BERLIN--(BUSINESS WIRE)--The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed the development strategy of lefitolimod (MGN1703) with the pivotal IMPALA study by scientific advice. “We are pleased with EMA’s agreement to our development program and we are making good progress to finalize the recruitment phase of the study by the end of the year”, said Dr. Mariola Söhngen, Chief Executive Officer of MOLOGEN AG.
IMPALA is a randomized, international, multicenter, open-label phase III trial. The study aims to prove that a switch maintenance therapy with an active immunotherapy leads to an increased overall survival of patients who have achieved a response during their first line treatment of metastatic colorectal cancer. The primary endpoint is overall survival and secondary study endpoints include progression-free survival, toxicity and safety, and Quality of Life (QoL).
Recruitment of the IMPALA study started in September 2014 and is expected to enroll 540 patients in 8 European countries. Patient recruitment is expected to be completed by the end of 2016.
Leading medical associations will collaborate: 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. The steering committee consists of international medical experts; among others the coordinating study investigator Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London.
For more information on the trial IMPALA please visit www.clinicaltrials.gov.
With new and unique technologies and active substances, the biotech company MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a focus on immuno-oncology, MOLOGEN also develops immunotherapies for the treatment of infectious diseases.
The cancer immunotherapy lefitolimod (MGN1703) is the company’s lead product and best-in-class TLR9 agonist. Treatment with lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mechanism of action, lefitolimod (MGN1703) has the potential to be applied to various indications. Lefitolimod (MGN1703) is currently being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small cell lung cancer (randomized controlled trial). Furthermore, it is also being investigated in a phase I study in HIV and a phase I combination study with the checkpoint inhibitor Yervoy® (ipilimumab) is expected to start within the first half 2016.
MOLOGEN’s pipeline focus is on new innovative immunotherapies to treat diseases for which there is a high medical need.
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®, dSLIM®, EnanDIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.
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