Noises In Your Ears Or Head Causing A Nuisance At Night? A Survey Reveals That Night Is The Worst Time For Tinnitus, UK

According to a new survey by the British Tinnitus Association (BTA), almost 65% of tinnitus sufferers surveyed by the BTA found their tinnitus bothered them at night.

The new findings mark the start of National Tinnitus Week 9 – 15 February 2009. During the week the BTA wants to raise awareness of their free phone helpline and website so that sufferers know who they can contact for help.

While most people find quiet helps them sleep, tinnitus sufferers experience the opposite – they can then become more alert and agitated, which in turn stops them from sleeping. Serious sleep deprivation can make people miserable and, over time, more prone to illness.

David Baguley PhD, Consultant Audiological Scientist, Head of Audiology at Cambridge University Hospitals and professional advisor to the British Tinnitus Association, commented: “When we go to bed we are surrounded by quiet. But due to the lack of external noise people with tinnitus can find that their ‘tinnitus noise’ becomes much starker. This can lead to sufferers feeling more vigilant and alert which in turn stops them from sleeping.”

If a tinnitus sufferer is already receiving treatment for their condition then the British Tinnitus Association advises that treatments such as a pillow speaker can additionally help by relieving symptoms in the quiet of the night.

“The main message to take away from these results is that tinnitus can have a detrimental effect on people’s lives – however it manifests itself. It’s important that anyone with troublesome tinnitus seeks professional advice so that they can access the correct care,” said Baguley.

Tinnitus is one of the most common health problems facing the UK today, affecting almost five million people in the UK – a staggering 10% of the adult population . Typically characterised by a persistent ‘ringing in the ears’ it can be a debilitating condition that causes great distress to sufferers and their families – and there is currently no cure.

Roy Bratby, Chairman of the BTA said: “We are here to help sufferers and their families. Tinnitus can be a distressing condition and although there is no cure there is advice and information that can help to reduce the level of noise.”

Roy added: “We have a trained team of advisors so if you need help please call our free phone helpline on 0800 018 0527 or visit our website at www.tinnitus.org.uk.”



The British Tinnitus Association (BTA)

The BTA was set up as an independent charity in 1991 and now supports thousands of tinnitus sufferers and advises medical professionals from across the world.

The experienced team at the BTA understands the impact that tinnitus can have on the lives of sufferers and those who live with them, so provides the most appropriate and expert advice and information free of charge – via a free helpline on 0800 018 0527 and online at http://www.tinnitus.org.uk. The BTA also offers printed information and audio support via post.



British Tinnitus Association

[Via http://www.medicalnewstoday.com]

Genes May Influence Popularity

A US study of the social networks of identical and non-identical twins concluded that a person’s popularity (as measured by the number of times

his or her name was mentioned by friends and the extent to which those friends also knew each other), was an inherited trait.

The study was the work of researchers from Harvard University and the University of California, San Diego, and was published online before print on

January 26 in the Proceedings of the National Academy of Sciences.

Principal investigator Nicholas Christakis, who is professor of sociology at Harvard’s Faculty of Arts and Sciences and professor of medical sociology

at Harvard Medical School, said:

“We were able to show that our particular location in vast social networks has a genetic basis.”

“In fact, the beautiful and complicated pattern of human connection depends on our genes to a significant measure,” he added.

The study is thought to be the first to look at inherited factors in social networks and to show that genes play a part in forming and configuring

them.

Christakis and colleagues Christopher Dawes and James Fowler, both of University of California (UC) San Diego, found that popularity (the number

of times a person was named as a friend, and the likelihood that those friends also knew one another) was strongly heritable. They also found

that whether a person was at the centre or the edge of his or her network also had a strong genetic link, but surprisingly, the number of people the

individual named as friends did not.

For the study, the researchers used data from the National Longitudinal Study of Adolescent Health and identified the social networks of 1,110

identical and non-identical adolescent twins. On comparing the network of each twin to that of his or her sibling, the researchers found greater

similarities among those of identical twins than among those of non-identical twins.

Perhaps there is an evolutionary explanation, said the researchers. There could be a survival advantage to being at the edges of a social group: for

instance when deadly infectious diseases spread in a community, fewer social contacts reduces exposure. And on the other hand, being in the middle

of the group exposes a person to more information that could also confer survival advantages, such as finding out about new food sources.

As Fowler, an associate professor of political science at UC San Diego, explained:

“One of the things that the study tells us is that social networks are likely to be a fundamental part of our genetic heritage.”

“It may be that natural selection is acting on not just things like whether or not we can resist the common cold, but also who it is that we are going to

come into contact with,” he added.

The researchers tested their findings using the existing theories of networks and found that none was able to explain the genetic variations they

observed. These assume that members of the network are like interchangeable cogs. What was needed was a model that took into account intrinsic differences

among members, differences that could influence the development of the network itself.

So they developed their own model, which they called “Attract and Introduce” and showed it was better able to explain how human social networks

develop and behave when members vary genetically. Run as a computer simulation, their model showed close resemblance to real human networks,

such as when an individual was added to any network, they eventually ended up in the same place within the network, depending on their genetic

characteristics.

The researchers said their findings could help us better understand how health habits, health information, and diseases spread in social networks and

thereby better inform public health initiatives on large scale issues like obesity and flu.

Fowler said:

“I think that going forward, we are going to find that social networks are a critical conduit between our genes and important health

outcomes.”

Fowler and Christakis have writte other papers about social networks, including the spread of obesity, smoking cessation and happiness.

The National Institute on Aging and the National Science Foundation paid for the study.



“Model of genetic variation in human social networks.”


James H. Fowler, Christopher T. Dawes, and Nicholas A. Christakis.

Proceedings of the National Academy of Sciences, published online before print January 26, 2009.


doi:10.1073/pnas.0806746106.



Click here for

Abstract.



Sources: UC San Diego, journal abstract.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

[Via http://www.medicalnewstoday.com]

Lose More Than Weight With Imported Diet Pills Cautions Doctor

Americans who use illegal diet pills from South America are taking amphetamines without knowing it and seriously risking both their health and their jobs. Physicians need to be made aware of the range of serious side effects of these drugs to allow them to identify and treat those patients presenting with unexplained symptoms. These findings1, by Dr Pieter Cohen from the Department of Internal Medicine at the Cambridge Health Alliance in the US and Harvard Medical School, have recently been published online in Springer’s Journal of General Internal Medicine.





Although the US Food and Drug Administration (FDA) has banned the majority of amphetamine-based appetite suppressants, many are still prescribed in other parts of the world, including South America. The second most often prescribed amphetamine-based appetite suppressant worldwide is fenproporex. It is known to be addictive and is rapidly converted into amphetamine in the body. The international availability of fenproporex, combined with Internet sales and other illegal markets, have led to its availability in the US, despite an FDA ban. Most physicians in the US are unaware of the existence of these diet pills combining fenproporex and benzodiazepines, selective serotonin reuptake inhibitors, diuretics, laxatives, thyroid hormones and other substances.





To illustrate the risks posed by taking these diet pills, Dr Cohen reviews two case reports of patients taking appetite suppressants containing fenproporex, illegally imported from Brazil. In the first case, a 26 year-old woman suffered from intermittent chest pains, palpitations, headaches and insomnia for two years. She consulted her doctor numerous times over the two-year period for these unexplained symptoms. Her urine tested positive for amphetamines and benzodiazepines, and both fenproporex and chlordiazepoxide were present in her pills. Her symptoms disappeared after she stopped taking the imported pills.





In the second case, a 38 year-old man tested positive for amphetamines after an occupational urine screening test and was suspended from work. Both fenproporex and fluoxetine were detected in his imported pills. While he was taking the pills he also experienced insomnia and palpitations, symptoms which disappeared after he stopped taking the pills. In both cases, not all the substances detected in the pills matched the ingredients on the vial labels.





Because of the ease of availability of these diet pills over the Internet amongst others, the health and economic consequences of diet pill use are likely to be widespread within certain communities in the US, according to Dr Cohen. He recommends that physicians be made aware of the composition and dangers of the fenproporex-based diet pills imported from South America.





He concludes that “Given the wide variety of potential adverse effects from the medications included in these diet pills, patients attempting to lose weight who experience unexplained symptoms should be specifically questioned regarding the use of imported diet pills.”





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Article adapted by Medical News Today from original press release.

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Reference


1. Cohen PA (2008). Imported fenproporex-based diet pills from Brazil: a report of two cases. Journal of General Internal Medicine DOI 10.1007/s11606-008-0878-4





Source: Renate Bayaz


Springer

[Via http://www.medicalnewstoday.com]

Conference: The Evolution Of Human Aggression, Feb. 25-27

As scientists celebrate 2009 as the bicentennial of Charles Darwin’s birth, experts in anthropology, biology, psychology and other fields will gather at the University of Utah Feb. 25-27 to debate how evolution has shaped human aggression and violence, from war to domestic abuse and homicide.





“What evolutionary forces underlie human violence, and how can we use this knowledge to promote a more peaceful society?” asks Elizabeth Cashdan, a conference organizer and professor and chair of anthropology at the University of Utah.





The conference – titled “The Evolution of Human Aggression: Lessons for Today’s Conflicts” – is presented by the university’s Barbara L. and Norman C. Tanner Center for Nonviolent Human Rights Advocacy.





It will be held at various locations – mostly at Fort Douglas on the University of Utah campus – from Wednesday evening, Feb. 25 through Friday afternoon, Feb. 27.





The public and news media are invited to attend the free conference.





Conference highlights include keynote lectures on the evolution of peacemaking among primates and the relationship between homicide and economic competition; panel discussions on conflict and reconciliation among great apes, violence and warfare, hormones and human aggression, and domestic violence; a scientific poster session; and a community forum on violence.





“This conference helps to bring science fully into the conversation about violence, conflict management and peacemaking,” says communication Professor George Cheney, director of the Tanner Center for Nonviolent Human Rights Advocacy. “This gathering, which is the third in our annual series, will include provocative presentations, lively debate and a roundtable discussion of how current research might be used to reduce violence in our own and other communities.”





200 Years after Darwin’s Birth, Evolution has Lessons for Modern Conflicts





“Curbing human violence is one of the great challenges humanity faces in the 21st century,” says David Carrier, a conference organizer and professor of biology at the University of Utah. “Many aspects of human aggression will be addressed at this conference: warfare, homicide, child abuse and domestic violence. We encourage public attendance because an increased understanding of the evolutionary basis of human aggression may help individuals prevent violence in their own lives and the lives of their friends and family members.”





“Every adult on the planet has experienced anger,” says Stephen Downes, a University of Utah philosophy professor and a conference organizer. “Some of us have committed violent acts against others out of anger. Why we feel this way and why some of us act in the way we do is a question that has consumed students of human nature for thousands of years.”





“Evolutionary theory gives some of the most revealing insights into this issue,” he adds. “Bringing together a group of the world’s leading experts on evolution and aggression is an appropriate tribute to Darwin in this ‘Darwin year’” – the 200th anniversary of Darwin’s birth and 150th anniversary of his “On the Origin of Species.”





While the modern view has grown more complex, Cashdan says that for decades, “there has been a lot of unproductive debate between people who argue that ‘humans are naturally aggressive’ and others who contend that ‘humans are naturally peaceful.’ There is plenty of evidence to support both claims: violence, reconciliation and cooperation are all part of human nature.”





Cashdan adds: “We begin with the working assumption that natural selection has shaped human nature to be both violent and peaceful, and ask how evolutionary arguments can help us to understand the factors that lead to both violent and peaceful outcomes. This can help show which policy changes are likely to be successful, and where we can most usefully intervene to allow the better angels of our nature to prevail.”




Abbreviated Conference Schedule:

• 7 p.m. Wednesday, Feb. 25, Utah Museum of Fine Arts Dumke Auditorium – Opening keynote address by primate expert and psychology Prof. Frans de Waal from Emory University in Atlanta. De Waal’s talk is titled, “Destined to Wage War Forever? The Evolution of Peacemaking among Primates.”

  
  
  
  

• 9 a.m. Thursday, Feb. 26, Officers Club, Fort Douglas – Panel discussion, Conflict and Conflict Resolution in Great Apes. One panelist is Harvard’s Richard Wrangham, who argues that power imbalances promote violence.

  
  
  
  

• Noon Thursday, Feb. 26, Post Theater, Fort Douglas – Keynote lecture by Martin Daly and Margo Wilson of McMaster University. They will discuss how homicide rates correlate with inequality of incomes, and how young men “who are most likely to kill or be killed are those with little to lose by competing dangerously.”

  
  
  
  

• 2:30 p.m. Thursday, Feb. 26, Officers Club, Fort Douglas – Panel discussion, Coalitionary Violence and Warfare. Among the panelists is Harvard University psychologist Steven Pinker, who contends: “Contrary to the popular impression that we are living in extraordinarily violent times, rates of violence at all scales have been in decline over the course of history.”

  
  
  
  

• 4:15 p.m. Thursday, Feb. 26, Officers Club, Fort Douglas – Panel discussion continues, Coalitionary Violence and Warfare. Among the panelists, Peter Turchin of the University of Connecticut will argue that conflict between groups generated the evolutionary pressures that favored the social forces holding together complex societies of hundreds of millions of people.

  
  
  
  

• 8 p.m. Thursday, Feb. 26, Alta Room at the Alta Club, downtown Salt Lake City – Poster presentations of research dealing with evolution and aggression.

  
  
  
  

• 9 a.m. Friday, Feb. 27, Officers Club, Fort Douglas – Panel discussion, Hormones and Human Dominance and Aggression. Among the panelists is Aaron Sell, of University of California, Santa Barbara. Sell will discuss why physically stronger men are more prone to anger.

  
  
  
  

• 10:45 a.m. Friday, Feb. 27, Officers Club, Fort Douglas – Panel discussion, Domestic Violence, focusing on spousal-partner abuse. One panelist, Aaron Goetz of California State University, Fullerton, will discuss debate over the extent to which men view their partners “as an entity that they privately own and control.”

  
  
  
  

• 1:45 p.m. Friday, Feb. 27, Officers Club, Fort Douglas – Panel discussion, Domestic Violence, focusing on child abuse. Panelists include keynoters Daly and Wilson, who will discuss the “Cinderella effect” – violence against stepchildren.

  
  
  
  

• 3:20 p.m. Friday, Feb. 27, Officers Club, Fort Douglas – Community Forum on Violence, including experts who deal daily with domestic violence.

The Barbara L. and Norman C. Tanner Center for Nonviolent Human Rights Advocacy promotes the understanding of human rights and encourages nonviolent conflict resolution and peacemaking. Founded in January 2006, the center is based in the university’s College of Social and Behavioral Science. The center’s previous annual conferences addressed migration, rights and identities, and the cultural and ethical values that drive terrorism.





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Article adapted by Medical News Today from original press release.

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The conference Web site, with links to the full program and abstracts, is at: http://www.humanrights.utah.edu/forum/conference_main.html





Lodging Information





Some rooms remain available at the University of Utah Guest House for Feb. 25-27 at $89 per night. Must book by Feb. 11. More rooms may be available at higher rates. Reservations: http://www.universityguesthouse.com/





Salt Lake City Marriott University Park, Reservations: http://www.marriott.com/hotels/travel/slcup-salt-lake-city-marriott-university-park/





Downtown Salt Lake City hotels: http://www.visitsaltlake.com/visit/hotels_and_lodging/





Source: Lee Siegel


University of Utah

[Via http://www.medicalnewstoday.com]

Circulation Publishes Pivotal Two-Year Results On XIENCE V(TM) Drug Eluting Stent

Data published online in Circulation from the SPIRIT III U.S. pivotal trial evaluating the XIENCE V(TM) Everolimus Eluting Coronary Stent System demonstrated that Abbott’s market-leading XIENCE V outperforms the TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System (TAXUS) in reducing major adverse cardiac events (MACE) at two years. In the SPIRIT III trial of 1,002 patients, XIENCE V demonstrated a 45 percent reduction in the risk of MACE, and a 40 percent reduction in the risk of cardiac death or heart attack (myocardial infarction, or MI) at two years in patients treated with XIENCE V compared to those treated with TAXUS. Additionally, at two years the study demonstrated a 32 percent reduction in the risk of target vessel failure (TVF, cardiac events related to the treated vessel) for XIENCE V compared to TAXUS. These published results were first presented in May 2008 at the EuroPCR Congress in Barcelona.

“As published in Circulation, the SPIRIT III study results demonstrate that the clinical benefits of XIENCE V continue to improve between one and two years of follow-up after stent implantation compared to TAXUS,” said Gregg W. Stone, M.D., Columbia University Medical Center; chairman, Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT III trial. “These data reinforce our earlier findings demonstrating the excellent angiographic and clinical results with the XIENCE V stent, resulting in fewer heart attacks and repeat reinterventions.”



The SPIRIT III trial demonstrated the following key results for XIENCE V at two years:

– A 45 percent reduction in the risk of MACE compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS, p-value=0.004)*. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, MI or ischemia-driven target lesion revascularization (TLR driven by lack of blood supply).

– A 40 percent reduction in the risk of cardiac death or MI (4.0 percent for XIENCE V vs. 6.6 percent for TAXUS, p-value=0.08).

– A 32 percent reduction in the risk of TVF compared to TAXUS (10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04)*. TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, MI or target vessel revascularization (TVR).

– A 40 percent reduction in the risk of ischemia-driven target lesion revascularization (ID-TLR) as compared to TAXUS (4.3 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.07).

– Low rates of stent thrombosis (blood clotting within the treated area) per the Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (1.3 percent for XIENCE V vs. 1.7 percent for TAXUS) and per the SPIRIT III protocol (1.0 percent for XIENCE V vs. 1.7 percent for TAXUS). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.

– Among patients who discontinued anti-platelet therapy with a thienopyridine (clopidogrel or ticlopidine) in the study after six months, trends showed that patients treated with XIENCE V experienced fewer stent thromboses compared to those treated with TAXUS at the end of two years (0.4 percent for XIENCE V vs. 2.6 percent for TAXUS).

“XIENCE V continues to demonstrate sustained excellence, and the data demonstrate why it is an important advancement in the treatment of heart disease,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “The consistent positive clinical trial findings, like those from SPIRIT III, are key contributors to why physicians have quickly adopted XIENCE V, making it the market-leading drug eluting stent in the United States and in key markets around the world.”



About the SPIRIT III Trial

SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients, 333 TAXUS patients) with either one or two de novo native coronary artery lesions. The trial was conducted across 65 academic and community-based centers in the United States between June 22, 2005, and March 15, 2006.

The primary endpoint of the SPIRIT III trial was in-segment late loss at eight months, wherein XIENCE V demonstrated superiority to TAXUS with a statistically significant 50 percent reduction in late loss (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS). In-segment late loss is a measure of vessel renarrowing. In the co-primary endpoint of TVF at nine months, XIENCE V demonstrated statistical non-inferiority compared to TAXUS with an observed 20 percent reduction in TVF (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS).

Additionally, in the pre-specified secondary endpoint of MACE, XIENCE V demonstrated a 43 percent reduction at nine months (4.6 percent for XIENCE V vs. 8.1 percent for TAXUS) and a 42 percent reduction in MACE at one year (6.0 percent for XIENCE V vs. 10.3 percent for TAXUS) compared to TAXUS.



About XIENCE V

XIENCE V is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure. XIENCE V is built upon Abbott’s market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.

The XIENCE V stent is available on both over-the-wire (OTW) and rapid exchange (RX) delivery systems. Rapid exchange is the most widely used type of delivery system because it provides physicians additional flexibility to work as single operators during stent procedures.

XIENCE V was approved by the U.S. Food and Drug Administration and launched in July 2008, and was launched in Europe and other international markets in October 2006. XIENCE V is an investigational device in Japan and is currently under review by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency.

Abbott also supplies a private-labeled XIENCE V to Boston Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System. PROMUS is manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti- proliferative properties.

Additional information about XIENCE V, including important safety and effectiveness information, is available online at http://www.xiencev.com.



About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.



About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

Abbott’s news releases and other information are available on the company’s Web site at http://www.abbott.com.

Abbott

http://www.abbott.com

[Via http://www.medicalnewstoday.com]

Mardil Inc. Advances Its Novel Cardiac Device To First-In-Human Trials For Mitral Valve Regurgitation

Mardil Inc., a cardiac device company with novel technology for treating mitral valve regurgitation, has successfully advanced its device to first-in-human testing, a milestone achievement for the 2-year-old company.

The first patient was successfully implanted with the Mardil device last month in India. The patient had a significant improvement in heart function after the procedure, according to preliminary data from a 20-patient pilot study. Pending U.S. Food and Drug Administration approval of the clinical protocol, Mardil will launch a multinational clinical trial in the U.S., Canada, Israel, Australia and Europe in the fall of 2009.

“Mardil’s concept is truly revolutionary in its approach in that the device simultaneously treats valvular dysfunction while supporting the weakened ventricular muscle, the latter of which is not being adequately addressed by the current therapies on the market,” said Dr. Lishan Aklog, chief of cardiovascular surgery at St. Joseph’s Hospital in Phoenix, Ariz.

Mitral regurgitation occurs when the mitral valve leaks blood backward into the heart, a condition that often leads to congestive heart failure and severe, debilitating symptoms. Current treatments for the condition, however, carry a range of serious complications and risks.

The average mortality rate for patients undergoing mitral valve repair and coronary artery bypass surgery together has risen to 10 percent, a statistic that Mardil founders hope to reduce with their device.

The Mardil device, called BACE(TM) (Basal Annuloplasty of the Cardia Externally), was pioneered by cardiothoracic surgeon Dr. Jai Raman in his efforts to develop a minimally invasive approach to treating mitral regurgitation.

“We designed BACE to reduce the significant costs, side effects and mortality rates associated with current mitral valve repair and replacement techniques,” said Gopal Muppirala, chief executive officer and co-founder of Mardil. “Our device is minimally invasive in that it sits outside the heart and does not require open heart surgery or stopping the heart to implant the device.”

BACE represents a departure from current devices because it addresses the root cause of the condition: a heart muscle that is weakened, stretched and enlarged, according to Raman, professor of surgery and director of adult cardiac surgery and cardiothoracic surgical research at the University of Chicago.

“The Mardil device is the next-generation treatment for mitral valve regurgitation,” said Raman. “BACE corrects the functional abnormality that leads to mitral regurgitation, whereas current devices on the market focus on replacing or repairing valves that are structurally normal.”

In addition, the novel feature of BACE is that it can be remotely adjusted through ports under the skin that funnel saline to and from four inflatable chambers built into the tension band. The efficacy of BACE can be assessed at the time of implantation through a real-time echocardiogram, allowing for immediate adjustments in pressure.

The company is now finalizing its multinational clinical trial protocol for submission to the FDA this summer.



ABOUT MARDIL INC.

Mardil Inc. is a medical device company with a mission to design, develop and market innovative, patented cardiac technologies. Each technology will fulfill a current unmet need in cardiovascular medical procedures by improving upon an existing technology or by designing new technology that more effectively treats cardiovascular conditions. The company’s first product is a minimally invasive device that treats functional mitral valve regurgitation. The device is currently in human trials.

Mardil Inc.

http://www.mardil.com

[Via http://www.medicalnewstoday.com]

Sirion Therapeutics New Drug Application For Ganciclovir Is Accepted For Review By The FDA For The Treatment Of Ocular Herpes

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus. The FDA has issued an action date in late fall of 2009, under the Prescription Drug User Fee Act.

“Herpes simplex keratitis remains one of the leading causes of corneal blindness and corneal transplants in the United States,” explained Barry Butler, CEO of Sirion Therapeutics. “If approved by the FDA, ganciclovir ophthalmic gel would become the first topical ophthalmic antiviral treatment launched in the U.S. in almost three decades. This product would provide a significant new option for physicians in the treatment of patients with herpetic keratitis.”

To assess the efficacy and safety of ganciclovir, four randomized, multicenter trials compared ganciclovir gel, 0.15%, with acyclovir ointment, 3%, both of which are used as first-line therapies outside the U.S. to treat herpetic keratitis. The studies found that ganciclovir is as effective as acyclovir and that the tolerability of ganciclovir was superior to acyclovir, particularly with regard to blurring and stinging or burning sensations after instillation. Additionally, since ganciclovir is formulated as an aqueous gel, it allows for prolonged contact time with the corneal surface.

“Based upon its proven safety and efficacy, the introduction of a new topical antiviral agent with improved tolerability, such as ganciclovir ophthalmic gel, would clearly be a valuable treatment option for U.S. clinicians who treat herpetic keratitis,” noted Herb Kaufman, M.D., Sirion Ophthalmologist Emeritus and renowned herpetic keratitis researcher and clinician.



About Herpetic Keratitis

Herpes simplex virus (HSV) infections are very common, with nearly 60% of the U.S. population showing evidence of infection by age five. Approximately 1% of infected patients develop ocular outbreaks, with 20,000 primary cases of ocular herpes diagnosed in the U.S. each year.

After the primary infection, ocular HSV typically becomes latent until triggers such as stress, UV radiation, and hormonal changes reactivate the virus and cause recurrent outbreaks. Those recurrences account for an additional 28,000 cases per year in the U.S. The risk of blindness increases with the number and severity of recurrences, making prompt treatment imperative to limit scarring and other more serious complications caused by herpetic epithelial ulcers.



About Ganciclovir Ophthalmic Gel, 0.15%

Sirion Therapeutics has an exclusive licensing agreement with Laboratoires Thea of France for the U.S. rights to develop and market ganciclovir ophthalmic gel, 0.15%. Available in Europe under the brand name Virgan(R), this topical ophthalmic antiviral gel has successfully treated herpetic viral infections for more than 10 years.

In 2007, Sirion received orphan drug designation from the FDA for ganciclovir ophthalmic gel. This designation is a special status for diseases or conditions that affect fewer than 200,000 patients in the United States.



About Sirion Therapeutics, Inc.

Sirion Therapeutics is a privately held biopharmaceutical company pursuing the discovery, development, and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight. Sirion’s diverse product portfolio includes products that address ocular diseases and conditions including uveitis, herpetic keratitis, dry eye, glaucoma and geographic atrophy associated with dry AMD. For more information, please visit http://www.siriontherapeutics.com.



About Laboratoires Thea

Laboratoires Thea (http://www.laboratoires-thea.com) was founded in 1994 and is managed by Henri and Jean-Frederic Chibret. Laboratoires Thea is the leading independent ophthalmic group in Europe and is committed to the development and marketing of innovative ophthalmic drugs, medical devices and nutraceuticals.

Sirion Therapeutics, Inc.

http://www.siriontherapeutics.com

[Via http://www.medicalnewstoday.com]

Pivotal Data Published For First Biomarker Combination Test To Determine Risk Of Ovarian Cancer In Women Who Present With Pelvic Mass

A pivotal clinical trial published in the January 2009 issue of the journal Gynecologic Oncology demonstrated the utility of combining Fujirebio Diagnostics’ HE4 and the CA125 test as an aid in estimating the risk of epithelial ovarian cancer in premenopausal or postmenopausal women presenting with pelvic mass. The HE4 test, which is under review by the U.S. Food and Drug Administration (FDA), was reported to successfully stratify patients into high- and low-risk groups when combined with CA125.

The combination test uses the results from two simple blood tests – CA125 and HE4 – and the Risk of Ovarian Malignancy Algorithm (ROMA(TM)) to identify patients at a high risk of having ovarian cancer. CA125 is the current gold standard for monitoring patients diagnosed with ovarian cancer. The HE4 assay was recently cleared by the FDA as an aid for monitoring recurrence of epithelial ovarian cancer (EOC), the most common type of ovarian cancer. Combining the HE4 and CA125 tests may enable physicians to pre-operatively identify those patients with a high risk of malignancy.

“Research suggests that ovarian cancer patients have better outcomes and improved survival when treated by gynecologic oncologists, surgeons that are trained and specialize in the treatment of patients with EOC,” said Richard G. Moore, MD, Director of Medical Education, Program in Women’s Oncology at Women and Infants’ Hospital, and Assistant Professor, Obstetrics and Gynecology, Brown University, Providence, R.I, and lead author of the Gynecologic Oncology paper. “Combining measurements of HE4 and CA125 helps us to identify women who are at high risk of ovarian cancer when they present with an ovarian cyst or mass. This will increase these women’s chances of receiving optimal treatment.”

The HE4 test and ROMA algorithm are the product of research efforts aimed at identifying combinations of biomarkers to add sensitivity to the existing CA125 test, which is limited in its sensitivity and specificity as well as its ability to detect early stage EOC. The pivotal data provide important validation for the use of the HE4 test in combination with CA125 in estimating EOC risk in women presenting with pelvic mass and, when used in conjunction with other clinical methods, may help to ensure these women receive appropriate treatment.

Dr. Moore and his colleagues conducted a prospective, double-blind, multicenter trial involving 566 women with pelvic mass who were scheduled for surgical intervention. Blood samples were obtained from study participants to measure for levels of HE4 and CA125. Two separate algorithms for premenopausal and postmenopausal women stratified patients into low- and high-risk groups. All patients then underwent surgical removal of the pelvic mass. All tissue specimens were examined to verify the diagnoses made by study site pathologists.

The combination of HE4 and CA125 with the ROMA algorithm was found to be highly accurate in assigning patients to high- and low-risk groups, with 88.7% of EOCs and low malignant potential tumors correctly classified as high-risk. For the postmenopausal group the combination test had a sensitivity of 92.3%, a specificity of 74.7%, and a negative predictive value (NPV) of 92.6%. For the premenopausal group the combination test had a sensitivity of 76.5%, a specificity of 74.8%, and an NPV of 95.0%.

“Research demonstrates that patients who are treated by a gynecologic oncologist fare better than patients who are treated by a non-specialist. Any additional diagnostic tools that help the physician identify who is at a high risk of EOC may result in more optimal referral patterns and improved outcomes,” said Karen Orloff Kaplan, Sc.D., Chief Executive Officer of the Ovarian Cancer National Alliance.



About HE4

HE4 in a manual format is currently FDA cleared for monitoring recurrent or progressive disease in patients with EOC, and CE-marked in Europe as an aid in estimating the risk of EOC in premenopausal or postmenopausal women presenting with a pelvic mass. The test is currently available in the U.S. exclusively through Quest Diagnostics Incorporated (NYSE: DGX). The HE4 manual test and corresponding Risk of Ovarian Malignancy Algorithm (ROMA(TM)) are pending clearance by the FDA for use in women who present with a pelvic mass.



About Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecologic cancers in the U.S. and the fifth-leading cause of cancer death in women. It accounts for 31% of cancers of the female genital organs. There are an estimated 22,000 new cases annually in the U.S. Women who are postmenopausal are at the greatest risk for ovarian cancer. In their lifetimes, 1 in 72 women will develop ovarian cancer.

Ovarian cancer is difficult to diagnose because its symptoms are easily confused with other non-cancerous conditions: bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, urgent or frequent urination, gastrointestinal upset and unexplained fatigue. Three quarters of cases of ovarian cancer are diagnosed at an advanced stage, when it is fundamentally incurable. Of patients who are diagnosed early (Stage I-II), more than 90 percent will live past five years. However, only 20 percent of cases are diagnosed in the early stages.



About Fujirebio Diagnostics

Fujirebio Diagnostics is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. Fujirebio Diagnostics is one of the group companies of Miraca Holdings Inc. in Japan, set up in July 2005 to combine Fujirebio Inc., the leading in-vitro diagnostics company, and SRL, Inc., the top provider of clinical laboratory testing services in Japan. Fujirebio Diagnostics has a worldwide distribution network, which enables physicians and patients to access its diagnostic products. For more information about Fujirebio Diagnostics, please call 610… or visit www.fdi.com.

Fujirebio Diagnostics

http://www.fdi.com

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Access Pharmaceuticals Presents New Combination Data On The Company’s Angiolix(R) Therapeutic Monoclonal Antibody

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) presented new data this week on its proprietary humanized monoclonal antibody, Angiolix, which confirmed that Angiolix(R) binds with high affinity to the its target, lactadherin, resulting in anti-angiogenesis and significant tumor growth inhibition in MCF-7 and MX-1 breast cancer xenografts. Its anticancer activity is greatly enhanced when given in combination with chemotherapy. The efficacies determined for Angiolix combinations were comparable to those of Avastin combinations. The mechanism of action of Angiolix is considerably more tumor specific than that of Avastin, potentially giving fewer adverse side-effects. The preclinical studies were conducted at Imperial College London and presented at the International Congress on Anti-Cancer Treatment, a World Leading Educational Congress, held in Paris, France, Palais des Congres 3rd – 6th February 2009.

Data was also presented on the ability of Angiolix to bind to various proteins. Dr. Agamemnon Epenetos, Access Pharmaceuticals’ Chief Scientific Officer, Europe explained, “Competitive binding experiments with a variety of ligands shows that Angiolix binds lactadherin selectively. This provides an excellent insight into Angiolix’s tumor selective mechanism. Angiolix(R) is a promising novel agent for anti-angiogenic cancer therapy. Angiolix has proven to be an effective anticancer drug candidate, in preclinical trials, that is much more tumor specific than Avastin, because it has a tumor specific target. By comparison, Avastin binds VEGF which is widely expressed by many normal tissues and supports many essential physiological functions.”

“We are delighted with these results which demonstrate that Angiolix is at least equally effective as Avastin with regard to efficacy, but may prove to be much less toxic. Given the widespread use of antiangiogenesis compounds in treating cancer, there is clearly a need to bring a more tumor selective product like Angiolix to the market,” stated Jeffrey B. Davis, President & CEO. “The data package we have on this product is attracting a lot of interest, and we are in active discussion with a number of potential partners regarding the further clinical development of Angiolix.”



About Angiolix:

Angiolix is a novel humanized monoclonal antibody which has considerable potential for the treatment of cancer through its affinity for a novel target, lactadherin. Lactadherin is an extracellular matrix protein that is released by numerous types of tumor cells, including most breast cancers, ovarian cancers and prostate cancer. Lactadherin has a critical role in promoting the growth of new blood vessels to support tumor growth through the activation of VEGF-mediated angiogenesis.



About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access’ products include ProLindac(TM), currently in Phase 2 clinical testing of patients with ovarian cancer, and MuGard(TM) for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin(TM)-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix(R), a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; Prodrax(R), a non-toxic prodrug which is activated in the hypoxic zones of solid tumors to kill cancer cells; Alchemix, a chemotherapeutic agent that combines multiple modes of action to overcome drug resistance. Access is also developing Phenylbutyrate (“PB”), an HDAC inhibitor and differentiating agent currently a Phase 2 clinical candidate. For additional information on Access Pharmaceuticals, please visit our website at http://www.accesspharma.com.



This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our ability to close the financing transaction, early results from our clinical trial, Access’ plans to continue and initiate clinical trials, the value of its products in the market, its ability to achieve clinical and commercial success and its ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access and MacroChem with the Securities and Exchange Commission.

Access Pharmaceuticals, Inc.

http://www.accesspharma.com

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Unexpected Birth Of Octuplets In California

After the seventh baby, baby G, was delivered “flawlessly” at Kaiser Permanente Medical Center in Bellflower, California, at 10.47 am on Monday 26

January, everybody thought that was it: but then, Dr Alejandro Vasquez, one of the medical team said, “Wait a minute, I think I feel a hand”, and one

minute later, an eighth baby, a boy identified as baby H, was delivered.

A press release said that preliminary research shows this is only the second set of octuplets ever to be born in the United States. The hospital did not

reveal any names or personal details, or say whether the mother had received fertility treatment. All 8 babies were delivered by cesarean

section.

While delighted, the medical team were taken by surprise: it would appear that baby H “had been hiding from the ultrasound”.

The team of 46 had practised several “dry runs” to prepare for the safe delivery of what was anticipated to be seven infants. The last dry run was

minutes before the real delivery started. Altogether four operating rooms were used for the delivery and care of the infants, and there were no

unexpected hitches in the “hand-off” from the delivery team to the care team.

The first baby, a boy weighing 2 pounds 11 ounces (1.22 kilos), was delivered at 10.43 am. Altogether, six boys and two girls were delivered, the

largest weighing 3 pounds 4 ounces (1.47 kilos) and the smallest, a boy, the fifth to be born at 10.46 am, weighed 1 pound 8 ounces (0.68

kilos).

Each baby cried spontaneously, said the doctors, which is always a good sign.

Dr Mandhir Gupta told CNN at a news conference on Monday evening that the babies could be in incubators for about six to eight weeks and in the

hospital for 10 weeks. They were delivered about 9 weeks before term.

He said the mother was doing well and she was “very excited” about the babies, who are “looking good so far”.

The hospital statement said the first 72 hours were expected to be the most critical.

According to the Associated Press, the world’s first live-born octuplets were born in Houston, Texas, in 1998.

One of the babies died about one week later, but the surviving siblings, 5 girls and 2 boys, celebrated their 10th birthday in December. Their mother,

Nigerian-born Nkem Chukwu, wished the new family well, “we’ll keep praying for them”, she told the AP, and had this message for the

parents:

“Just enjoy it. It’s a blessing, truly a blessing.”



Sources: Kaiser Permanente, Associated Press, CNN.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

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