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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

Topotarget announces updates on belinostat in two clinical trials - NSCLC and ovarian cancer

14-03-11 kl. 14/3 2011 13:46 | TopoTarget 0,00 (0,00%)

Copenhagen, Denmark - 14 March, 2011 - Today Topotarget A/S (NASDAQ OMX:
TOPO.CO) announced updates on belinostat in two clinical trials - NSCLC and
ovarian cancer.

NSCLC - SPI-1014-Bel (Topotarget-Spectrum joint collaboration)

The SPI-1014-Bel trial has enrolled the first patient in the
Topotarget/Spectrum-sponsored phase I/II trial of belinostat in combination
with carboplatin and paclitaxel in patients with stage IV NSCLC (non-small cell
lung cancer).

The study

The study is an open-label single-arm phase I/II with belinostat in combination
with carboplatin and paclitaxel in patients with previously untreated NSCLC. In
phase I, the primary study objective is to determine the maximal tolerable dose
of belinostat in combination with carboplatin and paclitaxel in the first-line
treatment of patients with NSCLC. In the second stage of the study, the
objective is to estimate the efficacy and safety of the combination.

Belinostat is administered as a 30-minute daily IV infusion on day one through
five with carboplatin and paclitaxel been administered on day three. Treatment
is given every third week and is repeated until disease progression. The study
is expected to recruit 35 patients.

Axel Mescheder, MD, CDMO says: “The initiation of the NSCLC cancer study is a
significant step forward for Topotarget as in this trial the BelCaP combination
will be used and we believe that this triple combination offers the highest
potential for clinical proof of benefit in the treatment of selected solid
tumors such as ovarian cancer, bladder cancer and non-small cell lung cancer.
In our pre-clinical model systems, we have shown excellent synergy between
belinostat and the combination of carboplatin and paclitaxel in lung cancer
cell lines. This treatment regimen was also used in the Topotarget-sponsored
trial in patients with cancer of unknown primaries which recently completed
enrollment”.

Ovarian cancer - GOG 0126-T (NCI-driven study)

Preliminary analysis of GOG 0126-T trial has not shown enough activity to enter
into second stage. Consequently the study will be ended.

The study

The study is an open-label single-arm phase II trial with belinostat in
combination with carboplatin given to patients with ovarian cancer who progress
during or shortly after first-line treatment with platinum containing
chemotherapy. The trial is sponsored by the GOG with support from the NCI.
Belinostat is administered as a 30-minute daily IV infusion on day one through
five with carboplatin being administered on day three. Treatment is given every
third week and is repeated until disease progression.

Axel Mescheder, MD, CDMO says that according to NCI: “The preliminary analysis
of the first stage of the GOG trial did not show enough activity to continue
into stage 2. However, in the GOG trial, belinostat was combined with
carboplatin only and this, in our minds, does not exploit the full potential of
belinostat. This is clearly demonstrated in an earlier Topotarget-sponsored
trial, CLN-8, where 21 heavily pretreated patients suffering from ovarian
cancer showed encouraging activity of the BelCaP combination treatment
(belinostat, carboplatin and paclitaxel - triple therapy) with a response rate
of 24%, progression-free survival of 5.5 months and a progression-free survival
at 6 months of 37%. The results from CLN-8 have been presented at the
AACR-NCI-EORTC conference in 2008 and demonstrate that the BelCaP regimen
warrants further investigation in a larger and controlled trial“. He continues:
”We will await more data from the NCI/GOG trial for thorough analysis. Further
plans will be envisioned based on triple combination at a later stage in
respect to our clinical development in ovarian cancer”.


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

Axel Mescheder, CDMO: Direct: +45 39 17 83 14; Mobile: +45 51 55
71 66

Anders Vadsholt, CFO: Direct: +45 39 17 83 45; Mobile: +45 28
98 90 55

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 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, 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 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.

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 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 commercialise
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 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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