BRANFORD, Conn., Dec. 19 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced today the initiation of patient dosing in a Phase II open-label, multi-center clinical trial evaluating the efficacy and safety of intravenous belinostat, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of patients with previously-treated thymoma and thymic carcinoma. This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for belinostat.
The Phase II clinical trial is being led by Giuseppe Giaccone, M.D., Ph.D., Chief, Medical Oncology Branch/CCR/NCI in Bethesda, MD. Patients with either thymoma or thymic carcinoma who have received at least one prior platinum-containing chemotherapy regimen are eligible for enrollment. The trial utilizes a Simon 2-stage design and is expected to enroll up to 33 patients who will receive belinostat administered by intravenous infusion once daily for five days every three weeks. Patients will continue to receive treatment with belinostat until disease progression.
The primary objective of the study is to determine the objective response rate by RECIST criteria. Secondary endpoints include evaluation of the time to response, duration of response, progression-free and overall survival. The pharmacodynamic activity of belinostat will also be evaluated by assessment of protein expression, changes in p21 and protein hyperacetylation, and identification of chromosomal gains or losses. Patients will be enrolled at multiple sites in the United States.
"Several key targets of HDAC inhibition, including modulation of T cells, induction of the cyclin-dependent kinase inhibitor p21, and the inhibition of angiogenesis are involved in the pathogenesis and growth of thymic neoplasms. Belinostat was previously shown to have activity in treating a patient with thymoma, and we are therefore very interested in learning more about the potential activity of belinostat from this NCI-sponsored trial," commented Timothy Shannon, President and Chief Executive Officer of CuraGen Corporation.
About Thymoma and Thymic Carcinoma
Thymoma and thymic carcinoma are rare tumors of the thymus with fewer than 1000 patients diagnosed in the United States per year. Histologically the tumors are of epithelial origin and can be classified as well-differentiated thymomas, moderately differentiated atypical thymomas or as poorly differentiated thymic carcinomas. The tumor is situated in the mediastinum and can be either locally invasive or metastatic. Primary treatment is surgery, but due to recurrence, unresectability or metastases there is a need for systemic chemotherapy. Platinum-based chemotherapy regimens are used as first-line treatment, but more than 50% of patients relapse and are in need of second line treatment. There are currently no drugs approved by the FDA for the treatment of thymoma or thymic carcinoma.
Belinostat is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, cis-retinoic acid, azacitidine, idarubicin and Velcade(R) (bortezomib) for Injection. 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, MDS, and liver, colorectal, and ovarian cancers, either alone or in combination with 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 (Nasdaq: 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.
TopoTarget (OMX: TOPO) is a biotech company, headquartered in Denmark and with subsidiaries in the 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 enrollment in and expected progress of clinical trials of belinostat for the treatment of thymoma and thymic carcinoma, 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 the Company'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, the Company'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.
SOURCE CuraGen Corporation