LEUVEN, Belgium, November 6 /PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on innovative treatments for eye disease, vascular disease and cancer, is today issuing a business update for the nine months period ended 30 September 2008.
Patrik De Haes, CEO of ThromboGenics, commenting on today's announcement, said: "ThromboGenics' clinical development programs continue to progress as anticipated. We are now working hard to prepare for the Phase III clinical program for microplasmin in eye disease following a successful End of Phase II Meeting with the FDA. The recent positive results from our Phase II trials with microplasmin have given us further confidence that this product has the potential to make a real difference in the field of eye disease. We are also developing a good working relationship with our strategic partner Roche as the clinical development of our new anti-cancer antibody TB-403 continues to progress. With our solid financial situation, I believe that ThromboGenics will deliver further important corporate milestones over the next 12 to 18 months as we continue to work to build value for our shareholders."
Financial Update
- In the first nine months of 2008, ThromboGenics achieved
revenues of EUR 30.3 million, mainly from out-licensing activities.
Operating expenses were EUR 17.0 million during this nine month period,
the majority of which were due to R&D expenses related to an increasing
number of clinical development programs.
- As of 30 September 2008, ThromboGenics had EUR 60.9 million
in cash and cash equivalents. This compares to EUR 50.6 million on 30
September 2007 and EUR 40.1 million on 31 December 2007. ThromboGenics
believes that this level of funding will allow it to complete the Phase
III program for the initial indication for microplasmin in eye disease.
- In late July, ThromboGenics announced that a group of
private investors based in Belgium had together acquired an 8% stake in
the Company. This stake was purchased from Biggar Limited, a charitable
foundation that is ThromboGenics' largest single shareholder. Biggar
now holds a 9.8% stake in ThromboGenics, and has informed the Company
that it intends to remain an important shareholder in ThromboGenics for
the long term.
- ThromboGenics shares entered the Bel Mid Index on 1 October
2008, following the quarterly review of the Belgian indices by
Euronext. The elevation of ThromboGenics to the Bel Mid Index reflects
the significant progress that the Company has made since its IPO in
2006.
Corporate Update
- On 1 September, Patrik De Haes, MD, formerly the Company's
Chief Operating Officer, was appointed to succeed Professor Desire
Collen as the Company's new Chief Executive Officer. Dr. De Haes will
be proposed to become a member of the Board of Directors of
ThromboGenics at the next General Meeting. In the meantime, he will be
invited to participate in Board meetings.
ThromboGenics will continue to benefit from Professor Collen's significant scientific and drug discovery knowledge. Professor Collen will remain Chairman of ThromboGenics' Board of Directors.
Pipeline Update
Microplasmin in Eye Disease
ThromboGenics is working to finalise its 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 the first trial expected to begin in Q1 2009. It is anticipated that this Phase III development program will use the 125 (micro)g dose of microplasmin.
The decision to move into this Phase III program was in part based on the positive results from the Phase IIb MIVI III trial announced in late June. The MIVI III (MIVI III - Microplasmin for Vitreous Injection) trial showed that the most effective dose of microplasmin studied (125 (micro)g) was able to resolve the underlying disease in approximately 30% of patients without the need for a vitrectomy (surgical intervention). The encouraging results from this study were presented by Dr. George Williams (Beaumont Hospital, Michigan, USA) on June 28 at the World Ophthalmology Congress in Hong Kong.
The MIVI III trial was a Phase IIb, randomized, double-masked, placebo-controlled, dose-ranging trial that evaluated three doses of microplasmin (25, 75 and 125 (micro)g) 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 study showed that microplasmin was well tolerated. The trial also showed a clear dose response curve with the highest dose (125 (micro)g) of microplasmin delivering the best results. In this group, 10 of the 32 patients receiving this dose of microplasmin had resolution of their underlying disease, and therefore did not need a vitrectomy for the indication for which they were being treated. This compares very favorably with the placebo group, where only 1 patient out of 31 achieved the same positive outcome. In addition, use of microplasmin was associated with a reduced amount and duration of suction needed to achieve a PVD in patients who progressed to surgical intervention, compared to placebo.
The visual acuity of all patients recruited into the study was also measured at day 35 after the injection of microplasmin or placebo, whether they had a vitrectomy or not. In patients who received the highest dose of microplasmin there was an improvement in vision (6.9 more letters read on a standard eye chart compared to a baseline reading prior to treatment); this compares with a 0.1 letter improvement for the placebo group.
Microplasmin in Stroke
In late September, the Company announced promising results from its MITI IV Phase II trial to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to acute stroke patients. The overall results of the study were presented by Dr. Vincent Thijs on September 27 at the World Stroke Congress in Vienna.
The MITI IV (Microplasmin In Treatment of Ischemic stroke - IntraVenous) trial was a Phase II, multicentre, randomized, double-blinded, placebo-controlled, ascending-dose clinical trial evaluating the safety and preliminary efficacy of the intravenous administration of microplasmin in 40 patients, 4 to 12 hours after onset of acute ischemic stroke
The study found that microplasmin was generally well tolerated with no evidence of increased bleeding risk; there were no systemic bleeding events reported and there was no evidence of increased rate of bleeding in general, in those patients that had been treated with microplasmin compared to those treated with placebo.
In addition, the study provided some interesting preliminary efficacy results. Approximately 25% of patients treated with microplasmin had reperfusion (restoration of blood flow) within eight hours of being treated, this compares with 10% of placebo-treated patients. Moreover, of the patients who had more severe vascular blockages, 33% of patients treated with microplasmin achieved reperfusion compared with 14% of placebo-treated patients. Due to the small number of patients in this study, neither of these endpoints were statistically significant. However, the study also showed that microplasmin-treated patients had a statistically significant improvement in the level of damage to the blood brain barrier compared to placebo-treated patients, measured using the marker of matrix metalloproteinase (MMP). MMP activation plays a crucial role in the pathogenesis of brain edema and hemorrhagic transformation after ischemic stroke.
It remains ThromboGenics' intention that it will only move forward with the development of microplasmin for the treatment of stroke in cooperation with a partner. This view is based on both the risks and cost associated with the development of new stroke therapies, and the Company's desire to invest in its other attractive pipeline product candidates, including microplasmin in the treatment of back of the eye diseases.
Staphylokinase (THR-100)
ThromboGenics partner for the clinical development and commercialization of THR-100, Bharat Biotech, continues to work with the Indian authorities to gain the necessary approvals to begin a Phase III trial with this novel variant of Recombinant Staphylokinase. The initial trial will evaluate THR-100 for the treatment of acute myocardial infarction (AMI), or heart attack. Given the commercial strengths of Bharat in this market and the clinical advantages of THR-100, it is hoped that this novel product will quickly become the market leader for the thrombolytic treatment of heart attacks in India.
TB-403 - Working with Roche on this Potential Breakthrough Cancer Treatment
ThromboGenics, in conjunction with its partner BioInvent, has made good progress in transferring this novel anti-cancer agent to Roche following the strategic alliance signed in June 2008.
Following the successful completion of the initial Phase I study, the parties have begun a Phase Ib trial with TB-403 in end-stage cancer patients. This study, which will recruit approximately 24 patients, is designed to provide both safety data on TB-403 when used in cancer patients and early efficacy data on the product.
The deal with Roche was a key element in ThromboGenics' corporate strategy, and has allowed the Company to focus on developing the other attractive products in its pipeline, particularly its lead product, microplasmin. The upfront payment from Roche has also provided a significant portion of the funds needed for the microplasmin Phase III program, which will evaluate the drug in a number of back of the eye disease indications.
TB-402 (Anti-Factor VIII) - A Unique, Long-acting Anti-coagulant
ThromboGenics is developing TB-402 in collaboration with BioInvent International. TB-402 is a novel human antibody which partially blocks Factor VIII, an essential blood clotting factor. TB-402 is being developed as an anticoagulant for the treatment and prevention of deep vein thrombosis (DVT) and atrial fibrillation. It is anticipated that TB-402 will be a novel, safe, and affordable anticoagulant, providing extended activity with a single dose, with ease of administration and compliance superior to alternative anticoagulants.
The Phase I interaction studies, which were successfully completed in the second quarter of 2008, have shown that TB-402 has the potential to be a safe and well controlled treatment for diseases where the prevention of blood clots is imperative. As a result of the encouraging results from these studies, TB-402 is expected to begin its Phase II clinical development by the end of 2008.
ThromboGenics will provide a further update when the Company reports its 2008 Full Year Results on 12th March, 2009.
For further information please contact:
ThromboGenics:
Patrik De Haes, CEO, Tel : +32-16-75-13-10,
patrik.dehaes@thrombogenics.com
Chris Buyse, CFO, Tel : +32-16-75-13-10,
chris.buyse@thrombogenics.com .
Citigate Dewe Rogerson:
Amber Bielecka/ David Dible/ Nina Enegren, Tel: +44(0)207-638-95-71,
amber.bielecka@citigatedr.co.uk
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery and development of biopharmaceuticals for the treatment of eye disease, vascular disease and cancer. The Company has several programs in Phase II clinical development including microplasmin, which is being evaluated as a treatment for vitreoretinal disorders and as a thrombolytic agent in stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 for cancer.
ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium and has subsidiaries in Dublin, Ireland and New York, U.S. 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.
SOURCE ThromboGenics NV
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