Acelrx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data that showed its sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met the primary and secondary efficacy endpoints in a placebo-controlled, Phase III study. In the 48 hours following major orthopedic surgery, patients treated with sufentanil NanoTabs realized a significantly greater score in the Summed Pain Intensity Difference (SPID) than placebo-treated patients. Secondary endpoint data showed
Data from the 50-patient study showed that single VRS-317 doses of 0.05 mg/kg, 0.10 mg/kg, 0.20 mg/kg, 0.40 mg/kg and 0.80 mg/kg safely increased the amplitude and duration of IGF-I responses in a dose-dependent manner
The 350-patient study will assess the dose-response of the drug at four dose levels compared to placebo after 24 weeks, using the change in glycosylated hemoglobin as the primary endpoint
The 260-patient study met or exceeded prespecified criteria for non-inferiority, and the company is planning a U.S...Diamyd Medical AB, of Stockholm, Sweden, said it's planning to start a new 60-patient study in February with diabetes vaccine Diamyd, testing it in combination with other drugs – relatively high doses of vitamin D and anti-inflammatory drug ibuprofen – to potentiate the effect of the vaccine's ability to help the body control blood sugar levels in newly diagnosed Type I diabetics
Achillion Pharmaceuticals Inc., of New Haven, Conn., said it completed enrollment in a pilot Phase IIa trial evaluating ACH-3102, a second-generation pan-genotypic NS5A inhibitor, in combination with ribavirin in patients with chronic genotype 1b hepatitis C virus (HCV) infection. The initial cohort enrolled eight patients to receive 12 weeks of combination treatment. To date, five patients have completed four weeks of treatment, and ACH-3102 has been well tolerated, with no serious adverse
Merrimack Pharmaceuticals Inc., of Cambridge, Mass., enrolled its first patient in a study of biomarkers in advanced colorectal, lung and triple-negative breast cancer for estimating delivery of compound MM-398 to tumors and for patient response to the drug
The 218-patient study is testing OCA, an FXR agonist, as a second-line treatment in PBC, an autoimmune liver disease that may progress to cirrhosis and liver failure
The 23-patient study showed that 74 percent of patients achieved an Investigator Static Global Assessment (ISGA) score of zero or 1 after four weeks of treatment, and 35 percent achieved an ISGA score of zero or 1 with a minimum two-grade improvement after four weeks
Preliminary results from the first 16 evaluable patients in a study of LCP-Tacro by Veloxis Pharmaceuticals A/S, of Horsholm, Denmark, in kidney transplant patients switching from tacrolimus showed a trend toward reduction of tremors, which are a common side effect of tacrolimus
RXi Pharmaceuticals Corp., of Westborough, Mass., said it started dosing in its three-cohort, nine-patient study testing anti-scarring drug RXI-109 for the management of surgical and hypertrophic scars and keloids
Jazz Pharmaceuticals plc, of Dublin, Ireland, said the first patient was enrolled and dosed in a 25-patient study testing Erwinaze (asparaginase Erwinia chrysanthemi) administered intravenously as an alternative method of administration to treat patients with acute lymphoblastic leukemia with hypersensitivity to E
Data from the 45-patient study showed that 13 patients maintained stable disease for up to 13.4 months with a median of 6.7 months...TransTech Pharma Inc., of High Point, N.C., said data from a 399-patient study testing TTP488, a small-molecule drug targeting the receptor for advanced glycation endproducts, demonstrated evidence of slowing cognitive decline over 18 months in patients with mild to moderate Alzheimer's disease
The primary endpoint of the 33-patient study is to determine the clinical benefit rate, while secondary objectives include progression-free survival and safety and tolerability
Active Biotech earned a milestone in May upon hitting the halfway mark in recruitment for the 1,200-patient study, and top-line data from the Phase III trial are expected by the end of 2013...Those and other data from the 155-patient study were presented at the European Association for the Study of Diabetes meeting in Berlin
Acelrx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data that showed its sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met the primary and secondary efficacy endpoints in a placebo-controlled, Phase III study. In the 48 hours following major orthopedic surgery, patients treated with sufentanil NanoTabs realized a significantly greater score in the Summed Pain Intensity Difference (SPID) than placebo-treated patients. Secondary endpoint data showed