Healthcare Industry News: 5-FU
News Release - December 14, 2006
CuraGen and TopoTarget Announce Expansion of Belinostat (PXD101) Clinical Trial in Cutaneous T-cell Lymphoma (CTCL)Single agent activity observed in CTCL patients with intravenous belinostat (PXD101)
BRANFORD, Conn., Dec. 14 (HSMN NewsFeed) -- CuraGen Corporation (Nasdaq: CRGN ) and TopoTarget A/S announced today that the companies have reviewed interim efficacy and safety data from the ongoing open-label trial evaluating belinostat (PXD101) monotherapy for the treatment of CTCL. The observed preliminary objective response rates have met the predefined criteria for expansion of the CTCL arm of the trial. The predefined criteria in the protocol required at least 2 objective responses be observed in the first 13 patients treated. The trial will now enroll up to a total of 34 patients with CTCL to further evaluate the single agent activity of intravenous belinostat (PXD101) for the treatment of this cancer.
"We are pleased by the interim results which suggest clear demonstration of single agent activity of belinostat (PXD101) being observed in this study. Based on the initial objective response rates in the CTCL arm we are now expanding this study to further characterize the efficacy of belinostat (PXD101) in CTCL, and will continue to enroll peripheral T-cell lymphoma (PTCL) patients into the PTCL arm of the study to evaluate the role of belinostat (PXD101) in the treatment of PTCL and other T-cell lymphomas," commented Dr. Timothy Shannon, Executive Vice President of Research & Development and Chief Medical Officer.
This Phase II study aims to establish the efficacy and safety of belinostat (PXD101) as a single agent treatment for T-cell non-Hodgkin's lymphomas (NHL), enrolling patients into two arms depending on the underlying disease classification. Up to 34 patients with CTCL will be enrolled into one arm. In a parallel arm, ongoing initial enrollment of up to approximately 13 patients with PTCL and other T-cell NHL is being conducted in the trial. The primary endpoint for the study is objective disease response using standardized criteria. Secondary objectives for the study include evaluation of safety, time to response and duration of response following single agent treatment with intravenous belinostat (PXD101). It is anticipated that preliminary results from this open-label, multi-center study will be available by mid-2007.
Dr. Frank Armstrong, President and Chief Executive Officer further commented, "This data adds to the previously reported positive data for belinostat (PXD101) in combination with carboplatin/paclitaxel and with dexamethasone, and enhances our understanding regarding the activity profile of belinostat (PXD101) across a number of different cancer types. We believe that these results, along with the data being generated from our broad development program, will allow us to identify during 2007 the most promising indications to advance into registrational development."
About T-cell Lymphoma
T-cell lymphomas are a type of NHL which arise from malignant T-lymphocytes, also known as T-cells, and account for approximately 15% of all NHL cases diagnosed in the U.S. CTCL is a slow-growing form of cancer where malignant T-cells are drawn to the skin and are usually deposited. CTCL is typically diagnosed in patients age 50 and older. There are approximately 1,500 new cases of CTCL diagnosed annually in the United States with nearly 20,000 patients living with the disease. PTCL and other T-cell NHL also involve malignant T-lymphocytes, and generally tend to be a more aggressive disease. Approximately 5,000 cases of PTCL and other T-cell NHL are diagnosed annually in the United States.
About Belinostat (PXD101)
Belinostat (PXD101) is a promising small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including 5-FU, carboplatin, paclitaxel, cis-retinoic acid, azacitidine and VelcadeŽ (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 (PXD101) is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T- and B-cell lymphomas, AML, mesothelioma, liver, colorectal, ovarian cancers, either alone or in combination with anti-cancer therapies. An oral formulation of belinostat (PXD101) 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 (PXD101) 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 (PXD101) in order to better understand its anti-tumor activity and to provide supporting information for clinical trials.
CuraGen Corporation (Nasdaq: CRGN ) is a biopharmaceutical company developing diverse approaches, including novel protein, antibody, and small molecule therapeutics, that aim to offer hope for patients with cancer, inflammatory diseases, and diabetes. CuraGen's strategic alliances have resulted in a deep pipeline of potential therapeutics that is being developed by the Company's experienced research and development teams. By leveraging the drug development strengths cultivated over the years, CuraGen expects to make a difference in the lives of patients by bringing forward promising therapeutics that address unmet medical needs. To further capitalize on CuraGen's extensive research and development expertise, CuraGen founded a majority-owned subsidiary, 454 Life Sciences, which has developed and is commercializing advanced technologies for the sequencing of DNA. CuraGen is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
TopoTarget (CSE: TOPO ) is a biopharmaceutical company, headquartered in Denmark and with subsidiaries in the UK and Germany, 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 enzyme regulators (mainly HDAC, mTOR, and topoisomerase II inhibitors) and a strong development foundation has been built. TopoTarget has a broad portfolio of small molecule preclinical drug candidates and seven drugs are in clinical development, including both novel anti-cancer therapeutics and new cancer indications for existing drugs. Savene(TM) is TopoTarget's first product on the market. In addition to organic growth, TopoTarget consistently looks for opportunities to strengthen and expand its activities through acquisitions and in-licensing. For more information, please refer to http://www.topotarget.com.
This press release contains forward-looking statements that are subject to certain risks and uncertainties. These forward-looking statements include statements regarding future expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future, including statements about the interim results of our clinical trials, our ability to identify promising indications for belinostat (PXD101) and advance them into registrational development, and the expected benefits of belinostat (PXD101). We caution investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: the risk that any one or more of the belinostat (PXD101) or any other CuraGen drug development program will not proceed as planned for technical, scientific 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; technological uncertainty and product development risks; uncertainty of additional funding; CuraGen's history of incurring losses and the uncertainty of achieving profitability; CuraGen's stage of development as a biopharmaceutical company; government regulation; patent infringement claims against CuraGen's products, processes and technologies; the ability to protect CuraGen's patents and proprietary rights; uncertainties relating to commercialization rights; and product liability exposure. Please refer to CuraGen's Annual and Quarterly Reports on Forms 10-K and 10-Q for a complete description of these risks. CuraGen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.
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