CuraGen Corporation And TopoTarget A/S Announce Initiation Of National Cancer Institute-Sponsored Phase II Clinical Trial With PXD101 For Acute Myelogenous Leukemia
BRANFORD, Conn., June 6 /PRNewswire-FirstCall/ -- CuraGen Corporation and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced today the initiation of patient dosing in a Phase II clinical trial evaluating the activity of PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of Acute Myelogenous Leukemia (AML). This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for PXD101 and will be conducted at multiple sites in the United States.
The Phase II clinical trial is an open-label study being led by Kenneth A. Foon, M.D., Director of Clinical Investigations at the University of Pittsburgh Cancer Institute, in collaboration with Mark Kirschbaum, M.D., Director of New Drug Development at City of Hope in Duarte, California. Patients under the age of 60 with relapsed or refractory AML, or patients over 60 with newly diagnosed or with relapsed or refractory AML are eligible for enrollment. Up to 55 patients will be enrolled and receive three week cycles of PXD101 administered by intravenous infusion. Patients demonstrating complete or partial response, as defined by the Revised Recommendations of the International Working Group, will continue to receive treatment with PXD101 until disease progression. The primary endpoint for the study is response rate, with secondary endpoints measuring overall survival and time to treatment failure.
"In preclinical experiments, PXD101 shows potent growth inhibitory activity on leukemic cell lines. The research we have conducted on HDAC inhibitors at City of Hope suggests that agents like PXD101 affect many of the critical pathways cancer cells use for survival," stated Dr. Kirschbaum. "Based on these intriguing results we have initiated patient treatment with PXD101 and look forward to evaluating the role of this HDAC inhibitor for the treatment of AML."
"Approximately 80% of AML patients who respond to first line treatments ultimately relapse and then have limited treatment options. For patients over the age of 60, the available treatments have significant adverse effects that can limit their use in this patient population," stated Dr. Foon. "We are therefore very interested in learning more about the role that HDAC inhibitors, such as PXD101, can play in the treatment of AML and expect to treat patients at the University of Pittsburgh Cancer Institute in the coming months."
Correlative pharmacodynamic studies will also be conducted to evaluate the potential inhibition of HDACs in AML cells from patients treated with PXD101. Evaluation of the genes regulating proliferation and apoptosis (programmed cell death), as well as differential gene expression in AML cells obtained both prior to and following treatment with PXD101 will also be performed.
About Acute Myelogenous Leukemia (AML)
Approximately 12,000 cases of AML, the most common type of leukemia, are expected to be diagnosed in the United States during 2006, with more than 9,000 deaths attributed to this disease. The average age of a person diagnosed with AML is 65 years, with men more likely than women to develop AML. Several chemotherapeutic agents are currently used to treat AML and can lead to initial response rates above 50%. However, the five-year survival for AML patients under the age of 65 is approximately 33%, while patients over 65 years have a five-year survival rate of less than 5%. While some patients may remain in remission for extended periods of time, the majority of AML patients relapse, highlighting the need for improved therapies for the treatment of this disease.
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, including 5-fluorouracil (5-FU), carboplatin, paclitaxel 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.
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 Cooperative Research and Development Agreement (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.
About CuraGen
CuraGen Corporation 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 therapeutics that is being developed by the Company's experienced research and development teams. By leveraging the drug development strength's 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. 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 effects and 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 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.
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 at CuraGen Corporation, +1-888-436-6642, gschulman@curagen.com