CuraGen Corporation
(Nasdaq: CRGN) 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 mesothelioma. This trial
is being sponsored by the National Cancer Institute (NCI) under a Clinical
Trials Agreement with CuraGen for the clinical development of PXD101.
The Phase II clinical trial is an open-label study being led by Suresh
Ramalingam, M.D., Assistant Professor of Medicine at the University of
Pittsburgh School of Medicine in Pittsburgh, PA. Patients with unresectable
malignant pleural mesothelioma, who have failed one prior line of
chemotherapy, will be enrolled and receive PXD101 by intravenous infusion
every three weeks. The primary endpoint for the study is response rate,
with secondary endpoints evaluating safety and measuring both the time to
treatment failure and survival. A total of approximately 37 patients are
expected to be enrolled into this study at multiple sites across the United
States.
"A significant amount of preclinical research suggests that HDAC
inhibitors, including PXD101, alter the regulation of many genes, resulting
in growth inhibition of human mesothelioma cells. Given the ability of HDAC
inhibitors to down-regulate genes such as BCL-XL and VEGF and up-regulate
cell-cycle regulating genes, including p21, we are excited to begin
evaluating PXD101 as a potential treatment for this type of cancer," stated
Dr. Ramalingam. "There are no proven treatment options beyond the
first-line chemotherapy regimen for mesothelioma, highlighting the
importance of evaluating promising therapeutics like PXD101 for this
patient population."
Correlative pharmacodynamic studies will also be conducted to evaluate
the potential inhibition of HDACs in mesothelioma tumor cells from patients
enrolled in this trial. Evaluation of the genes regulating proliferation
and apoptosis (programmed cell death), as well as acetylation of histone
and non-histone proteins, will be performed.
About Mesothelioma
As many as 3,000 new cases of malignant mesothelioma are expected to be
diagnosed in the United States in 2006. Mesothelioma is a type of cancer
arising from the cells, known as mesothelium, with the majority of cancers
beginning in the chest cavity. The incidence of mesothelioma increases with
age and is rarely diagnosed in patients under 55 years old. Although
environmental exposure to certain chemicals and radiation are believed to
play a role in the development of mesothelioma, exposure to asbestos is
believed to be the main cause of mesothelioma. The five-year survival rate
for mesothelioma is approximately 10%, with an average survival of one to
two years following diagnosis.
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 announced the signing of 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 (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 and 454 Life Sciences are headquartered in Branford,
Connecticut. For additional information on the companies please visit
curagen and 454lifesciences.
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
topotarget.
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.
CuraGen Corporation
curagen/
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