CuraGen and TopoTarget Report Belinostat Results Presented at ASH and Provide Regulatory Update Following End-of-Phase II Meeting with FDA
BRANFORD, Conn., December 10, 2007 /PRNewswire-FirstCall/ -- CuraGen Corporation , 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.
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.
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.
CuraGen Corporation 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.
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.
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.
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Posted: December 2007