BioWorld International Correspondent

MUNICH, Germany - MediGene AG, of Martinsried, announced positive results from a Phase I trial of a virus genetically engineered to treat a form of liver cancer.

The results are welcome news for one of Germany's most prominent biotechnology firms, which had been dealt a setback earlier in 2002 when development of its candidate treatment for congestive heart failure was halted. The company also recently announced a major restructuring that includes spinning off its cardiology unit (see BioWorld International, Aug. 21, 2002). MediGene's stock rose 11 percent on the Neuer Markt, to close at €5.40, on the day of the announcement.

The current study assessed the safety of MediGene's oncolytic herpes simplex virus vector, NV1020, for the treatment of colorectal carcinoma that has metastasized to the liver. The vector has been altered to kill cancer cells and to spare normal tissue. The study, undertaken with the Memorial Sloan-Kettering Cancer Center in New York, established dosages that are well tolerated, and also presented evidence that the vector replicates in tumor tissue.

"We're pleased that with only 12 patients we were able to get a significant amount of data," said Frank Trufaro, managing director of MediGene Inc., the company's San Diego subsidiary. "The study, while preliminary, suggests both efficacy and positive efficiency in manufacturing."

About 140,000 cases of colorectal cancer with metastatic spread to the liver are newly diagnosed in Europe and the U.S. each year. To date, treatments including surgery, radiation and chemotherapy have offered only limited therapeutic benefit. Patients with colorectal metastases to the liver generally have a poor prognosis and a short life expectancy.

"We believe that we have a good frame around the best dose," added Trufaro.

"The study was really a Phase I test where safety was the main objective," said Johanna Holldack, chief operating officer of MediGene AG. "But we did see some shrinkage in the tumors, as well as some CEA indications."

Holldack added that while MediGene is considering partnerships for the later stages of developing NV1020, the company also has the ability to move forward on its own. She said that the positive outcome of the trial confirmed the company's decision to spin off its cardiology unit and focus on oncology.

"We are still negotiating the financing of the spin-off," Holldack said, "and this will have an impact in 2003." She said that MediGene would retain a major stake in the new company."