tgAAVCF gene therapy with the CFTR chloride channel: Phase II

TGEN completed a Phase II trial of tgAAVCF in 23 CF patients with sinusitis who received the product in one sinus and placebo in the other. A total of 60 percent of the patients in the study had a recurrence of sinusitis on only one side (unilaterally). However, the unblinding of the data and determination of whether sinusitis recurred in the treated side or the placebo side will not be completed until the end of 1998 and will be submitted for publication in the first quarter of 1999. No adverse events related to treatment have been noted after three months of follow-up. Sinusitis may be a useful surrogate marker for lung disease in CF, TGEN said. ...