agents The long-awaited results of the pivotal phase 3 trial of
March 17, 2017
agents The long-awaited results of the pivotal phase 3 trial of denosumab proved to be AS-605240 good news for Amgen: The bone drug produced statistically significant reductions in the incidence of vertebral nonvertebral and hip fractures compared with placebo. remission of rheumatoid arthritis when it is given early in the course of the disease. A regimen of etanercept and methotrexate in patients whose RA had been classified as moderate to severe for less than 2 years led to remission in about half of the 542 people studied. After 1 year disease progression stopped in 8 of 10 people who received the combination therapy compared with about 6 of 10 patients who were treated with methotrexate alone. Hoping to make its own inroads in the RA market Roche released more positive data from two phase 3 trials of its interleukin 6 receptor blocker AS-605240 tocilizumab (Actemra). One of the studies published in evaluated difficult-to-treat patients with moderate to severe RA who had failed previous anti-TNF-α therapies. Half of those receiving tocilizumab achieved ACR20. Oncology trials Median survival and time to radiologic progression were 3 months longer for advanced liver cancer patients treated with Bayer’s sorafenib (Nexavar) than those who were given placebo. The multicenter double-blind placebo-controlled trial of 602 patients was published in the … Acknowledging that it had lost the race with Bayer to bring a liver cancer treatment to market Progen AS-605240 Pharmaceuticals abandoned development of its main product PI-88. The novel antithrombotic had been studied not only for liver cancer but also for skin and lung malignancies with mixed success. Ofatumumab (formerly HuMax CD20) hit primary and secondary endpoints in a phase 3 trial in patients with chronic lymphotic leukemia (CLL) who did not respond to methotrexate or TNF-α inhibitors. GlaxoSmithKline which spent $2 billion to license ofatumumab from Genmab plans to seek U.S. Food and Drug Administration approval before the end of the year. Ofatumumab also is being investigated for RA multiple sclerosis and non-Hodgkin’s lymphoma (NHL). … In a mid-stage study bendamustine (Treanda) Cephalon’s infusion therapy for CLL induced a clinical response in patients with NHL when used in combination with rituximab (Rituxan). Ark Therapeutics reported positive results from a late-stage trial of sitamagene (Cerepro) its gene therapy for malignant brain tumors. … Motesanib one of five Amgen oncology drugs in phase 3 testing delayed or reversed the growth of thyroid tumors found a study published in … In high-risk melanoma patients sargramostim (Leukine) increased mature dendritic cells which help the immune system recognize cancer cells. Bayer reported results of the prospective phase 2 study. … A late-stage trial of TroVax Oxford BioMedica’s therapeutic vaccine for renal cancer will not hit its endpoint because of too many patient deaths in the trial. A data safety monitoring board said the trial could continue but Mouse monoclonal to CD4/CD8 (FITC/PE). wanted further vaccinations discontinued. Other research of note Elan and Wyeth will proceed to a phase 3 study to determine the usefulness of bapineuzumab in patients with Alzheimer’s disease. Mid-stage results presented at the International Conference on Alzheimer’s Disease showed that bapineuzumab improved 3 of 4 measures of cognitive tasks in Alzheimer’s patients without ApoE4 a genetic variation found in about half of those people with Alzheimer’s and that predisposes them to the condition. But the drug failed to improve dementia symptoms. … If bapineuzumab makes it to market it could be the first disease-modifying Alzheimer’s AS-605240 drug available now that Myriad Genetics and Lundbeck have discontinued development of tarenflurbil (Flurizan). So concluded Decision Resources in an analysis issued after tarenflurbil’s late-stage failure to stop the buildup of toxic plaques. AtheroGenics’ antioxidant succinobucol appears to slow or prevent progression to diabetes in cardiovascular patients with a prediabetic condition according to data extracted from a 6 0 phase 3 study. … Topline results from a phase 3 trial of tasimelteon a novel melatonin agonist show significant improvements in sleep among adults with chronic primary insomnia. Vanda Pharmaceuticals also is AS-605240 evaluating tasimelteon as a potential treatment of circadian rhythm sleep disorders. … Novo Nordisk ended its phase 3 trial evaluating coagulation factor VIIa (NovoSeven) as a therapy for bleeding in the brain after a “futility analysis” predicted a low likelihood of positive outcomes. … While Insmed waits for development of a.