PsiOxus Therapeutics, a U.K.-based development stage biotech, has treated the first patient in its phase I/II clinical trial of ColoAd1 for the treatment of metastatic solid tumors.

The Evolve (EValuating OncoLytic Vaccine Efficacy) study is the first clinical trial of the systemically available oncolytic vaccine ColoAd1, a highly potent, broad-spectrum, anti-cancer therapeutic capable of destroying tumor cells at minute concentrations.

PsiOxus will conduct the multinational phase I/II study at up to 20 sites in Europe. Regulatory approvals to proceed with the study have so far been received for the U.K., Spain and Belgium. The safety, biological activity and efficacy of ColoAd1 will be evaluated in 126 patients, with initial results expected by the end of 2013. The first patient was dosed this week at a site in Belgium.

ColoAd1 was developed using the evolutionary principle of natural selection to generate an oncolytic vaccine with optimal anti-cancer properties. The vaccine is injected into the bloodstream, and is then delivered to the cancer sites, where it replicates inside of cancer cells and kills them. Each infected cell produces thousands of new copies of ColoAd1, which spread to nearby cancer cells and kills them as well, while ignoring normal cells. The approach represents a new generation of “self-amplifying” cancer therapy that has the effect of killing tumors and acting as a cancer vaccine.

“The Evolve study is a major milestone for both PsiOxus and ColoAd1 as we test a new form of anti-cancer agent with greatly improved selectivity for tumor cells in humans for the first time,” said John Beadle, CEO of PsiOxus. “While there remains much work to be done, the Evolve study could forge a path to a new treatment option for patients with metastatic cancer. The advantage of this type of cancer vaccine is that the immune response will be specific for each patient’s own personal cancer.”