Establishment of Global Oncology Advisory Board

Copenhagen, Denmark - 8 April, 2011 - Today Topotarget A/S (NASDAQ OMX: TOPO.CO) announced the establishment of the Global Oncology Advisory Board.


 

Topotarget presents the formation of its Global Oncology Advisory Board (GOAB). Professor Jean-Louis Misset is chairing the board. Professor Misset has a strong oncology background as an advisor in the field of drug development. He has been instrumental in the development of several important oncology drugs from companies such as Aventis, Roche and Eli Lilly. Furthermore he has published more than 200 publications in internationally well-known referenced journals.

 

We are confident this group of key opinion leaders will support our efforts in developing our lead compound belinostat. The members of the board are:

 

  • Professor Jean-Louis Misset
    • Professor of Oncology at the University and at the St. Louis Hospital Oncology Division in Paris, France
  • Dr. Matti Aapro
    • Dean of the Multidisciplinary Oncology Institute, Genolier, Switzerland
  • Professor James Cassidy
    • Professor of Oncology and Head of Academic Unit, University of Glasgow, Scotland
  • Assistant Professor Alain Catalin Mita
    • Assistant Professor of Medicine at the University of Texas Health Science Center San Antonio, Texas, US
  • Professor Hans-Joachim Schmoll
    • Professor of Internal Medicine and Director of the Department of Haematology and Oncology at the Martin Luther University, Halle-Wittenberg, Germany
  • Dr. Daniel D. Von Hoff
    • Physician in Chief, Senior Investigator and Director of Clinical Translational Research Division at TGen (Translational Genomics Research Institute) in Phoenix, Arizona, US

In connection with the formation of the GOAB additional indication-specific advisory boards (ISAB) within CUP (cancer of unknown primary), NSCLC (non-small cell lung cancer), bladder cancer, ovarian cancer, and CRC (colorectal cancer) are formed. These ISABs will improve the understanding of the pre-clinical and clinical work of belinostat.


Francois Martelet, CEO says: “We are very pleased to work with this group of distinguished oncologists representing several indications within oncology. During 2010 we have held two meetings and have discussed several potential development strategies for belinostat”. He continues: “During 2011 we plan to hold additional meetings with our global advisors and we believe that their acceptance to join this advisory board is an endorsement of the potential of belinostat”.

 

Today’s news does not change Topotarget’s full-year financial guidance.

 

 

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 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 pivotal trial 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, 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 targets are HDAC, NAD+, and topoisomerase II. 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.


Attachments

Announcement No 08-11 Establisment of Global Oncology Advisory Board.pdf