MOLOGEN AG
MOLOGEN AG: Final results from IMPACT trial with MGN1703 presented at ESMO WCGI 2013
MOLOGEN AG / Key word(s): Study PRESS RELEASE N 6 / 2013 of 07/05/2013 MOLOGEN AG: Final results from IMPACT trial with MGN1703 presented at ESMO WCGI 2013 Berlin, July 5, 2013 – MOLOGEN AG today announced that Prof. Dr. Hans-Joachim Schmoll has given an oral presentation at ESMO World Congress on Gastroinstestinal Cancer on the final analysis of the IMPACT trial with MGN1703. The abstract ‘Updated results of the phase 2 IMPACT trial: Maintenance with MGN1703 vs placebo in patients with advanced colorectal carcincoma (mCRC)’ had been chosen by ESMO to be among the most noteworthy ones this year. Prof. Schmoll, study coordinator and Director of the Oncological and Hematological Department at Martin-Luther-Universitaet Halle-Wittenberg, presented the results on the primary and secondary endpoints median progression-free survival (PFS) and overall survival (OS). In addition he reported on long-term responders which had been observed in the trial. Moreover, Prof. Schmoll presented new data from a pre-planned analysis on immunological biomarkers. These data showed that patients selected according to a certain biomarker, namely Natural Killer T-cells (NKT-cells), might benefit even more from treatment with MGN1703. The analysis on patients with a proportion of activated NKT-cells above a threshold resulted in a PFS hazard ratio of 0.27 with a p-value of 0.007 in favor of MGN1703. As reported at the ASCO Annual Meeting 2013, other analyses showed that CEA normalization and radiological response after induction chemotherapy may similarly help identify patients with greater benefit when treated with MGN1703. Professor Schmoll commented, ‘The PFS curves show that a subgroup of patients may benefit with this innovative treatment approach. Immune cells activation status or other biomarkers may allow to tailor in the future the maintenance treatment for metastatic CRC patients.’ ‘In the IMPACT trial we could show the efficacy of MGN1703 in activating the immune system and inducing very prolonged responses in a subgroup of patients, as reported by other immunotherapeutic approaches such as the so called ‘checkpoint blockers’. Differently from these however, we did not observe any severe auto immune adverse effect, even in patients treated for more than a year with MGN1703,’ stated Dr. Alfredo Zurlo, Chief Medical Officer of MOLOGEN AG. In summary the now completed final analysis of the IMPACT study has strengthened the proof-of-concept for MGN1703 in terms of efficacy and safety due to the considerably longer follow up. Based on this, MOLOGEN is currently preparing a pivotal international trial to confirm these results in a larger number of patients. In parallel, MOLOGEN pushes forwards its licensing activities for this very promising drug candidate. About the clinical study with MGN1703 (IMPACT study) About MGN1703 About MOLOGEN AG www.mologen.com Memberships in associations: MIDGE(R), dSLIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG.
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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 | |
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220040 05.07.2013 |