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Belinostat meets expectationsTopoTargets potential blockbuster belinostat, lives up to the great expectations. Results from four trials show that belinostat is active in cancers.
TopoTarget demonstrated the potential of belinostat at venues such as this years ASCO (American Society of Clinical Oncology) conference. One of the trial data presented concerns the treatment of ovarian cancer patients, specifically patients who are refractory, to the most effective treatment known for this disease: the combination of the carboplatin and paclitaxel. When belinostat was added to the drug combination (leading to the programme name: BelCaP), an activity that would not normally be expected was achieved in most of these patients. We are very encouraged by these positive results" said Neil J. Finkler, MD, FACOG, FACS, Investigator and Director of the Gynecologic Oncology Program at Florida Hospital Cancer Institute in Orlando. "The level of activity we have seen with BelCaP for the treatment of relapsed ovarian cancer, including substantial activity against platinum resistant tumors supports further development of BelCaP in patients with recurrent ovarian cancer. The addition of belinostat to platinum-based regimens represents a novel approach to therapy of ovarian cancer.
2010 a realistic goal for market launch 18 clinical trials are on-going with belinostat which has also shown activity in CTCL and PTCL. Fast track designation has been received by the FDA in PTCL and the company aims for market approval in this indication in 2010. More collaboration between industry and university TopoTargets CEO used his new title as honorary professor to advocate for more extensive well-defined collaboration between university research and the industry.
Representing both sides as clinical oncology professor and CEO of a biotech company, the newly appointed professor used his lecture to convey the message that he would like to see much more collaboration between the two worlds. Danish cancer research represents some of the worlds best research in the field, and that is a major responsibility, said Peter Buhl Jensen. If we are to maintain this level of research and win the fight against cancer, we must cooperate even closer TopoTarget and University Hospital Rigshospitalet the industry and the universities. The TopoTarget CEO said that it would be an illusion to think that the extremely costly research in cancer medication can be undertaken based on public funding alone. TopoTarget spent DKK 130 million on research in 2007. In the same period, the Danish Cancer Association allocated DKK 60 million externally, said Peter Buhl Jensen.Both Academia and Industry must remove the fear of the discussion to facilitate closer collaboration and to define the grey areas. It can be done the professor emphasised, quickly finding a good example: Steno Diabetes Center is a diabetological research hospital owned by Novo Nordisk A/S. Its about committing to the collaboration and defining your own limits instead of allowing the media to do it. Key words in this context are openness, prudent and honest communication, self-declaration and, above all: having a clearly defined playing field. Savene® awarded status as standard treatment TopoTargets first product officially recommended by European nurses.
Savene® is now recommended as the standard treatment by European oncology nurses. Only 18 months after being launched in the European market, the convincing data of TopoTargets successful antidote Savene® has led the European Oncology Nursing Society (EONS) to call for support for the use of Savene as a first-line gold standard treatment for anthracycline extravasations in order to avoid the terrible tissue damage that otherwise can occur. The new guidelines published by EONS state that Savene® is now recommended as the standard treatment for anthracycline extravasation being the only licensed treatment for this indication. The 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. The Oncology Nursing Society in the United Kingdom (UKONS) has subsequently adopted the EONS guidelines and the recommendation for the use of Savene®. Savene® (marketed under the Totect® brand in the USA) 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®. Sales of Savene® in Europe and Totect® in the USA are really starting to accelerate, and sales in the combined European and US markets are expected to double from 2007 to 2008.
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05.09.2008 Positive SPA reply from the FDA for TopoTarget's pivotal trial with belinostat in PTCL English Danish
19.08.2008 TopoTarget reports Q2 English Danish Conf Call Presentation
24.07.2008 Phase IV post marketing study results for Totect® accepted by the FDA English Danish
09.07.2008 TopoTarget Present New Clinical Results with belinostat at the 33rd ESMO Congress and the 7th Biennial Ovarian Cancer Research Symposium English Danish
19.06.2008 TopoTarget received detailed advice from the FDA concerning its pivotal trial with belinostat in PTCL English Danish
06.06.2008 TopoTarget announces positive data from a phase II study of belinostat monotherapy English Danish Posterpresentation
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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 9 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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