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Carcinoid Cancer Foundation Sets Sights On Raising Awareness

2009-03-03T12:00:00.000+02:00

Several high-profile cancers are infamous for being silent killers - but they are not the only cancers that catch victims by surprise. Carcinoid cancer can go undetected for many years. Over 90% of all carcinoid/neuroendocrine tumor (NET) patients are initially incorrectly diagnosed and treated for the wrong disease. Carcinoid cancers are frequently diagnosed accidentally.

Carcinoid and related neuroendocrine tumors (NETs) grow slowly and are found mostly in the gastrointestinal system, but can be in other body parts like the pancreas and lung. It usually takes many years before they cause symptoms. If the disease manifests in advanced stages, it can be deadly. Caught early, however, carcinoid cancer can often be managed or treated, an option not fully realized within the medical community or patient circles, according to Sharon Devereaux, the newly appointed president/CEO of the Carcinoid Cancer Foundation(TM) (CCF, http://www.carcinoid.org). Increasing awareness of this disease and opportunities for early detection are an integral part of the Carcinoid Cancer Foundation's mission, and Devereaux's initiatives include intensification of efforts to accomplish these goals.

"Carcinoid cancer occasionally creeps into the headlines, usually when some public figure is living with it or passes away," Devereaux says. "But that's where the news value ends because it's perceived as rare - 110,000 U.S. patients are experiencing carcinoid cancer today. However, new research and anecdotal evidence suggests that it's more widespread than is documented, yet it's tough to provide treatment because established opportunities for early-diagnostic testing don't exist."

Richard R.P. Warner, MD, Medical Director of CCF and one of the world's leading experts on these rare cancers, explains "that although a number of new drugs are being developed and tested, at present the only cure for carcinoid/NETs is dependent on early detection and surgery before these cancers have spread from their original site of origin." The CCF is a non-profit organization that strives to encourage and support research, in addition to educating the general public and healthcare professionals, about carcinoid cancer and NETs. Recently, the CCF has drawn attention to its cause through its "Zebra Ball - Stars for Stripes" (http://www.thezebraball.com), an annual benefit event held at The Peninsula Chicago to support The Carcinoid Cancer Foundation(tm). This year's ball, so named because zebra stripes symbolize "camouflaged" conditions, featured the stories of carcinoid cancer patient Don Meyer, Northern State University's (Aberdeen, S.D.) basketball coach, and cancer survivor Kari Jones of Indianapolis. The gala coincided with Valentine's Day, which has been designated by Mayor Richard Daley as Carcinoid Cancer Awareness Day in Chicago.

For more information or to donate, visit http://www.carcinoid.org or http://www.firstgiving.com/carcinoid.

About the Carcinoid Cancer Foundation(TM)

The Carcinoid Cancer Foundation(TM) is a non-profit organization chartered by the State of New York in 1968 for the purpose of encouraging and supporting research and education on carcinoid and related neuroendocrine cancers.

Carcinoid Cancer Foundation

Research And Markets: Lymphoma Drug Pipeline Update 2009

2009-03-02T12:00:00.000+02:00

Research and Markets has announced the addition of the "Lymphoma Drug Pipeline Update 2009" report to their offering.

Lymphoma is a broad term encompassing a variety of cancers of the lymphatic system. There are today more than 200 therapeutics targeting lymphoma in active development, from early preclinical to marketed drugs. In addition, the accumulated number of ceased drugs over the last three years amount to another 50 drugs.

Lymphoma Drug Pipeline Update lists all drugs and gives you a progress analysis on each one of them. Identified drugs are linked to 123 different targets. These targets are further categorized on the CD-ROM by 44 classifications of molecular function and with pathway referrals to BioCarta, KEGG and NetPath. Read more below on how the Lymphoma Drug Pipeline Update is organized.

How May Drug Pipeline Update Be of Use?

- Show investors/board/management that you are right on top of drug development progress in your therapeutic area.

- Find competitors, collaborations partners, M&A candidates etc.

- Jump start competitive drug intelligence operations

- Excellent starting point for worldwide benchmarking

- Compare portfolio and therapy focus with your peers

- Speed up pro-active in-/out licensing strategy work

- Fast and easy way of tracking drugs using search engines; just one click from inside the application and you may search the World Wide Web and PubMed for any drug.

- Drug Pipeline Update is delivered to you as a CD-ROM application, which requires no installation on your computer. Please read more about application features and system requirements below.

For more information visit here.

Research and Markets

Mesoblast Limited Presents Positive Adult Stem Cell Results To American Academy Of Orthopedic Surgeons (AAOS)

2009-02-27T12:00:00.000+02:00

Mesoblast Limited (ASX:MSB)(PINK:MBLTY) Australia's regenerative medicine company today announced that three separate papers disclosing clinical and preclinical trial results were presented this week to orthopaedic specialists attending the 55th annual meeting of the American Academy of Orthopedic Surgeons (AAOS) and the Orthopedic Research Society (ORS). The meetings, underway in Las Vegas, attract an estimated 15,000 orthopedic healthcare professionals from around the world.

A major highlight at the AAOS was the invited presentation given by Mr Richard de Steiger, the Principal Investigator of Mesoblast's long bone non-union clinical trial at The Royal Melbourne Hospital. Mr de Steiger presented the positive results from the company's successful trial in 10 patients treated with the proprietary adult stem cells for non-healing fractures of the tibia and femur.

At the ORS, Dr Tony Goldschlager of Mo! nash University in Melbourne presented results from preclinica! l trials showing that Mesoblast's allogeneic, or "off-the-shelf", cells were safe and highly effective for interbody fusion of the cervical spine in the neck.

Also at the ORS, Professor Peter Ghosh presented preclinical results which showed that a single injection of Mesoblast's allogeneic cells into knee joints with pre-existing osteoarthritis reduced disease progression and supported reconstitution of knee joint cartilage six months after administration.

Mesoblast will continue to ensure that its clinical achievements and cutting edge research are highlighted and recognised at respected and prestigious conferences, meetings attended by key opinion leaders, and peer-reviewed publications.

About Mesoblast Limited

Mesoblast Limited (ASX:MSB)(USOTC:MBLTY) is an Australian biotechnology company committed to the development of novel treatments for orthopaedic conditions, including the rapid commercialisation of a unique adult stem cell technology aimed at the regeneration and repair of bone and cartilage. Our focus is to progress through clinical trials and international regulatory processes necessary to commercialise the technology in as short a timeframe as possible.

Mesoblast has the worldwide exclusive rights for a series of patents and technologies that have been developed over more than 10 years and which relate to the identification, extraction and culture of adult Mesenchymal Precursor Cells (MPCs). The Company has also acquired a substantial interest in Angioblast Systems Inc, an American company developing the platform MPC technology for the treatment of cardiovascular diseases, including repair and regeneration of blood vessels and heart muscle. Mesoblast and Angioblast are jointly funding and progressing the core technology. Mesoblast's strategy is to maximise shareholder value through both corporate partnerships and the rapid and successful completion of clinical milestones.

Mesoblast Limited

Annual Event For Entrepreneurs In Biotech, Pharma And Healthcare - France

2009-02-26T12:00:00.000+02:00

Profession Bio-Entrepreneur, France's annual event for entrepreneurs in biotech, pharma and healthcare will take place this year on Thursday and Friday 12-13 March. It is organized by Centrale-Santé, part of the association of the Ecole Centrale, one of France's top graduate schools in partnership with MEDEC, France's annual healthcare show and conference. There is no charge for entry and registration may be done on-line (as long as space is available).

This 8th edition of the forum takes place at a time of great financial uncertainty and offers industry professionals two days of intense debate and networking to identify new issues and opportunities which will enable them to be better "bio-entrepreneurs".

This year's theme is "The convergence of diagnostics, therapeutics, imaging, medical devices and engineering".

The forum will also focus on Switzerland, the country which is this year's guest of honour, and which is a leading player in the international life sciences industry. Representatives of Roche, Merck-Serono, Debiopharm, Addex Pharmaceuticals, the Swiss Biotech Association, Biocartis and the EPFL (Ecole Polytechnique de Lausanne) are all planning to take part.

You can download the provisional programme of Bio-Entrepreneur 2009 and register for free on http://www.bio-entrepreneur.net.

Event partners include bodies such as the Adebiotech biotech association, ACIP (Association des Cadres de l'Industrie Pharmaceutique - Pharma industry managers' association), AMIPS (Association des Médecins des Industries des Produits de Santé - doctor's association), Leem (Les Entreprises du Médicament - French pharmaceutical industry association), Catalyse Biosciences, a group of regional bodies responsible for encouraging the life science industries, and Interbiotech, an association to stimulate networking and business development across all life sciences. Media partners are Biotech Info, Innovation, Pharmaceutiques with Andrew Lloyd & Associates handling the public relations. There are also a number of industry partners.

http://www.bio-entrepreneur.net

Government's GP Extended Opening Policy Widens Rich-Poor Gap, United Kingdom

2009-02-25T12:00:00.000+02:00

The UK Government's extended hours initiative has deprived small GP practices, and those in the poorest areas of the country, of millions in funding according to a major Pulse investigation.

Smaller practices find it far more difficult to offer evening and weekend appointments compared to those with a large number of GPs, disadvantaging their patients and reducing their funding by thousands of pounds.

There is also evidence the extended hours policy is widening the gap between rich and poor. Only 61% of urban practices in the highest quartile for deprivation will qualify for the average £18,000 annual payment for providing extended hours, compared with 75% of those in the lowest quartile for deprivation.

Only 44% of one-GP practices and 60% of those with two or three partners are currently offering extended hours, compared to 83% of those with eight or more partners, shows our analysis of 200 randomly selected practices from more than 100 PCTs.

Payments were recycled from other parts of the contract, meaning practices that are not offering extended hours are receiving less funding compared to one year ago.

Official government figures show the proportion of practices not offering extended opening has stabilised at almost 30%.

Pulse's investigation identifies for the first time specifically which practices are opening longer - based on calls to each practice to confirm extended opening, data on practice size from NHS Choices and indices of deprivation data from the Office for National Statistics.

The location of a practice is also a key factor, says the report. Some 68% of urban practices offer extended hours, compared with 59% in rural areas.

Dr Asad Mubarik, a GP in Rochdale, Greater Manchester, said his 'semi-rural' practice could not afford to open longer. "We would make a loss if we did,' he said, adding practices in deprived urban areas also faced safety concerns. Opening in deprived urban areas can be very scary. I know a GP who was assaulted after work and ended up in intensive care. The number of staff you would have to have working in the evening would be significant."

A spokesperson for the Department of Health said: "The issue is not the size of practice, their location or the patients they treat - it is whether GPs make the decision to provide extended hours for their patients. In some PCTs, nearly 100% of practices, from singlehanded to large surgeries and in both urban and rural areas, are delivering extended hours."

Richard Hoey, deputy editor of Pulse, said: "The Government insists that whether a GP practice offers extended opening is purely a matter of choice, but our statistics show that it is much easier for some practices than others. That means some groups of patients miss out twice over, because they don't get access to longer hours, and neither does their practice receive as much money for their healthcare. What's worse is that it is often poorer patients who are missing out, and it is they who often find it hardest to take time off work to see a GP."

About PulseToday

PulseToday is the GP's website in the UK providing general practice news, clinical education and practice information to GPs and primary care staff.

www.pulsetoday.co.uk

Written by - Christian Nordqvist

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

Diabetes Rising Faster In UK Than America

2009-02-24T12:00:00.000+02:00

A new study found that the rate of new cases of diabetes in the UK rose by 74 per cent between 1997 and 2003, and has now overtaken the rate in North America, which has one of the highest incidences of diabetes in the world.

The study's lead author is Elvira Massó González of the Spanish Centre for Pharmacoepidemiologic Research in Madrid, and is to be published this week in the online issue of Journal of Epidemiology and Community Health.

According to the Telegraph, Massó González told the press:

"Our results suggest that, although the incidence of diabetes remains lower in the UK than in the USA or Canada, it appears to be increasing at a faster pace."

The study looked at new and existing cases of type 1 and type 2 diabetes in the UK, using data from the Health Improvement Network database between 1996 and 2005.

The researchers found that over those ten years, 42,642 people in the UK were diagnosed either with type 1 or type 2 diabetes.

Type 1 usually affects younger people, and type 2 usually develops later in life due to being obese or overweight, but in recent years patients have been getting younger, some as young as seven, said a report from the BBC.

Of those newly diagnosed cases, just over 1,250 were for type 1 and more than 41,000 were for type 2 diabetes.

The results showed that the overall prevalence of diabetes went up from 2.8 per cent of the population in 1996 to 4.3 per cent in 2005, equal to an annual rise of just under 5 per cent and an increase of 54 per cent over the decade. The prevalence was found to be 29 per cent higher among men than among men.

The rise is predominantly due to a rise in type 2 cases: new cases of type 1 have remained much the same every year for those ten years, but type 2 new cases went up from 2.6 to 4.31 cases per 1,000 patient years, equivalent to a rise of 69 per cent over the decade, and rising even more rapidly in the latter part: by 74 per cent between 1997 and 2003.

Diabetes UK reports that the study shows obesity playing a significant role in the sharp rise of type 2 diabetes in the UK.

In 1996 of the people diagnosed with type 2 diabetes, 38 per cent were overweight and 46 per cent were obese. In 2005, these figures were 32 and 56 per cent respectively.

2.5 million of people in the UK have been diagnosed with diabetes and another half million have it and don't know it.

Douglas Smallwood, Chief Executive of Diabetes UK , said in a press statement:

"This research is a sad indictment of the current state of the UK's health."

"Sadly, the statistics are not surprising, as we know that the soaring rates of type 2 diabetes are strongly linked to the country's expanding waistline," he added.

Studies show it's possible for people to significantly reduce their risk of developing type 2 diabetes by keeping to a healthy weight and waistline.

"It is imperative that we raise awareness of the importance of eating a healthy, balanced diet and doing at least 30 minutes of physical activity a day if we want to make any headway in defusing the diabetes time bomb," warned Smallwood.

Tam Fry of the National Obesity Forum said that future projections show there is worse to come.

"Rates of obesity and diabetes will continue to rise unless we do something urgently," Fry told the BBC.

BBC News also reported that Professor Alan Maryon-Davis, president of the UK Faculty of Public Health, said early detection and treatment was vital.

"We must do whatever we can to find the half-million people who don't know they've got it," said Maryon-Davis.

Diabetes UK estimates that the NHS spends ten per cent of its budget, about 1 million pounds an hour, treating diabetes and its complications.

A spokesperson for the Department of Health told the BBC that the rise in recorded cases could be partly due to improved diagnosis, as well as rising obesity rates and an ageing population.

Click here for Journal of Epidemiology and Community Health.

Sources:Diabetes UK, BBC News, Telegraph.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

DWP Minister Replies To UKAF On Autism And Winter Fuel Poverty

2009-02-23T12:00:00.000+02:00

DWP Minister Rosie Winterton MP, (who is the Minister with responsibility for the Winter Fuel Payment) has replied to the call made by the UK Autism Foundation for urgent help for families and adults with autism and Asperger's Syndrome who are below the poverty line.

While Winter Fuel Payments are directed towards the elderly, the UK Autism Foundation has appealed to the Chancellor Alistair Darling to help all families with autism and Asperger's Syndrome who are in low-income households. There are families with autism who who have had to choose between heating and eating as they struggle to cope with life during the economic crisis.

Ivan Corea of the UK Autism Foundation said: 'We are delighted that DWP Minister Rosie Winterton is taking a long hard look at Autism and Winter Fuel Poverty. We urge Rose Winterton and Her Majesty's Government to look at the whole issue of Winter Fuel Payments and increase them for families with autism and Asperger's Syndrome in the 2009 Budget. The recession is affecting so many families with autism. Life is hard in any case, on a daily basis and the deepening recession is making matters worse. Parents, carers,children and adults with autism and Asperger's Syndrome in the UK need urgent financial help and support.'

Support for the UKAF's call came from parliamentarians of all parties in the House of Commons, in Westminster, with 55 MPs signing an early day motion (EDM 281) tabled by Rudi Vis MP on Autism and Winter Fuel Poverty in December last year.

DWP Minister Rosie Winterton has replied Ivan Corea's call to the Chancellor Alistair Darling to increase Winter Fuel Payments. The Minster said: ' We have negotiated a voluntary agreement with energy suppliers which means that the total level of assistance offered to vulnerable households by suppliers will increase to £150 million a year by 2011.' She added 'You may be interested to know that, as the Chancellor announced in his Pre-Budget report in November last year, for 2008/09 only, an extra payment of £60 will be made on top of the £10 Christmas Bonus. The Christmas Bonus is payable to those in receipt of a qualifying benefit during the relevant week.'

The DWP has also requested people to contact the following helpines regarding winter fuel payments:

* Disability Living Allowance and the disability premiums in the income-related benefits provide additional weekly payments and are related to the individual's circumstances. The most severely disabled people receive an additional amount of almost £8,000 per year in recognition of their extra costs. Employment and Support Allowance customers can receive an additional component for disability after 13 weeks rather than waiting 52 weeks for the payment of a disability premium as with Income Support. Where the support component is payable, there is also automatic entitlement to the enhanced disability premium (currently £12.60 for a single person).People can find out more about these benefits by telephoning the Benefit Enquiry Line on 0800 88 22 00.

* For information on the Warm Front, the main programme for tackling winter fuel poverty in the private sector in England, providing grants for insulation and home improvements to households in receipt of qualifying benefits - householders should call 0800 316 6011. Householders in Wales should call 0800 316 2815, householders in Scotland should call 0800 316 6009 to find out more about Warm Deal or 0800 316 1653 to find out more about the Central Heating Programme, householders in Northern Ireland should call 0800 181 667 to find out more about the Warm Homes scheme.

* To check whether a competing energy supplier can offer a better deal customers can can contact Consumer Direct on its consumer helpline, 08454 04 05 06. The Home Heat Helpline, 0800 33 66 99, run by the energy companies can also supply on fuel matters, including discounts that are available to certain groups of people.

UK Autism Foundation

Woodford Business Centre

113-115 George Lane

South Woodford

London E18 1AB

United Kingdom

http://www.ukautismfoundation.org

Prostate Specific Antigen Testing May Be Unnecessary For Some Older Men

2009-02-20T12:00:00.000+02:00

Certain men aged 75 to 80 are unlikely to benefit from routine prostate specific antigen (PSA) testing, according to a Johns Hopkins study published in the April 2009 issue of The Journal of Urology.

The researchers found that men in this age group with PSA levels less than 3 nanograms per milliliter are unlikely to die of or experience aggressive prostate cancer during their remaining life, suggesting that the use of PSA testing in many older men may no longer be needed.

The study, led by researchers from the Johns Hopkins University School of Medicine and the National Institute on Aging's Baltimore Longitudinal Study of Aging (BLSA), reviewed data from 849 men (122 with and 727 without prostate cancer) who were participating in the BLSA and who had undergone regular PSA testing.

Results showed that among men who were over 75 with PSA levels less than 3 nanograms per milliliter, none died of prostate cancer and only one developed high-risk prostate cancer. In contrast, men of all ages with a PSA level of 3 nanograms per milliliter or greater had a continually rising probability of dying from prostate cancer.

If confirmed by future studies, these results may help determine more specific guidelines for when PSA -based screening might be safely discontinued, according to lead investigator Edward Schaeffer, M.D., an assistant professor of urology at Johns Hopkins. While PSA screening remains a useful tool for helping detect early stages of prostate cancer and is credited with decreasing prostate cancer mortality, discontinuing unneeded PSA testing could significantly reduce the costs of screening and also potentially reduce morbidity resulting from additional tests or treatments.

"We need to identify where we should best focus our health care dollars by concentrating on patients who can actually benefit from PSA testing," Schaeffer says. "These findings give a very strong suggestion of when we can start to counsel patients on when to stop testing."

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Article adapted by Medical News Today from original press release.

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Other Johns Hopkins researchers who participated in this study include H. Ballentine Carter, M.D., Anna Kettermann, M.A., Stacy Loeb, M.D., Luigi Ferrucci, M.D., Ph.D., Patricia Landis, B.S., Bruce J. Trock, Ph.D., and E. Jeffrey Metter, M.D.

Source: Hope Marijan

Johns Hopkins Medical Institutions

Gene Therapy Study Shows Method Is Safe, Somewhat Beneficial, Researchers Report

2009-02-19T12:00:00.000+02:00

A study of gene therapy to treat HIV has shown that the treatment is safe and somewhat beneficial -- a "major advance" in efforts to combat the virus -- researchers said in a study published recently in the journal Nature Medicine, AFP/Google.com reports. According to the researchers, the study -- which was headed by Ronald Mitsuyasu of the University of California-Los Angeles -- confirms that this avenue of gene therapy in HIV research is a valid approach (AFP/Google.com, 2/15). The study involved 74 HIV-positive people, half of whom received blood stem cells that included a molecule, called OZ1, which is designed to block HIV from replicating by targeting two key proteins (BBC News, 2/16). The other half were given a placebo. The study aimed to determine whether the stem cells would survive the body's immune system and if this would curb the replication of HIV. The researchers found that after 48 weeks, there was no statistical difference between the two groups. However, after 100 weeks, the group that received the RNA enzyme gene had higher levels of CD4+ T cells and low HIV viral loads. The study also showed that the new blood stem cells depleted over time -- although DNA tests showing that the modified cells were present in 94% of the gene group at four weeks, this fell to 12% by week 48 and 7% by week 100. According to the researchers, the study's results showed the treatment was "safe" and modestly effective. Mitsuyasu said that instead of putting the technique through to a Phase III trial, the team plans to modify the technique and introduce new tests on a smaller group of participants. He said the study "gives some hope" to the gene therapy approach as a treatment for HIV and other diseases, such as cancer, adding, "It's a positive finding for the field and should move the field forward" (AFP/Google.com, 2/15).

Reaction

Mitsuyasu said that the treatment is "not yet as effective or as complete as current antiretroviral therapy in controlling HIV," although the recent study "did show proof" that using a single gene in an HIV-positive patient's own blood cells could reduce the spread of the virus. Jo Robinson of the HIV/AIDS organization Terrence Higgins Trust said, "Gene therapy is an exciting area which aims to create a one off treatment for HIV, avoiding the need for people to take daily medication," adding that the therapy is in its "early days in research terms, so we're a long way from something like this being on the market." Robinson said that the new study "has shown some promising results, which definitely warrant further investigation." Keith Alcorn of the U.K.-based HIV information service NAM added that although the study's results are "very modest," the researchers showed "enough of an effect for us to be hopeful that a gene therapy approach to HIV treatment might eventually deliver effective treatments for the disease" (BBC News, 2/16).

An abstract of the study is available online.

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Arthritis Drug Linked To Shingles Risk

2009-02-18T12:00:00.000+02:00

German scientists found that some arthritis drugs may be linked to an increased risk of developing shingles (herpes zoster), an infection that causes painful blisters.

The research was the work of Dr Anja Strangfeld of the German Rheumatism Research Center in Berlin, and colleagues, and is published in the 18 February issue of JAMA, Journal of the American Medical Association.

They found that use of certain drugs classed as monoclonal anti-tumor necrosis factor α (TNF-α) antibodies which are used to treat rheumatoid arthritis may be linked to a higher risk of developing herpes zoster (shingles).

Previous studies have suggested that treatment with anti-TNF-α agents puts rheumatoid arthritis patients at higher risk of bacterial infections but there have been few investigations into how they affect the risk of infection by viruses like shingles.

There are a number of anti-TNF-α drugs used to treat rheumatoid arthritis. They all act on the cytokine TNF (tumor necrosis factor), a chemical messenger in the immune system that sends signals to increase inflammation. TNF does other things as well (such as trigger cell death), but as far as rheumatoid arthritis is concerned it is its role in the promotion of inflammation that is important.

Anti-TNF-α agents stop TNF from binding to particular receptors on certain cells and prevents them from triggering an inflammatory response. Many arthritis patients produce too much TNF.

For this study the researchers looked at data on over 5,000 rheumatoid arthritis patients who were registed with RABBIT, a German biologics register, between May 2001 and December 2006. They enrolled on the register when they started treatment with infliximab, etanercept, adalimumab, or anakinra, or when they changed to a conventional disease-modifying antirheumatic drug (DMARD).

Infliximab and adalimumab are monoclonal antibodies and etanercept is a fusion protein and all three work by inhibiting TNF-α. Anakinra is not a TNF-α inhibitor, it blocks another inflammation signalling path that uses the interleukin-1 (IL-1) receptor.

Rheumatologists regularly assessed participants' treatment, clinical status and adverse events during follow up.

The aim of the study was to compare the number of times shingles was observed in patients receiving the various different treatments. In particular the researchers wanted to see if the TNF-α inhibitors together as a class, or separately either as anti-TNF-α antibodies (infliximab and adalimumab), or a fusion protein (etanercept), were related to higher rates of herpes zoster (shingles).

The results showed that:

There were 86 episodes of herpes zoster (shingles) recorded among 82 patients.

39 of the episodes were attributed to treatment with monoclonal anti-TNF-α antibodies, 23 to the fusion protein etanercept, and 24 to conventional DMARDs.

The crude incidence rate was 11.1 per 1,000 patient years for monoclonal anti-TNF-α antibodies, 8.9 for etanercept, and 5.6 for conventional DMARDs.

After adjusting for age, severity of disease, and use of glucocorticoid, the increased risk for treatment with monoclonal anti-TNF-α antibodies was a significant 1.82, but this was not high enough to reach clinical significance.

No significant links were found for use of etanercept (fusion protein) or for TNF-α inhibitors together as a class.

The authors concluded that:

"Treatment with monoclonal anti-TNF-{alpha} antibodies may be associated with increased risk of herpes zoster, but this requires further study."

They added that:

"Based on our data, we recommend careful monitoring of patients treated with monoclonal anti-TNF-α antibodies for early signs and symptoms of herpes zoster."

In an accompanying editorial, Drs Richard J. Whitley and John W. Gnann of the University of Alabama at Birmingham, commented on the findings:

"The TNF-α inhibitors provide tremendous benefit to a broad spectrum of patients with systemic inflammatory diseases. As with any therapy, time is required for all of the safety concerns related to these potent medications to become apparent. TNF-α inhibitors have revolutionized the management of a number of difficult diseases, especially inflammatory arthritis, but clinicians must continue to remain aware of the potential for serious infectious complications, which now include herpes zoster."

"Risk of Herpes Zoster in Patients With Rheumatoid Arthritis Treated With Anti-TNF-{alpha} Agents."

Anja Strangfeld; Joachim Listing; Peter Herzer; Anke Liebhaber; Karin Rockwitz; Constanze Richter; Angela Zink

JAMA . Vol. 301 No. 7, pp 737-744, February 18, 2009.

Click here for Abstract.

Sources: JAMA media and journal abstract.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

Roche Reinstated To ABPI Membership, UK

2009-02-17T12:00:00.000+02:00

Roche Products Limited has been reinstated to membership of the Association of the British Pharmaceutical Industry (ABPI) following the company's suspension from 14 July 2008. The ABPI Board of Management decided that Roche should be reinstated to membership with effect from February 16, but that the ABPI Board would review the report of a further audit to be held in November 2009 to ensure that progress was being maintained.

Roche was suspended from membership for a minimum of six months after it was found to be in breach of the Code, including Clause 2 which deals with activities that bring discredit on, or reduce confidence in, the pharmaceutical industry. ABPI Press Release, Monday 14 July 2008 - http://www.pmcpa.org.uk/?q=node/614

ABPI

First Use Of New Subcutaneous Heart Monitor

2009-02-16T18:00:00.000+02:00

Medtronic, Inc. (NYSE: MDT) today announced the commercial availability of its Reveal XT™ Insertable Cardiac Monitor (ICM) in the United States, along with the nation's first implant of the new device. The procedure was conducted by Blair Grubb, M.D., professor of Medicine and Pediatrics at the University of Toledo Medical Center, a renowned heart specialist. The Reveal XT device joins the Reveal® DX ICM as the industry's first insertable cardiac monitors that offer comprehensive remote monitoring capabilities, via the Medtronic CareLink® Network, and which allow physicians to confirm or rule out an abnormal heart rhythm.

Physicians may choose the Reveal XT insertable cardiac monitor for their patients with suspected arrhythmias, and in difficult-to-diagnose patients for whom long-term cardiac rhythm trending data may aid in a more informed diagnosis. The Reveal XT device is also an option for physicians seeking to detect the presence of atrial arrhythmias (irregular heart rhythms in the upper chambers), including asymptomatic episodes, or to monitor the amount of time a patient is in atrial fibrillation (AF) to assess whether medical treatment is necessary or should be adjusted.

"I see many patients desperately seeking answers for their unexplained symptoms," said Dr. Grubb. "By adding AF detection capabilities and greater diagnostic reporting, I expect the Reveal XT device to be an even more effective tool to help monitor and diagnose my patients' cardiac conditions."

Placed just under the skin of the chest area in a short outpatient procedure, the Reveal XT and DX devices capture an electrocardiogram (ECG) during the actual episode; to store an ECG, a patient places a hand-held, pager-sized assistant over the device, and presses a button. Later, a physician analyzes the stored information, transmitted via the Medtronic CareLink Network or during an in-office patient visit, and determines whether the episode was caused by an abnormal heart rhythm. Reveal device data has been accessible via the Medtronic CareLink Network since fall 2008, which allows patients to stay connected to their healthcare provider from home and offers physicians access to diagnostic data remotely, which may help them make timely, informed decisions.

"The Reveal XT monitor offers physicians a proven option for uncovering dangerous cardiac conditions, including atrial fibrillation. For patients experiencing arrhythmias or unexplained fainting episodes, having greater insights into the cause is incredibly valuable for both the patient and physician," said Elizabeth Hoff, vice president and general manager of the Subcutaneous Diagnostics and Monitoring unit of the Cardiac Rhythm Disease Management business at Medtronic. "Introducing the Reveal XT device expands the market-leading position in cardiac diagnostics and monitoring devices that Medtronic has held for more than 10 years."

Key Facts About Arrhythmias and Syncope

- Arrhythmias are simply irregular heart rhythms in the heart's atria (upper chambers) or ventricles (lower chambers).

- They can be dangerously fast heart rhythms, known as tachycardia or tachyarrhyhmias; dangerously slow rhythms, known as bradycardia or bradyarrhythmias; fibrillation, where the heart quivers instead of pumping blood effectively to the body; or asystole, which is the absence of electromechanical activity within the heart.

- AF is the most common irregular heart rhythm condition, found in approximately three million Americans and seven million people worldwide1.

- Syncope accounts for one to six percent of hospital admissions2 and one percent of total ER visits3 per year.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

1. Millennium Research Report; "Global Markets For Atrial Fibrillation Treatment Devices 2008," March 2008; 1.

2. Kapoor W. Evaluation and outcome of patients with syncope. Medicine (Baltimore). May 1990;69:160-175.

3. Brignole M, et al. Management of syncope referred urgently to general hospitals with and without syncope units. Europace. 2003;5:293-298.

Medtronic

VGX Pharmaceuticals Announces Filing Of Device Master File Amendment With The FDA For CELLECTRA Device - Intradermal Electroporation (ID-EP)

2009-02-16T12:00:00.000+02:00

VGX Pharmaceuticals announced the filing of a Device Master File (MAF) amendment with the U.S. Food and Drug Administration (FDA) for its patented CELLECTRA® adaptive constant current electroporation device for use with intradermal electroporation (ID-EP). The Company has been developing the CELLECTRA® device as its lead clinical device for delivering DNA vaccine and therapy products. Numerous preclinical efficacy studies have shown that delivery of DNA-based product candidates with the CELLECTRA® device optimizes DNA uptake and its subsequent expression in the target tissue, and results in enhanced immune responses in animals.

The company previously filed a MAF in January 2008 covering the use of the CELLECTRA® electroporation device for intramuscular (IM-EP) delivery of DNA. The present filing covering intradermal EP is an add-on to the previously filed MAF. Filing of the amended MAF, which includes technical, manufacturing, and non-clinical information about the medical device covering both ID-EP and IM-EP, marks an important milestone for VGX Pharmaceuticals. It facilitates the FDA review of the CELLECTRA® device when Investigational New Drug (IND) applications for DNA-based product candidates are filed that reference its use.

The company has initiated Phase I studies with the IM-EP device used in conjunction with its therapeutic cervical cancer vaccine (VGX-3100). Separately, in a study involving 10 healthy volunteers administered with saline followed by IM-EP from this device, the CELLECTRA® device was found to be generally safe and well tolerated.

In October 2008, VGX was awarded a $23.5 million contract, by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, to develop a preventive HIV DNA vaccine candidate in conjunction with its constant current electroporation technology for ID delivery of DNA vaccines. The company is presently focused on optimizing the combination of the HIV vaccine candidate and ID delivery parameters in pre-clinical studies under the contract.

"The addition of the ID delivery to the MAF submission for the CELLECTRA® device provides us and our partners with different choices for the optimal delivery of DNA vaccines and therapies based on the desired target specific immune responses," stated Dr. J. Joseph Kim, President and Chief Executive Officer. "Our aggressive development strategy will continue to validate the value of our vertically-integrated DNA Vaccines and Therapeutics Platform, which includes SynCon™ DNA-based product candidates, the CELLECTRA® device, and access to efficient and scalable cGMP manufacturing facilities."

The Company has entered into a definitive merger agreement with Inovio Biomedical Corporation (INO: NYSE Alternext).

About VGX Pharmaceuticals

More information about VGX can be found at http://www.vgxp.com.

VGX Pharmaceuticals