BioCentury
ARTICLE | Clinical News

GEN-003: Additional Phase II data

October 12, 2015 7:00 AM UTC

Additional data from a double-blind, placebo-controlled, U.S. Phase II trial in 310 patients with chronic genital HSV-2 infection showed that 60 ug intramuscular GEN-003 containing 75 ug Matrix M given 3 times 21 days apart reduced viral shedding rate, the primary endpoint, by 58% from baseline to 6 months after completion of dosing (p<0.0001). In 5 of 6 dose groups tested, GEN-003 and Matrix M significantly reduced patient-reported impact on genital lesion rates by 43-69% from baseline to 6 months. Additionally, 30-50% of patients were lesion-free at 6 months. Furthermore, time to first recurrence after completion of dosing with GEN-003 and Matrix M was 152->180 days. Patients are receiving placebo or 30 and 60 ug intramuscular GEN-003 containing 25, 50 or 75 ug Matrix M given 3 times 21 days apart. Data were presented at the IDWEEK meeting in San Diego. ...