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CuraGen and TopoTarget Report Belinostat Results Presented at ASH and Provide Regulatory Update Following End-of-Phase II Meeting with FDA
Date:12/10/2007

ations 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."

Summary of Phase II (CLN-6) Trial Results at ASH

In a poster entitled, "Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma: Results of a Phase II Study," updated data on a total of 32 patients, consisting of 12 patients with PTCL and 20 patients with cutaneous T-cell lymphoma (CTCL) were presented. Two of 10 evaluable patients with PTCL achieved a complete response (CR), and four additional patients had stable disease (SD) lasting a median of 14 weeks (range 12-23 weeks). Assessments for duration of response are ongoing with CR durations of 18 and 21 weeks at the time of presentation. In addition, three of 19 evaluable patients with CTCL achieved an objective response, including one CR and two partial responses (PR), and an additional 8 patients had SD. The CR duration is beyond 55 weeks with follow-up assessments ongoing. 71% of patients with evaluable SWAT scores had an improvement in skin burden of CTCL as demonstrated by a decrease in SWAT score. Enrollment is continuing into the study with a target of approximately 34 patients for each type of lymphoma.

"The quality of activity demonstrated by belinostat in both PTCL and CTCL is encouraging and we look forward to further characterizing the clinical benefit patients with T-cell lymphoma can receive from treatment with intravenous belinostat," commented Dr. Ranjana Advani, Associate Professor of Medicine/Oncology at Stanford Univ
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