Jun 24 2008

Seven biomarkers that may help pinpoint prostate cancer recurrence found

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Men’s Health News
A
simple blood test may help doctors better predict whether prostate cancer will recur or spread in patients who have undergone surgery for the disease, UT Southwestern Medical Center researchers have found.
In a study published in the June 15 issue of Clinical Cancer Research, UT Southwestern scientists identified a panel of seven biomarkers that can predict with 86 percent accuracy which prostate cancer patients will experience a recurrence and progression of the disease. Biomarkers are proteins circulating in a patient’s blood that are specific to a disease.
Current risk assessment methods, which include stage and grade of cancer and the level of prostate-specific antigen, can predict prostate cancer recurrence with about 70 percent accuracy.
"There are several unresolved issues in the clinical and surgical management of prostate cancer, one of them being the identification of men who have insignificant cancers and can be followed, and another being the identification of men most likely to have spread of disease and early or late recurrence," said Dr. Claus Roehrborn, chairman of urology at UT Southwestern and one of the study’s authors. "In the future, once we can reliably identify those patients, we may be able to offer additional treatment to counteract that risk and give those men a better chance for a permanent cure. The panel of biomarkers is an important step in this direction."
For nine years, Dr. Shahrokh Shariat, who is now a resident in urology at UT Southwestern and the study’s lead author, has been collaborating with basic-science researchers and clinicians to find a comprehensive group of biomarkers associated with prostate cancer that could more accurately predict the biological behavior of the disease.
Using commonly available blood testing methods, Dr. Shariat and his team measured the levels of seven biomarkers in 423 patients who were subsequently surgically treated with a radical prostatectomy and bilateral lymphadenectomy.
Of the study participants, 75 had a recurrence of their cancer. All 75 had elevated levels of at least several of the seven biomarkers. Dr. Shariat’s seven-biomarker model was able to accurately predict the risk for recurrence 86.6 percent of the time.
"We found that a combination of independent yet complementary markers may provide a more accurate prediction outcome compared to single markers," Dr. Shariat said. "This could help physicians provide individualized care and targeted therapy for patients. It will also allow us to design clinical trials to target these individual biomarkers."
Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer death in men in the United States. Although prostate-removal surgery and radiation therapy have been successful in controlling the disease, up to 40 percent of patients experience a relapse.
"A prediction tool based on the biomarkers we tested could improve the accuracy of standard models and help doctors counsel patients better about their risk for prostate cancer recurrence and help to determine the course of treatment," Dr. Shariat said. "There is no doubt that we are approaching a time when use of proper biomarkers will help detect, monitor and manage the progression of this disease, as well as assist with therapeutic decisions."
acheter generic viagra soft The next step is to explore the role of these biomarkers in patients treated with other therapies, such as radiation, and patients with a different range of disease severity.
Currently, the seven-biomarker panel is being externally validated in a clinical trial at two medical institutions, one in the United States and the other in Europe.
Dr. Jose Karam, a resident in urology at UT Southwestern, was also involved in the study.
An international team of researchers from the University of Montreal; Vita-Salute University in Milan, Italy; and Baylor College of Medicine contributed to the research.

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Jun 23 2008

1 In 10 Men Suffer From Erectile Dysfunction Due To Work Related Stress

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New research has shown that 1 in 10 men experience erectile dysfunction
(ED) and as many as 1 in 5 men suffer a loss of libido, as a result of
work-related stress.
These latest figures suggest that 90% of men have shown at least one
clinical feature of stress due to work but only 54% of men know that
stress from work may be the cause of their ED. Stress, either at work or
home, is a known cause of ED and prolonged stress is associated with low
testosterone levels.
Unfortunately 44% of men would not go to their GP if they experience
erection problems, and those who do go to their GP about their ED wait on
average 17 months before going for a consultation. But there’s no need to
delay - oral treatments for ED (PDE5 inhibitors), such as Levitra,
Viagra and Cialis, have revolutionised the treatment of men with ED
and are now widely prescribed as a first option for treatment.
Dr David Edwards, an Oxfordshire GP comments: "Work-place stress clearly has
a strong impact on the incidence of ED in men. Men should think about the
underlying cause
of their ED, including how to combat their stress levels;
not staying too late at work, a balanced and healthy diet, and regular
exercise. We know that oral treatments usually work well for men with ED,
but 1 in 3 men with ED are not able to have satisfactory sex the first time
they take a tablet and consequently a third of them do not return to their
doctor. These men could still be successfully treated by simply switching to
a different tablet or increasing the dose, and should be encouraged to
return to their GP."
Men have recently ranked ‘high success rate with first tablet’ as one of the
most desirable attributes that a treatment can have. It is important for
men with ED not to give up on their treatment too soon and return to their
GP to ensure that they have tried the range of treatments available.
Low testosterone levels (which may be stress-related) can cause ED and also
prevent PDE5 inhibitors working properly. All men with ED should ask
their GP to test their testosterone levels. If low, this can be treated
successfully alongside treatments for ED.
The SortED in 10 Campaign supported the research and highlighted that
erection problems are very common, affecting half of all men between the age
of 40 and 70. Given the range of oral treatments now available men should
waste no time in asking their GP or nurse about what help is available.

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Jun 19 2008

Definition Of Premature Ejaculation By International Society For Sexual Medicine (ISSM)

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Despite the fact that it has long been a major concern for men, an evidence-based definition for premature ejaculation has not existed until now. In October 2007, the International Society for Sexual Medicine (ISSM) gathered the world’s leading sexual health experts to develop an evidence-based definition of premature ejaculation. Experts will present the definition to reporters in a special press conference on May 19th at Monday, May 19, 2008 at 10:00 a.m. at the 103rd Annual Scientific Meeting of the American Urological Association (AUA).
The ISSM has defined premature ejaculation as "a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy."
"For something that has such a profound effect on men young and old, there needs to be a definitive measure to diagnose premature ejaculation," said Ira D. kaufen viagra soft Ohne Rezept Sharlip, M.D., the study’s main author. "The hope is that more people with these symptoms will understand this is an actual health condition and seek treatment. They no longer need to suffer in silence."
The ISSM panel of experts agreed that the constructs that are necessary to define PE are: time to ejaculation, inability to delay ejaculation and negative consequences from PE. The panel concluded that the definition could also apply to men with premature ejaculation who engage in sexual activities other than vaginal intercourse, although the definition does not apply to acquired premature ejaculation.
Sharlip ID, Hellstrom WJG, Broderick GA: The ISSM definition of premature ejaculation: a contemporary, evidence-based definition. J Urol, suppl., 2008; 179: 340, abstract 988.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients, including UrologyHealth.org, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.
American Urological Association (AUA)
1000 Corporate Blvd.
Linthicum, MD 21040
United
States

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Jun 19 2008

Predictors of personal stigma among those with high levels of depressive symptoms

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Men’s Health News
Personal
stigma associated with depression is higher among men and the less well educated, according to research published in the open access journal BMC Psychiatry. The findings by the Australian team highlight the importance of developing programs to tackle the stigma associated with depression.
Researchers from the Australian National University examined both personal stigma, which is the negative attitude a person has towards depression, and perceived stigma, which describes the stigma felt by a person with depression.
"We already know that stigma is a leading cause of concern for people suffering from depression but up until now not a lot has been done to examine it," explained lead researcher Kathleen Griffiths. "Our work is critical to the successful design and targeting of programs that address the public’s negative attitudes to people with depression and help to reduce the stigma felt by those who are already depressed."
Over six thousand Australian adults, including some with depression, answered the research surveys in an attempt to investigate and compare their own levels of perceived stigma as well as personal stigma. People who had come into contact with depression had lower levels of personal stigma. The researchers found that people who scored highest on a test of depression knowledge were less likely to stigmatize the condition.
At a national level, older people were more likely to hold stigmatizing views and to believe that the public viewed people with depression in a poor light. "Interestingly" said, Griffiths, "although it is often assumed that people from rural areas have more negative attitudes to mental disorders, we did not find any difference between stigma in the country and city."
Griffiths concluded; "This is the first study to investigate predictors of personal stigma among those people with high levels of depressive symptoms. Personal stigmas were higher for males, those with less education, those born overseas and people in greater psychological distress. comprare il viagra pillole While our study showed that stigma is not as high as many members of the public think, it is still a problem. For example, as many as one-in-five Australians say that they would not work with someone with depression". We recommend developing targeted programs to reduce these levels of stigma. A good place to start might be with men, older people, those with lower education levels and those born overseas."

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Jun 19 2008

Sciele Pharma And Plethora Solutions Holdings PLC Announce Initiation Of Pivotal Phase III Trials For PSD502 For Premature Ejaculation

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Sciele Pharma, Inc. ("Sciele") (NASDAQ:SCRX), a specialty pharmaceutical company, and Plethora Solutions Holdings PLC ("Plethora") (AIM:PLE), the specialist developer of products for the treatment and management of urological disorders, jointly announced that they have initiated patient enrollment for the Phase III clinical trials in the U.S. for PSD502 for the treatment of premature ejaculation. In May 2007, Sciele signed an exclusive licensing agreement for PSD502 with Plethora Solutions.
PSD502 is a proprietary formulation of two marketed drugs - lidocaine and prilocaine - dispensed by a metered dose aerosol and developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the U.S. and for which there currently is no FDA-approved prescription treatment. The product is applied locally when needed (often referred to as "on demand" therapy) and is effective within five minutes. The product has been shown to increase ejaculation latency time substantially when compared with placebo in a multi-center Phase II study. This data was published recently in BJU International (Dinsmore W et al 2007, BJU Int 99: 369-35).
Patrick Fourteau, President and Chief Executive Officer of Sciele Pharma, said, "We are pleased with the excellent progress Plethora has made with the development of PSD502, initiating the Phase III pivotal trials within our previously announced timelines. PSD502 for premature ejaculation addresses an unmet medical need that affects a significant number of adult males in all age groups."
Steven Powell, Chief Executive Officer of Plethora, commented, "We are pleased to be advancing PSD502 into the final stage of clinical development for the treatment of premature ejaculation. If patient recruitment proceeds as planned, we would expect to see headline data towards the end of 2008 which will be a major milestone in the life of both this product and Plethora."
Study Details:
Plethora intends to run the two pivotal studies in parallel, one in the U.S. and one in acheter cialis soft bon marche Europe. Each will be a multi-center, randomized, double-blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. Patients will be treated for a 12-week period with an optional five-month open-label phase. The primary endpoints will be Intra-vaginal Ejaculation Latency Time (IVELT), sexual satisfaction and ejaculatory control. Secondary endpoints will include Sexual Quality of Life and partner satisfaction. The study design and powering, in agreement with both U.S. and E.U. regulatory authorities, employ validated patient reported outcomes (PROs). The two studies will recruit patients in 36 centers in Europe and 38 in the U.S. and Canada, including almost all North American opinion leaders. It also has been agreed with the regulators that one-year open-label extensions to the studies are not required, which will reduce time to study closure considerably.
About Plethora Solutions
Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder, stress urinary incontinence, interstitial cystitis, gynecological pain and premature ejaculation. In January 2006, Plethora acquired Minneapolis (MN) based Timm Medical Technologies, Inc. which markets the ErecAid® and Rigiscan® products for the treatment of erectile dysfunction (ED) to urology clinics through a US-based specialty sales team. Most recently, the ErecAid has been found to be effective for men that fail Medical Management and for men recovering from prostatectomy. The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:PLE) Further information is available at
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic, Women’s Health and Pediatrics. The Company’s Cardiovascular/Metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women’s Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company’s success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.

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