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Belinostat in pivotal phaseBelinostat, an HDAC inhibitor with blockbuster-potential under co-development between TopoTarget and Spectrum Pharmaceuticals, is 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.
Belinostat has Orphan Drug status with the FDA and Fast Track designation was granted for the development of belinostat in this indication which supports TopoTarget's rapid to market entry strategy.
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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English Danish
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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04.02.2010
Spectrum Pharmaceuticals, to host Conference Call to discuss the Belinostat licensing agreement, Thursday 4 February 2010 at 19:00 CET (1:00 pm EST/10:00 am PST)
English Danish
Audio replays will be available through 24 February, 2010:
From the US:
+1-888-203-1112, code 5055446
International:
+1-719-457-0820, code 5055446
03.02.2010
Major Investor announcement:
Avanza Pension has exceeded 5% of TopoTarget's total share capital and total number of voting rights
English Danish
02.02.2010
TopoTarget signs an agreement with potential value of USD 350 million with Spectrum Pharmaceuticals for the development and commercialisation of Belinostat in North America and India
English Danish
Powerpoint Presentation
A replay of the teleconference held 02.02.2010 at 13:00 CET is available at: +353 1 436 4267, pin 2395851# or +44 2077 696425, pin 2395851#.
06.01.2010
Belinostat phase II trial initiated in ovarian cancer by the Gynecologic Oncology Group (GOG)
English Danish
14.12.2009
Infusion nurses society in the US references Totect® as the only antidote for the treatment of anthracycline extravasation
English only
08.12.2009
Positive belinostat phase II results in PTCL presented at ASH
English Danish
Powerpoint presentation
28.11.2009
Belinostat acts synergistically when combined with castration and anti-hormone therapy in hormone refractory prostate cancer models - Pre-clinical data presented at 2nd Multidisciplinary Meeting on Urological cancers in Barcelona EMUC-ESMO
English Danish
19.11.2009
Q3 Financial Report 2009
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PowerPoint Presentation
English
Replay from the Q3 conference call is available on: +353 1 436 4267, pin code: 2090186#.
17.11.2009
Positive belinostat phase I data presented at AACR/NCI/EORTC Conference in Boston
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Poster
03.11.2009
Powerpoint Presentation from Discovery On Target 2009 - 3rd Annual Conference on HDACi's
English
02.11.2009
Belinostat data to be presented at four international conferences
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19.10.2009
Presentation from Nordic Venture Forum
English
14.10.2009
Totect® manufacturing resumed
English Danish
29.09.2009
Powerpoint Presentation from Nasdaq OMX Investor Event - Århus
Danish
29.09.2009
Temporary suspension in Totect® supply in the US
English Danish
28.09.2009
Powerpoint Presentation from the 5th Swiss-Scandinavian Bio-Business Seminar in Zürich on October 1st
English
17.09.2009
Powerpoint Presentation from
Dansk Aktiemesse 2009
Danish
Webcasts from Dansk Aktiemesse 2009
Danish
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About Us
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