Archives: 2/2010

4326pant1 Pantecs  P.L.E.A.S.E.Transdermal Therapeutic System Shows Early Clinical Success
Pantec Biosolutions of Liechtenstein just announced positive results from a Phase I clinical trial of the FSH (follicle stimulating hormone) patch when used in conjunction with the firm’s proprietary P.L.E.A.S.E. microporation drug delivery device. The system, profiled by us before, uses painless lasers to create cutaneous micropores prior to transdermal injection of large molecular weight drugs. The P.L.E.A.S.E. system is designed to be flexible in the number of the micropores and the depth of delivery, allowing to fine-tune the amount of a therapeutic injectate.
From the latest announcement:
4326pant2 Pantecs  P.L.E.A.S.E.Transdermal Therapeutic System Shows Early Clinical Success

Although smaller peptides and some proteins have previously been delivered transdermally, this is the first time a molecule as large as this protein (32 KDa) has been successfully delivered in this way.
The purpose of the study was to investigate the primary pharmacokinetic characteristics as well as the safety and tolerability of the newly developed FSH protein patch in healthy male volunteers. Due to its size and physicochemical properties FSH, a 32 KDa protein hormone, cannot permeate passively across intact skin. Therefore, prior to patch application, the skin was microporated using Pantec Biosolutions’ P.L.E.A.S.E.® laser device. This pre-treatment creates microchannels in the skin’s outermost layer, the stratum corneum, that facilitate FSH transport through the skin and accelerate its entry into the systemic circulation.
The serum profiles further demonstrated that the P.L.E.A.S.E.® – FSH patch combination was able to achieve reproducible pharmacokinetics with negligible inter-individual variability. All of the volunteers considered the method to be convenient and easy to use, and there were no reports of any adverse events.

Product page: The P.L.E.A.S.E. – platform …
Animation showing the functionality of the P.L.E.A.S.E. system…
Press release: Pantec Biosolutions reports successful Phase I for delivery of FSH using P.L.E.A.S.E. …
Flashbacks: P.L.E.A.S.E. = Painless Laser Epidermal System ; P.L.E.A.S.E. To Improve Effectiveness of Drug Patches

ross RoSS Simulator Preps Surgeons to Use da Vinci RobotResearchers from Roswell Park Cancer Institute and State University of New York at Buffalo, developed a surgical simulator to help train physicians to operate the da Vinci robot. The RoSS Robotic Surgical Simulator has been turned into a product and commercialized by a spinoff called Simulated Surgical Systems of Williamsville, NY. Practicing physicians and students can train on common tasks like suturing and knot tying, and even perform complete procedures like radical prostatectomies and hysterectomies.
Features of the device:

  • Stand-alone surgical simulator that is independent of a surgical robot, vision cart
  • Cost of operating the RoSS is minimal as no consumables or disposables are required
  • The RoSS data management system allows performance analysis and measurement tools to objectively measure and record performance
  • User does not require monitoring thus enabling maximum flexibility and opportunity for training
  • Surgical procedures can be rehearsed
  • New surgical procedure modules can be added to the RoSS
  • RoSS does not require an operating room environment and can be set up in a location most advantageous to access and training needs
  • RoSS has a monitor which allows a user or tutor to observe the procedure
  • Comprehensive curriculum to train for motor, and cognitive skills required to operate surgical robot
  • Suite of simulated surgical procedures for fellow or resident to follow, and recreate the surgical steps of an expert surgeon

  • Press release: Introducing RoSS, a “Flight Simulator” for Robotic Surgery …
    Product page: RoSS Robotic Surgical Simulator …

    834nna33 Molecular Venus Flytrap Grabs and Holds Onto Cesium Ions
    Researchers from Northwestern University and Argonne National Lab have developed a material that can grab and encapsulate radioactive cesium isotopes, much like a Venus Flytrap does with flies. Cesium is an abundant byproduct of nuclear waste and has been difficult to concentrate/separate when cleaning up superfund sites polluted with the substance.

    The new material, a rigid frame composed of metal sulfides, has a negative charge. Its pores, therefore, attract positively charged ions. This makes it a good candidate for ion exchange—when immersed in a solution with other positive ions, the ions tucked inside the pores switch places with the ions outside.
    Sodium ions do this dance freely, switching as many times as they’re immersed. However, when the team filled the material with cesium ions, they refused to move out of the material.
    To find out why the material trapped cesium but not sodium, Kanatzidis [Mercouri Kanatzidis, Argonne] and Ding [Nan Ding, Northwestern] had to come up with an image of the material’s crystalline structure itself. They found that sodium bonded strongly to the water in the solution, which prevented it from becoming trapped by the framework; but a cesium ion doesn’t form strong bonds with water molecules, so it has less protection. The ion binds to several sulfur atoms in the rings of the framework, causing the rings to change shape, and the hole is sealed shut.

    Press release: New material traps radioactive ions using “Venus flytrap” method …
    Abstract in Nature Chemistry: Selective incarceration of caesium ions by Venus flytrap action of a flexible framework sulfide

    Pawan Sinha, a vision scientist at MIT, spoke at TED India last November about his research into the way the brain learns to interpret sight. His studies are part of a project to bring vision to children in India born with childhood cataracts.


    Link @ TED: Pawan Sinha on how brains learn to see..

    999436uh 42,000 Year Old Baby Mammoth Gets CT, MRI Scanned
    GE Health donated time on their latest CT and MR systems for researchers from the Field Museum in Chicago to image the insides of an ancient baby mammoth. Lyuba, apparently one of the finest preserved mammoth specimens, was found by a Siberian reindeer herder three years ago. Now, thanks to modern technology, the researchers believe they know the cause of death of the mammoth. Lyuba is currently on view at the “Mammoths and Mastodons: Titans of the Ice Age” exhibit at the Field Museum. Of course, there’s also something to be said for today’s tomography scanners with bore sizes that can accommodate a mammoth.

    First, she was scanned on the Discovery CT750 HD, a 64-slice, high definition CT scanner. The images obtained from this scan allow scientists to learn more about her internal mineral deposits as well as her bone structure. Second, in an effort to see her entire skeletal structure from head to tail, she was imaged on the Innova® 4100IQ, a three-dimensional digital X-ray system. Finally, Lyuba was scanned on a high performance open MRI system, the Signa OpenSpeed EXCITE 0.7T, to view her soft tissue including the brain, liver and heart.
    The scientists studying Lyuba also have been trying to determine what caused her death. As best as they can tell, she became trapped in a mud hole and inadvertently ingested mud. With the CT scan, the scientists now have evidence of silt in her trunk and in her lungs that confirm her cause of death as accidental suffocation. The cause of death is important because the scientists can reconfirm that Lyuba was not ill or poorly developed, factors that might negate her value as a normal mammoth specimen.


    GE press release: Ice-age mammoth in space-age scan at GE Healthcare …
    Exhibit: Mammoths and Mastodons: Titans of the Ice Age

    9412 temp stable vaccine01 New Technology Stabilizes Viral Vaccines for Room TempResearchers from Oxford University and Nova Bio-Pharma Technologies out of Leicester, UK have been able to keep viral vaccines stored at relatively high temperature without losing their effectiveness. The technology is showing promise in being able to ship unrefrigerated vaccines to remote areas where they’re most needed.

    Oxford University carried out the proof-of-concept study, showing that vaccines they are developing could be stabilised for months using Nova’s patented technology, called the Hypodermic Rehydration Injection System (HydRIS).
    The team demonstrated it was possible to store two different virus-based vaccines on sugar-stabilised membranes for 4–6 months at 45°C without any degradation. The vaccines could be kept for a year and more at 37°C with only tiny losses in the amount of viral vaccine re-obtained from the membrane.
    The method involves mixing the vaccine with the sugars trehalose and sucrose. The mixture is then left to slowly dry out on a simple filter or membrane. As it dries and the water evaporates the vaccine mixture turns into a syrup and then fully solidifies on the membrane.
    The thin sugary film that forms on the membrane preserves the active part of the vaccine in a kind of suspended animation, protected from degradation even at high temperature. Flushing the membrane with water rehydrates the vaccine from the membrane in an instant.


    Abstract in Science Translational Medicine: Long-Term Thermostabilization of Live Poxviral and Adenoviral Vaccine Vectors at Supraphysiological Temperatures in Carbohydrate Glass
    Oxford press statement: New method makes vaccines stable at tropical temperatures …

    y2gww3 Sorins C5 CPB Machine Gets Green Light in USMilan, Italy based Sorin Group has received FDA approval for the firm’s S5 Heart-Lung Machine. In its press release, the company touts C5 as a highly advanced “lighter in weight and more compact” system that has “excellent manoeuvrability and a well thought-out, logical structure, functional ergonomic design and reliable safety systems. Its solid, brushed stainless steel housing reflects the product’s high quality.” The cardio-pulmonary bypass (CPB) system has already earned European CE Mark of approval last year.
    Add’l features:

  • Console for 3 to 5 roller pumps
  • 2 additional roller pumps can be mounted on the mast
  • Panel with 3, 4 or 6 display modules
  • Flexible mast system
  • Pump heads can be rotated into position to optimize tubing layout
  • Two vertically and one horizontally moveable masts for mounting external devices and disposables
  • Up to four TFT displays can be stacked vertically in the mast panel and each can be configured according to your required perfusion parameters
  • The brushless, direct-drive motor of the roller pumps reduces noise and vibration, making S5 one of the quietest systems of its kind
  • The footprint of the S5 has been reduced by 20% and overall weight has been reduced by 10%
  • System panel can be easily mounted and adjusted both horizontally and vertically
  • High resolution TFT displays enable the perfusionist to easily view displayed values from greater distances and at an angle of up to 140 degrees
  • Full text messages for alarms and warnings
  • One key each for muting, clearing and overriding alarms
  • Differentiated alarm tones
  • Quick and easy replacement of all DCMs
  • UPS can bridge a power failure up to 130 minutes (20 minutes at full load)
  • Speed adjustments are performed via an Incremental Encoder, a maintenance-free technology that increases longevity and reliability
  • Clearly structured, intuitive and descriptive menu system eliminates guesswork, and one-touch accessibility improves user convenience
  • Miniaturized sensor modules utilize 100% SMD technology
  • Operated by PC-independent software using state-of-the-art microcontrollers in conjunction with a high-integrity serial CAN bus
  • No boot time required after power-up—the system is ready for operation within 3 seconds
  • Product page: S5 HLM…
    Press release: SORIN GROUP ANNOUNCES U.S. FDA CLEARANCE OF NEWEST GENERATION HEART LUNG-MACHINE (.pdf)…

    6423hhh H. pylori Gene Regulation DecodedA team of European researchers discovered a set of 60 sRNA’s (small ribonucleic acids) that are responsible for gene regulation within the pesky ulcer causing Helicobacter pylori bacteria. Until now it was not clear where gene regulation came from in this bacteria.

    The decoding of the H. pylori genome in 1997 revealed this pathogen to possess surprisingly few genes for transcriptional regulators, sparking a number of crucial questions: Where do the genes of Helicobacter start, and how are these switched on and off? Have all genes been discovered already?
    Researchers have been searching for new types of gene regulators in this pathogen, especially for sRNAs. It has recently been realized that these tiny RNA particles are far more abundant in all organisms than previously thought. They can regulate genes by binding to sequences of the genetic information, thereby inhibiting the production of a protein. Yet strangely enough, sRNAs seemed to be lacking in Helicobacter. Jörg Vogel, leader of the RNA Biology Group at the Max Planck Institute for Infection Biology, and his team have finally tracked down a number of sRNAs in the pathogen. To enable their discovery, they modified a technique called “deep sequencing”, to decipher millions of RNA-sequences newly produced in a cell. The surprised scientists found 60 sRNAs: “To date, it was believed that this organism completely lacks sRNAs”, says Vogel.
    “We found as many sRNAs in Helicobacter as in widespread intestinal bacteria like Escherichia coli or Salmonella”, explains Vogel. But a very important protein required for the regulation of gene expression by sRNAs is missing in Helicobacter pylori. The stomach pathogen possibly uses different signalling pathways, which makes it a possible candidate as a model in RNA-research. “We hope to get completely new insights into gene regulation”, says Vogel.
    Thanks to the novel technique, the researchers could also define the starting point of every gene in Helicobacter.

    Abstract in Nature: The primary transcriptome of the major human pathogen Helicobacter pylori
    More from Max Planck Society for the Advancement of Science: Gene regulation: Can we stomach it? …

  • Obama Readies a Fallback Health-Care Proposal… [WSJ]
  • What happens next in health care… [Politico]
  • What Obama Wants in the Health-Care Overhaul… [WSJ]
  • FDA Approves Pneumococcal Disease Vaccine with Broader Protection… [FDA]
  • ‘Seek, test and treat’ slows HIV… [Nature]
  • Study: Half of Infection Deaths Linked Directly to Hospital Care… [WSJ]
  • Covidien Announces New Source of Vital Medical Isotopes… [Covidien]
  • Physio-Control Resumes Unrestricted Global Shipments of Its LifePak® Defibrillators… [Medtronic]
  • ITGI wins $1m stent order for clinical trial… [Globes]
  • ETview in reverse merger with First SBS … [Globes]
  • Philips and VU Medical Center Amsterdam sign long term research agreement aimed at new multi-modality imaging solutions… [Philips]
  • Ethicon Endo-Surgery Announces Agreement with Hologic Inc. To Resolve Patent Disputes… [J&J]
  • FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma… [FDA]
  • FDA Announces Possible Safety Concern for HIV Drug Combination… [FDA]
  • Published Study Demonstrates Patients with Low Hemoglobin Levels Can be Managed Without Blood Transfusions … [Masimo]
  • Statins: Still worth taking… [Nature Blogs]
  • Researcher decodes a molecular process that controls the growth of nerve cells… [Max Planck Society for the Advancement of Science]
  • Induced Pluripotent Stem Cells From Patients With a Premature Aging Disorder Bring Surprises… [Johns Hopkins]
  • The mystery of symmetry is revealed… [CNRS]
  • What Model Organisms Can Teach Us about Emotion… [HHMI]
  • New Tool Illuminates Connections between Stem Cells and Cancer… [HHMI]
  • The microRNA network and tumor metastasis… [Oncogene]
  • Web 2.0 in Action in Hospitals… [ScienceRoll]
  • Sight savers: New weapons trained on blindness… [New Scientist]
  • Cell phones show human movement predictable 93% of the time… [Arstechnica]
  • Skype helping dementia patients, families stay in touch… [Computer World]
  • Caltech Scientists Investigate Physiological Evidence of Brain’s Response to Inequality… [Caltech]
  • Pregnant curler competing in Olympics… [SCOPE]