Autoimmune's Oral Tolerance Drugs Reach Pivotal Stage

Throughout the next 12 months, Autoimmune is set to present important new data in support of its proprietary oral tolerance technology, and now has resources in place to complete three different product license applications, according to president and chief executive Robert Bishop. The three applications will be for Myloral in multiple sclerosis, Colloral for rheumatoid arthritis and a second application for Colloral in juvenile arthritis.

Myloral is now in Phase III testing at 14 sites across North America. This trial has been designed to take into account some of the interesting findings in Phase I/II study, which indicate that some patients may be more responsive to Myloral than others. For example, males seemed to be more responsive to Myloral than females, as were patients who lacked the immunological marker protein DR2, noted Dr Bishop. The Phase I/II data indicated that Myloral reduced the number of exacerbations by 50% in male, DR2-negative patients.

The primary endpoint used in this study is the same as that used in the pivotal trial which supported the approval for Berlex' interferon beta-1b product. Secondary endpoints will include magnetic resonance imaging measures and disability status scores used by Biogen in its interferon beta-1a drug.