Boston Biomedical Inc., of Norwood, Mass., reported early Phase I data showing signs of a strong safety profile and clinical activity for BB1608, a cancer drug aimed to work by targeting the stem-like properties of some cancer cells

Comparing the efficacy and safety profiles of MoxDuo IR against component doses of morphine and oxycodone alone, the study showed the pairing reduces moderate to severe pain following bunionectomy surgery significantly better than its individual components

The vaccine has been well tolerated with an acceptable safety profile in all subjects tested

The analysis will include two major findings: The safety profile of HEPLISAV was comparable to that of Engerix-B, one of two currently licensed vaccines for the prevention of hepatitis B infection, and there is no difference in autoimmune adverse events or laboratory markers of autoimmunity between subjects vaccinated with HEPLISAV and Engerix-B

Both mucoadhesive buccal formulations displayed a good local safety profile, and results suggested that a single daily application may provide effective relief of severe chronic pain in cancer patients

Preliminary results later showed that the primary endpoint of progression-free survival was achieved in the normal LDH population, 68 percent of patients enrolled, with an acceptable safety profile, while in the elevated LDH population, no difference was observed between the two arms of the trial and a negative impact was observed for the survival endpoint

After one dose, at all three dosing levels, the vaccine achieved robust serological immune responses considered to be protective, though the single dose of 15 mcg appeared to be optimal to induce robust immune responses in broader age populations with a satisfactory safety profile

Roche said the results demonstrated that treatment with once-weekly taspoglutide led to significantly improved blood glucose control, consistent weight loss and a minimal risk of hypoglycemia, with a manageable safety profile

Data to date also demonstrate a good safety profile

Neovacs SA, of Paris, reported preliminary data from an ongoing Phase I/II trial of its TNF-alpha kinoid active immunotherapy in Crohn's disease showing that the drug's safety profile has been excellent to date, with no serious adverse events, unexpected infections or premature study withdrawals...QRxPharma Ltd., of Sydney, Australia, started a pivotal trial comparing the efficacy and safety profiles of MoxDuo IR against component doses of morphine and oxycodone alone for the management of moderate

The safety profile was comparable to placebo and no drug-related serious adverse events were reported

The safety profile of patients in the first cohort met pre-specified criteria for dose escalation and the second cohort has been opened for enrollment

Salix Pharmaceuticals Ltd., of Morrisville, N.C., gave several presentations at the American College of Gastroenterology meeting in San Diego, including data from an open-label maintenance extension study showing that rifaximin has a favorable long-term safety profile for maintenance of remission from overt hepatic encephalopathy

Emisphere Technologies Inc., of Cedar Knolls, N.J., said study results showed that a single dose of oral parathyroid hormone PTH1-34, which uses its Eligen Drug Delivery Technology, achieved potentially therapeutically relevant exposure and safety profiles to those of the currently available injectable formulation in healthy postmenopausal women

KaloBios Pharmaceuticals Inc., of South San Francisco, reported Phase I/II results showing that KB001, its Humaneered antibody fragment, showed an acceptable safety profile, as well as trends toward reducing tissue inflammation and clearance of bacterium in cystic fibrosis patients

Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., reported one-year follow-up data from a Phase I dose-escalation trial showing that Azedra demonstrated a positive safety profile and durable objective tumor responses in patients with neuroendocrine cancers, pheochromocytoma and paraganglioma

The objective of the study is to determine the pharmacokinetic, viral kinetic and safety profiles of ascending doses of once-daily and twice-daily ITMN-191 co-administered with low doses of ritonavir and standard dose Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in HCV-infected patients and for 14 days

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said linagliptin pivotal Phase III trials confirmed first results from the Phase III studies that consistently support the favorable efficacy and safety profile observed earlier...That data had shown significant results in hemoglobin A1c (HbA1c)-lowering (-0,73 percent, 5-mg dose) and a safety profile comparable to placebo

The study met its primary objective, which was to evaluate the safety profile and determine the maximum-tolerated dose of a single I.V