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Belinostat More than 700 cancer patients have been treated with belinostat and the product has shown an excellent activity, safety and tolerability profile. The ability of belinostat to be combined at full doses with a variety of anti-cancer therapeutic agents is one of belinostat's major competitive advantages over other HDAC inhibitors.
In collaboration with Spectrum Pharmaceuticals Inc. first wave in building up a regulatory dossier is a pivotal trial -the BELIEF trial- with belinostat in peripheral T-cell lymphoma (PTCL), a randomized controlled Phase 2 trial in cancer of unknown primary (CUP), and studies in ovarian, colorectal and soft tissue sarcoma patients are conducted.
NCI-sponsored trials (single agent and in combination with anti-cancer therapeutics) include studies in thymoma, hepatocellular, myelodysplastic syndrome (MDS), and other solid and hematologic cancers. Continous intravenous administration (CIV) is being evaluated in clinical trials in solid tumours as well as in AML. An oral formulation of belinostat is also being evaluated in patients with advanced solid tumours and lymphomas. TopoTarget in brief
TopoTarget is a fully integrated international biotech company formed in 2000 dedicated to developing improved cancer therapies. At year 2009 53 employees were providing international high level expertice in clinical drug development, cancer research and sales and marketing.
Savene®/Totect® is the first product on the market from Topotarget's drug discovery technology. This important drug was approved in 2006 and 2007 in Europe and US respectively. Savene®/Totect® is for the prevention of tissue damage caused by extravasation accidents in connection with chemotherapy. Totect® is marketed by the company's own salesforce in the USA. The European rights to, Savene® , were divested in March 2010 as a consequence of focus to develop and commercialize belinostat.
Belinostat is Topotarget's lead product in clinical development and is in its first pivotal trial in Peripherical T-cell Lymphomas (PTCL) In february Topotarget entered a development and commercialization agreement on belinostat for North America and India with Spectrum Pharmaceuticals, Inc.
Behind belinostat Topotarget has a broad clinical and preclinical pipeline of cancer drug candidates with various mechanisms of action from acquired anti-cancer programmes and from in house R&D. 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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