Advanced Life Sciences Holdings Inc., of Woodridge, Ill., said trial data from its lead candidate, cethromycin, a second-generation ketolide antibiotic, demonstrated safety and efficacy at multiple dose levels in community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and anthrax

Patients will receive two dose levels of EVT 201 and placebo, in a random order, for two consecutive nights with a five- to 12-day washout between each period

The double-blind, randomized, placebo-controlled study will enroll about 500 patients who have undergone segmental colectomy surgery to receive one of two dose levels of methylnaltrexone or placebo following surgery and every six hours until either the patient recovers gastrointestinal function or 10 days

Patients in the study received different doses, administered four weeks apart, and results demonstrated that, at each dose level, three injections yielded higher antibody titers than with two injections

The trial randomized patients to receive either placebo or one of three dose levels three times daily for 12 weeks followed by four weeks without the drug

Trigen Holdings AG, of Munich, Germany, said Phase II results of its intravenous direct thrombin inhibitor, TGN 255, showed that a continuous infusion of the drug was well tolerated at all dose levels and a clear dose response regarding coagulation parameters was demonstrated

A soluble fusion protein that neutralizes molecules implicated in the pathogenesis of several autoimmune diseases, it appeared to be well tolerated across all dose levels and schedules

Of note, there was an estimated difference of -1.74 percent compared to placebo at the highest dose level of the investigational Type II diabetes treatment

In the analysis, bavituximab showed signs of antiviral activity at all four dose levels, and it also showed evidence of a prolonged antiviral effect

Data showed the product is well tolerated with no adverse events at all dose levels either alone or associated with potent antigens

XP19986 was well tolerated at all dose levels with few reported adverse events

The agency is concerned that the dose levels of Dimebon used in one of Medivation's rat toxicology studies did not result in sufficient toxicity to define a maximum tolerated dose

In addition to meeting its primary endpoints of safety and tolerability at all dose levels, VEGF Trap showed positive preliminary efficacy results, and the company is starting a Phase II trial in wet AMD

Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported that the 200-mg/day dose level of valopicitabine (NM283), combined with pegylated interferon, demonstrated comparable antiviral activity to the 800 mg/day-containing arms in a preliminary analysis of an ongoing Phase IIb trial in treatment-na ve genotype 1 hepatitis C patients

The multicenter, double-blind, placebo-controlled Phase IIa trial randomized patients to receive placebo or one of three dose levels of arimoclomol capsules three times daily for a period of 12 weeks

Under the amended protocol, the study now is designated a Phase I/II trial and is more focused, as previously it was testing two dose levels of tgAAC94 in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

In the ascending, single-dose trial, there were no serious adverse events reported at any of the four dose levels tested, and no potential dose limiting toxicities were observed

In addition to meeting the study’s primary endpoint of a linear dose-response for pain relief over four hours as compared to placebo, secondary endpoint results showed statistically superior pain relief compared to placebo for the two highest dose levels of Rylomine and intravenous morphine 7.5 mg

Patients will be treated for two weeks to evaluate the safety and pharmacokinetics of three dose levels of the cortisol synthesis inhibitor, DIO-902