CuraGen Corporation And TopoTarget A/S Announce Initiation Of First National Cancer Institute-Sponsored Clinical Trial With PXD101
BRANFORD, Conn., March 29 /PRNewswire-FirstCall/ -- CuraGen Corporation and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced the initiation of patient dosing in a Phase I clinical trial evaluating the safety and tolerability of PXD101, a small molecule histone deacetylase (HDAC) inhibitor, in combination with bortezomib (Velcade(R)) for the treatment of patients with advanced malignancies, including solid tumors and lymphomas. This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for PXD101 and under a Cooperative Research and Development Agreement (CRADA) with Millennium Pharmaceuticals Inc. for bortezomib. NCI-sponsored clinical trials with PXD101 are being conducted in parallel to those clinical trials sponsored by CuraGen, including the Phase Ib/II study of PXD101 plus Velcade(R) (bortezomib) for the treatment of multiple myeloma initiated last week by CuraGen and TopoTarget.
This Phase I trial is an open-label, dose-escalation study being led by Dr. S. Gail Eckhardt, Director of the Developmental Therapeutics and GI Malignancies Programs and Professor of Medicine at the University of Colorado Health Sciences Center. The study aims to establish the maximum tolerated dose (MTD) and safety profile of PXD101 in combination with bortezomib for patients with advanced solid tumors or lymphomas, which are refractory to standard therapies or for which no standard treatment exists. Up to 36 patients will be enrolled in the dose escalation portion of the study and receive PXD101 and bortezomib in a three week cycle. Following determination of the MTD, the study will enroll approximately ten additional patients to further assess the biologic activity of PXD101 and bortezomib against tumor cells, including inhibition of HDAC and the proteasome.
"Based on the reported preclinical findings for PXD101 and bortezomib, these compounds appear to work through distinct pathways that are complementary to one another, and when combined, demonstrate synergistic activity against certain cancers in vitro. This Phase I study will build our knowledge and understanding of the safety and potential activity of the combination regimen, specifically for patients with refractory solid tumors or advanced lymphomas," stated Dr. Eckhardt, Principal Investigator.
In preclinical in vitro studies, PXD101 monotherapy demonstrated growth- inhibitory activity against a variety of solid tumor types. Furthermore, PXD101 monotherapy inhibited the growth of various hematological cancer cell lines, including lymphomas, at sub-micromolar potency and was highly active against cell lines that were resistant to other chemotherapeutics. Preclinical studies evaluating the combination of HDAC inhibitors and bortezomib have been reported in the literature and indicate synergistic anticancer activity against solid tumor and hematologic cancer cell lines.
About PXD101
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. 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.
PXD101 is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T-cell lymphoma, and colorectal and ovarian cancers, either alone or in combination with anti-cancer therapies. In August 2004, CuraGen signed a Clinical Trials Agreement with the NCI under which the NCI will sponsor several clinical trials to investigate PXD101 for the treatment of various cancers, both as a single-agent and in combination chemotherapy regimens. In May 2005, TopoTarget signed a CRADA with the NCI to conduct pre-clinical and non-clinical studies on PXD101 in order to better understand its anti-tumor activity and to provide supporting information for clinical trials of the therapy.
About CuraGen
CuraGen Corporation is a biopharmaceutical company dedicated to improving the lives of patients by developing a pipeline of novel protein, antibody, and small molecule therapeutics in the areas of oncology, inflammatory diseases, and diabetes. CuraGen has established broad development alliances with Abgenix, TopoTarget, and Bayer, and its experienced preclinical and clinical teams are advancing its pipeline of products for unmet medical needs. CuraGen is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
About TopoTarget
TopoTarget (CSE: TOPO) is a fully integrated biopharmaceutical company, headquartered in Denmark and with subsidiaries in the UK and Germany, and 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 key cancer enzyme regulators (mainly HDAC, mTOR, and topoisomerase II inhibitors) and a strong development foundation of proprietary, highly predictive cancer models has been built. TopoTarget has a broad portfolio of small molecule preclinical drug candidates and eight drugs are in clinical development, consisting of both novel anti-cancer therapeutics and new cancer indications for existing drugs. The most advanced drug candidate, Savene(tm) for extravasations is expected on the market end 2006. 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.
Safe Harbor
This press release contains forward-looking statements including statements about the expected benefits of 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 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 Quarterly Report on Form 10-K for the year ended December 31, 2005 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.
Velcade(R) is a registered trademark of Millennium Pharmaceuticals, Inc. Contact: Glenn Schulman, Pharm.D. Assistant Director of Investor Relations gschulman@curagen.com (888) 436-6642
CuraGen CorporationCONTACT: Glenn Schulman, Pharm.D., Assistant Director of InvestorRelations of CuraGen, +1-888-436-6642, gschulman@curagen.com