MediGene: Dose-Finding Trial of Oncolytic Virus NV1020 for the Treatment of Liver Metastases Shows Efficacy Trends

Martinsried/Munich – September 15, 2006. The biotech company MediGene AG (Frankfurt, Prime Standard) announced today that the interim analysis of the phase I/II trial of the cancer-killing virus NV1020 for the treatment of liver metastases in patients suffering from colorectal carcinoma has shown a clear indication of efficacy. Therefore the trial will be continued as scheduled, with the maximum dosage of the viruses.
In the first stage of the trial, 13 patients whose cancer was progressing despite treatment with chemotherapeutics and monoclonal antibodies were medicated with oncolytic viruses in different concentration. A total of four virus injections was administered at weekly intervals through the hepatic artery into the patients’ livers affected by metastases. Imaging techniques, clinical appearance, as well as blood analyses verify that the viruses have a dose dependent therapeutic effect in the patients treated. All patients receiving the maximum dosage showed either a disease stabilization or even a clear regression of liver metastases. Moreover, some of the patients showed regressing metastases in other organs as well, which indicates an effect of the viruses even beyond local application. Since the treatment shows a very good safety profile, the Data Safety Monitoring Board (DSMB), an independent board for the surveillance of the patients’ safety, has unanimously recommended the continuation of the trial with the maximum dosage. Due to the encouraging efficacy trends, another 18 patients are to be enrolled in the second part of the trial which is conducted by several medical centers at renowned US universities.
“We are going to continue this trial with great enthusiasm. We are encouraged not only by the very positive clinical results, but also by the clinical investigators’ great acceptance for our oncolytic HSV as an innovative therapy for cancer diseases”, states Peter Heinrich, Chief Executive Officer of MediGene AG.
NV1020: MediGene’s oncolytic herpes simplex virus (HSV) NV1020 is designed to selectively multiply in tumor cells, thus destroying the tumor (oncolysis). The technology is based on the assumption that oncolytic HSV function more specifically and efficiently than conventional therapies do, without causing serious adverse events. They could provide a therapeutic alternative against tumors that are inoperable or have developed a resistance to chemotherapy or radiotherapy. Moreover, the combination of oncolytic HSV and standard therapies such as chemotherapy or radiotherapy may create a synergistic effect.
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGene is a trademark of MediGene AG. TM
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MediGene AG is a publicly quoted (Frankfurt: TecDAX), biotechnology company located in Martinsried, Germany and San Diego, USA. MediGene is the first German biotech company with a drug on the market. The NDA for a second drug, Polyphenon® E Ointment, is under review by the FDA. In addition, several drug candidates are currently in clinical development. MediGene also possesses innovative platform technologies. The company’s core competence lies in research and development of novel approaches in anti cancer and autoimmune therapies. Thus MediGene focuses on indications of high medical need and great economic opportunities.

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