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news.Denmark-based biotechnology company TopoTarget has initiated patient recruitment in the pivotal study intended for registration of belinostat as monotherapy in the treatment of patients with peripheral T-cell lymphoma.
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The trial will enroll approximately 120 patients. TopoTarget has a special protocol assessment agreement with the FDA where the design of the study has been agreed.
Furthermore a fast track designation has been granted by the FDA for the development of belinostat in this indication which supports TopoTarget’s rapid market entry strategy. There is currently no standard therapy approved specifically for peripheral T-cell lymphoma (PTCL).
Peter Jensen, professor of TopoTarget, said: “We are proud to be able to announce the initiation of this first pivotal study for belinostat. PTCL is a disease with a poor prognosis for which there is no therapy specifically approved.
“This is the first step in accordance with our clinical development plan to bring belinostat to the market as fast as possible. At the same time we are pursuing the steps necessary to bring belinostat to the market in larger indications like solid tumors in combination therapy to fully exploit the clinical and commercial potential of belinostat.”