- Conference call to be hosted on Tuesday, December 11th at 9:00 a.m.
Eastern time - - Encouraging clinical results presented at ASH from the ongoing Phase II
trial in T-cell lymphomas - - Positive End-of-Phase II meeting held with the FDA for belinostat in PTCL
-
BRANFORD, Conn., Dec. 10 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced today that updated clinical trial results on intravenous belinostat for the treatment of T-cell lymphomas were reported today at the 2007 American Society of Hematology (ASH) 49th Annual Meeting in Atlanta, GA.
CuraGen and TopoTarget also reported today that the preliminary peripheral T-cell lymphoma (PTCL) results from this ongoing trial were submitted to the U.S. Food and Drug Administration (FDA) as part of an End-of-Phase II meeting held on November 29, 2007 to review the development of intravenous belinostat for the treatment of PTCL. Based on this meeting with the FDA, CuraGen plans to submit a clinical trial protocol to the FDA under a Special Protocol Assessment (SPA) and anticipates initiating a registrational clinical trial for PTCL during the second half of 2008.
"We are very encouraged by the overall activity, the complete responses
and the duration of responses we have observed with belinostat for patients
with advanced T-cell lymphomas. We are opening additional U.S. and
international sites to enhance enrollment in the ongoing Phase II study in
order to increase our understanding of the activity in T-cell lymphomas and
to gear up our oper
'/>"/>
| SOURCE CuraGen Corporation Copyright©2007 PR Newswire. All rights reserved |