In response to older adults representing 90% of annual influenza deaths in the United States, Inovio Pharmaceuticals, Inc. has announced that the first patients have been treated in a clinical trial evaluating immune responses in older adults immunized with Inovio’s H1N1 SynCon® universal influenza vaccine. This Phase I study will evaluate the ability of Inovio’s SynCon vaccine alone as well as in combination with the 2012 seasonal influenza vaccine to generate protective levels of immune responses, antigen-specific antibody immune responses against unmatched influenza strains, and T-cell immune responses.
Funded in part by a grant from the Canadian Institute of Health Research, the trial consists of 50 healthy older adult patients divided into three groups: one group of 20 participants will receive a 2-dose regimen of Inovio’s H1N1 SynCon flu vaccine delivered using Inovio’s proprietary Cellectra® intradermal electroporation device; a second group of 20 participants will receive one dose of Inovio’s SynCon vaccine delivered using electroporation followed by a dose of the 2012 trivalent seasonal flu vaccine 24 weeks later; a third group of 10 participants will receive a placebo delivered by electroporation followed by a dose of the seasonal flu vaccine 24 weeks later. The study will assess the tolerability, safety, and immune responses of the different vaccination regimens.
Source.“Inovio Initiates H1N1 Universal Influenza Vaccine Clinical Trial Targeting Over-65 Population, Which Represents 90% of Flu Deaths.” (2012, July 10). Retrieved August 8, 2012, from the PR News-wire website: http://s.tt/1houN.
Results of a 12-week, head-to-head, Phase III study published in Hypertension found systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone (Edarbyclor®) 40/25 mg were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide (Benicar®) 40/25 mg. Edarbyclor is the first and only hypertension medication to combine an angiotensin II receptor blocker with chlorthalidone, a diuretic, in a once-daily, single tablet.
Results after 12 weeks of treatment showed that the fixed-dose combination of Edarbyclor 40/25 mg reduced clinic SBP by 42.5 mm Hg from baseline. The reductions were statistically significantly (p < 0.001) greater than that of the fixed-dose combination of Benicar 40/25 mg (37.1 mm Hg). Similar results were observed across patient subgroups, including age, sex, and race.
The study sample included 1,071 patients with mean baseline clinic SBPs ranging from 160 to 190 mm Hg and diastolic blood pressures equal to or lower than 119 mm Hg. Two Edarbyclor fixed-dose combination groups were force titrated from 20/12.5 mg and 40/12.5 mg to 40/25 mg and 80/25 mg, respectively. In the Benicar fixed-dose combination group, patients were force titrated from 20/12.5 mg to 40/25 mg, the highest approved dose. The primary endpoint was change from baseline to Week 12 in trough (measured approximately 24 hours after the last treatment dose) clinic SBP, with changes in 24-hour ambulatory blood pressure monitoring as secondary endpoints.
After 12 weeks, Edarbyclor lowered blood pressure more effectively than Benicar at each hour of the 24-hour period between doses.
Source.“Edarbyclor (azilsartan medoxomil and chlorthalidone) Head-to-Head Data Published in Hypertension.” (2012, June 19). Retrieved August 8, 2012, from http://www.tpna.com/newsroom/press_release_detail.aspx?year=2012&id=243.…