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Patients randomized in the second segment (cohorts 4 to 6) of this Phase I/II study are currently being followed for safety and improvement in swelling of injected joints as well as additional measures aimed to assess functional improvement in treated joints. MRI will also be performed on treated joints in a subset of subjects. Data from cohorts in the Phase II segment are anticipated to provide additional insight into clinical observations and duration of response, as well as correlate clinical observations with image-based assessments of disease severity and response to tgAAC94. These data will guide further clinical development and design of the subsequent Phase II study. The Company expects to present additional data from the study in the second half of 2007, with complete results anticipated in mid-2008.

About the Trial

The Phase I/II trial is designed to enroll 120 patients with inflammatory arthritis in six cohorts, each with 20 subjects. Within each cohort, 15 patients receive tgAAC94 and five receive placebo, administered by injection to affected joints. The first three cohorts evaluated doses of 1x10(11), 1x10(12) and 1x10(13) DRP/mL joint volume, respectively. Enrollment in these three cohorts was sequential (e.g. cohort 1 was filled before subjects were enrolled in cohort 2, etc.). Cohorts 4 to 6 will evaluate the same three doses, but patients will be randomly assigned to a cohort so that all three cohorts will enroll subjects simultaneously. This randomization is designed to ensure that each dose is evaluated in a patient population with similar demographics, prior therapy and disease severity.

About tgAAC94

tgAAC94 is being developed as a potential supplement to systemic anti-TNF
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