DGAP-News

MOLOGEN AG: Successful financing and continuation of clinical studies with the lead product lefitolimod in the first quarter 2017 - Seite 3

MOLOGEN reached an important milestone in the IMPULSE study in the indication for small cell lung cancer. After the data analysis of the study was completed in the reporting period, the first findings were presented in April: these showed that lefitolimod delivers positive results with regard to overall survival in two of the previously defined subsets of patient groups when compared with the control group. The results of the study also delivered important evidence for the definition of patient groups which can benefit from treatment with lefitolimod beyond the IMPULSE study, even though in this highly challenging indication the primary endpoint OS was not met in the overall study population.

A comprehensive evaluation of data is currently still being carried out. MOLOGEN will be presenting the full study results at an international scientific conference.

The phase I/II TEACH study in the indication HIV that MOLOGEN is conducting in collaboration with the Danish Aarhus University Hospital will be continuing in an extension phase where patients will receive treatment over a longer time frame owing to the favorable results in the first phase of the study, in which a broad activation of the immune system triggered by lefitolimod was observed. According to data presented by Aarhus University at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, U.S., in February of this year, it was revealed through colon biopsies that lefitolimod can trigger a local antiviral immune response in patients with HIV who undergo antiretroviral treatment (ART) without inducing inflammation. Consequently, lefitolimod could be used to eradicate the virus, HIV, through the "kick and kill" concept.

In addition, the U.S. biopharmaceutical company Gilead Sciences, Inc. issued a grant of US$ 2.75 million to Aarhus University for a further combination trial in which lefitolimod will be investigated together with innovative virus-neutralizing antibodies that have been developed by the Rockefeller University in New York, U.S.. This innovative combination will be the latest approach in the "kick and kill" approach for the treatment of HIV.