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Press Release / Ad-hoc Announcement
MOLOGEN AG: Positive preliminary results onclinical trial with anti-cancer drug
- Preliminary results show superior safety profile - Patients’ responses exceed expectations - Study will be amended with additional dose group - Clinical trial phase 2 to start this year
The aim of the clinical trial phase 1 is mainly to evaluate the safety profile, but also to identify the efficacy potential of different doses of the anti-cancer drug in single and multiple dose settings. In this trial, patients with advanced solid tumors were enrolled for whom no standard therapy exists or who have failed standard therapy. The preliminary safety results show a favorable safety profile of MGN1703 in all patients treated with different doses of the anti-cancer drug for up to 6 weeks. The evaluation of systemic and local tolerability of the treatment exhibited very good results up to the dose of 30 mg.
The preliminary efficacy evaluation shows a high potential of MGN1703 to at least stabilize the underlying advanced solid tumor disease in the chosen patient population: A stable disease after completion of 6 weeks treatment was observed in over 40 per cent of the patients. Until now, four of the responding patients were treated for further 6 weeks with the anti-cancer drug. After completion of the extension therapy, an ongoing stable disease was still observed in two of these patients. This clinical data considerably exceeds the data provided by other current clinical trials conducted in this patient population or observed in best supportive care. The efficacy concept has been further confirmed by investigations of the relationship between the administered dose and the drug distribution in the body (pharmacokinetics) conducted within the scope of this clinical trial.
Based on the favorable safety and pharmacokinetic results in all treatment groups, Mologen AG has decided to extent the on-going study for a further dose increase. Additional quantities of the anti-cancer drug are currently being manufactured. MOLOGEN expects to announce first results from this additional dose group in the fourth quarter 2009. The company is currently intensively engaged in preparing additional clinical trials investigating the efficacy of MGN1703. A clinical trial phase 2 with colorectal cancer patients is scheduled to start this year.
“There are more than 1 million new cases of colorectal cancer worldwide. Approximately 20% of patients have already metastatic disease at diagnosis. According to the SEER cancer statistic review of the National Cancer Institute from 2009, a 5-year survival rate in such patients under using standard chemotherapy regimen remains low and usually can be achieved in approximately 11 % of cases,” says Dr.
About the clinical study with MGN1703 The study is designed as a phase 1b/2a, open-label, multi-centre, single and multiple dose escalation study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered MGN1703 in patients with advanced malignant solid tumors. Each group of patients receive different doses of MGN1703 subcutaneously in a single dose or multiple dose settings. The treatment in the multiple dose setting lasts 6 weeks and, in responded patients, can be extended for further 6 weeks. Primary endpoints are the safety and tolerability of escalating single and multiple doses of subcutaneously administered MGN1703. Secondary endpoints include evaluation of pharmacokinetics and pharmacodynamics of MGN1703 as well as to evaluate preliminary anti-tumor activity of MGN1703 after multiple dosing based on radiological, clinical and immunological parameters.
About MGN1703 MGN1703 is based on MOLOGEN’S proprietary dSLIM® immunomodulator. In dSLIM® (“double Stem Loop Immunomodulator”), MOLOGEN has developed an innovative DNA-based TLR9 agonist. Use of dSLIM® activates the immune system against tumor-associated antigens by targeting the different receptors, primarily TLR9, on certain immune cells. As a result of chemotherapy and radiotherapy, tumor-associated antigens (TAA) are released by cancer cells. The immune system activated by dSLIM® is in a position to overcome its fatal tolerance towards cancer cells and TAA and advance against them strategically.
About MOLOGEN
MOLOGEN 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 prognoses
Certain 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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