V-5 Immunitor: Interim Phase IIb data

Interim data from 34 patients at a second clinical site in the ongoing, double-blind, Ukrainian Phase IIb Study imm01 trial showed that once-daily oral V5 plus standard of care (SOC) led to a significantly higher rate of mycobacterial clearance in sputum smears vs. placebo (78.3% vs. 0%, p=0.009). Additionally, 23 of 24 patients (95.8%) treated with V5 plus SOC had a reduction in scoring of sputum bacillary load from baseline compared to 1 of 10 patients (10%) who received placebo plus SOC. The average weight gain in all V5-treated patients was 3.5 kg compared to 0.9 kg for the 6 placebo-treated patients who gained weight. V5 also significantly normalized elevated leukocyte counts and reduced erythrocyte sedimentation rate (ESR) from baseline, whereas no significant changes were observed for placebo. SOC consisted of ethambutol, isoniazid, rifampicin, streptomycin and pyrazinamide. Data were published in the Journal of Immune Based Therapies and Vaccines. ...