Science Weekly: Brain scans and volcanic ash

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Alok Jha discusses the new play Interior Traces; climate change and the general election; plus volcanic ash

Target Health Attending BioMed Israel in June

 

Target Health is pleased to announce that Dr. Jules Mitchel will again be attending the Biomed 2010 Conference to be held June 14-16, 2010 in Tel-Aviv, Israel. Target Health has many Israeli clients and looks forward to several regulatory approvals and original IND submissions in the not too distant future. Projects include drugs in the area of metabolism, hormone replacement, neurology, wound healing, oncology, diagnostics, gastroenterology. Please let us know if you will be attending.

For more information about Target Health and our software tools for paperless clinical trials, please contact Warren Pearlson (212-681-2100 ext 104) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at: www.targethealth.com

A Drug that Prevents Breast Cancer, Without the Side Effects?

 

A new study has shown that the drug used for the treatment of 1) ___, raloxifene, reduces breast cancer risk by 38% in women at high risk for the disease, without causing the serious side effects of similar drugs. That suggests more high-risk women should consider taking raloxifene, also known as 2) ___, says Victor Vogel, main author of the study presented at the American Association for Cancer Research meeting in Washington. “It’s not a cure, but it’s an important protection for women who are at very high risk,” says Vogel, who followed nearly 20,000 high-risk, 3) ___ women for almost seven years. Both raloxifene and another drug, 4) ___, are approved to prevent breast cancer in women at high risk. Few women take them for prevention, however, because of concerns about side effects. Tamoxifen reduces breast cancer by 50% but can also cause hot 5) ___ and other symptoms. So about half of breast cancer patients, who often take it to prevent a relapse, stop the drug early. Tamoxifen also doubles the risk of 6) ___ cancer, from about one in 1,000 women to about two in 1,000, so many doctors are cautious about prescribing it. Given these concerns, no more than 5% of high-risk women today even consider taking either drug. The impact of these drugs is potentially huge and the only thing that reduces the risk as much is a bilateral 7) ___. The new study which shows that raloxifene doesn’t substantially increase the 8) ___ of endometrial cancer should put those concerns to rest, says co-author Patricia Ganz, who runs a clinic for high-risk women at the University of California-Los Angeles. “We have two very effective agents for breast cancer 9) ___,” Ganz says. “If women were not so risk-averse, we might actually be able to reduce the risk of breast cancer in high-risk women.” A typical American woman has about a 10) ___% chance of getting breast cancer in her lifetime. That risk rises to about 18% for a woman whose mother or sister has had the disease, and to 30% for a woman with a breast lesion called atypical hyperplasia.

ANSWERS

1)      osteoporosis; 2) Evista; 3) postmenopausal; 4) tamoxifen; 5) flashes; 6) endometrial; 7) mastectomy; 8) risk; 9) prevention; 10) 12%

Spider Silk

 

Biomaterials, having evolved over millions of years, often exceed man-made materials in their properties. Spider silk is one outstanding fibrous biomaterial which consists almost entirely of large proteins. Silk fibers have tensile strengths comparable to steel and some silks are nearly as elastic as rubber on a weight to weight basis. In combining these two properties, silks reveal a toughness that is two to three times that of synthetic fibers like Nylon or Kevlar. Spider silk is also antimicrobial, hypoallergenic and completely biodegradable. Spider silk has been used in folk medicine for more than 2,000 years to fight infections, stop bleeding and heal wounds. In American Indian medicine, spider webs were used to banish scrapes, warts, and bruises, by simply covering the area with a web. They also were eaten on moldy bread to cure infections; and in Appalachian Folk medicine, cuts and scrapes on the skin were treated by placing a spider web over the area and blowing on it. These webs were used several hundred years ago as gauze pads to stop an injured person’s bleeding. Spider webs are rich in vitamin K, which can be effective in clotting blood. There is a large body of folklore concerning the antibiotic, wound-healing, and clot-inducing activity of spider silk. The lore dates to the first century CE when spider webs were prized as wound dressings. They even found a place in Shakespeare’s Midsummer Night’s Dream: “I shall desire you of more acquaintance, good master cobweb,” the character “Bottom” said. “If I cut my finger, I shall make bold of you.” Spider web silk, the strongest natural fiber known, could possess untapped medical potential in artificial tendons or for regenerating ligaments. A body of folklore dating back at least 2,000 years tells of the potential medical value of spider webs in fighting infections, stemming bleeding and healing wounds, explained molecular biologist Randolph Lewis at the University of Wyoming in Laramie. While research has found no evidence so far that spider webs can kill germs, studies on animals have revealed that spider silk triggers little if any immune responses, which cause rejection of medical implants. So his lab and others are spinning spider silks into fibers that they hope might be useful in medicine. Researchers at Tufts University in Medford, Mass., have found that spider webs could be used as scaffolds for regenerating ligaments damaged in one of the world’s most common knee injuries – ruptured anterior cruciate ligaments, or ACLs. Scientists are also developing spider silk to make exceptionally fine sutures for stitching up surgeries or wounds to nerves or eyes, to potentially help them heal without scarring. To mass-produce spider silk, researchers are pursuing the production of spider silk in alfalfa. Other researchers are experimenting with producing spider silk proteins in goat milk. Scientists generate these proteins outside spiders by inserting the genes for them into target cells. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2658765/

A Brain-Recording Device That Melts Into Place

 

According to an article published online in Nature Materials (18 April 2010), scientists have developed a brain implant that essentially melts into place, snugly fitting to the brain’s surface. The technology could pave the way for better devices to monitor and control seizures, and to transmit signals from the brain past damaged parts of the spinal cord. The study showed that the ultrathin flexible implants, made partly from silk, can record brain activity more faithfully than thicker implants embedded with similar electronics. Currently, the simplest devices for recording from the brain are needle-like electrodes that can penetrate deep into brain tissue. More state-of-the-art devices, called micro-electrode arrays, consist of dozens of semi-flexible wire electrodes, usually fixed to rigid silicon grids that do not conform to the brain’s shape. According to the authors, in people with epilepsy, the arrays could be used to detect when seizures first begin, and deliver pulses to shut the seizures down. In people with spinal cord injuries, the technology has promise for reading complex signals in the brain that direct movement, and routing those signals to healthy muscles or prosthetic devices. The implants contain metal electrodes that are 500 microns thick, or about five times the thickness of a human hair. The absence of sharp electrodes and rigid surfaces should improve safety, with less damage to brain tissue. Also, the implants’ ability to mold to the brain’s surface could provide better stability; the brain sometimes shifts in the skull and the implant could move with it. Finally, by spreading across the brain, the implants have the potential to capture the activity of large networks of brain cells. Besides its flexibility, silk was chosen as the base material because it is durable enough to undergo patterning of thin metal traces for electrodes and other electronics. It can also be engineered to avoid inflammatory reactions, and to dissolve at controlled time points, from almost immediately after implantation to years later. The electrode arrays can be printed onto layers of polyimide (a type of plastic) and silk, which can then be positioned on the brain. In the current study, the researchers approached the design of a brain implant by first optimizing the mechanics of silk films and their ability to hug the brain. They tested electrode arrays of varying thickness on complex objects, brain models and ultimately in the brains of living, anesthetized animals. The arrays consisted of 30 electrodes in a 5×6 pattern on an ultrathin layer of polyimide – with or without a silk base. These experiments led to the development of an array with a mesh base of polyimide and silk that dissolves once it makes contact with the brain – so that the array ends up tightly hugging the brain. Next, they tested the ability of these implants to record the animals’ brain activity. By recording signals from the brain’s visual center in response to visual stimulation, they found that the ultrathin polyimide-silk arrays captured more robust signals compared to thicker implants. In the future, the researchers hope to design implants that are more densely packed with electrodes to achieve higher resolution recordings.

ONCOLOGY

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Expression of Proteins Linked to Poor Outcome in Women with Ovarian Cancer

 

According to an article published online in Cancer (19 April 2010), scientists have established the presence of certain proteins in ovarian cancer tissues and have linked these proteins to poor survival rates in women with advanced stages of the disease. The proteins in question belong to the nuclear factor kappa Beta (NF-kB) family. NF-kB controls many processes within the cell including cell survival and proliferation, inflammation, immune responses, and cellular responses to stress. Abnormalities in NF-kB signaling have been found in several types of cancer, including ovarian cancer, but the mechanism and importance of such alterations in ovarian cancer was not defined. To address these knowledge gaps, the research team investigated the expression of NF-kB-related proteins in the cells of tumor tissue obtained at surgery from 33 previously untreated women who were newly diagnosed with advanced epithelial ovarian cancer. The patients had similar stage (all late stage), grade, and type of disease. All patients were treated with a three-drug regimen of standard chemotherapy agents in an NCI clinical trial that was conducted at the NIH Clinical Research Center. To assess NF-kB family members and associated proteins in ovarian tumor cells, the study used immunohistochemistry, a method that uses antibodies-a type of protein that the body’s immune system produces when it detects harmful substances-to identify specific molecules in tissue specimens. Subsequently, they looked for associations between the percentage of tumor cells in individual proteins and patient outcomes. The data revealed that the presence of one NF-kB family member-p50-in more than one-quarter of the cells was associated with poor survival. Low-frequency or nonexpression of a target gene, matrix metallopeptidase 9 (MMP9), was also associated with poor prognosis. Further, the team identified two NF-kB family members-p65 and RelB-and a protein called IKKa that plays a role in promoting inflammation, that were frequently expressed in the same cells, providing more evidence that NF-kB is active in some ovarian cancers. It is possible that the NF-kB activity in these cancers could increase their growth and/or resistance to treatment.

Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation

 

Endomyocardial biopsy is the standard method of monitoring for rejection in recipients of a cardiac transplant. However, this procedure is uncomfortable, and there are risks associated with it. Gene-expression profiling of peripheral-blood specimens has been shown to correlate with the results of an endomyocardial biopsy. As a result, a study published online in the New England Journal of Medicine (22 April 2010), randomly assigned 602 patients who had undergone cardiac transplantation within 6 months to 5 years to be monitored for rejection with the use of gene-expression profiling or with the use of routine endomyocardial biopsies. A noninferiority comparison of the two approaches with respect to the composite primary outcome of rejection with hemodynamic compromise, graft dysfunction due to other causes, death, or retransplantation. Results showed that during a median follow-up period of 19 months, patients who were monitored with gene-expression profiling and those who underwent routine biopsies had similar 2-year cumulative rates of the composite primary outcome (14.5% and 15.3%, respectively. The 2-year rates of death from any cause were also similar in the two groups (6.3% and 5.5%, respectively; P=0.82). Patients who were monitored with the use of gene-expression profiling underwent fewer biopsies per person-year of follow-up than did patients who were monitored with the use of endomyocardial biopsies (0.5 vs. 3.0, P<0.001). According to the authors, among selected patients who had received a cardiac transplant more than 6 months previously and who were at a low risk for rejection, a strategy of monitoring for rejection that involved gene-expression profiling, as compared with routine biopsies, was not associated with an increased risk of serious adverse outcomes and resulted in the performance of significantly fewer biopsies.

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

FDA Launches Initiative to Reduce Infusion Pump Risks – Agency Calls For Improvements in Device Design

Infusion pumps are widely used in hospitals, other clinical settings, and the home. The devices allow a greater level of control, accuracy, and precision in drug delivery, and help to reduce medication errors. However, infusion pumps also have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns. The FDA announced a new initiative to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner. As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance of a new draft guidance and letter to infusion pump manufacturers. FDA is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety. The most common types of reported problems have been related to:

  • software defects, including failures of built-in safety alarms;
  • user interface issues, such as ambiguous on-screen instructions that lead to dosing errors; and
  • mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.

 

Failures of infusion pumps have been observed across multiple manufacturers and pump types. The FDA says that many of the reported problems appear to be related to deficiencies in device design and engineering. As part of its initiative, the FDA’s draft guidance recommends that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices. The FDA issued a letter to infusion pump manufacturers, informing them that they may need to conduct additional risk assessments to support clearance of new or modified pumps. In addition to alerting them of this intended change, the letter offers manufacturers the option of submitting their infusion pump software codes to experts at the FDA for static analysis prior to premarket review. Static analysis is a diagnostic technique that can help detect software problems early in the device development process. The agency previously invited manufacturers to make use of an open-source software safety model developed through the Generic Infusion Pump project, an ongoing collaboration with outside researchers aimed at improving pump design. The FDA’s public workshop will be held May 25-26, 2010. Participants will discuss observed safety problems, and explore opportunities to work with others, including foreign regulators, to improve the design of infusion pumps on the market or in development, in order to reduce pump malfunctions and errors.

For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

Target Health, in business since 1993,  (www.targethealth.com) is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND (eCTD), IDE, NDA (eCTD), BLA (eCTD), PMA (eCopy) and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, EDC utilizing Target e*CRF®, and Medical Writing.

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