Anti-Tissue Remodeling Effects of Corticosteroids

Posted on October 9, 2014 by Hank

Tobacco is an important etiologic factor in the development of COPD, and is considered an aggravating factor in a number of interstitial lung diseases. In general, these pulmonary disorders are characterized by inflammation and the activation of tissue remodeling that result in structural alterations such as airway wall thickening and the destruction of alveolar septae. Corticosteroids are commonly used in the treatment of these disorders Viagra medstore, and their beneficial effects are often ascribed to their anti-inflammatory properties. More recently, attention has been given to the potential effects of corticosteroids on tissue remodeling. For example, inhalation of the corticosteroid fluticasone propionate (FP) was found to partially inhibit airway wall thickening and matrixdeposition in a rat model of allergen-induced airway remodeling, and limited the progression of structural airway changes in this model. These studies suggest that corticosteroids might ameliorate progressive tissue remodeling in diseases characterized by airflow obstruction, but the mechanisms responsible for this effect remain unelucidated. We speculate that corticosteroids might inhibit lung tissue remodeling by directly modulating the expression of extracellular matrix genes in lung fibroblasts.

In an attempt to elucidate the effects of corticosteroids on extracellular matrix gene expression, we studied the expression of fibronectin in fibroblasts treated Sildenafil online with FP. Fibronectin is an extracellular matrix glycoprotein that is highly expressed in acute and chronic forms of lung injury including COPD, asthma, and many interstitial lung diseases. Villiger et al demonstrated an increase in the production of fibronectin in alveolar macrophages obtained from smokers when compared to nonsmokers. Alveolar macrophages from patients with chronic bronchitis spontaneously released greater amounts of fibronec-tin than those from asthmatic patients and control subjects. The levels of fibronectin have been correlated with a decrease in pulmonary function in smokers with COPD. In asthma, airway wall remodeling is not only associated with increased deposition of extracellular matrices, but also with alterations in the composition of the airway wall connective tissue with increased deposition of fibronectin. The aforementioned studies have implicated excessive production of fibronectin as a marker of activation of tissue remodeling and a potential mechanism for promoting fibroproliferation in tobacco-related lung disease.

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Pharm News: Treatment in General

Posted on October 1, 2014 by Hank

Neurasthenia shows that through human nerves more electricity flows and that nervous system is shaken because of lots of work. In your bathrooms there is a faucet for cold water and one for hot water. If you open only the faucet for the hot water, you will be burnt. If you open only the faucet for the cold water, you will catch a cold. You shall open both faucets simultaneously and you shall carefully try until the water becomes pleasant for washing. Cold water comes from the head and warm water – from the sympathetic nervous system. You shall close a little bit the faucet of exceeding knowledge and open the faucet of Love. Knowledge and Love form a nice combination. If you have rheumatism – open the faucet of Love. If your shoulder hurts – pat it, become to love it.

Purity is one of the conditions for good health, for mind and feelings.

In order to heal someone clomid Australia, we shall free him from all alien elements, from all sediments that have deposited in him.

To recover, a patient shall clean his blood by breathing fresh air, exposing his back to the sun and by eating clean, healthy food.

You shall start from small microscopic experiments and gradually go to big ones, to great experiments. This method is observed also in science and in healing: from small to big results.

There is whammy in the world. For example, when somebody looks at you, you start feeling not quite well, you get a headache. There are people, who if they look at a bull or a cow, it immediately gets ill. The reason for that is the powerful look, which that person has directed toward you or to an animal, and that look is due to the electricity that comes out of the eyes of that person, which you cannot assimilate and that affects badly your organism. There are grandmothers, who know how to treat curses of the evil eye on people in the simplest way: they take one good egg and break it on the forehead of the bull or of the cursed person and he pulls himself together. Egg cures by absorbing the excess energy. However, only that grandmother, who is a good conductor of that electricity, may heal. Her organism shall withstand the impacts that come out of the ill person. The same may be said about doctors. Many doctors treat patients, but few of them have good results in healing. A true doctor must be a clue, through which the disease may get out. The doctor shall take and give something to the patient.

Any discomfort, either physical, or mental, is treated either by a method similar to the reason that has caused it, or by a method opposite to the reason. For example, frozen hands and feet are treated by coldness, and not by warmth.

They are oiled with olive oil, because it absorbs the warmth in itself and thus relieves the body of the excessive energy that it has accepted by burning.

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The Food Pyramid

Posted on September 15, 2014 by Hank

The food pyramid gives a good idea of how our daily food intake should be balanced. Understanding the food pyramid can help you keep your diet varied and interesting, while at the same time remaining healthy.

The bottom row is the carbohydrate group, with food that supplies us with energy in the form of glucose. This includes cereal, bread, potatoes, pasta, rice and grains. This is the largest group and six or more portions are recommended each day (up to twelve portions if you are very active). Wholegrains should be chosen where possible.

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Wholegrains

These foods are a good source of fibre and complex carbohydrates. Wholegrains are also a good source of vitamins and minerals, which are beneficial for maintaining a healthy blood pressure level and heart health. These include selenium, zinc, magnesium, iron, niacin, riboflavin, thiamine and Vitamin E.

As an example, brown rice has the same fat, protein and calories as white rice but also has additional fibre, calcium, iron, zinc and folic acid as well as Vitamins Bl, B2 and B6. It can help normalise blood sugar and is thought to be particularly good for the bowel, perhaps helping to lower the risk of bowel cancer. It can also lower blood cholesterol levels.

Ground flaxseed is an excellent way to add wholegrain to your diet. These small brown seeds can be crushed or ground in a food processor or coffee maker and added to food, e.g. a teaspoonful in hot cereal or yogurt. Flax seeds are high in fibre and also in omega-3.

Simple ways to increase the amount of wholegrains in your diet are shown below.

  • Fruit and vegetables make up the second largest group in the food pyramid and it is recommended that we eat at least five portions of fruit and vegetables per day. We should all eat more fresh fruit and vegetables. However, many Irish men fall short on this one. Fruit and vegetables are excellent for your health for a number of reasons. Firstly, they are an excellent source of vitamins and minerals and are naturally Viagra Jelly in Australia low in calories. Secondly, they are high in soluble fibre, which can lower cholesterol and help prevent heart disease. Thirdly, fresh fruit and vegetables are very rich in antioxidants, which can help prevent heart disease and cancer. Berries are a particularly rich natural source of antioxidants, especially blueberries. Broccoli is a rich vegetable source of antioxidants and as such is called a ‘superfood’. Fourthly, they can be quite filling, which means less space for high-fat foods. The key with fruit and vegetables is to eat them often, ideally with every meal. Keeping fresh fruit in a bowl in the kitchen or freshly chopped carrots or broccoli in the fridge makes a healthy snack readily available. The only fruit and vegetables to avoid would be vegetables in creamy sauces, fried vegetables in batter and canned fruit with heavy sweet syrup. Otherwise, for fruit and veg the sky’s the limit.
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Risk Factors of ED

Posted on September 3, 2014 by Hank

Diabetes

The pathophysiology of ED in men with diabetes mellitus (DM) is complex and multifactorial. Men with DM, even those without significant comorbidities, suffer from a wide range of sexual dysfunction Viagra in Australia online, including decreased desire and sexual satisfaction. Prevalence of ED among diabetic men that has been reported in the literature ranges widely. Unfortunately, many studies either have not differentiated between DM Type 1 and Type 2, or were not done in Type 1 diabetics. The prevalence of ED among men with DM in the MMAS was reported at three times the general population, or 28% versus 9.6%. A more recent study evaluated self-reported ED in males with DM Type 1 and found a prevalence of 20% overall and 47.1% in those 43 years of age or older. Along with objective factors, such as decreased libido, men with DM Type 2 demonstrate organic causes with a decreased nocturnal penile tumescence.

Several cellular and molecular derangements have been described in diabetic men that contribute to the increased risk of ED in this population. Vascular injury is an important cause of ED in this population. At gross anatomical level, men with diabetes have an increased prevalence of cavernosal arterial insufficiency, thus impaired arterial response, on ultrasound. An early study reported impaired endothelial-mediated vasodilation upon exposure to acetylcholine, a parasympathetic agent, in cavernosal tissue of diabetic men with ED. Since this study, endothelial dysfunction in cavernosal tissue of diabetic men has been characterized by abnormalities including, but not limited to, increased apoptosis, oxidative stress, and overactivity of protein kinase C. Thus, the effect of DM on penile vasculature is mechanically similar to its effect on other vascular structures throughout the body. Although advanced glycation end-products have been demonstrated in cavernosal tissue, their significance remains unclear. While a majority of research has focused on diabetic ED as vascular phenomenon, there is at least correlational evidence that autonomic neuropathy plays a role in the development of ED in diabetics. The existence of ED in men with diabetes is also predicted by age and other complications of diabetes, such as retinopathy and depression.

A large national epidemiologic study was able to review a very large database of the diabetic male population through the use of managed care claims. The study used this database to determine the prevalence of diabetes in men with and without ED. The prevalence of diabetes in men with ED was found to be much higher than the general population. Twenty percent of men suffering from ED were also found to have been diagnosed with diabetes; this is in comparison to only 7.5% in men without ED. Given this finding that men with ED are twice as likely to have diabetes as those without ED, the diagnosis of ED may indeed serve as a useable marker for diabetic screening. A similarly large national study in 2005 evaluating men with ED found four specific comorbidities to be significantly prevalent among men carrying the diagnosis of ED. The authors even suggested that ED may be used as an observable marker for all four: hypertension, hyperlipidemia, depression, and diabetes.

Treatment of ED in Diabetics

Although treatment of ED is discussed later in the book, it is prudent to mention here that certain trials in the past decade have been specifically dedicated to the treatment of ED in diabetic males. A retrospective analysis of data from twelve placebo-controlled trials evaluated the efficacy and safety of tadalafil for the treatment of ED in diabetic males. They confirmed that diabetic men have more severe ED than controls at baseline. Interestingly, they also found that baseline erectile function in the diabetic males correlated inversely with baseline HbA(1)c levels. They concluded that although ED was found to be more severe in the diabetic population, response to tadalafil was only slightly lower than controls for the treatment of ED.

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Effects of testosterone o sexual function

Posted on August 28, 2014 by Hank

It is commonly accepted that low serum testosterone may result in the combination of low sexual desire and erectile difficulties. In many patients, the correlation between sexual function  and serum testosterone values follows this logical pattern. Although this is a practical concept, and one that has been examined experimentally, the reality is not always as simple or clear. 140155284230psvnx8anaHypogonadal men may be capable of sexual erections with Viagra professional online Australia; for exam-ple, only 75% of men who received anti-androgen therapy were unable to develop erec-tions when tested with erotic video challenge. Additionally, hormonal supplementation resulting in normal testosterone values does not always result in restoration of libido and quality of erectile function. The presence of penile erections has been documented in male fetuses by antenatal ultrasound and castrati who have negligible circulating tes-tosterone. Therefore, in some circumstances, there appears to be a disconnect between the biochemical picture and the clinical situation.

Hypogonadism has been shown to reduce the frequency of sexual thoughts and inter-course. Low testosterone levels also decrease the frequency, volume, and quality of ejaculation. The effect of testosterone on different aspects of erectile function has been studied, and the current belief is that nocturnal penile tumescence and spontaneous erections are androgen-dependent. Audiovisual erotic stimulation predominantly causes erections through androgen-insensitive pathways, but some androgen sensitivity is likely. Rapid-eye-movement sleep has been shown to be reduced in hypogonadism, and although androgen reduction adversely affects sleep-related erections, it did not elimi-nate them over a 12-wk trial in healthy young adult men.

There are data for supranormal levels of testosterone from the exogenous administration of testosterone to normal males. The patterns of sexual intercourse, masturbation, and sexual interest were not found to change significantly. The information in this area has previously suggested compart-mentalization, with various functional aspects having different androgen sensitivities; the issue is unresolved but the sensitivities appear to overlap. The prospect that selective androgen modulation may be therapeutically harnessed remains a possibility. Certain types of age-related changes are associated with the length of the AR gene CAG repeat. CAG repeat lengths may play a role in setting different thresholds for the various androgen actions.

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Stop Premature Ejaculation Naturally: Why Masturbation May Not Work for You

Posted on April 25, 2014 by Hank

Learning how to stop premature ejaculation and knowing how to last longer in bed may be the key to regaining your manly pride. This is mainly because as a man, your ability to satisfy a woman sexually plays a large role in determining how you feel about yourself. It affects your self esteem, how you relate to women and even how confident you are in dealing with the day to day issues in your life.

Knowing that you cannot fully satisfy any woman you take to bed because of early ejaculation is emasculating. This is not only because of what you fear the woman will be talking about with her friends after the embarrassing encounter, but also because deep down, you will feel that you have failed as a man. When this is left to go on over a prolonged period of time, it can cause permanent psychological scars. It is thus important that you learn how to stop premature ejaculation as early as possible so as to start managing your condition as early as possible.

The truth is that managing premature ejaculation is quite easy. It is inexpensive since all that you have to do is to learn how to control the ejaculatory process with your mind. This mainly requires simple exercises which can be done at home and even in bedroom. These exercises do not even demand that you set aside a lot of time from your schedule. All that you will need is a little bit of effort on your part and the right information on how to go about treating premature ejaculation.

Given the number of people suffering from premature around the world, it is not surprising that everywhere one looks, there is a lot of information and advice about premature ejaculation. People have come up with “tips” and “tricks” that they claim can help treat premature ejaculation. Viagra online while there is a lot of valuable information out there, it is advisable that you be careful about what you choose to believe and what not to. This is because some of the “tips” and “methods” that people claim are useful in helping one stop premature ejaculation, are actually counterproductive.

Men suffering from premature ejaculation are sometimes usually advised to masturbate right before having sex. They are told that this is likely to help them last longer in bed. The reasoning behind this advice is that after a person ejaculates, some time has to pass before he gets excited enough to ejaculate the second time. This makes sense and in some instances, it actually works in helping some people prolong the time they take before they ejaculate.

However, there are two problems with this kind of advice.

1. The first is that when using masturbation as a technique to stop premature ejaculation, you may actually find it difficult to get an erection when you really need to and before having sex. This can be very embarrassing and is sometimes worse than ejaculating prematurely. This is because when a man ejaculates, he loses his erection and the penis becomes relaxed. It usually takes sometime before one can get a hard erection. This has made some people to assume that they are suffering from erectile dysfunction when in reality it is a natural biological process. Therefore, when deciding to use masturbation to stop premature ejaculation, you have to ensure that your timing is good or that you get easily aroused.

2. The other problem with using masturbation to stop premature ejaculation is the fact that you may end up conditioning your mind and body to cause early ejaculations. This is because masturbation is a way of seeking a quick relief from sexual tension with the sole object of ejaculating. When done continuously, the body may adapt to cause quick ejaculations and thus your condition may end up being worse. This is the major reason why it is inadvisable to use masturbation as a natural technique of controlling premature ejaculation.

This does not however mean that all people who masturbate are likely to suffer from premature ejaculation. The truth is that when done rightly, it is possible to actually lean to control your ejaculation by masturbation. The reason for this is that when masturbating, it is possible to know what excites you sexually and how your body responds when excited. It is possible, through masturbation, to get to know how exactly your body reacts just before you ejaculate. Using this knowledge, it then becomes easy for you to use other natural methods to stop premature ejaculation such as the “start and stop” method.

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Erectile Dysfunction in Young Men and What Causes It

Posted on June 23, 2013 by Hank

Erectile dysfunction in young men is a statement that seems far-fetched according to many people. It is believed that erectile dysfunction is a condition that normally affects old people i.e. people over the age of 40. This fact might have been true in earlier times, but not today. Nowadays, many young men suffer from ED all around the world. This statistic is even made worse by the fact that most of them do not seek medical advice for their condition. They prefer not to disclose this condition and live with it. Before we can continue with the causes and possible cures for erectile dysfunction in young men, let us look at this condition. ED is a sexual disorder that is common among men and is characterized by a person lacking the ability to achieve and sustain an erection during sexual intercourse. Young men are becoming susceptible to the condition because of their lifestyles. Various reasons can cause ED in young men. Doctors often have a difficult time diagnosing the exact cause of erectile dysfunction in young men. However, research has shortlisted some potential causes of this disorder in young men around the world.

Some of those causes include:

Psychological issues: These issues play a large part in causing dysfunction according to many researchers. Some of these issues may include anxiety before sexual activity, especially if you are doing it for the first time, sexual issues which occurred at an early age and other mental issues. If the young man’s mind is not in a sexual state, sexual intercourse becomes very difficult because sex is a state of mind.

Health ailments: Health conditions that are poor can cause erectile dysfunction in young men. Obesity, heart disease, diabetes, and many more affect the man’s sexual function. Surgical procedures can also affect a young man’s ability to get an erection.

Lifestyles that are unhealthy: The lifestyles that most young men lead are very unhealthy and this makes them prone to sexual disorders like ED. Bad habits like binge drinking, smoking, hard drugs and stimulants are very common in college situations. College and high school students will often indulge in such behaviors so that they can fit in with their peers. What they do not know is that these habits have a direct impact on their health and especially their sexual health. Alcohol, cigarettes, stimulants and hard drugs affect the nervous system thus blocking brain signals responsible for sexual stimulation and arousal.

If you are a young man suffering from the erectile dysfunction, you can use certain treatments, which can help you deal with the condition.

They include:

Medical treatments: Oral pills are the most popular forms of medical treatments. It is no different with erectile dysfunction in young men. Most of these pills are PDE5 inhibitors like Viagra Australia, Levitra, Sildenafil Australia and many more. Injections, pellets, prosthetic implants and surgery complete the list of ED medical treatments.

Natural treatments: This is by far the best form of ED treatment that you can indulge in. This is because the cures are not harmful to your health and do not have serious side effects unlike the medical treatments. Herbs, spices and aphrodisiacs fall into this category and have the power to cure erectile dysfunction. Other natural home remedies include eating plenty of green veggies, fresh and dry fruits. This will certainly go a long way in easing the symptoms of ED.

Psychological treatments: Seeking the services of a therapist might also cure the problem completely. Counseling will help determine the exact cause of the psychological problems causing ED. Erectile dysfunction in young men can be and is very serious condition, and none of the above treatments should be attempted before consulting a doctor.

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Erectile dysfunction: the problem

Posted on June 7, 2013 by Hank

Erectile dysfunction (ED) is defined as the persistent inability to achieve and then maintain an erection to permit sexual intercourse.

In the general population ED affects, to a varying severity, up to 52% of men aged 40– 70 years. In 1995, it was estimated that ED affected over 152 million men worldwide. As ED increases in incidence with age (a man aged 70 years is three times more likely to have ED than a man of 40 years) and as we are an ageing population, it is estimated that by the year 2025, over 300 million men worldwide will suffer some degree of ED.

Consequences
ED is a very distressing condition that not only has a negative impact on the man’s sexual ability but also has damaging repercussions on the couple’s quality of life. ED leads to depression, anxiety and loss of self-esteem and can contribute significantly to 20% of marital breakdowns. Men are reluctant to seek help for fear of not being taken seriously or out of embarrassment and become isolated within their relationship, which may lose all aspects of intimate contact. The tragedy is that treatment is readily available and highly effective, yet for many not utilized. Nearly 90% of men who have successful treatment for their ED report significant improvement of emotional and overall well-being. Encouraging men alone or with their partners to seek help is therefore a major challenge.

Causes of ED8b927246-99d2-4f78-9552-8da0f9ef26e6
The aetiology of ED was regarded until recently to be predominantly psychogenic, but with our increasing knowledge of the physiology of penile erection and pathophysiology of ED, it is now recognized to be mainly an organic condition, with vascular disease responsible for 70% of cases. For most men, the cause may be multifactoral, especially in the elderly (75% of men aged over 80 years have ED), with endocrine, cellular, neural and iatrogenic causes exacerbating vascular ED or being independently causative. Organic ED will have psychological consequences which must be recognized and addressed as part of the overall management.

Physiology of penile erection
A penile erection occurs in response to stimuli which may be visual, erotic, olfactory, auditory and tactile. It is a neurovascular event that may be modulated by hormonal and psychological factors. On sexual stimulation, there is increased parasympathetic activity and decreased sympathetic activity. The parasympathetic nerves release the neurotransmitters, the most important of which is nitric oxide (NO), which is also released by the endothelium. NO activates a soluble guanylate cyclase, which in turn raises the intracellular concentration of cyclic guanosine monophosphate (cGMP). Cyclic GMP then activates a specific protein kinase, which leads to the inhibition of calcium channels and the opening of potassium channels. The end result is relaxation of the smooth muscle in the penile arteries and the spongy tissue of the corpora cavernosa. A several-fold increase in blood flow to the penis occurs and, as the penis becomes erect with intracavernous pressures up to 100 mgHg, venous out flow is occluded and the erection is sustained. Cyclic GMP is regulated by phosphodiesterase type 5 (PDE5), which enzymatically degrades and inactivates this cyclic nucleotide. Penile rigidity is lost and flaccidity returns. Australia viagra online – cheap and high-quality.

When we consider the cascade of events, there are several areas where disturbances in the neurovascular sequence might lead to ED, but most attention has focused on PDE5 and its inhibition.

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Medication for the healthy?

Posted on February 27, 2013 by Hank

Modern Western culture does not restrict medication to the medically ill. Herbals, dietary supplements, and over-the-counter drugs, as well as highly publicized medications for sexual function such as Viagra (sildenafil) and Cialis (tadalafil), have blurred the categorical boundary between the sick and the well. An extensive review and discussion of the practice of taking such substances is beyond the scope of this book. It is important, however, for the clinician to carefully review the reported effects on sexual function of a substance used by a patient, as available at MEDLINEplus, and to have a clear view of what the substance purports to do in the area of sexual functioning. The distinction between an aphrodisiac and a drug to enhance physiological response is key in this regard.

For example, Cheap Viagra Australia and Cialis are not aphrodisiacs. They do not increase one’s desire for sex; they augment erectile activity and usually require stimulation—physical and psychic—to be effective. Testosterone, on the other hand, acts on the libido without significantly increasing erectile response. Thus, if a healthy man has erectile dysfunction and a normal testosterone level, there is no reason to give him exogenous testosterone for the erectile dysfunction. In a double-blind, placebocontrolled crossover study, Raul Schiavi and colleagues reported that there was no effect on erectile functioning when testosterone was administered to men with erectile dysfunction. Only a slight increase in ejaculatory frequency was noted, and this was not connected with the participants’ self-reports of any increased sense of sexual desire.
The question of medication use by the healthy to enhance sexual function most often arises in connection with the process of healthy aging. The normal aging decrements in function versus the limitations caused by a disease process is a complicated and controversial subject. For an approach to this question, I look at the question of the aging body and sex.

THE AGING BODY AND SEX

From the perspective of a healthy, albeit aging, body, the ability for sexual activity resembles that for any other physical activity. In this view, sexual functioning is similar to jogging, swimming, hiking, and climbing stairs: the more one has done this in the past, the better one is able to do it now and in the future. There may be a general decline in motivation, speed, and endurance, but if essential health is a quality of the aging body, the ability to perform physical activities will remain essentially intact. In the sexual realm, at least for healthy men, a parallel decline in the sensory/neural and autonomic functioning of the genitals is part of the aging process. Erections are slower to attain, briefer in duration; seminal ejaculate is less; and orgasmic pleasure is satisfying but less intense than in earlier years.

Will a healthy older person be able to function sexually? The simple answer is, “The past is prologue,” as research studies on sex and aging have taught us. At least for elderly married men, past patterns of sexual activity are strong indicators of sexual vitality in older age. The more complex answer is, “It depends.” Whether or not an older person is interested in sex and is sexually active depends on a number of factors other than physical health. Availability of a partner, quality of the relationship, history of sexual expression (or lack thereof), competing interests or commitments (e.g., chosen celibacy) are some of the factors that predict sexual activity in an aging person. These factors are best understood in the life story and behavior perspectives, and I return to examine them in later chapters.

Cialis Australia Over The Counter – Cheap Erectile Dysfunction Drugs Online

One carefully designed study captures many of the issues involved in sex and healthy aging in men. Raul Schiavi, at the time a psychia trist and sex researcher at Mt. Sinai School of Medicine in New York City, recruited a sample of men (ages 45 to 75) carefully screened to minimize the effects of disease or medications as confounding factors in sexual functioning. Seventy-two heterosexual couples were interviewed, the spouses separately, about their sexual lives together. The men participated in nocturnal penile tumescence (NPT) sleep studies in which erectile tumescence (erection) was monitored with strain gauges attached to the penis. Much to the surprise of the investigators, a high proportion of the men above 65 who failed to have full erections during sleep were, by their own and their partner’s independent reports, able to have intercourse regularly and were quite satisfied with their sexual lives.

The strong suggestion in this finding is that compromised physiological status (abnormal NPT) can be overridden by the physical and emotional stimulation of a spouse. The relationship of sex and aging is a complex phenomenon, not given to simple single-cause explanations. While disease processes and “normal” decrements in function are factors to be reckoned with, in real life, many factors enter into the picture. Other perspectives, especially the life story perspective, with its emphasis on value and meaning, need to be employed at this point to give due regard to the complexity of the lives involved.

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Pharmaceutical News: Spectrum signs ZEVALIN licensing deal with Bayer Adam Dempsey

Posted on January 26, 2013 by Hank

Spectrum signs ZEVALIN licensing deal with Bayer

Spectrum Pharmaceuticals has signed an agreement to acquire licensing rights to market ZEVALIN (ibritumomab tiuxetan) injection for intravenous use outside of the US from Bayer Healthcare.

As per the agreement, Spectrum will have all rights related to marketing, sales, and patents, and access to existing inventory of ZEVALIN from Bayer.

The Merchant Banking Group of Burrill & Company acted as advisor to Spectrum Pharmaceuticals in this transaction.

Spectrum will utilize a combination of company resources and partnerships to support the product outside the US, the company said.

ZEVALIN is approved for the treatment of follicular B-cell non-Hodgkin’s lymphoma, including countries in Europe, Latin America and Asia.

Spectrum chairman and CEO Rajesh Shrotriya said that with the licensing of ex-US, worldwide rights to ZEVALIN, they will be able to leverage their existing clinical, regulatory and marketing investments.

“Our access to the worldwide market will help patients with follicular lymphoma who can benefit from ZEVALIN,” Shrotriya added.

Auxilium Pharmaceuticals, Inc. Announces First Patients Dosed in XIAFLEX® Phase Ib Cellulite Study

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the first cohort of patients has been dosed in its phase Ib trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite. Cellulite has been reported to occur in 85-98% of post-pubertal females and rarely in men. The condition is prevalent in women of all races. (1,3)

Cellulite is described as a localized metabolic disorder of tissue under the skin, which can involve the loss of elasticity or shrinking of collagen cords, called septae, that attach the skin to lower layers of muscle. When fat in cellulite prone areas swells and expands, the septae tether the skin, which causes surface dimpling characteristic of cellulite. XIAFLEX treatment is intended to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin.

“For many women, cellulite can be a source of considerable embarrassment or self-consciousness,” said Dr. James Tursi, Chief Medical Officer at Auxilium. “Current treatments of cellulite with creams, light-based procedures or liposuction provide limited or no effectiveness. The clinical development of XIAFLEX, if successful, could lead to the first FDA-approved, office-based medical treatment option that is supported by scientific results.”

The phase Ib study is a single site, open-label dose-escalation study that is targeted to enroll 63 women between 21 and 60 years of age. The objectives of the study are to assess the safety, effectiveness, and pharmacokinetics of XIAFLEX for the treatment of EFP. Topline results are expected in the second half of 2012.

“Dosing in the cellulite clinical trial represents another important development milestone for Auxilium as we advance a fourth potential indication of XIAFLEX into the clinic, further diversifying XIAFLEX’s growing pipeline,” explained Adrian Adams, Chief Executive Officer and President of Auxilium. “We believe cellulite represents a significantly undertreated condition and that innovative approaches such as XIAFLEX may one day be a viable solution for treatment.”

To qualify for the study, participants must have EFP in the posterolateral thighs and/or buttocks for at least 12 months prior to a screening visit. Following screening and determination of eligibility, study participants will be assigned to one of seven groups that vary in treatment dose, injection concentration and volume. Subjects will receive 10 concurrent injections (0.1 or 0.5 mL per injection) of XIAFLEX via a standardized template over a targeted area (8 cm x 10 cm) of EFP. The total dose of XIAFLEX that will be administered into the targeted area will range between 0.0029 mg and 0.116 mg; these doses represent between 0.5% and 20% of the dose used in a single injection for Dupuytren’s contracture (0.58 mg). Safety will be evaluated through the collection of adverse events, as well as a targeted assessment of local reactions to the treatment. The treatment effectiveness will be evaluated by investigator and patient assessments, as well as 3-D photographic imaging techniques.

About CelluliteCellulite, also known medically as edematous fibrosclerotic panniculopathy, describes a pathologic inflammatory condition, in which lobules of subcutaneous adipose tissue extend into the dermal layer. These changes can visibly affect the shape of the epidermis and resemble an orange peel-like dimpling of the skin.(1)

In the normal subcutaneous fat layer directly under the skin, there are both perpendicular columnar and net-like fibrous connective tissue called septae. These fibrous septae, made of types I and III collagen, connect the epidermis to the dermis and create a network of compartmentalized adipose deposits. Women tend to have a higher proportion of columnar septae that are perpendicular to the epidermis, while men tend to have more of the net-like system. In cellulite, the subcutaneous fat cells swell and push upwards. (2) As a result, the skin between the septae is pushed up and the perpendicular septae act as an anchor to pull the epidermis downwards and form the classic cellulite dimple. The surrounding adipose tissue forms small bulges under the epidermis around the dimple that can give skin a “cottage cheese” texture.

Cellulite occurs mainly on the pelvic region, lower limbs, and abdomen and has been reported to occur in 85-98% of post-pubertal females and rarely in men. The condition is prevalent in women of all races. (1,3) Cellulite is different from generalized obesity. The fat cells found in generalized obesity are not limited to the pelvis, thighs, and abdomen. Further, the fat cells found in cellulite have different physiologic and biochemical property than fat tissue located elsewhere.(3) There is no definitive medical explanation for the presentation and prevalence of cellulite and, despite multiple types of therapeutic approaches for the attempted treatment of cellulite, there are no approved treatments and little scientific evidence that any current treatments are beneficial.(4)

About XIAFLEXXIAFLEX (collagenase clostridium histolyticum) is a biologic approved in the U.S. and the EU for the treatment of adult Dupuytren’s contracture patients with a palpable cord. XIAFLEX is a minimally invasive treatment for this condition and consists of a highly purified combination of several subtypes of collagenase, derived from clostridium histolyticum, in specific proportion. Together, the collagenase sub-types work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase. XIAFLEX is currently in phase III of a global development program for the treatment of Peyronie’s disease, in phase IIa of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and in phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy).

About AuxiliumAuxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopedic, general, and plastic surgeons who focus on the hand, and rheumatologists. Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren’s contracture patients with a palpable cord and Testim® 1%, a testosterone gel, for the topical treatment of hypogonadism in the U.S. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in Europe and Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan. Ferring International Center S.A. markets Testim in the EU and Paladin Labs Inc. markets Testim in Canada. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie’s disease, in phase IIa of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and in phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995This release contains “forward-looking-statements” within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the potential for XIAFLEX to treat edematous fibrosclerotic panniculopathy, commonly known as cellulite; the timing of release of topline results from the phase Ib study of XIAFLEX for the treatment of cellulite; the number of people with cellulite and the market opportunity represented by that number ; and products in development for Peyronie’s disease, Frozen Shoulder syndrome and cellulite; and all other statements containing projections, statements of future performance or expectations, our beliefs or statements of plans or objectives for future operations (including statements of assumption underlying or relating to any of the foregoing). Forward-looking statements can generally be identified by words such as “believe,” “appears,” “may,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and other words and terms of similar meaning in connection with any discussion of projections, future performance or expectations, beliefs, plans or objectives for future operations (including statements of assumption underlying or relating to any of the foregoing). Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including further evaluation of clinical data, results of clinical trials, decisions by regulatory authorities as to whether and when to approve drug applications, and general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in Auxilium’s Annual Report under the heading “Risk Factors” on Form 10-K for the year ended December 31, 2010 and the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2011, which are on file with the Securities and Exchange Commission (the “SEC”) and may be accessed electronically by means of the SEC’s home page on the Internet at http://www.sec.gov or by means of Auxilium’s home page on the Internet at http://www.Auxilium.com under the heading “For Investors — SEC Filings.” There may be additional risks that Auxilium does not presently know or that Auxilium currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.

In addition, forward-looking statements provide Auxilium’s expectations, plans or forecasts of future events and views as of the date of this release. Auxilium anticipates that subsequent events and developments will cause Auxilium’s assessments to change. However, while Auxilium may elect to update these forward-looking statements at some point in the future, Auxilium specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Auxilium’s assessments as of any date subsequent to the date of this release.

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