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
TopoTarget and CuraGen Report Belinostat Results Presented at ASH and Provide
Regulatory Update Following End-of-Phase II Meeting with FDA
- Encouraging clinical results presented at ASH from the ongoing Phase II trial
in T-cell lymphomas -
- Positive End-of-Phase II meeting held with the FDA for belinostat in PTCL -
- TopoTarget to hold conference call Wednesday, December 12 at 12.30 CET -
Copenhagen, Denmark - December 10, 2007 - TopoTarget A/S (OMX: TOPO) and
CuraGen Corporation (Nasdaq: CRGN), announced today that updated clinical trial
results on intravenous belinostat for the treatment of T-cell lymphomas were
reported today at the 2007 American Society of Hematology (ASH) 49th Annual
Meeting in Atlanta, GA.
TopoTarget and CuraGen also reported today that the preliminary peripheral
T-cell lymphoma (PTCL) results from this ongoing trial were submitted to the US
Food and Drug Administration (FDA) as part of an End-of-Phase II meeting held
on November 29, 2007 to review the development of intravenous belinostat for
the treatment of PTCL. Based on the meeting with the FDA, CuraGen plans to
submit a clinical trial protocol to the FDA under a Special Protocol Assessment
(SPA) and anticipates initiating a registrational clinical trial for PTCL
during the second half of 2008.
“The positive meeting with the FDA have underlined our belief that we have
compelling belinostat data to pursue a rapid to market strategy providing a
treatment for PTCL patients - a disease where there is a clear need for new
treatment alternatives.” said Professor Peter Buhl, CEO of TopoTarget. “In
addition to seeing positive data on PTCL we have also seen Complete Response
(CR) in CTCL and in more than 70% of the evaluable patients we have observed a
reduction in tumour size and severity as measured by SWAT score. Furthermore an
effect was seen in six out of seven patients with pruritus.”
“We are very encouraged by the overall activity, the complete objectives
responses and the duration of responses we have observed with belinostat in
patients with advanced T-cell lymphomas. We are opening additional US and
international sites to enhance enrollment in the ongoing Phase II study in
order to increase our understanding of the activity in T cell lymphomas and to
gear up our operations for the registrational study in PTCL, which we plan to
initiate in the second half of 2008,” commented Dr. Timothy Shannon, President
and Chief Executive Officer of CuraGen. “We are also excited about the
previously reported activity of belinostat in combination with carboplatin and
paclitaxel for the treatment of recurrent ovarian cancer. We are working with
our advisors to define the next steps in this indication, and look forward to
presenting additional Phase II data and clinical development plans in 2008.”
Summary of Phase II (CLN-6) Trial Results at ASH
In a poster entitled, “Belinostat (PXD101) in Patients with Recurrent or
Refractory Peripheral or Cutaneous T-Cell Lymphoma: Results of a Phase II
Study,” updated data on a total of 32 patients, consisting of 12 patients with
PTCL and 20 patients with cutaneous T-cell lymphoma (CTCL) were presented. Two
of 10 evaluable patients with PTCL achieved a complete reponse (CR), and four
additional patients had stable disease (SD) lasting a median of 14 weeks (range
12-23 weeks). The CRs are ongoing with durations of 18 and 21 weeks at the
time of presentation. In addition, 3 of 19 evaluable patients with CTCL
achieved an objective response, including one complete response (CR) and two
partial responses (PR), and an additional 8 patients had SD. The CR is ongoing
beyond 55 weeks. Enrollment is continuing in the study with a target of
approximately 34 patients for each type of lymphoma.
“The quality of activity demonstrated by belinostat in both PTCL and CTCL is
encouraging and we look forward to further characterizing the clinical benefit
patients with T-cell lymphoma can receive from treatment with intravenous
belinostat,” commented Dr. Ranjana Advani, Associate Professor of
Medicine/Oncology at Stanford University School of Medicine and lead author of
the poster presentation at ASH.
PTCL Development Plan
As part of the overall development plan for belinostat, TopoTarget and CuraGen
anticipate advancing belinostat into a registrational program for PTCL.
Following the End-of-Phase II meeting with the FDA, that took place on November
29, 2007, CuraGen anticipates submitting a clinical trial protocol for SPA
review during the first half of 2008 and expects to begin treating patients
during the second half of 2008. CuraGen anticipates that the pivotal trial
will be an uncontrolled, open-label clinical trial that will enroll
approximately 80 to 100 patients with a primary endpoint of objective response
rate and secondary endpoints including duration of response, progression free
survival, and overall survival. CuraGen expects to provide additional details
on the study design and timelines after the completion of the SPA process.
Conference Call Details and Dial-in Information
Date: Wednesday, December 12, 2007
Time: 12.30 CET
How to join the meeting:
Calling from Denmark: + 45 70 26 50 40
Calling from outside Denmark +44 208 817 9301
The poster is available on TopoTarget's website at www.topotarget.com
Today's news does not change TopoTarget's full-year financial guidance for 2007.
TopoTarget A/S
For further information, please contact:
Dr. Peter Buhl Jensen Telephone +45 39 17 83 41
Chief Executive Officer Mobile +45 21 60 89 22
Ulla Hald Buhl Telephone +45 39 17 83 92
Director IR & Communications Mobile +45 21 70 10 49
Background information
About Peripheral T-cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is a type of non-Hodgkin's Lymphoma (NHL)
which arises from malignant T-lymphocytes, also known as T-cells, and account
for approximately 15%, or more than 5,000 cases, of all NHL cases diagnosed in
the U.S. PTCL tends to be an aggressive form of NHL with a five-year survival
of less than 30%. There are currently no FDA approved drugs for the treatment
of PTCL.
About belinostat
Belinostat is a small molecule histone deactylase (HDAC) inhibitor being
investigated for its role in the treatment of a wide range of solid tumors and
hematologic malignancies as a single-agent and in combination with other active
anti-cancer agents, including carboplatin, paclitaxel, cis-retinoic acid,
azacitidine, idarubicin and bortezomib. 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, myelodysplastic syndrome,
and liver, colorectal, and ovarian cancers, either alone or in combination with
other 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.
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 CuraGen
CuraGen Corporation (NASDAQ: CRGN) is a dedicated clinical-stage
biopharmaceutical company developing diverse approaches for the treatment of
cancer including the histone deacetylase inhibitor, belinostat, and the
antibody-drug conjugate, CR011-vcMMAE. By leveraging drug development
strengths cultivated over the years, CuraGen expects to make a difference by
advancing its promising therapeutics to address the unmet medical needs of
cancer patients. CuraGen Corporation is headquartered in Branford, Connecticut.
For additional information please visit www.curagen.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.
