LONDON - The gene therapy company Cobra Therapeutics Ltd. received approval to go ahead with its first clinical trial, using a gene to trigger the conversion of a prodrug into an active chemotherapeutic within the tumor mass of patients with head and neck and liver cancer.

The trial, in up to 100 patients, will be carried out at the Cancer Research Campaign Institute for Cancer Studies in Birmingham and centers in Europe.

Richard Moulson, finance director, told BioWorld International, "We have already carried out a trial with the prodrug alone, showing it is safe and well tolerated. In this trial we will be assessing safety, looking for evidence that the gene is delivered and expressed, and for tumor shrinkage."

Cobra, of Keele, Staffordshire, also said it has signed license agreements with Coulter Pharmaceuticals Inc., of Palo Alto, Calif., and Glaxo Wellcome plc, of London.

Coulter has taken out a research license to investigate the use of Cobra's ubiquitous chromatin opening elements (UCOE) technology. UCOEs act by opening up the chromatin, which forms the major component of a chromosome. The chromatin is maintained in the open state, resulting in high and sustained levels of gene expression. Because of their ubiquitous nature, UCOEs likely are applicable to a range of conditions in which gene expression is involved.

Glaxo Wellcome has taken a license to evaluate the use of Cobra's operator repressor titration system in its DNA vaccine programs. This is a technique to increase yields in the manufacture of DNA.

Moulson said, "The significance of these licenses goes beyond the financial. This is the first time we have licensed use of our technology to another biotech or big pharma, and so it is an important milestone for the company.

"Clearly it will have a financial benefit," he said. "At first this will not have a big impact but if these technologies work in the hands of the licensees in the way we expect the financial returns could be significant."

Cobra is in the process of raising #5 million. "In the current climate," Moulson said, "fund-raising has become a non-stop exercise, but we are making reasonable progress." The company has sufficient money to fund the clinical trial and Moulson said the trial would not push the burn rate up significantly.