In the study, the high dose of NT-501 stabilized best corrected visual acuity at 12-months, with 96.3 percent (p=0.078) of treated-patients losing fewer than three lines of vision, or 15 letters, versus 75 percent of the patients in the sham-treatment group...Like a previously reported Phase II pressure ulcer trial, the mid-dose level of RGN-137 appeared to be the most active dose, with 33 percent of patients in that group having complete healing compared to 24 percent in the placebo group, 16
Data showed no adverse events related to intraocular pressure in low-dose patients, and 23.5 percent of the high-dose patients experienced IOP increases of 30 millimeters of mercury (mm Hg) or greater at some point...Data also showed that 27.3 percent of high-dose patients had improved best corrected visual acuity (BCVA) of 15 letters or greater over baseline, and 23.1 percent of the low-dose patients had an improvement in BCVA of 15 letters or greater over baseline
The robust response for the higher dose of AGI-004 was further supported by a statistically significant difference in the secondary endpoint of patient recorded severity of diarrhea, while positive trends were observed in the other secondary measurement of reduction in the use of rescue anti-diarrheal medications, the company said...Patients in the highest dose cohort reported mild adverse events, and no serious adverse events were reported
INT131-007 is a 24-week, high-dose active comparator (45 mg Actos) and placebo-controlled study of INT131 at four doses in poorly controlled Type II diabetics
The study of the product, which is a synthetic bioequivalent form of the anti-infective molecules produced by white blood cells, revealed significant clinical and mycological efficacy compared to the untreated control group at all doses evaluated, with the highest clinical and mycological efficacy rates of 36.6 percent (p < 0.0001) and 97.9 percent (p < 0.05), respectively, achieved in the highest dose group
Access Pharmaceuticals Inc., of Dallas, reported results from its Phase II monotherapy study of ProLindac in late-stage, heavily pretreated ovarian cancer patients, showing that 66 percent of patients who received the highest dose achieved clinically meaningful disease stabilization as measured by RECIST criteria...The data showed CVT-3619 was safe and well tolerated in this study up to a single dose of the highest dose tested, 1,800 mg in healthy subjects and up to 1,500 mg in overweight or obese
The aim of the trial is to reduce the relapse rate for those patients who have completed the standard combination therapy, consisting of high-dose injectable interferon alpha and oral ribavirin
The high dose of PS433540 produced a statistically significantly greater reduction in blood pressure than the active comparator, irbesartan, which was tested at its highest approved dose
The secondary endpoint of bone-specific alkaline phosphatase also showed a significant dose-dependent effect between the lowest and the two higher dose levels, as well as confirming the strong bone-targeting nature of Alpharadin, the company said
Volunteers treated with increasing doses of CNS 7056 were successfully sedated at the higher dose cohorts as expected and recovered to full consciousness rapidly
The study also met all key secondary endpoints, with the high dose demonstrating clinically and statistically significant superiority in the WOMAC OA score over the entire 21-day active treatment period and in the WOMAC subscales of pain, stiffness and physical function over the entire 35-day treatment and follow-up evaluation periods
Oxford BioMedica said it anticipates preliminary data from the three patients at the higher dose and to start the second stage of the trial in the first half of 2009
Pozen Inc., of Chapel Hill, N.C., said its PA32520 product candidate (enteric-coated aspirin 325 mg with immediate-release omeprazole 20 mg) might provide less upper gastrointestinal mucosal damage usually associated with higher doses of aspirin therapy and might allow for treatment with higher doses of aspirin (up to 325 mg daily) to maximize cardiovascular protection
The analysis showed that 50 percent of patients receiving the highest dose of DPS-101 achieved a state of "clear to almost clear" at the end of the 12 week study...Also, high dose DPS-101 showed statistically significant efficacy relative to placebo (p=0.002), statistically significant efficacy relative to nicotinamide monotherapy (p=0.02), and a trend towards statistical significance vs
Genzyme Corp., of Cambridge, Mass., and its partner, Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said Phase II results showed that patients with early relapsing-remitting multiple sclerosis taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 74 percent and the risk of sustained accumulation of disability by 71 percent compared with patients treated with Rebif (high-dose interferon beta-1a), which is marketed by EMD Serono Inc., of Rockland, Mass
In the study, the high dose of NT-501 stabilized best corrected visual acuity at 12-months, with 96.3 percent (p=0.078) of treated-patients losing fewer than three lines of vision, or 15 letters, versus 75 percent of the patients in the sham-treatment group...Like a previously reported Phase II pressure ulcer trial, the mid-dose level of RGN-137 appeared to be the most active dose, with 33 percent of patients in that group having complete healing compared to 24 percent in the placebo group, 16