CuraGen and TopoTarget Report Belinostat Results Presented at ASH and Provide Regulatory Update Following End-of-Phase II Meeting with FDA

- 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
 ( 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."
 
     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 University School of Medicine
 and lead author of the presentation at ASH.
 
     PTCL Development Plan
 
     As part of the overall development plan for belinostat, CuraGen
 anticipates advancing belinostat into a registrational program for PTCL
 during 2008. Following the End-of-Phase II meeting with the FDA that took
 place on November 29, 2007, CuraGen anticipates submitting a clinical trial
 protocol for SPA review during the first half of 2008 and expects to begin
 treating patients during the second half of 2008. CuraGen anticipates that
 the pivotal trial will be an uncontrolled, open-label clinical trial that
 will enroll approximately 80 to 100 patients with a primary endpoint of
 objective response rate and secondary endpoints including duration of
 response, progression free survival, and overall survival. CuraGen expects
 to provide additional details on the study design and timelines after the
 completion of the SPA process.
 
 

     Conference Call Details and Dial-in Information
     Date:      Tuesday, December 11, 2007
     Time:      9:00 a.m. Eastern time
     Dial-in:   877-272-5391 (domestic)
                706-758-4315 (international)
     Passcode:  27419639
     Webcast:   Access to the live webcast and presentation slides are
                available at http://www.curagen.com
     A replay of the conference call will be available starting at 12:00
 p.m. Eastern time on Tuesday, December 11, 2007 through Friday, January 11,
 2008 by dialing 800-642-1687 (domestic) or 706-645-9291 (international).
 The passcode for the replay is 27419639. An archive of the webcast will
 also be accessible at http://www.curagen.com.
 
     Reprints of the poster presentation will be made available on CuraGen's
 website at http://www.curagen.com or by emailing info@curagen.com
 
     About Peripheral T-cell Lymphoma
 
     Peripheral T-cell lymphoma (PTCL) is a type of non-Hodgkin's Lymphoma
 (NHL) which arises from malignant T-lymphocytes, also known as T-cells, and
 account for approximately 15%, or more than 5,000 cases, of all NHL cases
 diagnosed in the U.S. PTCL tends to be an aggressive form of NHL with a
 five-year survival of less than 30%. There are currently no FDA approved
 drugs for the treatment of PTCL.
 
     About Belinostat
 
     Belinostat is a small molecule histone deactylase (HDAC) inhibitor
 being investigated for its role in the treatment of a wide range of solid
 tumors and hematologic malignancies as a single-agent and in combination
 with other active anti-cancer agents, including carboplatin, paclitaxel,
 cis-retinoic acid, azacitidine, idarubicin and bortezomib. HDAC inhibitors
 represent a new mechanistic class of anti-cancer therapeutics that target
 HDAC enzymes and have been shown to arrest growth of cancer cells
 (including drug resistant subtypes); induce apoptosis, or programmed cell
 death; promote differentiation; inhibit angiogenesis; and sensitize cancer
 cells to overcome drug resistance when used in combination with other
 anti-cancer agents.
 
     Intravenous belinostat is currently being evaluated in multiple
 clinical trials as a potential treatment for cutaneous and peripheral
 T-cell lymphomas, B-cell lymphomas, AML, mesothelioma, soft tissue sarcoma,
 myelodysplastic syndrome, and liver, colorectal, and ovarian cancers,
 either alone or in combination with other anti-cancer therapies. An oral
 formulation of belinostat is also being evaluated in a Phase I clinical
 trial for patients with advanced solid tumors. In August 2004, CuraGen
 signed a Clinical Trials Agreement with the NCI under which the NCI will
 sponsor several clinical trials to investigate belinostat for the treatment
 of various cancers, both as a single-agent and in combination chemotherapy
 regimens. In May 2005, TopoTarget announced the signing of a Cooperative
 Research and Development Agreement (CRADA) with the NCI to conduct
 preclinical and nonclinical studies on belinostat in order to better
 understand its anti-tumor activity and to provide supporting information
 for clinical trials.
 
     About CuraGen
 
     CuraGen Corporation ( CRGN) is a dedicated clinical-stage
 biopharmaceutical company developing diverse approaches for the treatment
 of cancer including the histone deacetylase inhibitor, belinostat, and the
 antibody-drug conjugate, CR011-vcMMAE. By leveraging drug development
 strengths cultivated over the years, CuraGen expects to make a difference
 by advancing its promising therapeutics to address the unmet medical needs
 of cancer patients. CuraGen Corporation is headquartered in Branford,
 Connecticut. For additional information please visit www.curagen.com.
 
     About TopoTarget
 
     TopoTarget (OMX: TOPO) is a biotech company, headquartered in Denmark
 and with subsidiaries in US, Switzerland, Germany and the UK, dedicated to
 finding ''Answers for Cancer'' and developing improved cancer therapies.
 TopoTarget is founded and run by clinical cancer specialists and combines
 years of hands-on clinical experience with in-depth understanding of the
 molecular mechanisms of cancer. Focus lies on highly predictive cancer
 models and key cancer targets (including HDACi, NAD+, mTOR, FASligand and
 topoisomerase II inhibitors) and a strong development foundation has been
 built. TopoTarget has a broad portfolio of small molecule pre-clinical drug
 candidates and nine drugs (both small molecules and protein based) are in
 clinical development, including both novel anti-cancer therapeutics and new
 cancer indications for existing drugs. Savene(TM)/Totect(TM) was approved
 by EMEA in 2006 and the FDA in 2007 and is TopoTarget's first product on
 the market. For more information, please refer to www.topotarget.com.
 
     Safe Harbor
 
     Statements in this press release regarding CuraGen's belinostat
 development program, including CuraGen's plans to expand enrollment in its
 ongoing Phase II study of belinostat for the treatment of T-cell lymphomas,
 submit a clinical trial protocol to the FDA under a Special Protocol
 Assessment, initiate a registrational clinical trial for PTCL and begin
 treating patients under such trial during the second half of 2008 and
 statements regarding the study design and timelines for the potential
 registrational clinical trial may constitute forward-looking statements
 within the meaning of the Private Securities Litigation Reform Act of 1995.
 Forward- looking statements can be identified by terminology such as
 "anticipate," "believe," "could," "could increase the likelihood,"
 "estimate," "expect," "intend," "is planned," "may," "should," "will,"
 "will enable," "would be expected," "look forward," "may provide," "would"
 or similar terms, variations of such terms or the negative of those terms.
 Such forward-looking statements involve known and unknown risks,
 uncertainties and other factors including the risk that any one or more of
 CuraGen's drug development programs will not proceed as planned for
 technical, scientific, regulatory or commercial reasons or due to patient
 enrollment issues or based on new information from nonclinical or clinical
 studies or from other sources, the success of competing products and
 technologies, CuraGen's stage of development as a biopharmaceutical
 company, government regulation and healthcare reform, technological
 uncertainty and product development risks, product liability exposure,
 uncertainty of additional funding, CuraGen's history of incurring losses
 and the uncertainty of achieving profitability, reliance on research
 collaborations and strategic alliances, competition, patent infringement
 claims against CuraGen's products, processes and technologies, CuraGen's
 ability to protect its patents and proprietary rights and uncertainties
 relating to commercialization rights, as well as those risks, uncertainties
 and factors referred to in CuraGen's Quarterly Report on Form 10-Q for the
 quarter ended September 30, 2007, filed with the Securities and Exchange
 Commission under the section "Risk Factors," as well as other documents
 that may be filed by CuraGen from time to time with the Securities and
 Exchange Commission. As a result of such risks, uncertainties and factors,
 CuraGen's actual results may differ materially from any future results,
 performance or achievements discussed in or implied by the forward-looking
 statements contained herein. CuraGen is providing the information in this
 press release as of this date and assumes no obligations to update the
 information included in this press release or revise any forward-looking
 statements, whether as a result of new information, future events or
 otherwise.
 
 

     CRGN-P
 
     Contacts:
     Glenn Schulman, PharmD
     Director of Investor Relations
     gschulman@curagen.com
     (888) 436-6642
 
 

SOURCE CuraGen Corporation