LEUVEN, Belgium, May 13 /PRNewswire-FirstCall/ --
- Regulated Information
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on innovative treatments for vascular disease, eye disease and cancer, is today issuing a business update for the three month period ended 31 March 2008.
Prof. Desire Collen, CEO and Chairman of ThromboGenics, commenting on today's announcement, said: "ThromboGenics' clinical development programs are continuing to make the good progress that we had anticipated. During the first three months of 2008, we achieved a number of important clinical milestones that have clearly added further value to our exciting product pipeline. The positive results of our trials with microplasmin are giving us confidence that it has the potential to make a real difference in the field of eye disease. Our exciting new anti-cancer antibody TB-403 has also begun its clinical development. We anticipate seeing further encouraging results across our development pipeline during the remainder of 2008; a year in which we expect to advance ThromboGenics' business significantly."
- In the first quarter of 2008, revenue amounted to EUR 0.1 million, mainly coming from out-licensing. Operating expenses were EUR 3.2 million in the first quarter, the majority of which were due to R&D expenses related to our increasing number of clinical development programs.
- As of 31 March 2008, ThromboGenics had EUR 41.7 million in cash and cash equivalents. This compares to EUR 29.1 million on 31 March, 2007 and EUR 46.1 million on 31 December 2007.
- ThromboGenics completed patient enrolment for its Phase IIb MIVI III trial in the United States for microplasmin in vitrectomy.
Microplasmin is being developed as an adjunct for vitrectomy. A vitrectomy is an increasingly common surgical procedure which is carried out in the treatment of many back of the eye diseases such as retinal detachment, diabetic vitreous hemorrhage and macular hole. It is estimated that 600,000 vitrectomies are carried out annually worldwide.
Vitrectomy is used to induce a posterior vitreous detachment (PVD), which involves removing the vitreous from the eye. As microplasmin is a proteolytic enzyme, it is able to cleave the molecular structures which link the vitreous to the retina, meaning that it could facilitate, and in some cases even avoid, vitrectomy and therefore induce PVD without the risks inherent in the current surgical procedure.
The MIVI III trial, which has recruited a total of 125 patients, is designed to assess the safety and efficacy of administering microplasmin intravitreal injection 7 days prior to vitrectomy.
- ThromboGenics completed patient enrolment for its Phase II MITI IV trial
Microplasmin is also being studied for the treatment of acute ischemic stroke. In this indication, the fact that it is a direct-acting thrombolytic agent (breaks down blood clots) and is independent of plasminogen means that it could restore blood flow efficiently for a longer period after the stroke event, and with potentially fewer side-effects than other thrombolytic agents. The MITI IV study is placebo controlled and is evaluating the safety and preliminary efficacy of microplasmin in three different doses when administered intravenously to acute stroke patients between four and twelve hours after the onset of the stroke. This trial has recruited a total of 40 patients.
- In January, ThromboGenics announced that its novel anti-cancer antibody TB-403 had begun its initial Phase I clinical trial in Denmark.
TB-403 (Anti-PIGF) is a potential breakthrough in the treatment of cancer. It is a humanized monoclonal antibody that blocks the formation of the new blood vessels that are needed by solid tumours to support their growth. TB-403 therefore has the potential to minimise the growth and spread of cancer cells. It is unique because, in contrast to competing agents, TB-403 only blocks blood vessels in tumour tissue and not in healthy tissue. This novel product, which acts on PIGF, is being co-developed with BioInvent International.
TB-403 is attracting growing interest from potential pharma partners based on both the need for improved products for the treatment of cancer and the exciting pre-clinical results which were published in a Cell feature article in the November 2, 2007 issue.(1)
The commercial potential of TB-403 could also be enhanced as TB-403 could also be used to treat a number of important back of the eye diseases. This is because common eye diseases such as age-related macular degeneration and diabetic retinopathy are caused by uncontrolled blood vessel growth, which could be halted using TB-403.
The Remainder of 2008
ThromboGenics expects to deliver a number of value creating clinical milestones during the remainder of 2008. The expected milestones over this period are:
- Top line results are expected from the MIVI III Phase IIb trial of microplasmin in vitrectomy in June 2008.
ThromboGenics began the MIVI III Phase IIb trial in January 2007. The trial is evaluating the safety and efficacy of microplasmin intravitreal injection seven days prior to vitrectomy. The results from this trial will be presented at the World Ophthalmology Congress in Hong Kong on June 28, 2008.
Based on the results of this trial, ThromboGenics will select the best dose of microplasmin for use in two separate Phase III studies, one US and one European based. These trials, which are designed to clearly demonstrate the efficacy of microplasmin, are expected to begin before the end of 2008.
- Six month results from the MIVI IIT Phase IIa trial of microplasmin in vitreomacular traction are to be presented at the Euretina Conference in May.
The six month results from the first two cohorts of this trial will be presented by the lead investigator, Prof. Peter Stalmans, at the Euretina Conference on May 23, in Vienna. The third and fourth cohorts from this trial will be presented at major ophthalmic conferences in the second half of 2008.
- Results are expected from the Phase II MITI IV trial in mid 2008.
This Phase II trial is evaluating the safety and preliminary efficacy of microplasmin when administered intravenously to acute stroke patients. Once these data from the study have been reviewed, a decision will be made on the future development plans for microplasmin in the treatment of acute stroke.
It is ThromboGenics' current intention that it will only move forward with the development of microplasmin for the treatment of stroke in conjunction with a partner. This intention 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, such as microplasmin in the treatment of back of the eye diseases and TB-403.
- Results from the initial Phase I trial of this novel anti-cancer agent in healthy volunteers are expected in the third quarter of 2008.
Following the successful completion of this initial Phase I study, ThromboGenics expects to begin a Phase Ib trial with TB-403 in end stage cancer patients in mid 2008. This study, which will recruit approximately 24 patients, is designed to provide both safety data on TB-403 when used in cancer patients and some early efficacy data on the product.
- Top line results of the interaction studies to be announced by mid-2008.
TB-402 is being developed as an anti-coagulant for the prevention of deep vein thrombosis (DVT) after orthopaedic surgery and prevention of venous emboli in patients with atrial fibrillation. It is a novel human antibody that partially blocks Factor VIII, an essential blood clotting factor. The implication of this is that spontaneous bleeding events, which are a potential unwanted side effect if Factor VIII is completely inhibited, should not occur. Hence, there would be no need for the monitoring of coagulation parameters in the patient.
ThromboGenics is developing TB-402 in collaboration with BioInvent International.
In comparison to other current anticoagulants that require daily dosage, TB-402 has a prolonged half-life that will allow for a single-dose treatment in orthopaedic surgery patients and/or once-a-month administration for long-term stroke prevention in atrial fibrillation (AF).
- Initiation of Phase III by Bharat Biotech International Ltd in India.
ThromboGenics has entered into a partnership with Bharat Biotech to continue the clinical development and commercialization of THR-100. This novel variant of Recombinant Staphylokinase is initially being developed by Bharat in India 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 treatment of heart attacks in India. It is currently anticipated that THR-100 Phase III will be started in India in the third quarter.
Patrik De Haes, COO of ThromboGenics, commenting on today's release said, "ThromboGenics is confident that 2008 will be a transformational year for the Company. The important clinical milestones that we expect to achieve will further highlight the attractiveness of our clinical pipeline of innovative vascular biopharmaceuticals. These milestones will also provide us with a platform for signing partnership deals, which are an important element of our strategy to develop ThromboGenics into an important player in the areas of vascular disease, eye disease and cancer."
ThromboGenics will provide a further update when the Company reports its half year results on the 28th August, 2008.
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuticals for the treatment of a range of vascular diseases. 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 for vascular occlusive diseases such as acute stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), scheduled to enter Phase II clinical development in late 2008, and TB-403 (Anti-PlGF), which has begun Phase I clinical trials for the treatment of cancer. ThromboGenics has built strong links with the University of Leuven and has exclusive rights to certain therapeutics developed at the University. 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 prospectus.
(1) Cell, 2 November 2007, ANTI-PlGF INHIBITS GROWTH OF
VEGF(R)-INHIBITOR RESISTANT TUMORS WITHOUT AFFECTING HEALTHY VESSELS -
Christian Fischer, Bart Jonckx, Massimiliano Mazzone, Serena Zacchigna,
Monica Autiero, Emmanuel Chorianopoulos, Marta Koch, Maria Demol, Sabine
Wyns, Lucia Pattarini, Nico van Rooijen, Stephane Plaisance, Mauro Giacca,
Mieke Dewerchin, Lieve Moons, Jean Marie Stassen, Desire Collen & Peter
For further information please contact:
Prof. Desire Collen, Tel: +32(0)16-34-61-94;
Dr. Patrik De Haes, Fax +32(0)16-34-61-34.
Citigate Dewe Rogerson:
Sylvie Berrebi / Amber Bielecka / David Dible,
|SOURCE ThromboGenics NV|
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