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Belinostat in phase IIITopoTarget's blockbuster-potential, belinostat, is now in its first pivotal trial in the haemotological disease, Peripheral T-Cell Lymphoma (PTCL). TopoTarget has an agreement via a Special Protocol Assessment (SPA) with the US Food and drug Administration (FDA). This pivotal trial is to enroll approximately 120 patients.
Fast Track designation was granted for the development of belinostat in this indication which supports TopoTarget's rapid to market entry strategy. There is currently no standard therapy approved for PTCL.
Belinostat (PXD101) is an intraveneous (IV), continuous intraveneous infusion (CIV) and oral (capsul) class I and II HDAC inhibitor. Belinostat has demonstrated proof of concept as monotherapy in haematological malignancies and clinical effects in solid tumours such as platinum resistant ovarian cancer using combination therapy.
Belinostat has a benign safety profile and is TopoTarget's lead clinical drug candidate. TopoTarget owns the global rights to belinostat, and is focusing its resources to exploit the products broad potential in cancer indications. TopoTarget in brief
TopoTarget is a dynamic international biotech company dedicated to finding "Answers for cancer".
Founded by clinicians with a thorough knowledge of the molecular mechanisms of cancer, our goal is to find and develop cancer therapies, bringing them to the market to benefit patients. As well as a strong clinical development team, we have top class experts in our preclinical and regulatory departments.
Including belinostat, we currently have a broad late stage pipeline with 7 products in clinical development. Using our own highly specialised dedicated sales team, we launched our first product, Savene® in Europe in 2006, and in the US in 2007 under the brand name Totect®.
Savene®/Totect® is used for the treatment of anthracycline extravasation, an accident that can occur during chemotherapy. TopoTarget is headquartered in Denmark and is listed on the OMX Nordic Exchange in Copenhagen under the symbol (OMX: TOPO).
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Savene® and Totect® awarded status as standard treatment
TopoTarget’s first product cited in
nursing guidelines
Savene®/Totect® approved for treatment by regulating agencies, is now cited in nursing guidelines for the treatment of anthracycline extravasation in Europe and United States.
Only 18 months after being launched in the European market and the US market respectively, the convincing data of TopoTarget’s successful antidote Savene®/ Totect® has led to the awareness and creation of guidelines to support the use of Savene®/Totect® as a first-line and only regulatory agency approved treatment for anthracycline extravasations in order to avoid the tissue damage that otherwise can occur.
The EONS (Euopean Oncology Nursing Society) guidelines offer a practical guide to extravasation management from prevention and recognition through to management strategies and advice on implementation of guidelines into clinical practice. Several European National Societies have subsequently adopted the EONS guidelines and the recommendation for the use of Savene®.
Savene®/Totect® has received much publicity and support among healthcare professionals after it was launched. The widespread support is reflected for example in journals, which include an increasing number of articles about Savene® and Totect®. The value of Savene® and Totect® is also reflected in the increasing sales of the product. From 2007 to 2008 sales almost doubled.
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02.07.2009
Articles of Association of TopoTarget A/S
English Danish
02.07.2009
TopoTarget A/S completes fully subscribed rights issue
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25.06.2009
Insiders' dealing
Report pursuant to the Danish Securities Trading Act,
Section 28a
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24.06.2009
Insiders' dealing
Report pursuant to the Danish Securities Trading Act,
Section 28a
English Danish
24.06.2009
Major shareholder exercises significant number of pre-emptive subscription rights in connection with the announced offering
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23.06.2009
Insiders' dealing
Report pursuant to the Danish Securities Trading Act,
Section 28a
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02.06.2009
Announcement of publication of Offering Circular
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02.06.2009
Offering Circular
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30.05.2009
Positive belinostat data in thymoma presented at ASCO
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Poster
30.05.2009
Positive oral belinostat data in lymphoma presented at ASCO
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Poster
29.05.2009
Positive oral belinostat data in solid tumors presented at ASCO
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Poster
27.05.2009
Proceedings at the EGM
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Power Point presentation
Danish only
14.05.2009
Notice to convene EGM
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Q1 Financial Report 2009
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PowerPoint Presentation
English
Replay from Conference call, please dial:
+353 1 436 4267, pin code: 1666 758#
Plans For Rights Issue EGM and Expressions of Interest from Third Parties
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20.04.2009
Positive sales increase for Savene/Totect in Q1 2009
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16.04.2009
First CUP patient dosed in randomized phase II study in BelCaP
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