BioCentury
ARTICLE | Clinical News

GEN-003: Additional Phase II data

April 4, 2016 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 50 or 75 ug Matrix M given 3 times 21 days apart reduced viral shedding rate, the primary endpoint, by 64% and 52%, respectively, from baseline to 12 months after completion of dosing (p<0.0001 for both). GEN-003 containing 50 or 75 ug Matrix M also reduced genital lesion rate by 65% and 47%, respectively, from baseline to 12 months after completion of dosing (p<0.0001 for both). Additionally, 30% of patients who received GEN-003 containing 50 ug Matrix M and 21% of patients who received GEN-003 containing 75 ug Matrix M were lesion-free at 12 months after completion of dosing. Patients received placebo or 30 and 60 ug intramuscular GEN-003 containing 25, 50 or 75 ug Matrix M given 3 times 21 days apart. Genocea previously reported data from the trial (see BioCentury, May 25, 2015 & Oct. 12, 2015). ...