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| Datum : | 05.05.2014 |
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DGAP-News: MOLOGEN AG: Submission of international pivotal study IMPALA with MGN1703 in colorectal cancer initiated |
| Meldung : | DGAP-News: MOLOGEN AG / Key word(s): Study MOLOGEN AG: Submission of international pivotal study IMPALA with MGN1703 in colorectal cancer initiated 05.05.2014 / 08:00 --------------------------------------------------------------------- MOLOGEN AG: Submission of international pivotal study IMPALA with MGN1703 in colorectal cancer initiated - Phase III trial evaluates efficacy of MGN1703 as maintenance treatment - Primary endpoint is overall survival (OS) Berlin, May 5, 2014 - MOLOGEN AG has started to submit clinical trial applications for MGN1703 in metastatic colorectal cancer to the competent authorities in Europe. The applications will also be submitted to the responsible ethics committees. The pivotal phase III clinical trial IMPALA is designed as an open-label, two-arms, randomized, controlled and multicenter study. The aim of the study is to evaluate the efficacy of the first-line maintenance treatment with MGN1703 in patients with metastatic colorectal cancer. The primary endpoint of the study is to determine patient overall survival. It is planned to include patients from more than 100 sites in eight European countries, including the five major European pharma markets. In addition, three renowned national cancer associations will participate in the IMPALA trial and contribute their specific expertise: Arbeitsgemeinschaft Internistische Onkologie (AIO) in Germany, Grupo Españiol de Tratamiento de Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) in France. MOLOGEN expects to start first patient enrollment in the second half of 2014, directly after receipt of the necessary approvals. The Chief Medical Officer of MOLOGEN, Dr. Alfredo Zurlo, stated, "We are very encouraged by the interest and support from the leading experts in Europe. As a matter of fact, three very important study groups in Europe, AIO, TTD and GERCOR, will participate in the trial. We are very much looking forward to starting the trial soon." The coordinating study investigators are Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, head of Klinik für Tumorbiologie Freiburg at the Albert Ludwigs University in Freiburg. They are members of the international steering committee* of the IMPALA study among other leading experts in gastrointestinal oncology in Europe. The IMPALA trial is based on the data from the phase II study IMPACT presented at ESMO World Congress on Gastrointestinal Cancer in July 2013. The study was chosen by ESMO to be among the most important contributions of the conference. The final analysis provided proof-of-concept evidence for MGN1703 in terms of efficacy and safety. The pivotal phase III international trial is to confirm these results in a larger number of patients. "It is very exciting to test immunotherapy in patients who suffer from one of the major cancers with high mortality", said Prof. David Cunningham. "Based on the results of the IMPACT study we identified those patients who are best suited to be treated with MGN1703", commented Prof. Dirk Arnold. According to the World Health Organization (WHO), colorectal cancer is among the major cancer indications worldwide and there are approx. 1.4 million newly diagnosed colorectal cancer cases per year. About the IMPALA clinical study in metastatic colorectal cancer IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is an international phase III, randomized, open-label, two-arms, and multicenter clinical study. The trial will include patients with metastatic colorectal cancer who had tumor reduction after receiving first-line chemotherapy with or without biological agents. The primary endpoint is overall survival and secondary study endpoints include progression-free survival from start of induction therapy, toxicity and safety, and Quality of Life (QoL). The design of the phase III study IMPALA will be presented at the ESMO 16th World Congress in Gastrointestinal (GI) Cancer 2014 in Barcelona, Spain, from 25-28 June 2014. *Members of the International Steering Committee: Prof. David Cunningham, UK; Prof. Dirk Arnold, Germany; Prof. Michel Ducreux, France; Prof. Ramon Salazar, Spain; Univ.-Prof. Dr. Werner Scheithauer, Austria; Prof. Alberto Sobrero, Italy; Prof. Eric Van Cutsem, MD, PhD, Belgium; Prof Christophe Tournigand, France. About MGN1703 MGN1703 is based on dSLIM(R) ("double Stem Loop Immunomodulator"), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM(R) activates the immune system against tumor-associated antigens by targeting various receptors on certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM(R), the immune system is able to overcome its fatal tolerance toward cancer cells and TAA and attacks them selectively. Due to this mechanism of action, MGN1703 can be applied to different indications of cancer. About MOLOGEN AG MOLOGEN AG is a publicly listed biotechnology company headquartered in Berlin and specializes in the research and clinical development of innovative drugs in the fields of oncology and infectious diseases. One of the company's most important product candidates is the DNA immunomodulator MGN1703, which is being clinically developed for colorectal cancer and lung cancer. The cell-based cancer therapy MGN1601 for the treatment of renal cancer is also currently at the stage of clinical development. With unique, patented technologies and innovative product developments, MOLOGEN is one of the leading biotechnology companies in the fields of DNA medicine and cell-based therapies. MOLOGEN AG shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange. www.mologen.com Memberships in associations: Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI) MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG. MOLOGEN AG PRESS SERVICE: Prof. h.c. Peter W. Huebner Head of Corporate Communications Tel: +49 - 30 - 84 17 88 - 38 Fax: +49 - 30 - 84 17 88 - 50 huebner@mologen.com INVESTOR RELATIONS: Jörg Petraß Tel: +49 - 30 - 84 17 88 - 13 Fax: +49 - 30 - 84 17 88 - 50 investor@mologen.com External Investor Relations: Kirchhoff Consult AG Sebastian Bucher Tel: +49 - 40 - 60 91 86 - 18 Fax: +49 - 40 - 60 91 86 -16 sebastian.bucher@kirchhoff.de Note about risk for future predictions Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation. End of Corporate News --------------------------------------------------------------------- 05.05.2014 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------- Language: English Company: MOLOGEN AG Fabeckstraße 30 14195 Berlin Germany Phone: 030 / 841788-0 Fax: 030 / 841788-50 E-mail: info@mologen.com Internet: www.mologen.com ISIN: DE0006637200 WKN: 663720 Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, München, Stuttgart End of News DGAP News-Service --------------------------------------------------------------------- 266268 05.05.2014 |
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