Anti-herpes virus drug treatment may benefit some chronic fatigue syndrome patients

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 30 Jul 2013 - 0:00 PDT Current ratings for:
Anti-herpes virus drug treatment may benefit some chronic fatigue syndrome patients

Many experts believe that chronic fatigue syndrome (CFS) has several root causes including some viruses. Now, lead scientists Shara Pantry, Maria Medveczky and Peter Medveczky of the University of South Florida's Morsani College of Medicine, along with the help of several collaborating scientists and clinicians, have published an article in the Journal of Medical Virology suggesting that a common virus, Human Herpesvirus 6 (HHV-6), is the possible cause of some CFS cases.

Over 95 percent of the population is infected with HHV-6 by age 3, but in those with normal immune systems the virus remains inactive. HHV-6 causes fever and rash (or roseola) in infants during early childhood, and is spread by saliva. In immunocompromised patients, it can reactivate to cause neurological dysfunction, encephalitis, pneumonia and organ failure.

"The good news reported in our study is that antiviral drugs improve the severe neurological symptoms, including chronic pain and long-term fatigue, suffered by a certain group of patients with CFS," said Medveczky, who is a professor of molecular medicine at USF Health and the study's principal investigator. "An estimated 15,000 to 20,000 patients with this CFS-like disease in the United States alone may ultimately benefit from the application of this research including antiviral drug therapy."

The link between HHV-6 infection and CFS is quite complex. After the first encounter, or "primary infection," all nine known human herpesviruses become silent, or "latent," but may reactivate and cause diseases upon immunosuppression or during aging. A previous study from the Medveczky laboratory showed that HHV-6 is unique among human herpesviruses; during latency, its DNA integrates into the structures at the end of chromosomes known as telomeres.

Furthermore, this integrated HHV-6 genome can be inherited from parent to child, a condition commonly referred to as "chromosomally integrated HHV-6," or CIHHV-6. By contrast, the "latent" genome of all other human herpesviruses converts to a circular form in the nucleus of the cell, not integrated into the chromosomes, and not inheritable by future generations.

Most studies suggest that around 0.8 percent of the U.S. and U.K. population is CIHHV6 positive, thus carrying a copy of HHV-6 in each cell. While most CIHHV-6 individuals appear healthy, they may be less able to defend themselves against other strains of HHV-6 that they might encounter. Medveczky reports that some of these individuals suffer from a CFS-like illness. In a cohort of CFS patients with serious neurological symptoms, the researchers found that the prevalence of CIHHV-6 was over 2 percent, or more than twice the level found in the general public. In light of this finding, the authors of the study suggest naming this sub-category of CFS "Inherited Human Herpesvirus 6 Syndrome," or IHS.

Medveczky's team discovered that untreated CIHHV-6 patients with CFS showed signs that the HHV-6 virus was actively replicating: determined by the presence of HHV-6 messenger RNA (mRNA), a substance produced only when the virus is active. The team followed these patients during treatment, and discovered that the HHV-6 mRNA disappeared by the sixth week of antiviral therapy with valganciclovir, a drug used to treat closely related cytomegalovirus (HHV-5). Of note, the group also found that short-term treatment regimens, even up to three weeks, had little or no impact on the HHV-6 mRNA level.

The investigators assumed that the integrated virus had become reactivated in these patients; however, to their surprise, they found that these IHS patients were infected by a second unrelated strain of HHV-6.

Further studies are needed to confirm that immune dysregulation, along with subsequent chronic persistence of the HHV-6 virus, is the root cause of the IHS patients' clinical symptoms, the researchers report.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our infectious diseases / bacteria / viruses section for the latest news on this subject.

The USF-led study was supported by the HHV-6 Foundation and the National Institutes of Health.

Article citation: “Persistent human herpesvirus-6 infection in patients with an inherited form of the virus; ” Shara N. Pantry, Maria M. Medveczky, Jesse H. Arbuckle, Janos Luka,Jose G. Montoya, Jianhong Hu, Rolf Renne, Daniel Peterson, Joshua C. Pritchett, Dharam V. Ablashi, andPeter G. Medveczky; Journal of Medical Virology; published online July 25, 2013; DOI: 10.1002/jmv.23685

University of South Florida (USF Health)

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FDA approves treatment for major depressive disorder in adults

Main Category: Depression
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 30 Jul 2013 - 2:00 PDT Current ratings for:
FDA approves treatment for major depressive disorder in adults

Forest Laboratories, Inc. announced that FETZIMA (levomilnacipran extended-release capsules) was approved by the FDA for the treatment of Major Depressive Disorder (MDD) in adults. MDD, also generally known as depression, affects almost 16 million adults in the United States every year. MDD is a serious medical condition, and despite available options, people with MDD often struggle to find a treatment that works for them -- so FDA approval of FETZIMA may be important for adults living with MDD.

FETZIMA is the most recent addition to Forest's growing mental health portfolio. For more than 15 years, Forest Laboratories has been driven by a focus on addressing unmet needs in the area of mental health. Forest's franchise now includes two marketed products for MDD:

VIIBRYD® (vilazodone HCl), launched in 2011, is the first and only selective serotonin reuptake inhibitor (SSRI) and 5-HT1A partial receptor agonist and is indicated for the treatment of adults with MDD.And now FETZIMA, approved in July 2013, is a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for MDD in adults.Please see Important Safety Information, including Boxed Warning, for FETZIMA and VIIBRYD below.

Together, these products reflect Forest's research-driven approach toward identifying and developing a range of treatment options for the millions of Americans who live with MDD.

In three placebo-controlled, pivotal Phase III studies of adult patients with MDD, statistically significant and clinically meaningful improvement in depressive symptoms was demonstrated across three FETZIMA dosage strengths of 40, 80, and 120 mg once daily compared with placebo as measured by the Montgomery Åsberg Depression Rating Scale (MADRS) total score (primary endpoint). FETZIMA also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score (secondary endpoint).

FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults.

FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. FETZIMA is not approved for use in pediatric patients.

FETZIMA is contraindicated in patients with a hypersensitivity to levomilnacipran, milnacipran HCl, or to any excipient in the formulation.The use of MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA is contraindicated due to an increased risk of serotonin syndrome. The use of FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.Starting FETZIMA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated due to an increased risk of serotonin syndrome.Do not use FETZIMA in patients with uncontrolled narrow-angle glaucoma. All patients being treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when increasing or decreasing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients daily. Prescriptions for FETZIMA should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue FETZIMA and initiate supportive treatment. If concomitant use of FETZIMA with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.SNRIs, including FETZIMA, have been associated with increases in blood pressure. Blood pressure should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Pre-existing hypertension should be controlled before initiating treatment with FETZIMA. For patients who experience a sustained increase in blood pressure, discontinuation or other appropriate medical intervention should be considered.SNRIs including FETZIMA have been associated with an increase in heart rate. Heart rate should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Pre-existing tachyarrhythmias and other cardiac disease should be treated before starting therapy with FETZIMA. For patients who experience a sustained increase in heart rate, discontinuation or other appropriate medical intervention should be considered.SSRIs and SNRIs, including FETZIMA, may increase the risk of bleeding events, some serious. Concomitant use of aspirin, warfarin, NSAIDs and other anticoagulants may add to this risk.Mydriasis has been reported in association with SNRIs including FETZIMA; therefore, FETZIMA should be used with caution in patients with controlled narrow-angle glaucoma. Patients with raised intraocular pressure should be monitored. DO NOT use FETZIMA in patients with uncontrolled narrow-angle glaucoma.SNRIs, including FETZIMA, can affect urethral resistance. Caution is advised when using FETZIMA in patients prone to obstructive urinary disorders.Symptoms of mania/hypomania were reported in 0.2% of FETZIMA-treated patients and 0.2% of placebo-treated patients in clinical studies. As with all antidepressants, FETZIMA should be used cautiously in patients with a history or family history of bipolar disorder, mania or hypomania. Prior to initiating treatment with FETZIMA, patients should be adequately screened to determine if they are at risk for bipolar disorder. FETZIMA is not approved for use in treating bipolar depression.FETZIMA should be prescribed with caution in patients with a seizure disorder.Discontinuation symptoms, some serious, have been reported with discontinuation of serotonergic antidepressants such as FETZIMA. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients when discontinuing FETZIMA. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.Advise patients that if they are treated with diuretics or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking FETZIMA. Although no cases of hyponatremia resulting from FETZIMA treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. FETZIMA should be discontinued in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

The most commonly observed adverse reactions in MDD patients treated with FETZIMA in placebo-controlled studies (incidence =5% and at least twice the rate of placebo) were: nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations.

Please also see full Prescribing Information for FETZIMA.

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of VIIBRYD or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. VIIBRYD is not approved for use in pediatric patients.

Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with VIIBRYD or within 14 days of stopping treatment with VIIBRYD. Do not use VIIBRYD within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start VIIBRYD in a patient who is being treated with linezolid or intravenous methylene blue.

All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients daily. Prescriptions for VIIBRYD should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including VIIBRYD, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue VIIBRYD and initiate supportive treatment. If concomitant use of VIIBRYD with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. Patients should be monitored for the emergence of serotonin syndrome.

Like other antidepressants, VIIBRYD should be prescribed with caution in patients with a seizure disorder.

The use of drugs that interfere with serotonin reuptake, including VIIBRYD, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of VIIBRYD and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation or bleeding.

Symptoms of mania/hypomania were noted in 0.1% of patients treated with VIIBRYD in clinical studies. As with all antidepressants, VIIBRYD should be used cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.

Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. VIIBRYD is not approved for use in treating bipolar depression.

Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.

Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking VIIBRYD. Although no cases of hyponatremia resulting from VIIBRYD treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. Discontinuation of VIIBRYD in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

The most commonly observed adverse reactions in MDD patients treated with VIIBRYD in placebo-controlled studies (incidence =5% and at least twice the rate of placebo) were: diarrhea (28% vs 9%), nausea (23% vs 5%), insomnia (6% vs 2%), and vomiting (5% vs 1%).

Please also see full Prescribing Information for VIIBRYD.

Article adapted by Medical News Today from original press release. Source:

Forest Laboratories

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'FDA approves treatment for major depressive disorder in adults'

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View the original article here

New idea and approach in the treatment of vascular dementia

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our alzheimer's / dementia section for the latest news on this subject.

Article: " A ginkgo biloba extract promotes proliferation of endogenous neural stem cells in vascular dementia rats " by Jiwei Wang2, Wen Chen1, Yuliang Wang1 (1 Department of Physiology, Weifang Medical University, Weifang 261042, Shandong Province, China; 2 School of Medicine, Shandong University, Jinan 250012, Shandong Province, China).

Wang JW, Chen W, Wang YL. A ginkgo biloba extract promotes proliferation of endogenous neural stem cells in vascular dementia rats. Neural Regen Res. 2013;8(18):1655-1662.

Full text: http://www.sjzsyj.org:8080/Jweb_sjzs/CN/article/downloadArticleFile.do?attachType=PDF&id=634

Neural Regeneration Research

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Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today

Main Category: Liver Disease / Hepatitis
Also Included In: Alcohol / Addiction / Illegal Drugs
Article Date: 25 Jul 2013 - 1:00 PDT Current ratings for:
Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today

The burden of liver disease could be dramatically reduced by increasing treatment for hepatitis C infection among people who inject drugs, suggest new recommendations developed by researchers from the Kirby Institute at UNSW, in collaboration with colleagues from the International Network on Hepatitis Care in Substance Users (INHSU).

In Australia, 226,000 people are living with chronic hepatitis C and over 10,000 new cases are reported every year. Hepatitis C can lead to serious liver complications such as liver failure or cancer, which are associated with considerable costs to the health care system. Although almost 80 per cent of all infections occur among people who inject drugs, only one per cent of these people currently receive treatment.

"Treatment for hepatitis C infection among people who inject drugs remains unacceptably low," said Dr Jason Grebely, Senior Lecturer at the Kirby Institute, UNSW, and co-lead author of the recommendations. "Clinicians have been hesitant to recommend treatment in this population because of a lack of understanding about how lifestyle factors may impede successful treatment."

But research supporting the first set of international recommendations ever released for treating hepatitis C in people who inject drugs has shown that treatment can be very successful when barriers are addressed within a supportive environment.

"Reducing the significant burden of liver disease related to hepatitis C in Australia and internationally will require improved assessment and treatment of the population most affected: people who currently inject drugs and those who have injected drugs in the past," says Philip Bruggmann, President of INHSU. "By providing appropriate care to this group, we can reduce the burden of hepatitis C-related liver disease in this vulnerable population and slow the spread of this world-wide epidemic. These new recommendations serve as a first step towards elimination of hepatitis C."

The global recommendations are published online today in the journal Clinical Infectious Diseases ahead of World Hepatitis Day on July 28. They are part of a supplement entitled "Prevention and Management of Hepatitis C Virus Infection Among People Who Inject Drugs: Moving the Agenda Forward", developed in collaboration with INHSU.

Additional Stakeholder Comments:

"These are exceptionally positive and welcome findings. Following the listing of new hep C treatments for subsidy by the Australian Government in April, almost all people in Australia living with hepatitis C in Australia can enjoy cure rates of around 75 to 80 per cent. This new evidence shows us that people who have been least able to access treatment in the past, can and should be able to benefit from these new treatment advances."

Stuart Loveday
CEO of Hepatitis NSW

"This report is most welcomed. It finally provides the much needed endorsement that peer support requires to validate it as an efficacious treatment modality. That combined with the recognition that people who continue to inject or use drugs can access treatment will mean that more people will be able to access treatment. For too long those most affected by hepatitis C have been on the periphery, this report puts them where they belong - front and centre."

Nicky Bath
CEO of the NSW Users and AIDS Association

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Institute, Kirby. "Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today." Medical News Today. MediLexicon, Intl., 25 Jul. 2013. Web.
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Institute, K. (2013, July 25). "Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/263862.php.

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'Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today'

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First patient receives innovative new treatment to tackle combined diabetes and obesity in NHS approved trial initiated by the ABCD, UK

Main Category: Diabetes
Also Included In: Obesity / Weight Loss / Fitness
Article Date: 26 Jul 2013 - 2:00 PDT Current ratings for:
First patient receives innovative new treatment to tackle combined diabetes and obesity in NHS approved trial initiated by the ABCD, UK

Combined diabetes and obesity, 'diabesity', is a serious health problem with considerably increased risks of premature heart attack, stroke and death. If not controlled, it can also affect the eyes leading to blindness, the kidneys leading to kidney failure and the feet leading to ulcers and amputation.

The number of patients with diabesity is increasing rapidly, both in the UK and world-wide. Despite all the available expertise and best use of the most modern treatments there are many patients who remain considerably overweight and with poor diabetes control, rendering them vulnerable to these complications.

For such patients a possible new treatment has become available. It is called endobarrier and consists of a 60cm tube-like liner made from a thin, flexible and durable impermeable polymer. It is inserted by the simple procedure of endoscopy and is anchored in place, just beyond the stomach, by a basket of very thin wire made of Nitinol-an alloy of nickel and titanium. The endobarrier prevents food from contacting the first two feet of small intestine and this leads to considerable weight loss (18% reduction) and improvement in diabetes control (87% of patients reach the target control level).

Because this treatment could well be just what is needed for the patients who remain in trouble from their diabetes despite the best treatments available, ABCD have initiated a national trial of the new device funded by a grant from their Diabetes Care Trust (ABCD ) Registered Charity Number 1139057. The study is supported by the NHS and is centred at Birmingham's City Hospital with supporting centres in London (King's College Hospital and Guy's and St Thomas' Hospitals) and Glasgow (Glasgow Royal Infirmary).

Dr Piya Sen Gupta, ABCD Research Fellow, who is conducting the study for ABCD, said: "This trial presents an exciting opportunity for patients with combined diabetes and weight problems, who currently have limited treatment options, to kick start their way back to health.

"It is a novel idea to use a device to treat diabesity when the usual medications have failed and it may offer a valuable treatment option, avoiding in some, the need for invasive bariatric surgery. By opening this study up to NHS patients in Birmingham, London and Glasgow, the results will be relevant throughout the UK. This study has been so named, as we do hope that it goes some way to REVISE-Diabesity"

The first patient to receive the new treatment in the trial is due to have her device inserted on the morning of Thursday 25th July, 2013, at Birmingham's City Hospital.

ABCD Chairman, Dr Chris Walton, said :"The twin epidemics of obesity and diabetes may bankrupt our healthcare systems. The projected spend on diabetes rises from the current 10% of NHS expenditure to 17% of NHS expenditure by 2035 and it is estimated that, for type 2 diabetes, the cost of complications of the disease is more than threefold the cost of treatment. ABCD is keen to research new technologies that confront obesity in diabetes and which may prevent the relentless progress to complications, so the placement of the first endobarrier device in this study is a landmark date''

Dr Bob Ryder, Principal Investigator for the ABCD study, said: "At the moment we have many patients who remain overweight and with poor diabetes control, despite all the available diabetes treatments. Because the endobarrier reduces weight and improves the diabetes control, it is a treatment that could break the cycle of problems for these patients who have otherwise come to the end of the line.

"The best thing about the endobarrier is that it is not permanent and after insertion at endoscopy, it is removed up to a year later, and we then have to hope that the improvement is sustained. This treatment is not currently an NHS treatment, but this is an NHS approved study, and if the trial proves successful and cost effective, we expect that the device will be considered by NICE for approval as part of mainstream NHS diabetes treatment in the future".

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our diabetes section for the latest news on this subject.

The Association of British Clinical Diabetologists (ABCD) is the national organisation of Consultant Physicians in Britain who specialise in Diabetes Mellitus. Most are also Acute General Physicians, and many are also Specialists in Endocrinology and Lipid Metabolism.

The Association of British Clinical Diabetologists (ABCD)

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The Association of British Clinical Diabetologists. (2013, July 26). "First patient receives innovative new treatment to tackle combined diabetes and obesity in NHS approved trial initiated by the ABCD, UK." Medical News Today. Retrieved from
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posted by Dr.K.Ramakrishnan on 26 Jul 2013 at 10:12 am

Of course, the procedure is fantastic. Here some more clarifications needed. 1. Since the endobarrier is kept for one year ,is there a possibility of vital nutrient dificiency. 2. Can the procedure recommend for obesity and overwieght? 3. After one year is there any weightgain?

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'First patient receives innovative new treatment to tackle combined diabetes and obesity in NHS approved trial initiated by the ABCD, UK'

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Injectafer receives US FDA approval for the treatment of Iron Deficiency Anaemia

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Injectafer receives US FDA approval for the treatment of Iron Deficiency Anaemia

Injectafer® has received US Food and Drug Administration (FDA) approval for the treatment of Iron Deficiency Anaemia (IDA). Luitpold Pharmaceuticals, Inc., the US partner of Vifor Pharma, a company of the Galenica Group, will immediately launch the product. Injectafer® will be produced at the Luitpold manufacturing facility in Columbus, Ohio.

Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) has received US Food and Drug Administration (FDA) approval for the treatment of Iron Deficiency Anaemia (IDA) in adult patients who have had an unsatisfactory response to oral iron or who have intolerance to oral iron.

Injectafer® is the first non-dextran intravenous iron therapy to gain US FDA approval for the treatment of IDA in a diverse group of patients with this debilitating condition, irrespective of the underlying origin. Injectafer® is also indicated for Iron Deficiency Anaemia in adult patients with non-dialysis dependent Chronic Kidney Disease (ND-CKD).

The approval is based on the evaluation of two large, multi-centre, randomised, controlled clinical trials conducted by Luitpold Pharmaceuticals, Inc. that studied more than 3,500 patients, of which approximately 1,800 were treated with Injectafer®. Both trials met their efficacy and safety endpoints and were presented at the American Society of Nephrology's (ASN) Kidney Week 2011. The results of the VIT 31 study were recently published in the peer-reviewed journal "Transfusion"; results from the VIT 30 study (REPAIR-IDA trial) are anticipated to be published in another peer reviewed medical journal in the near future.

Luitpold Pharmaceuticals, Inc., the Vifor Pharma partner in the United States, will immediately launch Injectafer® to provide this important new drug to US physicians and their patients. In the US market, the product is available in 750mg vials and will be produced at the Luitpold manufacturing facility in Columbus, Ohio.

In the United States there are an estimated 7.5 million people with IDA, a condition that occurs when body iron stores are inadequate for normal red blood cell production. IDA is a frequent complication in many gastro-intestinal disease states and conditions, affecting up to one-third of inflammatory bowel disease patients, and up to 24% of patients undergoing bariatric bypass surgery. It is also prevalent in children and women, with over 3 million US women of childbearing age affected due to conditions such as heavy uterine bleeding, postpartum anaemia and pregnancy.

Ferinject® was approved by both the Swiss regulatory agency Swissmedic and the UK Medicines & Healthcare products Regulatory Agency (MHRA) in 2007. With the UK as Reference Member State, the MHRA has supported the subsequent approval of Ferinject® throughout the European Union. Ferinject® is currently registered for use in 46 countries and has been launched in 37 markets worldwide.

Injectafer® (US brand name of Ferinject®) is an innovative non-dextran intravenous (i.v.) iron replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Ferinject®. To date, Ferinject® (brand name of Injectafer® outside the US) has gained marketing authorisation in 46 countries worldwide for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other diseases. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further clinical trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and women's health are ongoing.

Iron Deficiency Anaemia (IDA) is a state in which iron stores are inadequate for normal blood formation, as the iron requirements exceed the supply. In severe cases red cells in a patient with IDA are both microcytic (small) and hypochromic (pale), and values for mean corpuscular volume (MCV) and mean corpuscular Hb concentration (MCHC) are characteristically reduced. According to the World Health Organization (WHO) it is estimated that about 700 million people have iron deficiency anaemia* (IDA).

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our blood / hematology section for the latest news on this subject.

* Source: World Health Organization. Preventing and controlling Iron Deficiency Anaemia through primary health care. Available here.

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'Motion sensor' may aid autism diagnosis and treatment

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Main Category: Autism
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
'Motion sensor' may aid autism diagnosis and treatment

Scientists have developed a new screening tool that could use an individual's movement to diagnose and treat autism, according to a series of studies published in the journal Frontiers in Integrative Neuroscience.

Researchers from Indiana University School of Medicine and Rutgers University have developed the method, which presents individuals with various images while a sensitive tracker monitors their movements.

The researchers say that this method, which can be used in children over the age of three, could provide an earlier, more objective and more accurate diagnosis of autism.

The method was tested on 78 children and adults with autism, including non-verbal autistic children and those with mild forms of the disorder.

The researchers say that the tool correctly diagnosed all of the participants, and even diagnosed autism subtypes, identified gender differences and tracked individual progress in treatment and development.

A movement tracker is attached to the individual, which senses "systemic signatures," measuring each person's movement as they respond to various screen images from an advanced computer program, showing 240 images a second.

The researchers say that this tool analyzes the importance of changes in movement and movement sensing, enabling the identification of stable capabilities in each individual, as well as highlighting the impairments of a person's movement system.

They add that the screening tool can measure tiny fluctuations, determining exactly how an individual's movement differs to that of a more typically developing child or adult. Dr Jorge José, vice president of research at Indiana University, says:

"We can estimate the cognitive abilities of people just from the variability of how they move. This may lead to a complementary way to develop therapies for autistic children at an early age."

The researchers say this tool can change the way autistic children learn and communicate by helping them to develop self-motivation, as opposed to being told or conditioned in what to do.

As part of the screening method, 25 autistic children were presented with a variety of media visuals, including videos of themselves, cartoons and music videos, and were given games to play. The children communicated which visuals they liked in a single motion.

Dr Elizabeth Torres, assistant professor in psychology at the School of Arts and Sciences, Rutgers University, explains:

"Every time the children cross a certain region in space, the media they like best goes on. They start out randomly exploring their surroundings. They seek where in space that interesting spot is which causes the media to play, and then they do so more systematically.

"Once they see a cause-and-effect connection, they move deliberately. The action becomes an intentional behavior."

She adds that through this method, the children independently learned that they could control their own bodies in order to communicate what they wanted to watch.

At present, there is no medical test to diagnose autism, and the disorder is diagnosed through specialists' opinions on an individual's behavior and communication.

The researchers say it is too early to see whether this research will lead to methods of therapy and diagnosis that are publicly available.

But Torres says she is confident that parents of autistic children would find it easy to adapt to her computer-aided technique and help their children.

Dr Jorge José adds:

"This research may open doors for the autistic community by offering the option of a dynamic diagnosis at a much earlier age and possibly enabling the start of therapy sooner in the child's development."

Written by Honor Whiteman

Copyright: Medical News Today
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Autism: the micro movement perspective, published in the journal Frontiers in Integrative Neuroscience, July 24, 2013

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NICE gives green light to treatment for wet AMD in final guidance

Main Category: Eye Health / Blindness
Article Date: 26 Jul 2013 - 2:00 PDT Current ratings for:
NICE gives green light to treatment for wet AMD in final guidance

The National Institute for Health and Care Excellence (NICE) has published final guidance recommending aflibercept solution for injection as an option for treating wet age-related macular degeneration (AMD).

Wet AMD is an eye condition that affects the macula (a tiny part of the retina at the back of the eye). AMD causes problems with central vision - for example, straight lines may appear wavy and blind spots may develop in the field of vision.

Macular degeneration is diagnosed as either dry (non-neovascular) or wet (neovascular). Neovascular refers to growth of new blood vessels in an area, such as the macula, where they are not supposed to be.

There are an estimated 26,000 new cases of wet AMD in the UK each year. Risk factors include increasing age, cigarette smoking (smokers having a 3.6 times greater risk of developing age-related macular degeneration compared with people who have never smoked), and exposure to high levels of UV light. It is also more common in women than men [i].

Aflibercept is recommended as an option for treating wet age related macular degeneration only if: it is used in accordance with the recommendations for ranibizumab in NICE technology appraisal guidance 155 [ii] (re-issued in May 2012), and the manufacturer provides aflibercept solution for injection to the NHS under the terms agreed with the Department of Health as part of a patient access scheme.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "Wet AMD can have a significant impact on vision, independence and quality of life. Today's guidance, which comes soon after aflibercept received its licence, provides healthcare professionals with clear advice on where and when this treatment can add value as another treatment option for those affected by this distressing condition. "

This is NICE's final guidance on this technology and now replaces local recommendations across the country.

The guidance is available on the NICE website.People currently receiving aflibercept solution for injection whose disease does not meet the criteria detailed above should be able to continue treatment until they and their clinician consider it appropriate to stop.Aflibercept solution for injection (Eylea, Bayer Pharma) is a soluble vascular endothelial growth factor (VEGF) receptor fusion protein which binds to all forms of VEGF-A, VEGF-B, and the placental growth factor. Aflibercept solution for injection prevents these factors from stimulating the growth of the fragile and permeable new blood vessels associated with wet age-related macular degeneration. Aflibercept solution for injection has a UK marketing authorisation 'for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD)'.The summary of product characteristics states that the recommended dose for aflibercept is 2 mg and that treatment should be given monthly for 3 consecutive 2 mg doses, followed by 1 injection every 2 months. Each 100 microlitre vial contains 4 mg of aflibercept. Aflibercept solution for injection must only be administered by a qualified doctor experienced in administering intravitreal injections. The summary of product characteristics also states that there is no need for monitoring between injections. After the first 12 months of treatment, the treatment interval may be extended based on visual and anatomic outcomes. In this case, the schedule for monitoring should be determined by the treating doctor.The list price of aflibercept 40 mg/ml solution for injection is £816 per 100-microlitre vial (excluding VAT; 'British national formulary' [BNF] edition 52).The Committee noted that its preferred analyses incorporated the confidential discount to the list price of aflibercept and a range of discounts (from 0 to 50%) to the list price of ranibizumab. It also noted that, when discounts to the list price of ranibizumab ranged from 0 to 45%, aflibercept had lower costs and quality-adjusted life years (QALYs) than ranibizumab, which resulted in ICERs for aflibercept compared with ranibizumab ranging from £1,692,500 to £16,700 saved per QALY lost and that, when a 50% discount was applied to the list price of ranibizumab, aflibercept was dominated by ranibizumab in both the worse-seeing eye and better-seeing eye model. However, the Committee was aware that, in both the manufacturer's and the ERG's analyses, the differences in total costs and QALYs were very small. The Committee therefore concluded that aflibercept could be recommended as a cost effective use of NHS resources if ranibizumab would otherwise be the treatment used.The independent Appraisal Committee decided that an appraisal consultation document (ACD) was not needed for this appraisal, so the recommendations went straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licensed indication.The manufacturer of aflibercept has agreed a patient access scheme with the Department of Health. This involves a confidential discount applied to the list price of aflibercept solution for injection. The level of the discount is commercial-in-confidence.NICE technology appraisals apply across the NHS in England and Wales.Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication.Further details on NICE technology appraisals.

Steve Winyard, RNIB's Head of Campaigns, said: "We welcome the news NICE has approved the use of a further drug to treat the biggest cause of sight loss in the UK.

"Not only does it mean patients now have the choice of two different drugs to treat their condition, it also means if they choose the newly approved drug it could mean less visits to the hospital.

"Some people with wet AMD do not respond to the current NICE approved treatment and another option could mean the difference between saving and losing their sight.

"We've recently launched a national campaign encouraging over 50s to spot the signs of wet AMD, which affects about 40,000 people each year and can destroy a person's sight in as little as three months.

"Losing your central vision can have profound consequences with many people unable to carry out basic tasks such as driving, chopping vegetables, or writing a shopping list. However, it doesn't have to be this way and people should not be losing their sight unnecessarily when there's treatment available."

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Related NICE guidance

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Study features practical solution for MRI-ultrasound fusion to enable tumor-targeted, tissue-preserving prostate HIFU treatment

Main Category: MRI / PET / Ultrasound
Also Included In: Prostate / Prostate Cancer
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Study features practical solution for MRI-ultrasound fusion to enable tumor-targeted, tissue-preserving prostate HIFU treatment

Study results published in the current issue of British Journal of Urology International (10.1111/bju.12223) demonstrate that new software to register and fuse information from magnetic resonance imaging (MRI) and ultrasound (US) images enables intraoperative visualization of tumors, not ordinarily seen in a US image. This technology has the potential to support new tissue-preserving treatments for prostate cancer, such as focal therapy.

In the study, "Image-Directed, Tissue-Preserving Focal Therapy of Prostate Cancer: a Feasibility Study of a Novel Deformable MR-US Registration System" researchers from University College London (UCL) evaluated the feasibility of using a computer-assisted, deformable image registration software to enable three-dimensional, multi-parametric MRI derived information on tumor location and extent to inform both the planning and treatment phase of focal high intensity focused ultrasound (HIFU) therapy using SonaCare Medical's Sonablate® 500 system.

Nested within the multi-center INDEX Trial, this pilot study employed computer assisted MRI-US image registration software within the planning of the first 26 men with a MRI-visible tumor treated at UCL with HIFU using a tissue-preserving quadrant, hemispheric (hemi) or extended hemi ablation therapy. Results demonstrated that thesoftware, developed at UCL, enables information of tumor location to be used for therapy planning using the Sonablate® 500 system without adding significant extra time to the standard procedural workflow. Such planning is particularly important for new tissue-preserving treatment approaches to ensure that the tumor is completely treated.

"Multi-parametric MRI has shown promise as an accurate method for determining the focality of tumors, and has promise as a potentially important enabler for minimally-invasive, tissue-preserving, or focal, HIFU treatments. However, most ablative technologies for localized prostate cancer use an ultrasound platform to plan and deliver treatment, on which the tumor cannot be accurately localized. This often results in discrepancies between the tumor and target volumes, potentially leading to under-treatment at the margins, or treatment of larger tissue volumes to compensate for inaccuracies in targeting," said lead author Louise Dickinson of UCL. "We are very pleased that the results of this pilot study demonstrate that deformable image registration is feasible and safe when introduced into a HIFU ablative therapy setting and suggests potential for improving the accuracy of targeting lesions using a tissue-preserving focal therapy approach."

The researchis based on breakthrough image analysis algorithms developed at the UCL Centre for Medical Image Computing and has undergone extensive clinical evaluation as part of clinical research studies led by Professor Mark Emberton, MD, Professor of Interventional Oncology and Director of the Division of Surgery and Interventional Science at UCL. Twenty-six prostate cancer patients have been successfully treated at UCLH using the Sonablate(®) 500 with the aid of this software as part of the INDEX Trial.

Dr. Dickinson added: "Indeed, if on-going clinical trials demonstrate clinical utility for focal therapy as an alternative to current standards of care, it is possible that image registration software may be essential for the efficient implementation of truly focal therapy techniques in which individual tumors are treated within an appropriate and safe surgical margin. The use of MRI-US registration potentially provides a cost-effective solution that, as shown in this study, can be easily integrated within existing workflows and interfaces, using standard surgical equipment."

Subsequent to this research, the team at UCL, led by Dr. Dean Barratt, is now developing a commercial version of their prostate image registration/fusion software, called "SmartTarget", with funding from the UK Department of Health and Wellcome Trust Health Innovation Challenge Fund. The SmartTarget project focuses on translating technology, which combines state-of-the-art diagnostic imaging with advanced image guidance technology to provide doctors with information on cancer location, size and shape so that it can be used to direct and guide prostate biopsy and minimally-invasive cancer treatments. In particular, the SmartTarget system exploits MRI, which can detect and characterize clinically significant cancers in a large proportion of patients.

"The adoption of tissue preserving approaches for the treatment of prostate cancer has been hampered by limitations in diagnosing and localizing clinically significant prostate cancers," said Mark Carol, M.D., Chief Development Officer for SonaCare Medical. "The publication of these results in the British Journal of Urology International is a tremendous validation of UCL's pioneering research in image registration and fusion technology that has led to significant advances in the validation and adoption of focal HIFU. We are proud to work with UCL to expand access to this breakthrough technology designed to enable targeted treatment of clinically significant prostate cancers."

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Recently SonaCare Medical, a global leader in minimally-invasive High-Intensity Focused Ultrasound (HIFU) technologies, and UCL Business PLC (UCLB), a leading technology transfer company that supports and commercializes research and innovations from UCL, announced a partnership to integrate SmartTarget image registration and fusion software into SonaCare Medical's innovative Sonablate® 500 HIFU system.

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Researcher finds way to convert blood cells into autoimmune disease treatment

Main Category: Immune System / Vaccines
Also Included In: Blood / Hematology;  Arthritis / Rheumatology;  Crohn's / IBD
Article Date: 19 Jul 2013 - 2:00 PDT Current ratings for:
Researcher finds way to convert blood cells into autoimmune disease treatment

Cells from one's own blood could be converted into a treatment for autoimmune diseases, like rheumatoid arthritis and Crohn's disease, based on the discovery of a Purdue University researcher.

Chang Kim, a professor of comparative pathobiology, has created a way to direct the differentiation of T-cells, a white blood cell that is a key player in the body's immune system. The method uses naive T-cells, immature cells from which all T-cells develop, and induces them to become suppressive T-cells that block the development of painful inflammation associated with autoimmune diseases.

Naive T-cells can be gathered from a patient's blood, treated and then re-injected, said Kim, who also is a university faculty scholar and member of Purdue's Center for Cancer Research and Weldon School of Biomedical Engineering.

"These cells are being directed to become a type of cell that is already present in our bodies, where a fine balance between inflammatory T-cells and suppressive T-cells is maintained," he said. "We are just tipping the scales in favor of suppressive T-cells to reduce inflammation. Because of this there are none of the toxic side effects associated with many immune-suppressive drugs. In addition, cells from one's own body aren't rejected and remain in the body much longer. Instead of taking a pill every day, this could lead to a treatment administered, for example, every six months."

Autoimmune diseases occur when the immune system attacks one's own body instead of fending off infection from viruses, bacteria and other foreign cells. An overactive immune system sends T-cells to healthy tissue and organs where they cause inflammation and tissue destruction.

Suppressive T-cells migrate to areas of inflammation and suppress the T-cells there without significantly lowering the number of T-cells in other areas of the body where they are needed for proper immune function, Kim said.

"Treatment with suppressive T-cells has the potential to be a much more precise and targeted regulation of immune function than what currently exists," he said. "Treating autoimmune diseases without compromising a patient's immune system has been a big problem in the field. We need to catch the thief without taking down the house, and this has that potential."

Kim discovered that naïve T-cells cultured in the presence of the hormone progesterone can be induced to become suppressive T-cells. This discovery and his work have been detailed in papers in the Journal of Immunology and the European Journal of Immunology. The group also filed a patent based on this work. The national Institutes of Health and the Crohn's and Colitis Foundation of America funded the research.

Studies in mice showed that about 500,000 suppressive T-cells are needed to have an effect on inflammation, Kim said.

"More work needs to be done to determine the appropriate dosage of cells for a human patient, but the amount of blood many people regularly donate would likely yield multiple treatments," he said.

Kim next plans to study at the molecular level how progesterone causes the cells to differentiate into suppressive T-cells and to uncover the proteins and protein receptors involved. An understanding of the molecular regulation of these cells could lead to a way to control their differentiation and function without using progesterone, he said.

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posted by Su Su on 20 Jul 2013 at 6:54 am

How long will this take to get it helping those suffering and on Big Drugs with deadly side effects? I would like to share with Chang Kim what I have learned about RA.

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New Treatment For Management Of Advanced Prostate Cancer After First-Line Hormonal Treatments And Docetaxel Chemotherapy Failure, Available In UK

Main Category: Prostate / Prostate Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Jul 2013 - 2:00 PDT Current ratings for:
New Treatment For Management Of Advanced Prostate Cancer After First-Line Hormonal Treatments And Docetaxel Chemotherapy Failure, Available In UK

Available now, XTANDI TM (enzalutamide) has been licensed for the treatment of men with advanced prostate cancer whose disease has become resistant to first-line hormonal treatments and has progressed following docetaxel chemotherapy[i], marking an important step in managing prostate cancer, which is the most common cancer among males in the UK.[ii] The UK licence has been granted based on pivotal trial data showing a 37% reduction of the risk of death versus placebo for patients taking enzalutamide during the study.[iii] Enzalutamide was also shown to be generally well tolerated.[iii] Enzalutamide is the latest in a new generation of drugs which can prolong and improve the quality of life for men with incurable advanced prostate cancer.[iii]

Professor Johann de Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, and Global Chief Investigator in the AFFIRM trial said: "Enzalutamide is a much needed development in prostate cancer treatment and will provide a new option for the increasing number of men with advanced prostate cancer in the UK, whose disease has become resistant to first-line hormonal treatments and who have had docetaxel chemotherapy. Enzalutamide has already demonstrated a positive impact on quality of life whilst increasing the life-span of patients with this common disease. Its use will bring significant benefits, establishing it as a key component of advanced prostate cancer treatment in the UK."

Prostate cancer is the second most common cause of cancer death in men in the UK.[ii] Although early stage disease can often be cured, when prostate cancer spreads to other parts of the body (known as advanced or metastatic prostate cancer), most commonly the bones, the disease is incurable.[iv] In patients who present with advanced disease, 72% will die within 5 years of diagnosis.[v]

Many men with advanced disease eventually develop resistance to first-line hormone treatment; this is called castration-resistant prostate cancer (CRPC).[vi] On average, 10-20% of prostate cancer patients develop CRPC within approximately 5 years of follow up, and of those almost 84% have metastatic disease at the time of diagnosis.[vii]

Enzalutamide is a once-daily, oral treatment administered without the need for routine product- specific monitoring.i Steroids are not required to be taken with enzalutamide, however, they can be prescribed at the judgement of a doctor.[i]

Enzalutamide works differently from other treatments for patients with advanced prostate cancer: enzalutamide works at three steps in the androgen receptor (AR) signalling pathway within the cancer cells stopping the cancer growing.[i] In advanced prostate cancer enzalutamide has been shown to decrease cancer cell growth and can cause cancer cell death.[i,iii]

The granting of the UK licence for enzalutamide follows the submission of data from the AFFIRM trial - a multinational study evaluating enzalutamide (160 mg/day) versus placebo in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy.[iii] From today, enzalutamide will provide UK clinicians with a treatment option which improves overall survival by an average of 4.8 months versus placebo, whilst potentially helping to maintain a good quality of life.i,iii Enzalutamide is available in England via the Cancer Drugs Fund.[viii]

About advanced prostate cancer

Advanced (or metastatic) prostate cancer refers to a cancerous tumour which has extended beyond the prostate and moved to other parts of the body, most commonly the bones.[ix,x] These 'advanced' prostate tumours cannot be cured.iv Treatment of advanced prostate cancer usually involves reducing testosterone either by surgical or medical methods.iv However, advanced prostate cancer can become resistant to this type of therapy at which stage it is known as metastatic castration- resistant prostate cancer (mCRPC).[xi] When prostate cancer is advanced, treatment can usually be given to slow the progression of the cancer, relieve symptoms and improve quality of life.[xii]

About enzalutamidei

Enzalutamide is a novel, oral, once-daily androgen receptor signalling inhibitor which works in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.

Enzalutamide is licensed in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy.[i]

Enzalutamide was licensed by the U.S. Food and Drug Administration on August 31, 2012 for the treatment of patients with mCRPC who have previously received docetaxel therapy.[xiii]

About AFFIRM[iii]

The phase III AFFIRM trial is a randomised, double-blind, placebo-controlled, multinational trial evaluating enzalutamide (160 mg/day) versus placebo in 1,199 men with progressive mCRPC who were previously treated with docetaxel-based chemotherapy. Enrolment was completed in November 2010 and the interim analysis was triggered at 520 events. The median age of study participants was 69 years at baseline.

The AFFIRM study was conducted at sites in the United States, Canada, Europe, Australia, South America and South Africa.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our prostate / prostate cancer section for the latest news on this subject.

References

[i] European Medicines Agency, Xtandi (enzalutamide) Summary of Product Characteristics, 2013

[ii] Cancer Research UK, Prostate Cancer, available at http://publications.cancerresearchuk.org/downloads/Product/CS_KF_PROSTATE.pdf, last accessed May 2013

[iii] Scher H I, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy, New England Journal of Medicine, N Engl J Med 2012; 367:1187-1197

[iv] Cancer Research UK, Treatment options for prostate cancer, last accessed June 2013

[v] National Cancer Institute, SEER Fast Statistics, last accessed June 2013.

[vi] Macmillan Cancer Support. Treatment for advanced prostate cancer/hormonal therapy, last accessed June 2013

[vii] Kirby M, Hurst C, Crawford ED. Characterising the castration-resistant prostate cancer. Int J Clin Pract 2011;65:1180-92

[viii] NHS England, National Cancer Drugs Fund List, updated June 18th 2013, last accessed June 2012

[ix] Prostate cancer UK, what is advanced prostate cancer?, last accessed May 2013

[x] Cancer Research UK: The Stages of Prostate Cancer, last accessed June 2013

[xi] Maluf, F,Smaletz O, Herchenhorn, D, Castration-resistant prostate cancer: systemic therapy in 2012, last accessed June 2013 ?

[xii] Macmillan Cancer Support. Treatment for advanced prostate cancer, last accessed June 2013

[xiii] FDA, Xtandi (enzalutamide), prescribing information, 2012

Astellas

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Non-Invasive Pain Treatment Now In Illinois

Main Category: Pain / Anesthetics
Article Date: 12 Jul 2013 - 2:00 PDT Current ratings for:
Non-Invasive Pain Treatment Now In Illinois

Gracie Bagosy's condition is so painful the suicide rate is 68%.

Yet after three years of failed narcotics, other drugs, and occupational therapy, her pain was finally controlled by a new non-invasive, painless, totally safe treatment. That treatment, currently under investigation at the Mayo Clinic and University of Wisconsin, has now reached Illinois.

"When I came to Illinois for this treatment, I thought it was a hoax," says Ms. Bagosy. "Yet I knew almost instantly it was working."

"This has the potential to be the first-line medical treatment for chronic pain conditions affecting millions of sufferers," says Mitchell Weisberg M.D. The internist and psychopharmacologist is Medical Director of Spero Pain Relief Therapy of Illinois in Riverwoods.

Ms. Bagosy's pain started in 2010 during a routine pre-surgical nerve block. Her anesthesiologist was inserting a needle in her right shoulder when "I suddenly felt a peculiar sensation. Imagine the cavity of your arm is on fire, but at the same time someone is putting dry ice on your skin. The slightest touch, even a breeze, made the pain worse."

The 39-year-old Iowan's symptoms were classic for Complex Regional Pain Syndrome (CRPS). CRPS is caused by an aberrant response to nerve injury that causes constant inflammation of the nerve. Ms. Bagosy lived with the pain for three years. An interventional pain procedure was ineffective. Narcotics were also useless and caused so many side effects one day she simply threw them in the garbage. She says, "For a long time I thought nothing could take away the pain of this disease. Nothing."

But Ms. Bagosy refused to face a lifetime of pain...and the risk of suicide "I've never backed away from a battle," she says. "I knew I had to find an answer."

Then last year Ms. Bagosy learned about a new treatment called Calmare on the web. Italian researchers discovered the treatment in the 1980s when they discovered a synchronized, microprocessor-controlled series of electric potentials delivered to tissue adjacent to pain could relieve the neuropathic pain caused by chemotherapy. "This is completely different from something like TENS," says Dr. Weisberg. "The conventional TENS treatment is just a simple uniform voltage put directly on a pain source. Researchers think Calmare works by tricking the brain over time into thinking it's now receiving a signal from a healthy, not an injured, nerve."

Gracie Bagosy had her first treatment last October. She says, "I only came to Illinois because my insurance would pay for it. But I knew almost immediately something was happening. I touched my arm then literally started hitting it because I couldn't believe there was no longer any pain in that arm!"

After a series of ten 45-minute treatments she says her average pain has gone from an 8 to a four. She says for the day or two after a booster treatment, she now has no pain at all.

Dr. Thomas Smith, now of Johns Hopkins Hospital, recently reported a 64% reduction in pain among palliative care patients. The Mayo Clinic is now testing the treatment for shingles pain. In addition, 13 military medical centers nationwide actively use the device. Spero Pain Relief Therapy has just introduced the treatment to Illinois but Norman J. Black, Founder and Clinic Manager, says "About 90% of pain patients exposed to a single treatment then choose to continue their regimens."

Spero's Dr. Weisberg says the Calmare treatment has also been shown to reduce chemotherapy-induced nerve pain, sciatic and lumbar pain, diabetic neuropathy, phantom limb syndrome, and other conditions. He believes the treatment is a safe alternative to risky interventions like Spinal Cord Stimulation, powerful medications, or narcotics.

As for Gracie Bagosy she says her pain just keeps lessening. And soon she hopes to go back to her career as an Electronic Engineering Technician.

"This treatment," she says, "has transformed my life."

Article adapted by Medical News Today from original press release. Source:

Dr Michael Breen & Associates

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Researchers Discover A Role For A Protein That Has Implications For Treatment Of Cancer And Heart Disease

Main Category: Cancer / Oncology
Also Included In: Heart Disease
Article Date: 14 Jul 2013 - 0:00 PDT Current ratings for:
Researchers Discover A Role For A Protein That Has Implications For Treatment Of Cancer And Heart Disease

St. Jude Children's Research Hospital scientists have discovered that a protein used by cancer cells to evade death also plays a vital role in heart health. This dual role complicates efforts to develop cancer drugs that target the protein, but may lead to new therapies for heart muscle damage. The research appeared in a recent edition of the scientific journal Genes & Development.

The protein, MCL1, is currently the focus of widespread cancer drug development efforts. MCL1 is best known as an inhibitor of death via the cell's suicide pathway in a process called apoptosis. The protein is elevated in a variety of cancers, and a number of MCL1 inhibitors are in the cancer drug development pipeline worldwide. The protein has also been linked to drug resistance in cancer patients. Until now, however, MCL1's role in heart muscle cells was unclear.

"Our study shows that MCL1 is required for normal cardiac function and that the protein may be critical in protecting the heart from apoptosis," said Joseph Opferman, Ph.D., an associate member of the St. Jude Department of Biochemistry and the paper's corresponding author. Unlike skin or blood cells, heart muscle cells cannot be replaced, so even a small loss through apoptosis can be devastating. In this study, knocking out MCL1 in mice led to death from cardiomyopathy within weeks.

"These findings suggest that cancer-related drug development efforts should focus on reducing MCL1 expression in target cells rather than eliminating the protein's function completely," Opferman said.

The results also have implications for treating heart muscle damage following heart attacks or other insults. While limiting MCL1 in cancer cells might aid in destroying them, providing higher levels of the protein in heart muscle cells might benefit a patient recovering from a heart attack or other heart damage. "These findings have broad implications for human health," Opferman said.

MCL1 belongs to a protein family involved in regulating apoptosis. The body uses apoptosis to rid itself of damaged, dangerous or unneeded cells. MCL1 prevents apoptosis by blocking the activity of other members of the same protein family that promote the process.

This research builds on previous work from Opferman's laboratory that identified a second form of MCL1. That form works inside rather than outside the mitochondria and helps to produce the chemical energy that fuels cells. Mitochondria are specialized structures inside cells that serve as their power plants.

The latest results suggest both forms of MCL1 are necessary for normal heart function, said the paper's first author Xi Wang, a University of Tennessee Health Science Center graduate student working in Opferman's laboratory.

When investigators knocked out the mouse version of the human MCL1 gene in the heart and skeletal muscle of both embryonic and adult mice, the animals rapidly developed lethal cardiomyopathy. Without MCL1, researchers found that muscle fiber in heart muscle cells was replaced by fibrous tissue, and the pumping ability of the animals' hearts diminished. Loss of MCL1 was also associated with a rise in apoptosis sufficient to cause fatal heart muscle weakness.

To better understand MCL1's role in normal heart function, researchers blocked apoptosis by deleting genes for the proteins Bak and Bax as well as MCL1. Bak and Bax promote apoptosis. Knocking out all three genes restored normal heart function in the mice. The animals lived longer, but mitochondria in the heart muscle did not look or function normally. These results suggest that normal heart function requires both forms of MCL1. "The question is whether, with time, you would see deleterious effects from the loss of MCL1 separate from apoptosis," Opferman said.

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The other authors are Madhavi Bathina, John Lynch, Brian Koss, Christopher Calabrese, Sharon Frase, John Schuetz and Jerold Rehg, all of St. Jude.

The research was funded in part by a grant (HL102175) from the National Institutes of Health (NIH), a grant (CA021765) from the National Cancer Institute (NCI) at the NIH, the National Cancer Society and ALSAC.

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Swissmedic Approves Zonegran® (Zonisamide) Monotherapy Treatment For Epilepsy

Main Category: Epilepsy
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Jul 2013 - 2:00 PDT Current ratings for:
Swissmedic Approves Zonegran® (Zonisamide) Monotherapy Treatment For Epilepsy

Zonegran(R) (zonisamide) has been approved by Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, for the monotherapy treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy. Monotherapy is when treatment is given with one single drug.

Already a successful add-on therapy, once-daily zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure which is unrelated to any other AEDs.[1] For patients with newly diagnosed epilepsy, monotherapy is the preferred option for managing their condition as this reduces the potential for adverse drug interactions and encourages treatment compliance.[2]

"Monotherapy is the optimal treatment approach for managing epilepsy and therefore the availability of zonisamide in this setting will provide newly diagnosed epilepsy patients with access to this already proven treatment as a first-line option in their care pathway," commented Professor Michel Baulac, Head of Neurology, Université Paris VI.

Epilepsy is one of the most common neurological conditions in the world[3] with an estimated 70,000 people living with the condition in Switzerland alone[4]. The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a significant challenge and up to 30% of patients fail to achieve seizure freedom with existing AEDs[5].

"The approval of zonisamide monotherapy in Switzerland is a very welcome advance for both doctors and patients. The new extended monotherapy indication for Zonegran will provide patients with an alternative option to help improve their seizure control. The monotherapy indication will become an increasingly important option in the early treatment of partial epilepsy," said Dr. Christiane Kordeuter, Medical Director, Eisai Switzerland. "Zonegran is one of only six AEDs available as monotherapy, allowing doctors to tailor treatment to individual patient needs."

The efficacy and safety of zonisamide as monotherapy has been demonstrated in a double-blind, randomised, multicentre study of 583 newly diagnosed adult partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy. The study's primary endpoint was the proportion of seizure-free patients at six months. Zonisamide demonstrated high response rates for achieving seizure freedom in newly diagnosed patients with epilepsy,[6] similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg. Zonisamide was considered non-inferior to carbamazepine, was well tolerated and had no apparent safety concerns after one year of treatment at doses ranging from 300 to 500 mg/day.

The continued development of zonisamide underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our epilepsy section for the latest news on this subject.

1. Zonegran Summary of Product Characteristics

2. St. Louis, K. Rosenfeld. W. Bramley, T. Antiepileptic Drug Monotherapy: The Initial Approach in Epilepsy Management (2009) &(2): 77 - 72

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010 (Accessed June 2011)

4. EPI Swiss Epilepsy Centre (Accessed August 2011)

5. Kwan P, Brodie MJ Early identification of refractory epilepsy. New England Journal of Medicine 2000; 342:314-9

6. Baulac, M. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurology (2012), 11 (7) 579 - 588

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