CuraGen Corporation (CRGN)

[surf1944]

CuraGen and TopoTarget Report Belinostat Results Presented at ASH and Provide Regulatory Update Following End-of-Phase II Meeting with FDA
Monday December 10, 5:00 pm ET
- 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 operations for the registrational study in PTCL, which we plan to initiate in the second half of 2008," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen. "We are also excited about the previously reported activity of belinostat in combination with carboplatin and paclitaxel for the treatment of recurrent ovarian cancer. We are working with our advisors to define the next steps in this indication, and look forward to presenting additional Phase II data and clinical development plans in 2008."
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