MediGene AG, of Martinsreid, Germany, and Berlin-based Schering AG commenced multicenter Phase I/II clinical trials of the former company's therapeutic vaccine, HPV16L1E7CVLP, for treatment of precancerous lesions of the cervix caused by human papilloma virus.

"We will have the first patient in November," MediGene spokeswoman Christine Bohner told BioWorld International. The companies did not disclose the locations involved in the trial, nor the anticipated time frame.

The move into the clinic follows the establishment of a global alliance between the two companies in March to commercialize the product. The deal is potentially worth EUR55 million to MediGene, exclusive of royalties on product sales. (See BioWorld International, April 5, 2000.)

The vaccine represents MediGene's third drug candidate to enter the clinic, but it is the first that it has developed in-house. It licensed in its two lead compounds, Etomoxir for congestive heart failure and PolyphenonE ointment for genital warts. Both are nearing the end of Phase II trials, Bohner said, and they are expected to progress to the Phase III stage by the first quarter next year. A second tumor vaccine, for treatment of malignant melanoma, is expected to commence clinical trials early next year, she said.

HPV16L1E7CVLP is based on a fusion protein, which self-assembles to form chimeric virus-like particles (CVLPs) that cause a pseudo-infection. The construct comprises an L1 structural protein, which drives the assembly process and induces the production of neutralizing antibodies, and part of the E7 early viral protein, which elicits a cytotoxic T-cell response. The trial, which will examine both safety and efficacy, will focus primarily on the therapeutic aspect of the drug, Bohner said.

According to MediGene, 450,000 women develop cervical cancer every year, and the disease causes 350,000 deaths annually. The addressable market is, therefore, quite substantial. "We believe it will be around US$250 million in peak sales," Bohner said. The two companies are jointly conducting the current trial. Schering, which holds worldwide rights for sales and sublicensing, will be responsible for subsequent development of the vaccine.

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