Xoma To Fund 25% Of hu1124 Phase III Trial With Genentech Loan

Xoma will fund 25% of Phase III development costs for the monoclonal antibody hu1124 and receive 25% of product revenues according to a new agreement with Genentech announced April 15.

Genentech will fund Xoma's share of development costs with long-term convertible loans payable by 2005 or upon approval of the T-cell inhibitor.

Xoma and Genentech have collaborated on the development of hu1124 (anti-CD11a) since April 1996. Xoma has been responsible for development of the monoclonal antibody for the treatment of psoriasis up through Phase I and Phase II.

Xoma has received $34 mil. from Genentech to date in milestone payments and R&D funding.

The companies are planning to meet with FDA in the near-term to discuss Phase III protocols and the results of the Phase II trials.

Approval of hu1124 will be sought initially for the treatment of psoriasis, but the companies expect to pursue additional indications for T-cell mediated conditions such as rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and asthma, Xoma said.

Phase II data show that 25% of patients treated with hu1124 experienced "excellent" clinical improvement compared to 2% on placebo; 47% hu1124-treated patients demonstrated "good or better" improvement compared with 15% in the placebo-treated group.

The most common side effects are reported to be mild headache and low grade temperature.

Xoma and Genentech stated that initial data indicate hu1124 has a longer half-life and duration benefit over other immunosuppressive treatments for T-cell mediated conditions, such as cyclosporine or methotrexate.

During Phase II trials, hu1124 was administered intravenously once every eight weeks with 30 or 60 minute infusions. Genentech indicated during an April 12 analyst meeting that hu1124 may be administered subcutaneously in Phase III studies.