First stage accrual of a belinostat phase 2 trial in platinum-resistant ovarian cancer by the Gynecologic Oncology Group (GOG) completed
15-11-10 kl. 15/11 2010 06:38 | TopoTarget 0,00 (0,00%)
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Announcement No. 26-10 / Copenhagen, 15 November 2010 Topotarget A/S
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Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.Topotarget.com
First stage accrual of a belinostat phase 2 trial in platinum-resistant ovarian
cancer by the Gynecologic Oncology Group (GOG) completed
Copenhagen, Denmark - 15 November 2010 - Topotarget A/S (OMX: TOPO) announced
today that GOG (the Gynecologic Oncology Group, US) has completed first stage
accrual of a phase 2 trial evaluating efficacy and safety of belinostat and
carboplatin in the treatment of recurrent or persistent platinum-resistant
ovarian, fallopian tube or peritoneal cancer. This study is sponsored by the
Division of Cancer Treatment and Diagnosis under a Clinical Trials Agreement
with Topotarget and led by GOG, an NCI supported cooperative group.
Under the heading “This study has been suspended”, GOG has announced the
completion of first stage accrual of a belinostat phase 2 trial in
platinum-resistant ovarian cancer.
This is a second line trial examining the combination of belinostat and
carboplatin given to patients who progress during or shortly after first line
treatment with platinum containing chemotherapy. A total number of 28 patients
had been enrolled on 1 November 2010. During the analysis recruitment is
suspended but will resume if the endpoint of the initial analysis is meet.
Today's news does not change Topotarget's full-year financial guidance.
Topotarget A/S
For further information, please contact:
Francois Martelet, CEO: Direct: +45 39 17 83 43; Mobile: +45 51 32 83 41
Anders Vadsholt, CFO: Direct: +45 39 17 83 45; Mobile: +45 28 98 90 55
Background information
About belinostat
Belinostat is a promising 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, doxorubicin, idarubicin,
cis-retinoic acid, azacytidine, 5-FU, etoposide and Velcade® (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 in phase III in peripheral T-cell lymphoma (PTCL) and
is currently being evaluated in multiple clinical trials as a potential
treatment for, cancer of unknown primary (CUP), ovarian cancer, small cell lung
cancer, thymoma, liver, soft tissue sarcoma, lymphoma, AML, Myelodysplastic
Syndrome (MDS), either alone or in combination with other anti-cancer
therapies. Continuous intravenous administration (CIV) is being evaluated in
clinical trials in solid tumours as well as in AML. Topotarget has 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.
About Topotarget
Topotarget (NASDAQ OMX: TOPO) is a Scandinavian based international biotech
company headquartered in Denmark, dedicated to improve cancer therapies. In
collaboration with Spectrum Pharmaceuticals, Inc. Topotarget currently focuses
on the development in pivotal studies of its lead drug candidate, belinostat,
which has demonstrated a clear anti neoplastic effect in both hematological
malignancies and solid tumors. Belinostat can be used in combination with full
doses of chemotherapy, and is currently in a pivotal trial within PTCL
(peripheral T-cell lymphoma) and phase II in cancer of unknown primary (CUP).
Topotarget's key cancer drug targets are HDAC, NAD+, mTOR, Fas ligand and
topoisomerase II. Totect® is a product on the market developed from
Topotarget's drug discovery technology. Totect® is marketed by the company's
own sales specialists in the US. The European rights to Savene® were divested
in March 2010 as a consequence of the focus to develop and commercialize
belinostat. For more information, please refer to www.topotarget.com.
Topotarget Safe Harbour Statement
This announcement may contain forward-looking statements, including statements
about our expectations of the progression of our preclinical and clinical
pipeline including the timing for commencement and completion of clinical
trials and with respect to cash burn guidance. Such statements are based on
management's current expectations and are subject to a number of risks and
uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements. Topotarget cautions 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 drug development programs of
Topotarget will not proceed as planned for technical, scientific or commercial
reasons or due to patient enrolment issues or based on new information from
non-clinical or clinical studies or from other sources; the success of
competing products and technologies; technological uncertainty and product
development risks; uncertainty of additional funding; Topotarget's history of
incurring losses and the uncertainty of achieving profitability; Topotarget's
stage of development as a biopharmaceutical company; government regulation;
patent infringement claims against Topotarget's products, processes and
technologies; the ability to protect Topotarget's patents and proprietary
rights; uncertainties relating to commercialization rights; and product
liability exposure; We disclaim 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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