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MediGene's phase I trial of G207 for treatment of malignant glioma started
San Diego | Friday, June 10, 2005, 08:00 Hrs  [IST]

The German-American biotech company MediGene AG has commenced of a clinical phase I trial of the drug candidate G207 for the treatment of malignant glioma at the University of Alabama, Birmingham (UAB).

This is a research collaboration between UAB and MediGene substantially supported by a SPORE grant (Specialized Programme of Research Excellence) awarded by the National Cancer Institute (NCI). The commercialization rights will remain with MediGene. G207 is a herpes simplex virus, genetically modified for the specific destruction of tumour cells without harming healthy tissue. The first patient has already been enrolled into the trial.

The trial will evaluate safety, tolerability and efficacy trends of G207 as well as potential synergies with radiation therapy. It is planned to enrol approximately 20 patients over the next 24 months. The study's principal investigator, James M. Markert, explains: "Previous clinical studies have shown that single doses of G207 administered intra-cerebrally are well tolerated and suggest that G207 may induce tumour regression. In addition, pre-clinical studies indicate synergism between G207 and radiation therapy."

G207 is a herpes simplex virus that has been genetically engineered to replicate in and kill cancer cells while sparing normal cells. Its unique properties allow it to be delivered directly into brain tumours without harm to surrounding healthy tissue. G207 can be inactivated by common anti-herpes drugs. Further, synergistic effects of combining G207 with standard radiation therapy have been observed in pre-clinical studies.

Malignant gliomas are the most common brain tumours in adults with 10,000 to 15,000 new cases every year.

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