LONDON ¿ KS Biomedix plc said it has achieved positive preliminary results for CBF-BS2 in a Phase II trial in rheumatoid arthritis, and announced a rights issue raising #15.4 million (US$24.5 million) to allow it to move the compound into Phase III.

The money also will be used to fund a Phase III trial of CB-2431 in osteoarthritis after discussions with pharmaceutical companies led KS Biomedix to conclude it should retain control in order to maximize financial returns.

CEO Kim Tan told BioWorld International, ¿We are talking about co-development. We are not going to market these products ourselves; that was never our intention. But what we think we can do better [than a pharmaceutical partner] is manage the clinical side and speed the process.¿ By bearing a minority of the costs of Phase III trials, Tan said it would be possible to double the royalty rate.

The Phase III trial of CBF-BS2 will involve about 800 patients and is expected to start before the end of the year. KS Biomedix, based in London, hopes to sign on two or three regional pharmaceutical companies that in return for helping fund the trial would receive marketing rights in certain territories. ¿We are in an area where a lot of drug development is going on, and the big boys have already got big programs in arthritis. The regional players are keener [to agree to partnerships], yet still have a substantial presence in their territories.¿

The Phase II trial of CBF-BS2 was a multi-center, double-blind placebo-controlled study involving 131 patients with a minimum of 12 months of active disease. Patients were treated for 28 days by daily, oral administration. Patients receiving CBF-BS2 experienced significant improvement over placebo, and no serious side effects were reported. Full analysis of two-, three- and five-month follow-up data will be published in April.

KS Biomedix already has found two potential partners for the osteoarthritis drug CB-2431. ¿We need one more on board to give us input on marketing data to ensure we make the trial as comprehensive as possible,¿ Tan said. Both compounds are small-molecule enzyme inhibitors.

The company also reported progress with its sheep monoclonal antibodies, where it is about to carry out imaging trials on patients. These are designed to confirm the high affinity of the monoclonal antibody 6H9 for colon cancer cells, which was seen in animal studies. If the imaging trial is positive, trials of 6H9 tagged with active drugs should start later this year.

¿The whole monoclonal antibody story is coming to fruition,¿ Tan said. ¿The advantage of our single-chain sheep antibodies is that they have a very high affinity. Once they reach the target they stay bound for eight to 10 days, compared to human or humanized antibodies which dissociate in minutes. This provides a terrific opportunity to kill cancer cells.¿