhesion in someDME patients. The data from this trial were presented at the ASRS Conferencein New York on 3 October, 2009 by Professor Peter Stalmans, UniversityHospitals Leuven, Belgium.
The MIVI II DME trial was designed to be the initial step in evaluatingmicroplasmin in patients with diabetes, a group which is more prone to eyedisease, and specifically diabetic retinopathy. ThromboGenics will finalizethe next step in the development plan for microplasmin in this patientpopulation once the results from the first Phase III trial (TG-MV-006) arereported. These results will provide significant additional data that willhelp ThromboGenics to refine the development plans for microplasmin inpatients with diabetic retinopathy.
TB-402 - Phase II trial assessing the long-acting anticoagulant TB-402for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopedicsurgery.
In October, ThromboGenics announced the completion of patient recruitmentfor the Phase II trial of TB-402 ahead of schedule. TB-402 is a novel, longacting anticoagulant that is being developed for the prevention of deep veinthrombosis (DVT) following orthopedic surgery. It is anticipated that theresults of this study, which has recruited 315 patients, will be presented inthe second quarter of 2010.
TB-402 has the potential to be a very important new entrant into theanticoagulant market. TB-402 is a recombinant human monoclonal antibody thatpartially inhibits Factor VIII, a key component of the coagulation cascade.This novel mode of action is expected to reduce the risk of undesirablebleeding events, even at high doses, as well as the need for patientmonitoring. These are the two main drawbacks associated with currentanticoagulant therapy. In addition, TB-402 is a long-acting agent, whichmeans it could be given as a single dose to prevent the development of DVT inpatients undergoing surgery. This would be an attractive option, as allcurrent anticoagulant treatment options require daily treatment for up toseveral weeks.
ThromboGenics and its partner BioInvent plan to out-license TB-402 forits later stage development and commercialization. This out-licensingstrategy is driven by the large sales potential of the product and the broadrange of prescribers that could use an anticoagulant with TB-402's uniqueprofile.
The clinical development of TB-403 is progressing as planned and theresults of a Phase Ib trial are to be presented at the AACR conference inBoston, MA USA on November 15-19, 2009. The Phase Ib trial was designed toassess TB-403's tolerability, pharmacokinetics and pharmaco-dynamics inpatients with advanced cancer.
In June 2008, ThromboGenics and its co-development partner BioInventsigned a strategic alliance deal with Roche for its novel anti-cancer agent,TB-403 (anti-PlGF). In January, 2009, ThromboGenics and BioInvent receivedtheir first success fee from Roche based on the successful transfer andimplementation of technology and process development for TB-403 production.ThromboGenics received EUR3 million of the overall EUR5 million success fee.
Corporate Update
ThromboGenics is Shortlisted for "Biotech Company of the Year" and"Licensing Deal of the Year" at the Scrip Awards 2009
About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on the discovery anddevelopment of innovative medicines for the treatment of eye disease,vascular disease and cancer. The Company's lead product microplasmin is inPhase III clinical development for the non-surgical treatment of back of theeye diseases. Microplasmin is also being evaluated in Phase II clinicaldevelopment for additional vitreoretinal conditions. In addition,ThromboGenics is developing novel antibody therapeutics in collaboration withBioInvent International; these include TB-402 (Anti-Factor VIII), a longacting 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. The Company is listed on Eurolist byEuronext Brussels under the symbol THR. More information is available athttp://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.Financial Update - ThromboGenics achieved revenues of EUR3.7 million in the third quarter of 2009, the majority of which came from out-licensing. R&D expenses were EUR12.6 million during this nine month period. In Addition EUR10.4 million of expenses related to the microplasmin Phase III clinical program have been capitalized over the first nine months of this year. - As of September 30, 2009, ThromboGenics had EUR43.1 million in cash and cash equivalents. This compares to EUR60.9 million on September 30, 2008 and EUR58.9 million on December 31, 2008. Business Highlights Clinical Highlights
SOURCE ThromboGenics NV
