TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen Ø
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com
To OMX Nordic Exchange Copenhagen, Investor News
Investor News No. 04-08 / Copenhagen, May 16, 2008
TopoTarget Announces Presentations of belinostat clinical data at the American
Society of Clinical Oncology (ASCO) 2008 Annual Meeting and the 2008
International Conference on Malignant Lymphoma
Copenhagen, Denmark - May 16, 2008 - TopoTarget A/S (OMX: TOPO) today
announced the presentation of clinical data from two ongoing company sponsored
belinostat Phase II studies at the ASCO 2008 Annual Meeting being held in
Chicago, IL, US from May 30-June 3 and data from the ongoing T-Cell Lymphoma
Phase II study at the 2008 International Conference on Malignant Lymphoma being
held in Lugano, Switzerland on June 4-7 2008. In addition, data from two NCI
sponsored studies (belinostat monotherapy in patients with ovarian tumors, and
belinostat in combination with azacytidine in patients with myeloid neoplasms)
will be presented at ASCO. TopoTarget will host a conference call with
management at 2pm CET on 2 June 2008 to discuss the results from ASCO and
provide an update on the belinostat clinical development programme.
ASCO presentation details:
Title: Phase II Multicenter Trial of the Histone Deactylase Inhibitor (HDACi)
Belinostat, Carboplatin and Paclitaxel (BelCaP) in Patients (pts) with Relapsed
Epithelial Ovarian Cancer (EOC)
Date/Time: Sat May 31/2-6pm local time poster display
Location: Room S403
Poster Discussion Sat May 31/5-6pm local time
Location: Room S406
Title: A phase II trial of the Histone Deacetylase inhibitor Belinostat
(PXD101) in patients with platinum resistant epithelial ovarian tumors and
micropapillary/borderline (LMP) ovarian tumors. A Trial of the PMH Phase II
Consortium. (NCI sponsored)
Date/Time: Sat May 31/2-6pm poster display
Location: Room S403
Poster Discussion Sat May 31/5-6pm
Location: Room S406
Title: Phase I study of PXD101 plus azacitidine (AZC) in patients with advanced
myeloid neoplasms (NCI sponsored)
Date/Time: Sat May 31/8am-12 noon General Poster session
Location: S Hall A1
International Conference on Malignant Lymphoma presentation details
Title: Phase II open-label trial of Belinostat (PXD101) in patients with
recurrent or refractory peripheral or cutaneous T-Cell Lymphoma
Date/Time: June 5, 8am-6pm local time poster display
Poster discussion 12.05pm-1pm
Room:MarqueeParcoCiani
The posters for presentations of company sponsored studies will subsequently be
available on www.topotarget.com.
Dial in numbers for telephone conference call on June 2 at 2.00pm CET,
Dial phone number for:
Europe: +45 3690 0936
US: (+1) 866 481 9887
Enter the host-id: 70843
Enter PIN: 9339 (speak and listen) / 6050 (listen only)
TopoTarget A/S
For further information, please contact:
Ulla Hald Buhl Telephone +45 39 17 83 92
Director IR & Communications Mobile +45 21 70 10 49
Background information
About TopoTarget
TopoTarget (OMX: TOPO) is a biotech company, headquartered in Denmark and with
subsidiaries in the US, Switzerland, Germany and the UK, 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 highly predictive cancer models and key cancer targets
(including HDACi, NAD+, mTOR, FasLigand and topoisomerase II inhibitors) and a
strong development foundation has been built. TopoTarget has a broad portfolio
of small molecule pre-clinical drug candidates and nine drugs (both small
molecules and protein based) are in clinical development, including both novel
anti-cancer therapeutics and new cancer indications for existing drugs.
Savene®/Totect® was approved by EMEA in 2006 and the FDA in 2007 and is
TopoTarget's first product on the market. For more information, please refer to
www.topotarget.com.
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, cis-retinoic acid,
azacitidine 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 currently being evaluated in multiple clinical trials
as a potential treatment for cutaneous and peripheral T-cell lymphomas, B-cell
lymphomas, AML, mesothelioma, soft tissue sarcoma, MDS, and liver, colorectal,
and ovarian cancers, either alone or in combination with anti- cancer
therapies. An oral formulation of belinostat is also being evaluated in a
Phase I clinical trial for patients with advanced solid tumors. In August
2004, CuraGen signed a Clinical Trials Agreement with the NCI under which the
NCI will sponsor several clinical trials to investigate belinostat 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
preclinical and nonclinical studies on belinostat in order to better understand
its anti-tumor activity and to provide supporting information for clinical
trials.
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 expo-sure; 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.
