Genetic Engineering & Biotechnology News

JUL 2016

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.

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32 | JULY 2016 | GENengnews.com | Genetic Engineering & Biotechnology News at Notre Dame, animals are moved from a Bruker benchtop 1 tesla MR machine called the ICON, to the Albira II, to a bio- luminescence detector called the Xtreme if multimodal imaging is desired. To do this, technicians place animals in a holding and monitoring apparatus called a bed. "This is actually my favorite," says Chap- man of a special "multimodal" animal bed. "It actually fts on the Albira, and you have a chamber so that it fts on the Xtreme." An animal bed that fts all instruments is the only way to achieve perfect overlay, says Chapman, because it ensures that the animal never moves. Last year, Bruker introduced the PET/MR 3T, which uses the same PMT detectors as the Albira Si to create a platform that com- bines PET and MR imaging. "This is really one of the big revolutions in PET technol- ogy," asserts Dr. Sasser. "With traditional PMT detectors, any electric field would throw off the PET detection." The new instrument will allow two mo- dalities in one device, promising com- binatorial examinations of soft tissues and spectroscopy. It represents a technological paradigm that has already reached clinical practice, and it may lead currently compet- ing ideas to merge. Imaging Continued from page 31 TRANSLATIONAL MEDICINE > Arthritis Pfzer reported top-line results from the Oral Psoriatic Arthritis triaL (OPAL) Beyond, the second Phase III study of XELJANZ® (tofacitinib citrate) being investigated with patients with ac- tive psoriatic arthritis (PsA). This trial assessed the efcacy and safety of tofacitinib in adult patients with active PsA who had inadequate responses to at least one tumor necrosis factor inhibitor (TNFi). OPAL Beyond met its primary endpoints and is the frst PsA study to focus exclusively on TNFi-IR patients, according to the company . > Dravet Syndrome Zogenix initiated its second Phase III trial for its lead candidate ZX008 for adjunc- tive treatment of seizures for children with Dravet syndrome. Zogenix intends to enroll 105 subjects in each of the two studies, with 35 patients in each treat- ment arm. The primary endpoint of both studies is the change in frequency of convulsive seizures as compared to placebo. The key secondary endpoints include 40% and 50% responder analy- ses, which are important for European regulatory submissions. > Giant Cell Arteritis Genentech reported positive results from the Phase III study GiACTA, eval- uating Actemra® (tocilizumab) in peo- ple with giant cell arteritis (GCA). The study met its primary endpoints and showed that Actemra when combined with a six-month steroid more efec- tively sustained remission through one year compared to patients on a steroid-only regiment for six or 12 months. While adverse efects were similar to those in previous studies, Sandra Horning M.D., CMO and head of global product development, said, "These results are encouraging for pa- tients with this rare disease, for which there have been no new treatments in more than 50 years. " > Migraine The last patient has been randomized in CoLucid Pharmaceuticals SAMAURI study, a Phase III trial of lasmiditan oral tablets for the treatment of acute migraine in adults. The study is ex- pected to treat a single migraine in up to 1,483 migraine patients with las- miditan. Patients include those with migraine who have cardiovascular risk factors or cardiovascular disease. At least 80% of all migraine patients enrolled in SAMURAI had multiple risk factors for cardiovascular disease . n News Clinical Trials Find out what is possible, visit www.cellimager.com WHAT YOU NEVER THOUGHT POSSIBLE DO Cytation ™ 5 is the compact, automated cell imaging and multi-mode reader that easily and quickly captures and analyzes brilliant images and transforms them into meaningful results. Simplicity, precision and fexibility—all in one powerful bench top solution. Consistently Brilliant Microscopy Remarkable Data & Image-Based & Laser AutoFocus www.biotek.com

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