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Press Release; Berlin, December 10th, 2007
MOLOGEN AG submits application for clinical studies with innovative cancer treatment dSLIM®
Berlin, December 10, 2007 - By submitting its clinical study application, Berlin-based biotechnology company MOLOGEN today achieved an important milestone in the product development of its highly innovative immunomodulator dSLIM®. Phase Ib and IIa studies for investigating the safety and effectiveness of dSLIM® for use against various cancer diseases are planned. MOLOGEN expects to receive the study approval from the relevant authorities during the first quarter of 2008. The clinical studies are to be performed firstly in two well-known German cancer centers.
In the dSLIM® technology, MOLOGEN has a highly innovative approach to combating cancer. The approach is based on activation of the human immune system triggered by immunomodulation. This could overcome the body's frequently fatal tolerance of cancer cells. The preclinical and clinical tests with dSLIM® performed so far produced initial indications of good effectiveness and a positive safety profile for the therapy. As a result of the universal mode of action of dSLIM®, it may be possible to use it against a number of cancer diseases as well as other serious illnesses.
Immunomodulators represent a completely new and promising class in the treatment of cancer. According to expert assessments, the market for innovative immunomodulating therapies is expected to be worth USD 8 billion in 2015. With the clinical studies planned to start next year, MOLOGEN is excellently positioned to share in this market development.
“With today’s application for clinical studies with our innovative cancer treatment dSLIM®, we have successfully concluded an intensive phase of preparation”, commented Prof. Dr. Burghardt Wittig, CEO of MOLOGEN AG. “The application is based on all knowledge we obtained from previous investigator driven studies. We now hope to start the applied clinical tests as soon as possible. Initial first results should be available as early as next year.”
dSLIM® - an innovative TLR9-agonist In dSLIM® (“double Stem Loop Immunomodulator”), MOLOGEN has developed an innovative Toll-like Receptor 9 (TLR9)-agonist. The effect of the dSLIM® molecules is triggered inter alia by binding to TLR9 which occur in certain human immune cells. TLR9 recognize certain patterns within the DNA of penetrating pathogens which are not present in the DNA of men and animals. Thanks to their special structure and sequence, the dSLIM® molecules simulate the penetration of pathogens, thus activating the immune system.
Due to its broad range of activity, dSLIM® can be used for rapid defense against infections, even if the type of pathogen and therewith its target structures (antigens) is not yet known. Based on this properties, dSLIM® is in particular suitable for the use in cancer treatment. The manifold target structures (antigens) of a patient’s tumor disease are often, due to patient specific distinctions, not known. dSLIM® activates the immune system against the individual cancer antigens and induces in this field particularly pronounced anti-tumor effects.
About MOLOGENMOLOGEN AG, a biopharmaceutical company based in Berlin, specializes in the research and development of innovative medicines based on DNA structures (DNA: deoxyribonucleic acid).
Its patented DNA-based technology platforms MIDGE® and dSLIM® form a universal foundation with a wide range of possible applications. Activities focus on product developments for the treatment of cancer and vaccines for serious infections in humans and animals.
MOLOGEN was founded in 1998 and was the first German biotechnology company to go public. MOLOGEN AG shares are listed in the General Standard of Deutsche Börse (ISIN DE 0006637200).
Disclaimer concerning prognosesCertain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.
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