Danish biopharmaceutical company TopoTarget has taken a significant step forward following a green light from the US Food and Drug Administration (FDA) for the company to commence a phase III trial of its candidate cancer drug belinostat in peripheral T-cell lymphoma, writes regional newspaper Fyens Stiftstidende.
Peter Buhl Jensen, CEO of TopoTarget, told the newspaper: "It isn't just that we are going into phase III. It is also agreed that if our study turns out as expected, we will also receive an approval. It is an agreement with the FDA on how our product can reach the American market."
TopoTarget's share price rocketed 23% on the OMX Nordic Exchange Copenhagen following the company's announcement on Friday last week. TopoTarget has been stock exchange listed since 2005.
TopoTarget was founded in 2000, and is headquartered in Denmark with subsidiaries in the US, UK, Switzerland and Germany. The company, which currently employs 95 people, focuses on improved treatments for cancer patients and has a late stage clinical pipeline of eight products.
TopoTarget launched its first product Savene in Europe in 2006, and in the US in 2007 under the name Totect. It is a damage-limiting agent for use following accidental leakage into surrounding tissue of injected anthracycline anti-cancer drugs.