BioWorld International Correspondent

LONDON - Oxford BioMedica plc won regulatory approval for a second gene therapy clinical trial, a move that qualifies the company to move up from the junior Alternative Investment Market (AIM) to a full listing on the London Stock Exchange.

The approval is for a Phase I/II trial of TroVax, a gene-based cancer vaccine, in colorectal cancer. Twelve patients coming back for a second round of surgery will be treated in the trial, at the Christie Hospital in Manchester. Following surgery they will receive the vaccine, which is designed to stimulate an immune response, prompting the destruction of any residual cancer cells or undetectable metastases.

"We now meet all the criteria for a full listing, and are sure [moving up from AIM] is the right thing to do," Finance Director Andrew Wood told BioWorld International. "The shareholders will be better served.

"We are preparing, but are not committed to a particular date. The last thing we want to do is move up and see the shares decline because of cyclical slump."

However, Wood said he was confident whatever the sector does, Oxford BioMedica, based in Oxford, UK, will have good news flow over the next 12 months. He believes that gene therapy is about to become more popular with investors. "I think it is like the antibody companies, which have been promising good things since the 1980s, and have just started getting products on the market in the past few years.

"The fundamental blockage has been removed. In the past there was no detectable gene transfer in vivo; now there is, and the race is on to see what genes you can get in and what you can do with them."

Within the next two to three years the first gene therapy product will receive approval, he said. "Then anyone else in the field will see a quantum leap in value."

Oxford BioMedica currently has £12 million (US$18 million), enough to last for 24 months, so Wood said he is undecided about whether to use the move to a full listing to raise more money. "Twenty-four months money is a position of relative comfort for a biotech company. But there is a lot of effort involved in the groundwork for moving to the main market, so it may be appropriate to raise money at the same time."

Wood also said he is involved in "some substantial negotiations for serious-value deals," which could mean there is no need to go back to shareholders.

"For example, we could have done a deal last year for TroVax when it was preclinical," he said. "If we get anything like the data we hope for [from the Phase I/II] it will be a 10-times bigger deal."

The TroVax viral delivery system carries a gene encoding for tumor-associated antigens. In preclinical models the vaccine broke immune tolerance to tumors and protected against further tumor growth.