To the OMX Nordic Exchange Copenhagen
Announcement No. 29 / Copenhagen 7 August 2007
Update on clinical trials of belinostat
Copenhagen, Denmark - 7 August 2007 - TopoTarget A/S (Copenhagen Stock
Exchange: TOPO) announced today an update on belinostat an intravenous and oral
pan HDACi for the treatment of multiple cancer indications in clinical
development.
Belinostat is developed as an intravenous and oral administration and is
currently evaluated in a total of 15 studies run by CuraGen, TopoTarget and the
NCI (National Cancer Institute, US).
TopoTarget whishes to give an update on the following trials:
Belinostat in combination with Velcade® (bortezomib) for Injection against
Multiple Myeloma (MM)
In the Phase II open-label clinical trial evaluating intravenous belinostat in
combination with Velcade® (bortezomib) for Injection in patients with advanced,
refractory MM, two out of four patients enrolled developed acute deterioration
in already existing renal insufficiency (ARI) in the first cycle of combination
treatment. ARI is a common complication in the treatment of MM patients due to
deposition of myeloma protein in the kidney. Three similar events were seen in
previously conducted single agent studies with belinostat in patients with MM.
No ARI has been observed in any other indication for which intravenous or oral
belinostat is being evaluated.
An ongoing Phase I NCI-sponsored clinical trial evaluating intravenous
belinostat plus Velcade® (bortezomib) for Injection against solid tumors and
lymphoma remains open for enrollment and is continuing to treat patients with
the combination.
Peter Buhl Jensen, CEO of TopoTarget said, "Our data show that this finding is
limited to patients with multiple myeloma, a population known to be at risk of
this complication due to pre-existing renal changes. Until we know more about
how to prevent the complication in this specific patient population, we have
decided not to enroll further patients in this trial and will focus our
resources onto the other ongoing studies in cancer indications where belinostat
is demonstrating a therapeutic benefit. We have reported positive preliminary
safety and efficacy data from three indications including single agent activity
against peripheral T-cell lymphoma and cutaneous T-cell lymphoma, as well as
the combination of belinostat with carboplatin and paclitaxel in the treatment
of ovarian cancer. We are very excited about the activity reported in these
indications, as we feel they represent potential registrational paths for
belinostat and look forward to reporting updated results in the fourth quarter
of 2007."
Belinostat in combination with carboplatin and paclitaxel against ovarian cancer
To date, three partial responses (two confirmed, one unconfirmed) have been
achieved in the 23 heavily pretreated patients with recurrent ovarian cancer
enrolled, of which 14 patients remain on study with best response yet to be
determined. The response rate observed in Stage I of the study design has
triggered expansion of enrollment to a total of 32 patients in this Phase II
Simon-Two stage design clinical trial in order to gain a better estimate of the
objective response rate and duration of response. TopoTarget anticipates
presenting updated results during the fourth quarter of 2007.
Belinostat in combination with carboplatin and paclitaxel against bladder cancer
Patient treatment was recently initiated in this Phase II open-label trial. A
total of 15 patients with transitional cell cancer of the bladder will be
enrolled to evaluate the safety and efficacy of intravenous belinostat in
combination with carboplatin and paclitaxel.
Peter Buhl Jensen further commented, “We are excited by the extent of activity
we have seen with belinostat in combination with carboplatin and paclitaxel,
and look forward to further assessing the activity of the combination from the
maturing data in recurrent ovarian cancer and transitional cell cancer of the
bladder.”
Belinostat in combination with idarubicin against Acute Myelogenous Leukemia
(AML)
A Phase I/II clinical trial evaluating belinostat in combination with the
idarubicin for the treatment of AML is being initiated at multiple sites in the
EU. Patients under the age of 60 with relapsed or refractory AML, or patients
over 60 with newly diagnosed or previously treated AML, are eligible for
enrollment in the trial. Up to 70 patients will be enrolled and receive
intravenous treatment in one of two regimens. Patients will either receive
intravenous belinostat administered once daily for five days in combination
with idarubicin or a continuous infusion of belinostat with or without
idarubicin. Enrollment into the treatment arms will occur in parallel to
define the maximum tolerated dose (MTD) for each treatment regimen.
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
Tim Corcoran Telephone +44 1235 443 713
Chief Operating Officer Mobile +44 787 656 1027
Background information
About TopoTarget
TopoTarget (OMX - The Nordic Exchange: TOPO) is a biotech company,
headquartered in Denmark and with subsidiaries in the UK, Germany, Switzerland
and the US, 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 eight 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™ is TopoTarget's first product on
the market. The product is expected to be approved and launched in the US in
the second half of 2007. In addition to organic growth, TopoTarget consistently
looks for opportunities to strengthen and expand its activities through
acquisitions and in-licensing. 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.
