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MediGene Completes Patient Recruitment for Clinical Trial of Cancer-Killing Virus NV1020

06 Sep 2007

Today the biotech company MediGene AG completed patient recruitment for the clinical phase I/II trial of cancer-killing viruses (NV1020)

MARTINSRIED and MUNICH, Germany | September 5, 2007 | Today the biotech company MediGene AG (Frankfurt,

Prime Standard: MDG) completed patient recruitment for the clinical phase I/II trial of cancer-killing viruses (NV1020). Following four weeks of treatment, the course of the disease will be observed. The duration of this observation period depends on the patients' response to the treatment. Consequently the final analysis of the trial is expected during 2008.

The phase I/II trial of NV1020 for the treatment of liver metastases in in patients suffering from colorectal carcinoma is conducted by seven oncological centers in the USA. In September 2006, MediGene reported positive safety data and efficacy trends obtained in the first part of the trial. Afterwards the phase II part of the trial of NV1020 was initiated, with another 18 patients enrolled for treatment with the maximum dosage, as scheduled.

Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: "We are glad that we have been able to complete patient recruitment for the phase II part of this trial so quickly. After publishing the interim results last year, we encountered a significantly increased interest in this highly innovative treatment on the part of clinical investigators, patients, and the public in general. Therefore we are awaiting full of suspense the final evaluation of the trial."

NV1020: MediGene's oncolytic herpes simplex virus (oHSV) NV1020 is designed to selectively multiply in tumor cells, thus destroying the tumor (oncolysis). The technology is based on the assumption that oHSV 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 oHSV and standard therapies such as chemotherapy or radiotherapy may create a synergistic effect.

Trial design: The CT 1030 trial is composed of a dose-finding part wich was completed last year, followed by a phase II part to investigate tolerability and efficacy of the optimum dose of NV1020. The patients participating are suffering from a colorectal adenocarcinoma which has metastasized. They are treated with four injections of NV1020, followed by an approved standard chemotherapy. This treatment is administered at renowned oncological centers at seven leading American universities, i.e. Vanderbilt University, Nashville; Mary Crowley Medical Research Center (MCMRC), Dallas; Mayo Clinic Medical School, Rochester; Harvard Medical School, Boston; Memorial Sloan Kettering Cancer Center (MSKCC), New York; University of California San Diego (UCSD), and University of Pittsburgh Liver Cancer Center.
Presentations of the ongoing trial CT1030 held at the following congresses:
- ILCA 2007, October 05-07, 2007. Barcelona, Spain
- ESMO 2007, July 05-08, 2007, Lugano, Switzerland
- ASCO GI Cancer Meeting, January 19-21, 2007, Orlando, FL., USA
- DDW 2006, May 2006, Los Angeles, CA., USA

This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment 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. MediGeneTM is a trademark of MediGene AG.

MediGene AG is a publicly quoted (Frankfurt: Prime Standard: MDG) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company with a drug on the market. Another drug obtained marketing authorization for the USA, two drug candidates are currently undergoing the European approval procedures. Furthermore MediGene has several drug candidates for the treatment of various types of cancer and autoimmune diseases in clinical development, and possesses innovative platform technologies for drug development.

SOURCE: MediGene AG

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