Independent Data Monitoring Committee recommends continuation of the belinostat pivotal BELIEF study in Peripheral T-Cell Lymphoma (PTCL)
28-03-11 kl. 28/3 2011 10:55 | TopoTarget 0,00 (0,00%)
Copenhagen, Denmark - 28 March, 2011 - Today Topotarget A/S (NASDAQ OMX:
TOPO.CO) announced independent Data Monitoring Committee recommends
continuation of the belinostat pivotal BELIEF study in PTCL patients.
Recommendations from the Data Monitoring Committee (DMC)
The interim safety assessment and futility analysis were performed after the
first 45 patients have entered the study and have received at least one dose of
belinostat. The PTCL diagnosis had to be confirmed by an independent
international pathology review committee for treated patients to be evaluable.
No safety concerns were raised
-- The DMC recommends that the study continues according to the protocol until
100 evaluable patients are enrolled
The belinostat BELIEF is a pivotal open-label, multicenter, single arm efficacy
and safety study in patients with relapsed or refractory peripheral T-cell
lymphoma who have failed at least one prior systemic therapy. This study is
funding through our US partner Spectrum who expects to file a rolling New Drug
Application for Peripheral T-Cell Lymphoma in 2011/2012.
“We are pleased that the DMC through their independent review found that the
data supports continuation of this pivotal trial,” said Francois Martelet, MD,
CEO of Topotarget. “Belinostat is a novel HDAC inhibitor that has the potential
to play an important role in cancer therapy in a variety of indications. It has
activity as a single agent and in combination at full-doses with other
chemotherapy drugs in multiple cancer clinical trials, has a favorable
tolerability and safety profile, and is being studied via intravenous or oral
administration. We will continue to enroll patients into the BELIEF study,
which is recruiting patients from EU, USA, Israel and South Africa.”
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 41; Mobile: +45 51
32 83 41
Axel Mescheder, CMO: Direct: +45 39 17 83 14; Mobile: +45 51 55
71 66
Annette Lykke, IR Direct: +45 39 17 83 44; Mobile: +45
23 28 98 14
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 pivotal trial 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, and 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 Clinical
Trial Agreement (CTA) with the NCI to clinical studies on belinostat in order
to better understand its anti-tumor activity.
About Topotarget
Topotarget (NASDAQ OMX: TOPO.CO) 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 site
(CUP). Topotarget's cancer drug targets are HDAC, NAD+, 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.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with focus
in oncology. The company's strategy is comprised of acquiring and developing a
broad and diverse pipeline of late-stage clinical and commercial products. For
more information, please visit the company's website at www.sppirx.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 enrollment 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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Announcement No 05-11 Independent Data Monitoring Committee recommends continuation of belinostat pivotal BELIEF-study in PTCL.pdf 



