MediGene begins clinical trial of potential cancer killing drug

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

G207 is a herpes simplex virus that has been genetically modified to replicate in and kill cancer cells while sparing normal cells. Its unique properties allow it to be delivered directly into brain tumors 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.

The patients participating in the trial suffer from malignant glioma, which is progressive despite radiotherapy and chemotherapy. G207 is one-time administered to these patients, followed by radiation therapy. The trial is designed as a two stage dose de-escalation trial. The first stage includes conventional radiation therapy whereas in the second stage radiation surgery (gamma knife technology) is used.

The work is part of a research collaboration between University of Alabama, Birmingham (UAB) and MediGene, substantially supported by a grant awarded by the National Cancer Institute (NCI). The commercialization rights will remain with MediGene.