Copenhagen, Denmark - 26 September 2011 - Today Topotarget A/S (NASDAQ OMX:
TOPO.CO) announced that Topotarget and Spectrum Pharmaceuticals achieve target
enrollment for the pivotal PTCL trial for the treatment of relapsed or
refractory peripheral T-cell lymphoma (PTCL).

-- Registrational trial under a Special Protocol Assessment by FDA
-- Granted Fast Track and Orphan Drug Designation by FDA
-- On track to file New Drug Application in 2012


Topotarget and Spectrum Pharmaceuticals have now completed the enrollment of a
minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma
(PTCL) patients in the PTCL registration trial. Belinostat, a novel HDAC
inhibitor, is being evaluated, under a Special Protocol Assessment (SPA), as
monotherapy treatment for relapsed or refractory PTCL, an indication for which
it has been granted Orphan Drug and Fast Track Designation by the U.S. Food and
Drug Administration (FDA). Central review of pathology for all patients entered
into the trial is currently ongoing.


“It is of major importance to us that we successfully achieved this key
milestone by completing the enrollment of the pivotal BELIEF trial for the
treatment of relapsed or refractory PTCL” says Francois Martelet, MD, CEO of
Topotarget. “We are delighted that our lead project is on track for filing in
the US”.


“We are pleased to announce that belinostat's pivotal, registrational trial in
relapsed/refractory PTCL has achieved its target enrollment,” says Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum
Pharmaceuticals. “Belinostat is a novel HDAC inhibitor that has the potential
to play an important role in therapy for PTCL, an often lethal disease with
significant unmet medical need, and in a variety of other indications. It has
shown to be active as a single agent and in combination with other
chemotherapeutic agents in multiple clinical trials. We plan to file a New Drug
Application in 2012. If approved, we believe belinostat will add value to our
existing hematology/oncology portfolio, increase our current sales efforts in
hematology/oncology, and demonstrate our commitment to developing novel
treatments for lymphoma.”


According to the Lymphoma Research Foundation (www.lymphoma.org), lymphoma is
the most common blood cancer. The two main forms of lymphoma are Hodgkin's
lymphoma (HL) and non-Hodgkin's lymphoma (NHL). Lymphoma occurs when
lymphocytes, a type of white blood cell, grow abnormally where they reside in
the lymph glands. The body has two main types of lymphocytes that can develop
into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells). PTCL
comprises a group of rare and aggressive NHLs that develop from mature T-cells.
PTCL accounts for approximately 10 to 15% of all NHL cases in the US.


About the BELIEF Registrational trial

Belinostat is currently in a registrational, pivotal trial, under a SPA, as
monotherapy for relapsed and refractory PTCL, an indication which has been
granted Orphan Drug and Fast Track Designation by the FDA. The registrational
trial is an open-label, multicenter, single arm efficacy and safety trial in
patients with relapsed or refractory PTCL, who have failed at least one prior
systemic therapy. The primary endpoint is centrally reviewed objective overall
response rate (ORR).



Today's news does not change Topotarget's full-year financial guidance for 2011.



Topotarget A/S


For further information, please contact:


Francois Martelet, CEO: Direct: +45 39 17 83 41; Mobile: +45 51
32 83 41

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

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 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.

Belinostat is in pivotal trial in peripheral T-cell lymphoma (PTCL) and is
currently being evaluated in multiple clinical trials using IV and oral
formulation as a potential treatment for cancer of unknown primary (CUP), a
randomized, controlled Ph II trial, 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 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 cancer drug target is HDAC. 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 commercialize 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.

Announcement no. 17-11 Belinostat PTCL trial fully enrolled.pdf