MOLOGEN AG extends clinical study to include another dosing group

Berlin, July 27, 2009 – Following positive interim results in the current clinical study with MOLOGEN AG's cancer drug MGN1703, the authorities responsible have approved an extension of the study to include an additional dosing group. This means that the company can now start prompt investigation of the maximum dosage of 60 mg per treatment with two courses of treatment per week. Initial results achieved with this additional dosing group will probably be available towards the end of the third quarter of 2009.

The cancer drug MGN1703 is a DNA-based immune modulator that is being developed for immune therapy with patients who have solid tumours.

Since the patients' response to the innovative new cancer drug in the phase I clinical study has exceeded all expectations, the Management Board of the company took a decision in May to extend the study to include another dosing group. The additional amounts of the cancer drug MGN1703 needed for this purpose have in the meantime been produced, filled and packaged.

The preliminary evaluation of its effectiveness and its positive safety profile indicate that MGN1703 has high potential to at least stabilise the basic illness in the form of an advanced solid tumour with the patient population selected: more than 40 per cent of the patients were in a stable condition after completion of the 6-week course of treatment.

MOLOGEN AG is currently making intensive preparations for additional clinical studies, in which the effectiveness of MGN1703 will be investigated. Phase 2 of the clinical study on patients with colorectal cancer is scheduled to start this year.

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.