CBio gears up for Phase II trials of autoimmune drug

Queensland biotech CBio presented its Phase I clinical trial results at the World Congress of Immunology in Montreal last week, and is raising capital and readying itself for Phase II trials.

The company completed its Phase I clinical trials for its lead candidate Chaperonin 10 (Cpn10) as a potential therapeutic for autoimmune diseases including multiple sclerosis and rheumatoid arthritis earlier this year.

Cpn10, a member of the heat shock family of proteins, shows a reproducible biological response indicating systemic anti-inflammatory activity.

"The results were very clear," said CEO Dr Wolf Hanisch.

In the Phase Ia trial, which looked at escalating doses in healthy volunteers, measurable changes in a surrogate marker chosen to track modification of the immune response were observed above the threshold dose. And in the Phase Ib trial, which looked at the response to repeated doses of the drug in multiple sclerosis patients whose disease was in remission, 100 per cent of the patients showed the response. In both cases the drug appeared to be safe and well tolerated.

With approval of Phase II trials likely to occur in the near future, CBio is planning to conduct several staggered Phase IIa trials to evaluate the drug in a variety of autoimmune conditions including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. The first Phase IIa trial is expected to begin before the end of this year, with additional trials in place by the end of the first quarter of 2005, Hanisch said.

The public unlisted company, whose shareholders include Psiron (ASX: PSX), Uniquest and the Australian Technology Innovation Fund, raised $4 million in an oversubscribed placement earlier this year to support preparations for the Phase II clinical trials.

A second capital raising is underway to raise an additional $10 million to finance the first stage of the Phase II trials.

CBio is also in the process of acquiring a controlling 51 per cent interest in ailing biotech company Bresagen (ASX: BGN), which went into voluntary administration in January.

"Bresagen was making our Phase II material so by taking control of Bresagen we will ensure access to clinical material," Hanisch said. "But it will stay Bresagen ... the company will develop its own business plan and be autonomous. We would like to see Bresagen be successful again."

According to Hanisch, CBio has no plans to use Bresagen as a vehicle to list on the Australian Stock Exchange.