TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com
Copenhagen, Denmark - 2 November 2009 - TopoTarget A/S (OMX: TOPO) has
announced that data from two clinical trials and one preclinical study from the
belinostat program will be presented at conferences during Q4 2009. A general
presentation of belinostat pipeline will be presented at Cambridge Healthcare
Institute “Discovery on Target 2009” - 3rd Annual Conference on HDACi, in
Cambridge from November 2-3. Data from a phase I NCI-sponsored trial in solid
tumors and lymphomas with belinostat in combination with bortezomib will be
presented at the AACR/EORTC/NCI Molecular Targets and Cancer Therapeutics
Conference held in Boston MA from November 15-18. Data from a preclinical study
of belinostat in combination with the androgen receptor antagonist,
bicalatumide in hormone refractory models of prostate cancer will be presented
at The 2nd European Multidisciplinary Meeting on Urological Cancers in
Barcelona from November 27-29. Final data on the phase II PTCL+CTCL trial that
led to the initiation of the pivotal BELIEF trial in PTCL patients (aimed for
regulatory filing in December 2010) will be presented at an oral session at the
51st Annual Meeting of American Society of Hematology (ASH) 2009 which will be
held in New Orleans, from December 5-8.
Cambridge Healthcare Institute “Discovery on Target 2009” - 3rd Annual
Conference on HDACi, November 2-3, Cambridge, US
Tuesday November 3, 2009 09:10 AM (local time)
General presentation of belinostat pipeline.
Belinostat: A Pan HDAC Inhibitor with Clinical Potential in Both Hematological
Malignancies and Solid Tumors.
Oral presentation by Steven Butcher, Chief Operating Officer, TopoTarget A/S
and Richard Penson, Massachusetts General Hospital.
AACR/EORTC/NCI Molecular Targets and Cancer Therapeutics Conference 2009,
November 15-18, Boston MA, US
Tuesday, November 17, 2009 12:30 PM - 2:30 PM (local time)
A phase I study of Belinostat (PXD101) in combination with Bortezomib in
Patients with advanced solid tumors or Lymphoma.
S Nallapareddy, S Leong, DR Camidge, L Gore, S Diab, DL Gustafson, K Lewis, C
Weekes, A Jimeno, J Wright, I Espinoza-Delgado, SG Eckhardt, CL O'Bryant;
University of Colorado Cancer Center, Aurora, CO, US; Colorado State
University, Fort Collins, CO, US; NCI Cancer Therapy Evaluation Program,
Bethesda, MD, US.
Poster Session B.
Therapeutic Agents: Biological 1.
Location: Halls C-D, 2nd Floor, Hynes Convention Center.
Abstract # permanent B238/temporary # 627.
2nd Multidisciplinary Meeting on Urological cancers in Barcelona EMUC- ESMO
2009, November 27-29th, Barcelona, Spain
Saturday November 28, 2009 13:30 PM - 15.00 PM (local time)
Histone deacetylase inhibitor PXD-101 represses androgen receptor expression
and acts synergistically with castration and bicalutamide treatment to inhibit
prostate cancer growth in Hormone refractory models.
Giovanni Luca Gravina, Paola Muzi, Leda Biord, Enrico Ricevuto, Vincenzo
Tombolini and Claudio Festtuccia; University of L'Aquila, 67100 L'Aquila,
Italy.
Abstract # P002.
51st Annual Meeting of American Society of Hematology (ASH) 2009,
December 5-8, New Orleans, US
Tuesday, December 8, 2009 7:30 AM - 9:00 AM (local time)
Oral presentation of Final Results of a Phase II Trial of Belinostat (PXD101)
in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell
Lymphoma.
Brad Pohlman, Ranjani Advani, Madeleine Duvic, Kenneth Hymes, Tanin
Intragumtornchai, Arnuparp Lekhakula, Ofer Shpilberg, Adam Lerner, Dina
Ben-Yehuda, Marie Beylot-Barry, Uwe Hillen, Jan Fagerberg and Francine Foss.
Session Name: Lymphoma: Chemotherapy, excluding Pre-Clinical Models - New
Treatments.
Room: 260-262 (Ernest N. Morial Convention Center).
Abstract # 20945.
Oral Presentation by: Dr. Pohlman, Cleveland Clinic Taussig Cancer Institute,
Cleveland, OH, US.
TopoTarget A/S
For further information, please contact:
Peter Buhl Jensen Telephone +45 39 17 94 99
CEO Mobile +45 21 60 89 22
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, cis-retinoic acid,
azacytidine 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. An oral formulation of
belinostat is also being evaluated in a Phase I clinical trial for patients
with advanced solid tumors. Several trials in the belinostat program are
conducted under a Clinical Trials Agreement (CTA) under which the NCI sponsors
clinical trials to investigate belinostat for the treatment of various cancers,
both as a single-agent and in combination chemotherapy regimens. Furthermore
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 (OMX: TOPO) is an international biotech company headquartered in
Denmark, dedicated to finding ''Answers for Cancer'' and developing improved
cancer therapies. The company was founded and is run by clinical cancer
specialists and combines years of hands-on clinical experience with in-depth
understanding of the molecular mechanisms of cancer.
TopoTarget has a broad clinical pipeline but is currently focusing on the
development of belinostat, which has shown proof of concept as monotherapy in
treating haematological malignancies and positive results in solid tumours
where it can be used in combination with full doses of chemotherapy, and is in
phase III in PTCL. TopoTarget's expertise in translational research is
utilizing its highly predictive in vivo and in vitro cancer models. TopoTarget
is directing its efforts on key cancer targets including HDACi, NAD+, mTOR,
FasLigand and topoisomerase II inhibitors. The company's first marketed product
Savene®/Totect® was approved by EMEA in 2006 and the FDA in 2007 and is
marketed by TopoTarget's own sales force in Europe and the US. 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 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.
