Combining cytarabine with conventional monochemotherapy (high-dose methotrexate) improves remission rates in patients with primary central nervous system lymphoma. (primary CNS lymphoma). The findings are discussed in an Article published Online First and in an upcoming edition of The Lancet. The Article is written by Dr Andr?©s J. M. Ferreri, San Raffaele H Scientific Institute, Milan, Italy, and colleagues from the International Extranodal Lymphoma Study Group (IELSG).

Primary CNS lymphoma typically occurs in individuals with a median age of 60 years old, with a similar prevalence between men and women. In this randomised phase 2 trial, the researchers assessed the effect of adding high-dose cytarabine to methotrexate in patients with newly diagnosed primary CNS lymphoma. This is the first worldwide randomised trial to be successfully completed; an earlier randomised study was stopped due to insufficient recruitment.

The trial took place in 24 centres in six countries; 79 patients with non-Hodgkin lymphoma exclusively localised into the CNS, cranial nerves, or eyes, aged 18-75 years were given four courses of either methotrexate 3???5 g/m?? on day 1 (40 patients) or methotrexate 3???5 g/m?? on day 1 plus cytarabine 2 g/m?? twice a day on days 2 and 3 (39). Both regimens were administered every 3 weeks and were followed by whole-brain irradiation (also a standard treatment). The primary endpoint was complete remission rate after chemotherapy.

The researchers found that, after chemotherapy, seven patients given methotrexate and 18 given methotrexate plus cytarabine achieved a complete remission, with a complete remission rate of 18% and 46%, respectively. Nine patients receiving methotrexate and nine receiving methotrexate plus cytarabine achieved a partial response, with an overall response rate of 40% and 69%, respectively. As expected, a higher, but manageable, blood toxicity rate was observed in the methotrexate plus cytarabine group than in the methotrexate group (36 [92%] vs. six [15%]), and four patients died of toxic effects (three vs. one). Importantly, the drugs combination was associated with a significantly lower proportion of patients experiencing lymphoma relapse with respect to methotrexate alone, with a 20% improvement in the progression-free survival at 3 years.

The authors conclude: “The addition of high-dose cytarabine to high-dose methotrexate is associated with a remarkable outcome benefit in patients with primary CNS lymphoma. This combination could be used as an upfront approach in patients aged 75 years and younger and with adequate liver and kidney function, with appropriate antimicrobial prophylaxis.”

In an accompanying Comment, Dr Peter O’Brien, Department of Radiation Oncology, Calvary Mater Oncology, Newcastle, NSW, Australia, and Dr John Seymour, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia, say that rather than confirming these results, future investigators’ efforts would be better spent investigating the benefits other aspects of treatment, such as contemporary biological agents and radiotherapy, the place of which they describe as ‘uncertain’. They conclude: “The IELSG, and more latterly the International Primary CNS Lymphoma Study Group, have set the standard for a continuing international cooperative approach to improving the outcome for the diverse group of patients with this rare but potentially curable cancer.”

Link to article and comment

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Tiny gold particles can help doctors detect tumor cells circulating in the blood of patients with head and neck cancer, researchers at Emory and Georgia Tech have found.

The detection of circulating tumor cells (CTCs) is an emerging technique that can allow oncologists to monitor patients with cancer for metastasis or to evaluate the progress of their treatment. The gold particles, which are embedded with dyes allowing their detection by laser spectroscopy, could enhance this technique’s specificity by reducing the number of false positives.

The results are published online in the journal Cancer Research.

One challenge with detecting CTCs is separating out signals from white blood cells, which are similarly sized as tumor cells and can stick to the same antibodies normally used to identify tumor cells. Commercially available devices trap CTCs using antibody-coated magnetic beads, and technicians must stain the trapped cells with several antibodies to avoid falsely identifying white blood cells as tumor cells.

Emory and Georgia Tech researchers show that polymer-coated and dye-studded gold particles, directly linked to a growth factor peptide rather than an antibody, can detect circulating tumor cells in the blood of patients with head and neck cancer.

“The key technological advance here is our finding that polymer-coated gold nanoparticles that are conjugated with low molecular weight peptides such as EGF are much less sticky than particles conjugated to whole antibodies,” says Shuming Nie, PhD, a professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. “This effect has led to a major improvement in discriminating tumor cells from non-tumor cells in the blood.”

The particles are linked to EGF (epithelial growth factor), whose counterpart EGFR (epithelial growth factor receptor) is over-produced on the surfaces of several types of tumor cells.

Upon laser illumination, the particles display a sharp fingerprint-like pattern that is specific to the dye, because the gold enhances the signal coming from the dyes. This suggests that several types of nanoparticles could be combined to gain more information about the growth characteristics of the tumor cells. In addition, measuring CTC levels may be sensitive enough to distinguish patients with localized disease from those with metastatic disease.

“Nanoparticles could be instrumental in modifying the process so that circulating tumor cells can be detected without separating the tumor cells from normal blood cells,” Nie says. “We’ve demonstrated that one tumor cell out of approximately one to ten million normal cells can be detected this way.”

In collaboration with oncologists at Winship Cancer Institute, researchers used nanoparticles to test for CTCs in blood samples from 19 patients with head and neck cancer. Of these patients, 17 had positive signals for CTCs in their blood. The two with low signals were verified to have no circulating cells by a different technique.

“Although the results have not been compared or validated with current CTC detection methods, our ‘one-tube’ SERS technology could be faster and lower in costs than other detection methods,” says Dong Moon Shin, MD, professor of hematology and oncology and otolaryngology, associate director of academic development for Winship Cancer Institute and director of the Winship Cancer Institute Chemoprevention Program. “We need to validate this pilot study by continuing with larger groups of patients and comparing with other tests.”

Writer:
Quinn Eastman

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Fat cells – liposuctioned from a patient’s belly – can safely boost heart function after a heart attack, according to a first-of-its-kind study presented at the American Heart Association’s Scientific Sessions 2010.

“The study suggests that these cells can be safely obtained and infused inside the hearts of patients following an acute heart attack,” said Eric (HJ) Duckers, M.D., Ph.D., lead author of the small study and head of Molecular Cardiology Laboratory at the Thoraxcenter, Erasmus University Medical Center in Rotterdam, Netherlands.

The treatment reduced the amount of damaged heart tissue, increased blood flow in the heart and improved the heart’s pumping ability. These changes were not statistically significant, but the fat-derived stem cells worked as expected, Duckers said.

Duckers and colleagues recruited 11 men and three women for the prospective, double-blind, placebo-controlled APOLLO study (A Randomized Clinical Trial of AdiPOse-Derived Stem ceLLs in the Treatment of Patients With ST-Elevation myOcardial Infarction). They randomized the 14 patients – 10 received stem cells and four got a placebo infusion. All patients had suffered a severe heart attack and had a catheter procedure to evaluate their heart damage within two to 12 hours of symptom onset.

With the patients’ consent, researchers liposuctioned 200-250 cubic centimeters of fat from the abdomen of each, using a system called Celution 800 device (Cytori Tx). From the fat cells, they isolated 20 million regenerative stem cells, which took nine to 10 minutes to infuse.

With the Celution device, physicians can isolate and sometimes infuse stems cells into the heart while the original catheter is still in place. APOLLO participants received cells within 24 hours after their catheterization.

At six months follow-up, researchers found encouraging results in the treatment group:
Those receiving stem cells showed a 3.5-fold improvement in heart perfusion. The treatment arm also had a 5.7 percent increase in the amount of blood ejected by the left ventricle versus those receiving placebo.
The average size of heart muscle damage dropped from 31.6 percent to 15.4 percent in the treatment group. For the placebo arm, the average area of damage remained the same as when the patients enrolled in the study – i.e. 24.7 percent.
The infused stem cells did not interfere with blood flow in the heart.
Stem cell therapy was not associated with ventricular arrhythmias, which are potentially fatal erratic heartbeats.
Two patients experienced adverse events from the liposuction procedure. Both formed a hematoma, an area of swelling filled with blood.

Although the APOLLO patients were white Europeans from the Netherlands (13) and Spain (one), “findings in the European Union population should be directly applicable to the United States population,” Duckers said. “But, it’s unclear whether the results would apply to non-Caucasians.”

APOLLO’s major limitation is its small size, and therefore its low statistical power to detect differences. This may be why researchers didn’t find a significant difference between the treatment and placebo groups.

Duckers and his colleagues have initiated a phase II-III clinical trial called ADVANCE that will enroll up to 375 patients at 35 medical centers in the European Union. It will focus on acute heart attack patients with a left ventricle ejection fraction less than 45 percent. Forty percent of patients will receive 20 million stem cells; another 40 percent will get 30 million stem cells; and 20 percent will make up the placebo group.

“The primary efficacy endpoint of ADVANCE will be absolute improvement in infarct size at six months follow-up,” Duckers said. “Several studies have shown that this is an excellent and more consistent predictor of survival and major adverse events (than other endpoints) in patients after an acute heart attack.”

Co-authors are: Jaco Houtgraaf, M.D., Ph.D.; Robert Jan van Geuns, M.D., Ph.D.; Bas. D. van Dalen, M.D., Ph.D.; Evelien Regar, M.D., Ph.D.; Wim van der Giessen, M.D., Ph.D.; Peter de Jaegere, M.D., Ph.D.; C. Schultz, M.D., Ph.D.; Michael Martin, M.D., Ph.D.; Alexander Milstein, M.D., Ph.D.; F. J. Fernandez-Aviles, M.D., Ph.D.; and Patrick. W. Serruys, M.D., Ph.D. Author disclosures are on the abstract. Cytori Therapeutics, Inc. funded the study.

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Stress is a factor in the healing of wounds, whether they be in skin or mucosal tissue, but stress affects healing in these tissues differently, according to new research conducted at the University of Illinois at Chicago.

“We believe what may improve healing in one tissue type may possibly worsen healing in a different type of tissue,” says Christopher Engeland, assistant professor of periodontics at UIC. Engeland will present the findings March 5 at the American Psychosomatic Society’s 67th annual meeting at the Chicago Downtown Marriott Hotel, 540 N. Michigan Ave.

In the new study, 65 UIC dental students received a small circular wound and a small longitudinal wound on the hard palate of the mouth at two different times: during the high-stress week of examinations, and during their relatively relaxed summer vacation.

The circular wound was videographed daily to monitor closure.

Biopsies from the longitudinal wound were taken 6 and 24 hours after wounding to assess the early and late stages of the inflammatory process, Engeland said. The levels of expression of eight genes involved in inflammation were determined from these biopsies.

The researchers found that wound closure was delayed during high stress. The stress of examinations was associated with a state of “hyper-inflammation” in healthy tissue and higher inflammatory responses in wounded tissue, Engeland said.

Previous studies showed that stress is associated with reduced inflammation in skin wounds, an effect that appears to be reversed in the mucosal tissue of the palate. The paradox suggests that attempts to improve healing by altering inflammation should be made in a tissue-specific manner, Engeland said.

“It is also interesting to note that the degree of inflammation in unwounded tissue was indicative of healing rates following injury,” Engeland said. This suggests that healing rates might be predicted from the immune status in normal tissue prior to surgery, he said.

Dr. Phillip Marucha, professor and head of periodontics at UIC, assisted with the research.

For more information about UIC, visit uic.

University of Illinois at Chicago
601 S Morgan St., MC 288
Chicago
IL 60607-7113
United States
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Potentia Pharmaceuticals,
Inc. announced today that it is entering the clinical phase of development
for POT-4, its lead drug candidate for the treatment of age-related macular
degeneration (AMD). POT-4 is a complement inhibitor, which shuts down the
complement activation system that could lead to local inflammation, tissue
damage and upregulation of angiogenic factors such as vascular endothelial
growth factor (VEGF).

Four landmark studies published in April 2005 demonstrated a genetic
link between the complement system and AMD, providing evidence that
complement activation plays a significant role in the cause of the disease.
Less than two years after the publication of the studies, POT-4 will be the
first complement inhibitor tested in patients with AMD.

“These recent data have sparked hope that AMD can be treated with
complement inhibitors, which help treat the early stages of the disease. We
are hopeful that POT-4 may represent a new therapeutic option for patients
with dry and wet forms of the disease,” said Cedric Francois, M.D., Ph.D.,
Potentia’s President and CEO.

AMD is the leading cause of blindness in the elderly of the western
world and affects more than 10 million patients in the United States alone.
The current standard of care for AMD relies primarily on angiogenesis
inhibitors, an approach geared towards the approximately 10-15% of AMD
patients with complications resulting from ocular angiogenesis (growth of
new blood vessels and bleeding in the back of the eye). No drug currently
on the market has been approved for the treatment of the remaining
patients, who suffer from the so-called “dry” form of the disease.

About the Complement System and POT-4

Complement activation is an inflammatory process involving dozens of
plasma proteins, ultimately leading to cell membrane disruption through the
membrane attack complex. Activation of the complement system is an
important part of the body’s defensive immune response against pathogens
such as bacteria and viruses. In spite of its defensive function,
inappropriate or excessive complement activation can have pathological
consequences. Multiple studies published over the past 2 years have
strongly linked the complement system to the pathology of AMD.

POT-4 is a synthetic peptide discovered by Professor John Lambris at
the University of Pennsylvania. It binds tightly to complement component
C3, preventing its participation in the complement activation cascade. As
C3 is the central component of all major complement activation pathways,
its inhibition effectively shuts down all downstream complement activation
that could otherwise lead to local inflammation, tissue damage and
upregulation of angiogenic factors such as vascular endothelial growth
factor.

About Age-Related Macular Degeneration

AMD is the progressive deterioration of the critical central region of
the retina called the macula. This disorder leads to irreversible loss of
central vision. More than 25 million patients worldwide suffer from AMD,
including roughly one-quarter of those 70 years and older. Ten to fifteen
percent of patients with AMD develop a complication in which leaky blood
vessels grow into the retina. This form of the disease is referred to as
‘neovascular’ or ‘wet’ AMD, as opposed to ‘atrophic’ or ‘dry’ AMD when this
complication does not emerge. Pharmacological treatments of AMD are
primarily limited to drugs that inhibit blood vessel growth and leakage and
are therefore approved for use only in patients with wet AMD.

About Potentia’s AMD Program

With the ultimate goal of making AMD a preventable disease, Potentia’s
AMD program focuses on developing new therapies that target AMD early in
the disease process. Potentia’s AMD pipeline includes POT-4 formulated to
protect patients from the disease for prolonged periods of time after each
treatment.

About Potentia Pharmaceuticals, Inc.

Potentia Pharmaceuticals, Inc. (potentiapharma/) is a
privately held, biotechnology company based in Louisville, KY. Together
with its corporate and academic partners, Potentia is developing new
approaches to the treatment of complement-related inflammatory diseases
such as AMD.

This press release contains “forward-looking statements” regarding the
potential therapeutic benefits and progress of Potentia’s research and
development programs. These statements are hereby identified as
“forward-looking statements”. Forward-looking statements include statements
regarding Potentia’s expectations, beliefs, intentions or strategies
regarding the future and include statements containing forward-looking
words such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “should,” “will,” and “would” or similar words. Such
statements are based on our management’s current expectations and involve
risks and uncertainties. Actual results and performance could differ
materially from those projected in the forward looking statements as a
result of many factors, including, without limitation, uncertainties
relating to drug discovery; formulation development; clinical development
processes; enrollment rates for patients in our clinical trials; changes in
relationships with strategic partners and dependence upon strategic
partners for the performance of certain activities under collaborative
agreements; the impact of competitive products and technological changes;
uncertainties relating to patent protection and uncertainties relating to
our ability to obtain funding. Potentia disclaims any intent or obligation
to update this press release or forward-looking statements contained
therein.

Our logo, trademarks, and service marks are the property of Potentia
Pharmaceuticals, Inc. All other trade names, trademarks, or service marks
are property of their respective owners.

Potentia Pharmaceuticals, Inc.
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The traditional prescriptions for a healthy life — sensible diet, exercise and weight control — extend life by reducing signaling through a specific pathway in the brain, according to Howard Hughes Medical Institute researchers who discovered the connection while studying long-lived mice.

They said their findings underscore the importance of maintaining a healthy lifestyle and may also offer promising research directions for understanding and treating diabetes and Alzheimer’s disease.

Howard Hughes Medical Institute investigator Morris F. White and his colleagues published their findings in the journal Science. Akiko Taguchi and Lynn Wartschow in White’s laboratory in the Division of Endocrinology at Children’s Hospital Boston and Harvard Medical School were co-authors of the research article.

In their experiments, the researchers sought to understand the role of the insulin-like signaling pathway in extending lifespan. This pathway governs growth and metabolic processes in cells throughout the body. The pathway is activated when insulin and insulin-like growth factor-1 switch on proteins inside the cell called insulin receptor substrates (Irs).

Other researchers had shown that reducing the activity of the pathway in roundworms and fruitflies extends lifespan. Despite those tantalizing clues, White said, “The idea that insulin reduces lifespan is difficult to reconcile with decades of clinical practice and scientific investigation to treat diabetes.”

“In fact, based on our work on one of the insulin receptor substrates, Irs2, in liver and pancreatic beta cells, we thought more Irs2 would be good for you,” said White. “It reduces the amount of insulin needed in the body to control blood glucose, and it promotes growth, survival and insulin secretion from pancreatic beta cells.

In earlier work, the researchers had found that knocking out both copies of the Irs2 gene in mice reduces brain growth and produces diabetes due to pancreatic beta cell failure. However, in the new study, when the researchers knocked out only one copy of the gene, they found the mice lived 18 percent longer than normal mice.

Because reducing insulin-like signaling in the neurons of roundworms and fruitflies extends their lifespan, the researchers decided to examine what would happen when they knocked out one or both copies of the Irs2 gene only in the brains of mice.

Mice lacking one copy of the Irs2 gene in brain cells also showed an 18 percent longer lifespan, and the near complete deletion of brain Irs2 had a similar effect. “What’s more, the animals lived longer, even though they had characteristics that should shorten their lives — such as being overweight and having higher insulin levels in the blood,” said White.

However, both sets of Irs2 knockout mice exhibited other characteristics that marked them as healthier, said White. They were more active as they aged, and their glucose metabolism resembled that of younger mice. The researchers also found that after eating, their brains showed higher levels of superoxide dismutase, an antioxidant enzyme that protects cells from damage by highly reactive chemicals called free radicals.

“Our findings put a mechanism behind what your mother told when you were growing up — eat a good diet and exercise, and it will keep you healthy,” said White. “Diet, exercise and lower weight keep your peripheral tissues sensitive to insulin. That reduces the amount and duration of insulin secretion needed to keep your glucose under control when you eat. Therefore, the brain is exposed to less insulin. Since insulin turns on Irs2 in the brain, that means lower Irs2 activity, which we’ve linked to longer lifespan in the mouse.”

White and his colleagues are planning their next studies to better understand how healthy aging and lifespan are coordinated by Irs2 signaling pathways in the body and the brain. White speculated that the insulin-like signaling pathway in the brain might promote age-related brain diseases.

“We are beginning to appreciate that obesity, insulin resistance, and high blood insulin levels are connected to Alzheimer’s disease, Huntington’s disease, and dementias in general,” he said. “It might be that, in people who are genetically predisposed to these diseases, too much insulin overactivates Irs2 in the brain and accelerates disease progression. Thus, insulin resistance and higher insulin levels might be the environmental influences that promote these diseases,” he said.

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A new test could predict which women have an aggressive form of breast cancer in the milk ducts (DCIS ) and spare other women from unnecessary radiotherapy, according to research1 published in the British Journal of Cancer today (Wednesday).

The test looks at and compares the unique features of DCIS cancer cells. By comparing these, the researchers – part funded by Cancer Research UK – discovered common traits in cells from the most aggressive form of the disease.

Women whose cells showed these characteristics were 40 per cent more likely to have a cancer that came back than the rest of the women in the study.

The researchers believe this test could be used to predict which women will need radiotherapy after surgery to prevent their cancer coming back, and which women will be unlikely to have a cancer recurrence.

Study author Professor Sarah Pinder, based at King’s College London, said: “Screening is incredibly effective at identifying DCIS but we don’t have a reliable system to identify which cancers are likely to be aggressive and need further treatment.

“We believe that our test will help identify a group of women who are at a much greater risk of the disease returning after surgery. We need to confirm this in larger studies but it’s reasonable to suggest that this group of women should have the disease completely removed and receive radiotherapy to help prevent the disease returning.”

DCIS accounts for around 20 per cent of breast cancers picked up by mammography. But DCIS is a highly variable disease – differing in how it looks on a mammogram, under a microscope and how it will develop.

For some patients DCIS will transform quickly, over a few years, into aggressive breast cancer but for others their DCIS will not cause further problems. But the features that differentiate between the two types have previously been unclear.

Treatment for DCIS now involves surgery to remove the DCIS and some of the surrounding area. This may be followed by radiotherapy to reduce the risk of developing an invasive cancer in the future. But there is no accurate test to determine which women would benefit most from this.

The new test was designed by comparing the features of over 1,200 DCIS samples2 from different women, by looking at characteristics such as cell size, shape and growth pattern. While this research confirms features that have previously been linked to increased risk of the disease returning, it more accurately identifies those with aggressive forms of the disease.

Dr Lesley Walker, director of cancer information at Cancer Research UK, said: “Since screening was introduced, a large number of DCIS have been diagnosed. Improvements in imaging and new diagnostic tests such as this will help determine which women need further treatment such as radiotherapy.

“Each year breast screening saves the lives of around 1,400 women and we’d encourage women go when invited.”

Notes

1. Pinder, S. (2010). A new pathological system for grading DCIS with improved prediction of local recurrence: results from the UKCCCR/ANZ DCIS trial British Journal of Cancer DOI: 10.1038/sj.bjc.6605718

2. These samples were part of the UKCCCR/ANZ DCIS randomised clinical trial examining the value of radiotherapy and tamoxifen in the treatment of DCIS treated by breast conserving surgery. The initial results of this have been previously published and showed that radiotherapy to the breast after removal of DCIS reduces the risk of the disease recurring (UK Coordinating Committee on Cancer Research Ductal Carcinoma in situ Working Party. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet 2003;362:95-102).

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A prominent US cancer institute has posted a notice on its website urging cell phone users to take
precautions when using cell phones because advice from an international panel of experts says cell
phones have not been around long enough for scientists to be sure about their safety.

The announcement comes from the Center for Environmental Oncology (CEO), part of the University of
Pittsburgh Cancer Institute, based in Pittsburgh, Pennsylvania and says that following the advice of an
international panel of experts, comprising cancer experts from Europe and the US:

“Electromagnetic fields generated by cell phones should be considered a potential human health
risk.”

Not enough time has elapsed for us to be sure of the biological consequences of cell phone and
cordless phone technology, said the CEO, and until then, people should be careful.

The CEO said that recent studies “which include subjects with a history of cell phone usage for a
duration of at least 10 years, show a possible association between certain benign tumors (acoustic
neuromas) and some brain cancers on the side the device is used”.

Research that estimates the penetration of electromagnetic radiation from cell phones based on age,
shows that children are considerably more vulnerable than adults, said the CEO, explaining that the
frequency bands used by cell phones (from 800 to 2200 MHz), even below the power threshold
required by most safety standards, causes “an increase in the permeability of the blood-brain barrier
and an increased synthesis of stress proteins”.

Neither the expert panel nor the CEO suggests people should stop using cell phones, which they refer
to as “a remarkable invention and a breakthrough of great social importance”. One of the experts, a
brain cancer survivor, Dr David Servan-Schreiber, continues to use his cell phone.

The message therefore, is that users should take precautionary measures, and especially those who
have cancer already.

The CEO suggested this 10-point list of precautions:

Children should only use cell phones for emergencies. Organs that are still growing are likely to be
the most sensitive to electromagnetic fields.
When using your cell phone, keep it away from the body as much as you can. Compared to
holding it next to your head, the amplitude of the electromagnetic field drops to 25 per cent at two
inches (5 cm) distance and to 2 per cent at three feet (about 1 metre).
Use speakerphone, or a wireless Bluetooth headset, as much as possible. These have less than 1
per cent of the emission of a normal cell phone. A hands-free ear piece may also reduce
exposure.
Using your cell phone in public, crowded places, like a bus, means others are passively exposed to
your phone’s electromagnetic fields, so avoid using it in these places.
Keep your phone away from your body as much as possible – don’t carry it on your body. Don’t
keep it near your body at night (eg under a pillow or on a bedside table), especially if you are pregnant.
Put it in “flight” mode, which stops electromagnetic emissions (you can still other functions such as
the alarm in this mode).
If you have to carry it on your body, keep the keypad toward you and the back of the phone
pointing away from you so more of the transmitted electromagnetic field moves away from you rather
than toward you.
For long conversations use a landline with a corded phone, not a cell phone or a cordless phone,
since both use similar electromagnetic emitting technology.
Alternate right and left ear when using your cell phone, to spread the exposure. Wait until the
person you are calling answers before placing the phone next to your ear. In other words, do
everything you can to cut your exposure time with the phone close to your body.
Avoid using your phone when travelling at speed, such as on a train, or when the signal is weak.
The phone will be trying to connect to a new relay antenna, and uses higher power to do this.
Text rather than call, as much as you can. This limits exposure in two ways: less time on the
phone and the phone is further away from your body.
Choose a phone with the lowest possible Specific Absorption Rate (SAR, a measure of the
strength of the magnetic field absorbed by the body). Use the keyword phrase “sar ratings cell
phones” to search on the Internet.

There has been a somewhat sceptical reaction to the CEO announcement in the press today,
with many reports saying there is a considerable body of research that has found no risk to health from
cell phone usage.

The National Cancer Institute website says that studies have so far failed to show a link between brain
tumours and cell phone use.

The US Food and Drug Administration (FDA) says on its website that:

“The available scientific evidence does not show that any health problems are associated with using
wireless phones. There is no proof, however, that wireless phones are absolutely safe. “

In research, there is a saying “absence of evidence is not evidence of absence”, which perhaps urges
us all to consider this news carefully and make up our own minds.

Click
here to read the full CEO announcement “The Case for Precaution in the Use of Cell
Phones”.

Click here for “Cell
Phone Facts, Questions and Answers”, from the FDA

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The first comprehensive comparative effectiveness clinical trial of three widely used anti-seizure drugs for childhood absence epilepsy – the most common form of epilepsy in kids – has established an evidence-based approach for initial drug therapy.

Published March 4 in the New England Journal of Medicine, data from the double-blind, randomized, comparative clinical trial fill a large information gap in the treatment of childhood absence epilepsy, also known as “petit mal” epilepsy. The research, which identifies important differences between drugs in seizure control and side effects, is expected to impact how physicians select and monitor initial therapy for children with the disorder and ultimately lead to improved outcomes.

“Involving 453 children, 32 U.S. medical centers and the National Institutes of Health, this landmark study establishes clinically important differences between the three medications most commonly used as initial therapy for childhood absence epilepsy,” said Tracy A. Glauser, M.D., the study’s lead investigator and director of the Comprehensive Epilepsy Center at Cincinnati Children’s Hospital Medical Center.

Although childhood absence epilepsy is common, the comparative efficacy and tolerability of initial therapy with ethosuximide, valproic acid or lamotrigine had not been comprehensively or rigorously assessed in patients until the current clinical trial. The study is the largest pediatric epilepsy clinical trial ever funded by the National Institute of Neurological Disorders and Stroke (NINDS), of the National Institutes of Health.

“Although childhood absence epilepsy is often perceived as a benign form of epilepsy, many affected children have cognitive deficits and long-term psychosocial difficulties. This study helps physicians and families make informed choices about how to approach its treatment,” said Deborah Hirtz, M.D., a co-author of the study and a program director at NINDS.

The research team found that ethosuximide provided the best combination of seizure control and fewest attentional side effects over the initial 16- to 20-week period after starting therapy. The researchers concluded ethosuximide – one of the oldest available anti-seizure medications in the U.S. – is the “sensible choice for initial monotherapy in childhood absence epilepsy.”

Children were eligible for the study if they were between 2.5 and 13 years, had newly-diagnosed childhood absence epilepsy and were free of other medical conditions, such as autism or developmental delay. Once enrolled, children were randomly assigned to take ethosuximide (156 children), valproic acid (148) or lamotrigine (149). Children, their parents and the clinical sites were all blinded to which study medication each child was taking. Study medication doses were incrementally increased until the child was either seizure free (both clinically and by a one hour video electroencephalogram, EEG) or the child reached the maximal allowable or highest tolerated dose.

The study’s primary outcome goal was to determine the “freedom-from-failure” rate for each medication, defined as being seizure free without intolerable side effects at the 16th week of treatment. A few children who still had seizures but had not yet reached either maximum allowed or tolerated dosage at the 16th week were allowed one more dosage increase and re-evaluated at the 20th week of treatment.

The study’s secondary outcome examined how the study medications affected attentional abilities in these children. Attentional abilities were measured using the Confidence Index score from the age appropriate computerized Conners’ Continuous Performance Test. Attention dysfunction was defined a Confidence Index of 0.60 or higher. The Confidence Index provides a confidence level that suggests closeness of the match to a clinical or nonclinical profile of attention deficit. An index of 0.60 corresponds to a 60 percent probability that the child has a clinically significant attention disorder.

Of the three drugs, ethosuximide’s freedom-from-failure rate was 53 percent compared to 58 percent for valproic acid and 29 percent for lamotrigine. The freedom-from-failure rates of ethosuximide and valproic acid were similar to each other and both were significantly higher than that for lamotrigine. A significantly lower percentage of children taking ethosuximide (33 percent) had abnormal Conners’ confidence index scores compared to those taking valproic acid (49 percent). Researchers concluded that ethosuximide was preferred as initial therapy because of its improved seizure control compared to lamotrigine and fewer attentional effects compared to valproic acid.

Although the clinical trial establishes a rational evidence-based approach for initial drug therapy, the researchers are careful to point out that “even the best empirical therapy fails in almost 50 percent of newly diagnosed cases.” Also, as patients with childhood absence epilepsy grow into adolescence, they are at risk to develop tonic-clonic (“grand mal”) seizures, which are resistant to treatment by ethosuximide.

“The results of this clinical trial answer important decades old questions and raise new ones” explained Dr. Glauser, also a professor of pediatrics at the University of Cincinnati College of Medicine. “We want to know why specific patients respond differently to different drugs, how we can improve our overall rate of success with initial therapy, and whether those medications that work best in the short-term continue to be the best choice over the long-term.”

According to the Epilepsy Foundation, 45,000 children in the United States under the age of 15 develop epilepsy every year. An estimated 10 to17 percent of those cases involve childhood absence epilepsy, an epilepsy syndrome in which seizures can occur dozens to hundreds of times per day. The seizures consist of sudden loss of awareness as children stop activities and stare blankly into space for 10-30 seconds. Children suffering these seizures can be unresponsive to voice and often display flickering eyelids, lip smacking or other non-voluntary movements.

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Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) today announced that it was awarded a $2.5 million matching grant by the National Cancer Institute (NCI) to bring to market and expand the array features for its LightTouch™ non-invasive cervical cancer detection technology. The award provides resources to complete the regulatory process and begin manufacturing ramp up for the device and single-patient-use disposable.

“This grant provides significant non-dilutive resources for us to begin manufacturing LightTouch devices and disposables for an international launch, as we simultaneously complete the U.S. Food and Drug Administration (FDA) pre-market approval (PMA) application process,” said Mark L. Faupel, Ph.D., President and CEO of GT.

Including the new award, the company has been awarded approximately $6 million in six consecutive grants from the NCI to develop the new, pain-free test for detecting cervical disease.

“We believe that the grant validates the development of our cost effective cancer detection technology, as the NCI reviewed a combination of our technical approach, commercialization plan and clinical performance to date in making the award,” said Shabbir Bambot, Ph.D., Vice-president of Research and Development for GT and principal investigator of the grant. “Additionally, we believe that our scientific approach and underlying intellectual property position were key factors in being awarded this grant.”

The GT LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively, by analyzing the wavelengths of light reflected from cervical tissue. The technology distinguishes between normal and diseased tissue, by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require a tissue sample or laboratory analysis, and is designed to provide results immediately. The technology is designed as a device employing a single-use disposable patient interface.

Since development of the technology began, more than 3,000 women have been tested with the LightTouch, including more than 1,900 women who were evaluated as part of the FDA pivotal clinical trial.

According to studies published in the peer-reviewed Journal of Lower Genital Tract Disease, the non-invasive LightTouch test has the potential to be significantly more accurate when compared to tissue sample-based tests such as the Pap smear.

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