New route of administration provides greater convenience and choice for physicians and patients

TORONTO, March 15, 2012 /CNW/ – Janssen Inc. announced today that Health Canada has approved an expanded indication for VELCADE® (bortezomib) to include subcutaneous administration in the treatment of multiple myeloma, a form of blood cancer.1,2 this route of administration was studied in patients with relapsed multiple myeloma. with this approval, Canadians living with multiple myeloma can now receive a convenient, subcutaneous (under the skin) injection that allows for greater physician and patient treatment choice.3 VELCADE® was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of multiple myeloma patients who have relapsed following front-line therapy and are refractory to their most recent therapy. In 2008, VELCADE® was also approved as part of combination therapy for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation.

"the new option of the subcutaneous delivery route has the potential for more patients to benefit from bortezomib. Patients with poor venous access will have improved convenience. For patients with pre-existing peripheral neuropathy and patients at high risk for developing peripheral neuropathy this alternate route will also result in improved safety with the reduced risk of developing worsening of neuropathy," said Dr. Kevin Song, MD, FRCPC, BC Cancer Agency, Vancouver General Hospital and the Leukemia/Bone Marrow Transplant Program of BC, Vancouver. "In addition, subcutaneous delivery of bortezomib provides physicians and patients the opportunity to tailor treatment based on individual preferences and circumstances. I have no doubt that the subcutaneous delivery route will become the preferred option."

Multiple myeloma is characterized by excessive numbers of abnormal plasma cells in the bone marrow.4 Symptoms of the disease often include bone pain, fatigue, unusual bleeding (usually from the nose and gums), frequent infections and fevers, thirst, weight loss and nausea or vomiting. Multiple myeloma may also cause structural bone damage resulting in painful fractures.5 the goal of multiple myeloma treatment is to relieve symptoms, avoid complications, and prolong life.6

"Myeloma Canada endorses Health Canada's decision to approve the subcutaneous administration of VELCADE®," said Aldo Del Col, Co-Founder and Executive Director of Myeloma Canada. "From a patient perspective, subcutaneous administration may reduce the risk of neuropathy, thereby allowing patients to continue their treatment to optimize clinical outcomes."

The results of an open-label, randomized, phase III non-inferiority study1 conducted with 222 patients with relapsed multiple myeloma randomly assigned to receive subcutaneous or intravenous bortezomib found that patients receiving bortezomib subcutaneously achieved a four-cycle overall response (ORR) of 42 per cent and complete response (CR) rate of six per cent, while patients receiving bortezomib intravenously achieved an ORR of 44 per cent and a CR rate of nine per cent. the overall safety profile was similar between the two arms. However, differences were observed in the incidence of peripheral neuropathy (PN). In the subcutaneous arm of the trial, six per cent of patients experienced PN of grade three or higher, compared with 16 per cent in the intravenous arm. In the subcutaneous arm, 38 per cent of patients experienced PN of all grades, compared with 53 per cent of patients in the intravenous arm. Dose reductions occurred due to drug related adverse events in 31 per cent of patients in the subcutaneous treatment group compared with 43 per cent of the intravenously treated patients.7 In the subcutaneous treatment group, 18 per cent of patients discontinued study treatment due to a drug-related adverse event compared with 23 per cent in the intravenous treatment group.8

"this new indication further supports the efficacy of bortezomib for patients living with multiple myeloma," added Dr. Song. "In addition, subcutaneous delivery may offer greater convenience to patients and healthcare providers."

About Multiple Myeloma in CanadaMultiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma.9 In 2011, there were approximately 7,000 Canadians living with multiple myeloma and the prevalence in Canada continues to rise.1 according to the 2011 Canadian Cancer Statistics report released by the Canadian Cancer Society, the total new cases of multiple myeloma diagnosed annually in Canada are estimated at 2,300, with the total number of deaths from multiple myeloma estimated at 1,370 annually.8 the average age at diagnosis is 62 years for men and 61 years for women, and only four per cent of cases are diagnosed in individuals under the age of 45.11

About VELCADE® (bortezomib) for Injection1VELCADE® offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the proteasome. by blocking the proteasome, VELCADE® disrupts processes related to the growth and survival of cancer cells. the proteasome is a structure that exists in all cells and plays an important role in breaking down proteins that control how the cell lives and grows.

VELCADE® was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of patients with multiple myeloma who have relapsed following front-line therapy and are refractory to their most recent therapy.

VELCADE® was also approved in June 2008 for the treatment of patients with mantle cell lymphoma (MCL), who have relapsed or are refractory to at least one prior therapy. MCL is a type of non-Hodgkin's lymphoma, which is a cancer of the blood that affects the white blood cells.

VELCADE® is approved in more than 90 countries and has been used to treat more than 300,000 patients worldwide.

VELCADE® Safety Information1 VELCADE® is approved as part of combination therapy for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation and for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have undergone or are unsuitable for stem cell transplantation. VELCADE® is also approved for the treatment of patients with mantle cell lymphoma (MCL), who relapsed or are refractory to at least one prior therapy.

VELCADE® must be administered under the supervision of a physician qualified in the use of anti-cancer drugs.  VELCADE® is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients. VELCADE® should not be administered intrathecally. Fatal events have occurred with intrathecal administration of VELCADE®.

Serious side effects that may occur with VELCADE® include: low blood pressure and other serious heart disorders; bleeding into the brain or gastrointestinal tract (stomach or bowel); muscle weakness due to nerve damage (severe motor neuropathy); and acute lung disease (acute diffuse infiltrative pulmonary disease). Both men and women must use effective contraception while receiving VELCADE®, and for three months after their treatment. Women should be advised not to take VELCADE® while pregnant or breast-feeding.

The safety and effectiveness of VELCADE® in children and adolescents (<18 years of age) have not been established.

These are not all of the possible side effects with VELCADE®. Please refer to the VELCADE® product monograph complete prescribing information including contraindications available at janssen.ca.

About Janssen Inc. As a member of the Janssen Pharmaceutical Companies, Janssen Inc. is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, immunology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, gastroenterology and women's health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.

*All trademark rights used under license.

References:

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1 VELCADE® Product Monograph. Available at: janssen.ca2 Canadian Cancer Society.  Canadian Cancer Encyclopedia. info.cancer.ca/cce-ecc/default.aspx?cceid=1478&toc=29&Lang=E3 Moreau MMY3021 Mateos Commentary Lancet Oncology, Published online April 19, 2011. Available at: thelancet.com/oncology4 Canadian Cancer Society, What is multiple myeloma? Available at: cancer.ca/Canada-wide/About%20cancer/Types%20of%20cancer/What%20is%20multiple%20myeloma.aspx?sc_lang=enLast accessed on February 28, 2012.5 Canadian Cancer Society. Signs and Symptoms of Multiple Myeloma. Available at: cancer.ca/Canada-wide/About%20cancer/Types%20of%20cancer/Signs%20and%20symptoms%20of%20multiple%20myeloma.aspx?sc_lang=en Last accessed on February 28, 2012.6 PubMed Health. Multiple myeloma. Available at: ncbi.nlm.nih.gov/pubmedhealth/PMH0001609/ Last accessed on February 28, 2012.7 VELCADE® Product Monograph. Available at: janssen.ca. Page 20.8 VELCADE® Product Monograph. Available at: janssen.ca. Page 20.9 Myeloma Canada. About Myeloma. Available at: myelomacanada.ca/en/aboutmyeloma.htm  Last accessed on February 28, 2012.10 Canadian Cancer Society. Canadian Cancer Statistics 2011 report. Available at: cancer.ca/Canada-wide/About%20cancer/~/media/CCS/Canada%20wide/Files%20List/English%20files%20heading/PDF%20-%20Policy%20-%20Canadian%20Cancer%20Statistics%20-%20English/Canadian%20Cancer%20Statistics%202011%20-%20English.ashx Last accessed on February 28, 2012.11 Myeloma Canada. Incidence and Prevalence of Myeloma in Canada. Available at: myelomacanada.ca/en/incidence_prevalence.htm Last accessed on February 28, 2012

KNOXVILLE, Tenn.–(BUSINESS WIRE)–Provectus Pharmaceuticals, Inc. (OTCBB:PVCT,pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced top-line data for the company’s randomized controlled trial (RCT) of PH-10 for mild-to-moderate plaque psoriasis.

The Phase 2 trial (protocol PH-10-PS-23) compared safety and efficacy of three dose levels of PH-10 (0.002% Rose Bengal, 0.005% Rose Bengal and 0.01% Rose Bengal) against vehicle. Ninety-nine subjects with mild-to-moderate plaque psoriasis of the trunk and/or extremities were randomized to one of the four study arms and applied their assigned test article once daily for 28 consecutive days. Subjects were assessed weekly during the treatment interval, and returned one week and four weeks after their final application for final assessment of safety and efficacy. Efficacy was assessed using the Psoriasis Severity Index (PSI), the Plaque Response Assessment scale, and the Pruritus (itching) self Assessment scale. Similarity of the patient population, study events schedule and study assessments allows results from the randomized trial to be compared side-by-side with those of a prior single-arm trial of PH-10 using a lower dose level (protocol PH-10-PS-22, which used PH-10 at 0.001% Rose Bengal). The study began in December 2010 and was completed in August 2011, with final data collection for primary outcome completed in February 2012.

Results for all three efficacy parameters showed improvement in psoriasis symptoms over the treatment interval, with the low dose of PH-10 (0.002%) providing uniformly consistent improvement, while reduced therapeutic activity was observed at the two higher doses. Response for PH-10 at 0.002% Rose Bengal was comparable to that observed previously using PH-10 at 0.001% Rose Bengal. after 28 days of treatment with PH-10 (all strengths), 23-29% of subjects achieved complete or nearly complete resolution of all PSI component symptoms (erythema, induration and desquamation), compared to no subjects in the vehicle arm. Thirty eight percent of subjects receiving the low dose of PH-10 reported no itching after 28 days compared with 14% of those receiving vehicle (45% of subjects receiving 0.001% Rose Bengal in the earlier study reported no itching after 28 days). PH-10 at 0.002% and 0.005% (along with 0.001% in the prior study) exhibited maximum improvement in Plaque Response Assessment, with the improvements for 0.002% achieving high significance (p < 0.001) after two weeks of treatment; all strengths proved superior to vehicle after 28 days, with the highest strength exhibiting the least activity. As noted in prior studies, PH-10 was generally well tolerated with only transient mild to occasionally moderate adverse experiences limited to the application site.

Dr. Craig Dees, Ph.D., CEO of Provectus said, “We are excited by the positive data reported for this randomized trial of PH-10. despite the complexity of this four-arm study, we are pleased that it clearly showed that the low dose level was optimal of the three doses tested, with similar activity to that seen in our earlier single-arm trial, and that it was superior to vehicle. These important results provide us with powerful data to guide us as we ramp up our development efforts. We expect the data from this randomized study will eventually lead to a term sheet for a proposed licensing agreement which will trigger the engagement of a financial advisor to assist us with that transaction.”

according to the National Institutes of Health, as many as 7.5 million Americans, approximately 2.2 percent of the population, have psoriasis. The National Psoriasis Foundation reports that approximately 125 million people worldwide, 2 to 3 percent of the total population have psoriasis. it also reports that total direct and indirect health care costs of psoriasis for patients are approximately $11.25 billion annually.

About PH-10

PH-10 is an aqueous hydrogel formulation of Rose Bengal disodium for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. Rose Bengal is a compound that has been in use for over thirty years by ophthalmologists to assess damage to the eye and has an established safety history. it has also been used as an intravenous diagnostic to detect ailments of the liver.

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. Its dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed Phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company’s other clinical trials can be found at the NIH registry, clinicaltrials.gov. for additional information about Provectus please visit the Company’s website at pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Photo Courtesy Of Dr. Patricia Wong Eczema and other dry-skin conditions can lead to chapped lips. they can also be a sign of actinic cheilitis, a premalignant skin problem.

During winter, psoriasis and eczema can flare and dry skin can become a problem. Unaware they are prone to eczema, most people experience their first episode when the heat is turned on and humidity and outdoor temperatures drop.

Not only is it important to moisturize, but one must also use the correct emollients to reduce water loss and avoid damaging the protective lipid barrier on the surface of the skin. Showering with harsh soaps can further contribute to dry skin.

It is better to be proactive than to frantically apply random lotions to treat dry skin after it develops.

Pay attention to symptoms such as itching, which is often the first signal of distressed skin. Itching typically appears before a rash. start treating your skin immediately – do not wait for a rash to erupt.

The importance of genetics

An eczema breakout depends on interactions between exposures to various environmental triggers and genetic composition. five major genes have undergone mutations and can cause atopic dermatitis (eczema). if you have inherited these mutations, it is likely that you will develop eczema irrespective of environmental influences. These genes cause a baseline hyperreactive state in the skin.

If you have only two genes with the mutations, then environmental triggers play a larger role in eczema flares.

The case of chapped lips

Although chapped lips can result from eczema or dry skin conditions, they can also be a sign of a premalignant skin problem – actinic cheilitis.

This condition commonly presents with discrete dry or crusted areas on the lower lip, where the border of the lip and the skin meet. Red, rough areas on the upper lip are also typical for precancers that can develop into squamous cell carcinoma, a type of skin cancer that has the potential to spread to lymph nodes in the neck and elsewhere.

If you have areas of dryness or scaling that are persistent, discrete and not resolved with moisturizing, seek evaluation from a dermatologist. Picking at the skin to remove the rough areas will not result in clearing the lesions and may delay treatment and result in more complex surgical procedures or irradiation.

Avoid cleansers that list sodium lauryl sulphate as the main ingredient. This chemical will strip the natural lipids out of the skin, damaging its protective layer, causing water loss and making the skin appear cracked, scaly, red and/or with a crazed tile or mosaic appearance.

Over-the-counter emollient washes, oatmeal-based cleansers, ceramide cleansers or nonsoap lipid cleansers, such as Aveeno, Balneum plus and Oilatum, are available and preferred. they are gentler on the skin and remove less of the moisturizing protective barrier.

Squeaky-clean skin results from overly aggressive washing and is not healthy. the use of exfoliating products is harmful for dry skin and is not recommended.

Avoid cleansers that contain fragrances and dyes. When the skin is irritated, the protective layer is damaged, allowing penetration of chemicals and harmful substances into the deeper layers and causing additional inflammation that prolongs recovery.

Dermatologists used to recommend less frequent bathing for dry skin. we now know that it is not the frequency of bathing that makes the difference, but how you moisturize the skin. Moisturizers should be applied within the first three minutes after bathing to trap water in and rehydrate skin layers. Balneotherapy – soaking the skin in acidic hot springs – has proven effective. Bathing also removes allergens and bacteria from the skin.

Adding bath oils or oatmeal to the bath does not promote skin hydration.

The best moisturizers contain humectants, substances that attract and hold water inside the skin. if you experience stinging, burning or redness with use, consult a dermatologist. Creams tend to be more effective than lotion formulations.

Dust mites and bacteria produce enzymes – proteases – that can dissolve the protective skin barrier. Measures to reduce dust mites may be helpful.

Topical corticosteroids can be a mixed blessing when treating eczema. although these medications can relieve itching, they can also damage – and do not repair – the lipid protective skin layer. they should be used judiciously and in conjunction with proper cleansing and emolliating under supervision of a dermatologist. Corticosteroids are not moisturizers.

When the water content of the skin drops below 10 percent, it loses its flexibility and will crack. Cracked heels on feet and cracked, sore fingers should be treated as discussed above. in addition, a liberal application of moisturizer and prescription medication at bedtime with cotton gloves for several nights can speed healing. never pick or pull the skin off – it can cause open sores leading to infection and can cause medications to burn.

Including foods that are high in essential fatty acids in your diet can strengthen the skin’s protective layer that seals in moisture. Docosahexaenoic acid and eicosapentaenoic acid are the two important omega-3 fatty acids. Walnuts, salmon, sardines, flaxseed and avocado are foods rich in omega-3 fatty acids.

There are many skin diseases that mimic eczema. Sometimes a biopsy may be needed to determine the correct diagnosis. if your skin problem is not improving with the above measures, seek evaluation and advice from a board-certified dermatologist.

Dr. Patricia Wong is a dermatologist in private practice in Palo Alto. For more information, call 473-3173 or visit patriciawongmd.com.

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Houston, TX — (SBWIRE) — 02/14/2012 — according to Trichologist Hair loss provokes anxiety and distress (more profound than its objective severity would appear to justify), which reflects the symbolic and psychosocial importance of hair. Hair loss is a common disorder that affects men and women of all ages; and about 50% of men and Women suffer from hair loss by the age of 40. Andro-genetic alopecia and diffuse hair loss (Telogen effluvium) are the common causes, while alopecia areata (patchy balding) affects1.7% of the population. “Telogen effluvium” develops over a period of several months, is usually, not a permanent form of hair loss, and eventually, the hair follicles can recover. The potential causes of Telogen effluvium include malnutrition and crash dieting, pregnancy and childbirth, UV radiation exposure, drugs, endocrine disorders, extreme physical and emotional stress, and severe systemic illness. Topical application of biological response modifiers, and anti-androgens are currently available therapies for the management of Telogen effluvium (in women, HRT can also be used); however, the low success rate and associated adverse effects limit their clinical use.“Anti-Hair Loss Cream from Himalaya” is said to an effective natural herbal remedy for Hair loss, stated by Experts. Anti-Hair Loss Cream from Himalaya is a polyherbal formulation recommended for the management and Stimulating Hair Growth, Preventing Hair Loss, Increase Hair Follicle Density and is treat Alopecia Areata & Telogen effluvium, and contains the extracts of the flowers of Butea frondosa and the stem bark of Butea parviflora.A clinical Study was conducted to evaluate the efficacy of and safety of Anti-Hair Loss Cream from Himalaya. A total of 100 patients both men and women, in the age group of 18-50 years, who were suffering from mild to moderate Hair loss problems, and who were willing to give informed written consent were enrolled in the study. All the patients were advised to apply sufficient quantity of Anti-Hair Loss Cream from Himalaya to the affected area of scalp, daily, at night, for a period of 6 months, with gentle massage, and were advised to leave the Hair Loss Cream overnight. Patients were told to restrict themselves to Himalaya Hair Loss Cream as the only treatment for their diffuse hair loss and no other active treatment intervention was allowed.All the patients were followed up every month for a period of 6 months. The results showed a significant reduction in the associated symptoms (itching, irritation and dryness of the scalp) within a week, and by the end of fortnight, all these symptoms disappeared. There was a significant improvement in the tensile strength of hair after one month’s period, and the improvement trend continued till the end of the study period. There was a significant reduction in the mean number of hairs lost after one-minute combing. Also, there was improvement in the hair follicle count in selected shaved scalp areas.these beneficial effects might be due to the synergistic effects of the ingredients of the Himalaya Anti-Hair Loss Cream. therefore, it may be concluded that Himalaya Anti-Hair Loss cream is effective and safe in Hair Loss Treatment.You can buy Cheapest Anti-Hair Loss Cream from Himalaya online, the natural Herbal Hair Loss Treatment cream only at OnlineHerbs.com.about OnlineHerbsOnlineHerbs is an online herbal pharmacy which aims at providing the best quality herbal medicines like natural herbal remedies and natural herbal health supplements for healing various diseases. OnlineHerbs offer the herbal products from very well-known companies, ‘Himalaya Herbals’, ‘Avesta Herbals’, ‘Olay Naturals’, ‘Lotus Herbals’ and ‘Olivia Herbals’.for more details please visit at onlineherbs.com/Email: onlineherbs.com/blog.onlineherbs.com/Now get a free shipment on cheapest Anti Hair Loss Cream from Himalaya at OnlineHerbs online store.Browse the natural herbal medicine to deal with Hair fall and Dandruff at:onlineherbs.com/anti-hair-loss-cream-from-himalaya-50ml.html

According to a report published by market research company Mintel, more than half of all women are concerned about excess body hair. It’s estimated that one in ten of us suffers from excess facial and body hair. But what causes it? Dr Rina Davison, an endocrinologist from Whipps Cross University Hospital, London, with a special interest in excess hair says that eating large amounts of sugary, refined carbohydrates, such as biscuits and cakes, may trigger excess hair. These foods have a high glycaemic index, which means they release their energy quickly and can cause insulin resistance, explains Dr Davison. Insulin is the hormone that controls blood sugar level; ‘resistance’ means the hormone becomes less effective at lowering blood sugar, so the body has to produce more of it to get the job done.“the problem is that a raised insulin level may trigger growth factors which make the ovaries produce too much of the ‘male’ hormone testosterone, which can lead to excess hair,” the dailymail.co.uk quoted Marilyn Glenville, a women’s health expert and nutritionist, as saying. “Being overweight can also cause insulin resistance.”But there are other factors — from commonly prescribed drugs to poor diet and certain ailments — that could be to blame. Polycystic Ovaries is also another cause of excess hair in women. all women produce androgens. However, sometimes women produce higher levels, or they may have normal levels, but their hair follicles are more sensitive to androgens. “If excess hair is due to a hormonal imbalance, then it tends to occur in areas such as the chin, upper lip, sideburns, chest and inner thighs,” says Dr Davison.“Patients with skin problems such as eczema or psoriasis can also develop excess hair,” add Dr Davison. People suffering from anorexia have lanugo hair — an excess of fine, downy hair that covers the body. in this case, the excess hair is unlikely to help the person’s already negative image of their body.Corticosteroids, used to reduce inflammation in the body and are prescribed to treat conditions such as asthma and rheumatoid arthritis, contain a synthetic version of the hormone cortisol and levels can build up in the body over time. the problem is that if the drugs are taken for more than four to six months, this can cause a condition called Cushing’s syndrome. Symptoms include weight gain, a red, puffy face and excess hair growth all over the body. Menopause is another condition that accelerates the growth of facial hair in women. "As the hormone oestrogen declines at the menopause, testosterone (the ‘male’ hormone) can become more dominant,” explains Marilyn Glenville. “you don’t have more testosterone, but the ratio of oestrogen to testosterone has changed, making women prone to symptoms of male pattern baldness or other male characteristics such as facial hair and acne,” adds Glenville. 

Image courtesy: Blogspot.com

FORT WALTON BEACH — When the 2011 Jingle Bell run for Arthritis kicks off Dec. 3 downtown, Maj. Mari Garcia and her three daughters will be at the starting line.

The annual race, and the fight to cure arthritis, holds a special place in Garcia’s heart. her middle daughter, Emma, was diagnosed with psoriatic arthritis when she was 11 months old.

“she came home from day care with these swollen fingers and toes,” recalled Garcia, who is stationed at Hurlburt Field. “they were like sausages.”

Emma, who wasn’t walking yet, couldn’t bend her fingers or toes. after examinations and X-rays didn’t reveal anything, doctors referred Garcia to a pediatric rheumatologist at Nemours Children’s Clinic in Pensacola.

“he took one look at her and knew exactly what was wrong,” she said. “At first they tried a low-dose chemo drug and that didn’t work.”

Eventually doctors tried Enbril, a drug designed to relieve symptoms of certain auto-immune disorders. it had to be injected, which Garcia described as unpleasant but necessary.

“I had to learn how to fill the syringe and flick the bubbles out,” she said. “Auri, my oldest daughter, would help me hold her arms. … I couldn’t have done it without her. (Emma) would cry and then she’d get Skittles.”

After two years, Emma went into remission.

“It’s sort of like cancer,” Garcia said. “they don’t say you’re cured. We’re just believing that God has healed her. I just believe that he directed our path.”

Today, Emma is an active 5-year-old who loves karate and gymnastics.

“Oddly enough, she is my most energetic, non-stop (child),” Garcia said. “She’s the first one up in the morning. I had to put her in karate because ballet just wasn’t her thing. she needed to scream and beat things.”

After Emma’s diagnosis, Garcia said she was overwhelmed with questions and began researching the disease.

“Arthritis is for old people,” she said. “I’d heard of psoriasis and I had heard of arthritis, but I hadn’t heard of them together, and certainly not in an 11-month-old.”

Garcia said she was especially “floored by the auto-immune part.”

“your body is attacking itself,” she said. “How do you deal with that?”

Out of gratitude for the research that developed the drug that helped her daughter, Garcia supports the Jingle Bell 5K each year. she always wears the T-shirt she received from her first Jingle Bell run in 1994 — well before she had children and would be affected by the disease.

This year Garcia has formed a team with friends, and even her youngest daughter, 3-year-old Maddie, will participate.

Without the Enbrel that forced her condition into remission, Emma’s life would have been much more difficult, Garcia said.

“she wouldn’t have been able to hold a pencil in school,” she said. “she wouldn’t have been able to make a fist.”

For more information about the Jingle Bell run for Arthritis, call Pat Faber at 779-1449.

Barney Simon – It means a Healthy Body!

Don’t be surprised on your next doctor’s visit if she wants to examine your nails. And it has nothing to do with your pretty new nail polish. Your fingernails contain a wealth of information about your health. the color and texture can actually reveal if you have any number of illnesses, from hepatitis to heart disease. Here are 10 possible signs of serious conditions manifested in your fingernails: 1.    White nails: Liver diseases, such as hepatitis 2.    Yellowish, thickened, slow-growing nails: Lung diseases, such as emphysema 3.    Yellowish nails with a slight blush at the base: Diabetes 4.    Half-white, half-pink nails: Kidney disease 5.    Red nail beds: Heart disease 6.    Pale or white nail beds: Anemia 7.    Pitting or rippling of the nail surface: Psoriasis or inflammatory arthritis 8.    Clubbing, a painless increase in tissue around the ends of the fingers, or inversion of the nail: Lung diseases 9.    Irregular red lines at the base of the nail fold: Lupus or connective tissue disease 10.    Dark lines beneath the nail: MelanomaDo note that changes in the nails are rarely the first symptom of serious diseases. instead, you’ll feel other symptoms before nail abnormalities are present.

GW Pharmaceuticals plc

Phase III data on efficacy and tolerability of Sativex? in MS spasticity presented at ECTRIMS

Porton down, UK; 24 October 2011: GW Pharmaceuticals plc (AIM:GWP) is pleased to note the announcement by Almirall, S.A. reporting data from three Phase III trials involving over 1,500 MS patients as well as first everyday clinical practice data were presented by a panel of international experts at the European Congress of Multiple Sclerosis (ECTRIMS) in Amsterdam

The full text of the announcement by Almirall S.A. follows.

full Phase III data highlight the efficacy and tolerability of Sativex? as therapy for the treatment of spasticity in MS

?      Data from three Phase III trials involving over 1,500 MS patients as well as first everyday clinical practice data were presented by a panel of international experts at the European Congress of Multiple Sclerosis (ECTRIMS) in Amsterdam

?      Almirall announces sponsorship of two post-graduate clinical research projects

Barcelona, 24th October 2011 -Almirall, S.A. (ALM:MC) presented full results from three Phase III studies with Sativex?, in a satellite symposium at the 27th ECTRIMS congress,which took place in Amsterdam from 19th to 22nd October 2011.

These Phase III studies provide evidence of the long term efficacy of Sativex? (2.7 mg delta-9-tetrahydrocannabinol and 2.5 mg cannabidiol per puff) in symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. These data have led to the approval of this first-in-class medication in the UK, Spain, Denmark, Germany and Czech Republic, with additional countries expected to grant approvals in the near future. (1, 2, 3)

Professor H.P. Hartung, Chair of Neurology at Heinrich-Heine University, Dusseldorf, Germany and Chairman of the satellite symposium, commented: "Sativex? has proven to reduce the severity of symptoms and improve patients' quality of life and functional status, in patients with spasticity in multiple sclerosis, meaning that they can undertake everyday tasks more easily. Also, importantly, clinical experience to date has demonstrated that the tolerability profile of this medicine is favourable, with limited relevant adverse effects and – particularly reassuring – the drug does not appear to lead to withdrawal effects if patients suddenly stop using it."

"The Sativex? data show this is a unique opportunity to help patients with MS spasticity, a clearly underserved indication. We believe Sativex? will offer a new way to help the patients with MS spasticity", said Bertil Lindmark, Chief Scientific Officer at Almirall.

Professor Xavier Montalb?n, Director of the Multiple Sclerosis Center of Catalunya and the Unit of Clinical Neuroimmunology, Vall d?Hebron University Hospital, Barcelona, also announced the award of 2 post-graduate clinical research grants by Almirall, aimed at fostering clinical research in multiple sclerosis spasticity across Europe. The project selection board is comprised of Professor Montalb?n, who will provide guidance on the development of project proposals, Professor Hartung and Almirall's global Medical Affairs Department. The resulting projects will be developed in 2012, and results will be published by authors in Q2 2013.

Sativex? has been developed by the UK-based company GW Pharmaceuticals plc and is marketed in Europe (except the UK) by Almirall, S.A.

Almirall PR / Emanate

+44 (0)20 7611 3881

fiona.gildea@emanatepr.com ,

Notes to Editors

Sativex? is a first-in-class endocannabinoid system modulator and is indicated as treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication (4) and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. (4)

The main active ingredients, delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), are extracted from selected chemotypes of Cannabis Sativa. Sativex? is administered as a mouth spray, which provides optimal delivery of the active ingredients and allows for dosing flexibility in order to enable each individual patient to manage the variable nature of their spasticity.

Sativex? is manufactured through a controlled series of processes resulting in a reproducible finished product manufactured to good Manufacturing Standards. Each 100 microlitre spray contains 2.7 mg THC and 2.5 mg CBD. The formulation also contains other cannabinoids, terpenoids and flavonoids at standardized doses, which contribute to the uniqueness of the medicine. Sativex? was developed by UK-based GW Pharmaceuticals plc.

Sativex? is a registered trade mark of GW Pharmaceuticals plc and GW Pharmaceuticals plc is the Marketing Authorisation holder for Sativex?. Manufactured by GW Pharmaceuticals under Home Office licence, Sativex? is marketed in Europe (except the UK) by Almirall, S.A.

there are almost 500,000 people suffering of MS in the top five EU countries. (5)  Spasticity is a symptom defined by patients and carers as muscle spasms, stiffness, rigidity and/or difficulty to move, and is one of the most common symptoms of MS, occurring in as many as 75% of people with MS. Spasticity can affect many aspects of MS patients' daily life, and is a major contributor to their distress and disability. (6)

Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people's health and wellbeing.   

Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and other dermatological conditions.

Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 12 affiliates.

1              Collin C, Davies P, Mutiboko IK, et al.Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol 2007;14:290-296.

2              Collin C et al. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res 2010 ;32:451-459.

3              Ambler Z, Davies P, Gasperini C, et al. A two-phase study of Sativex in the relief of spasticity due to multiple sclerosis: Phase A single-blind response assessment followed by Phase B double-blind randomized, placebo-controlled, parallel-group study. Mult Scler 2009;15:S258.

4              Sativex? Summary of Product Characteristics, 2011.

, 16/06/2010. top five EU countries include: France, Germany, Italy, Spain and UK.

6              Rizzo MA Hadjimichael OC, Preiningerova J, et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004; 10:589-595.

Lisbon, Portugal, October 21, 2011

– Isoconazole nitrate is not only a potent antifungal agent, but may also be effective against a broad range of bacteria which can cause bacterial superinfection of dermatomycoses. this is the result of an in vitro study previously presented by Intendis as a poster(1) at the EADV Congress 2011 in Lisbon, Portugal.

Microbic (fungal and/or bacterial) infections of the skin and nails form are very widespread. for instance, in the last few decades, the prevalence of superficial mycotic infections has risen effecting approximately 20 to 25 percent of the world’s population(2). Due to their widespread and contagious nature, such infections require an effective antimicrobial treatment that can both reduce morbidity and discomfort and limit the spread of the disease to other sites or individuals. Isoconazole nitrate is highly effective in the treatment of the vast majority of pathogenic organisms implicated in superficial infections of the skin, including dermatophytes, yeast and moulds. the study results presented are evidence of a bacteriostatic and bactericidal action of isoconazole nitrate against a broader range of potentially pathogenic bacterial species such as Staphylococcus aureus, Staphylococcus haemolyticus, Propionibacterium acnes and Corynebateria tuberculostearicum. Interestingly, isoconazole was also effective in inhibiting a multiresistant Staphylococcus aureus strain (MRSA).

“Our results show that the antimicrobial range of isoconazole is broader than previously supposed,” said Dr. Viktor Czaika, Department of Dermatology and Allergy, Charit? – Universit?tsmedizin, Head of Section Dermatology – Campus Benjamin Franklin, Berlin, Germany, and corresponding author of the study. “The compound provides fast and effective treatment of superficial mycotic and/or bacterial infections.”

the study design

in the study several aspects of the antibacterial action of isconazole nitrate were evaluated:

(i) the minimal inhibition concentration against bacteria strains from the microorganisms culture collection of the German Resource Centre for Biological Material DSMZ as reference strains as well as against isolates was determined using the broth dilution method. (ii) the bactericidal activity was evaluated by counting cells stained with Hoechst 33342 (Invitrogen, USA) or propidium iodide (Roth, Germany). Using this method the change in number of dead and living bacteria could be differentiated. (iii) Furthermore, killing curves were identified.

To evaluate a possible mode of action, reactive oxygen species production of S. aureus was determined. in this experiments bacteria were stained with singlet oxygen sensor green (Invitrogen, USA) after the incubation with isoconazole nitrate.

the study demonstrates a broad bacteriostatic and bactericidal action of Isoconazole nitrate against gram positive bacteria. in addition to the current literature the study demonstrated action against S. epidermidis, S. haemolyticus, Strept. salivarius, Coryneb. tuberculostearicum, P. acnes as well as a multiresistant S. aureus strain. the antibacterial effect might be attributed to the production of reactive oxygen species (ROS).

About superficial microbic infections

Superficial microbic (mycotic and/or bacterial) infections of the skin are common and ubiquitous, affecting millions of people worldwide, irrespective of skin type and age group. the most common pathogens relevant to clinical practice can be subdivided into four groups: dermatophytes, yeasts, moulds and gram positive bacteria. the chief symptoms experienced by patients with superficial microbic infections are itching, burning and redness. Intendis markets products for superficial fungal infections of the hands, the interdigital spaces of the feet and in the inguinal region and the skin of the genital regions. another indication is the initial or interim treatment of those superficial fungal infections that are accompanied by highly inflammatory or eczematous skin changes.

About Isoconazole nitrate at EADV 2011

PO158 – Bacteriostatic and bactericidal effects of isoconazole nitrate

V. Czaika, J. Siebenbrock, M. Friedrich, F. Czekalla, B. N??lein, M. Sieber (Berlin, Germany)

the results of this in vitro study shows that Isoconazole nitrate has antibacterial activity against a broader range of gram-positive bacteria than previously known.

PO182 – Analysis of penetration and storage of Isoconazole nitrate in the stratum corneum and the hair follicles after regular application of anti-mycotic drug

J. Lademann, A. Patzelt, S. Schanzer, H. Richter, G. Thiede, B. Havlickova, C. Guenther, M. Friedrich, S. Seifert, J.W. Fluhr (Berlin, Germany)

the in vivo study demonstrates that hair follicles represent excellent long-term reservoirs for topically applied Isoconazole nitrate which is of clinical importance where a long-lasting therapeutic effect beyond the application time is required, e.g. for prevention of re-infection.

PO1357 – Isoconazole nitrate versus isoconazole nitrate and diflucortolone valerate in the treatment of tinea inguinalis: Results of a multicentre retrospective study

S. Veraldi, M.C. Persico, R. Schianchi (Milan, Italy)

this clinical study in patients with tinea inguinalis demonstrates that the use of a combination therapy of an antimycotic and corticoid leads to a significantly faster relief of inflammation including faster relief of pruritus compared to monotherapy with a pure antimycotic.

Travocort contains 1% diflurcortolone valerate and 0.1% isoconazole nitrate in a cream with good emollient properties. Isoconazole nitrate, the antifungal component of Travocort?, belongs to the N-substituted imidazole class of antimycotic agents. Isoconazole nitrate has a broad fungistatic and fungicide activity and is active against gram positive bacteria. the efficacy of isoconazole nitrate in the treatment of dermatomycoses has been shown in a series of three controlled, multi-centre studies, with cure rates of 90-94%. Diflurcortolone valerate, the second active ingredient of Travocort is a class III-corticosteroid with demonstrated rapid onset of action and safety. Its anti-inflammatory effect is of particular benefit in counteracting the pruritus commonly experienced by patients with superficial microbic infections.(3) the product is marketed in 70 countries over the world.

Intendis is an integrated pharmaceutical business with its headquarters in Berlin, Germany. it has annual sales of EUR 300 million (2010). Intendis is part of Bayer HealthCare and completely dedicated to dermatology. the company focuses on the development, manufacturing and marketing of high quality, innovative topical therapies, targeted to treat skin disorders. the current product portfolio comprises treatments of eczematous disorders including atopic dermatitis, psoriasis, acne, rosacea, hemorrhoidal disease and fungal skin infections (mycoses). Find out more at .

About Bayer HealthCare

the Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. the company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at

bayerhealthcare.com

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Forward-Looking Statements

this release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . the company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

(1) PO158 – Bacteriostatic and bactericidal effects of isoconazole nitrate, V. Czaika, J. Siebenbrock, M. Friedrich, F. Czekalla, B. N??lein, M. Sieber (Berlin, Germany)

(3) Schropl, F.; Travocort/Travogen cream. Multicentre clinical study. Travocort/Travogen Workshop, Experta Medica 1980 Amsterdam.

Holly Widdowfield can laugh now. And she does so freely, while she leans back on a lounge chair in a dim room that can only be described as otherworldly.

The floors, walls and steeple-shaped window frames are all covered in a blizzard of three tons of white Dead Sea salt. The air is filtered outside and cleansed every 45 minutes, kept between 40 and 60 percent humidity and infused with tiny particles of crushed up salt.

It’s the Salt Spa Colorado in Boulder, the only dry aerosol therapy facility in the state and one of fewer than a dozen in the nation.

The premise is simple: Inhale the salt particles, and you’ll breathe better.

Advocates say this nearly century-old therapy is backed by research, Eastern and Western medical principles and an almost innate common sense. we spray saline in our noses and eyes, and we gargle salt water when we have a sore throat. Hospitals use saline drips. And think about how it feels to breathe ocean water. for advocates, a salt spa — even if the room does look like a mystical scene from a C.S. Lewis book — is an obvious and logical treatment.

Still, more traditional medical professionals don’t recommend it, noting there is no credible scientific evidence that it works. Skeptics chalk up anecdotes, like Widdowfield’s, to another point for the placebo effect.

Earlier this year, whenever 65-year-old Widdowfield would laugh, her lungs would crash into an unstoppable coughing fit. It might seem small, but that’s the worst part of having Chronic Obstructive Pulmonary Disease from a lifetime of smoking, says the Boulder County resident.

“I couldn’t laugh,” she says. “And I like to laugh.”

Today is Widdowfield’s 24th visit since April. It took a few sessions for her to start feeling a change in her breathing, but today, she says the air gets so much deeper into her lungs.

She sits in one of eight chairs in one of two salt rooms, across from Mari Anne Kacy, who drives to Boulder’s salt spa twice a week from Fort Collins.

Kacy has suffered with severe asthma for 45 years and tried “every medicine known to mankind,” to no avail, she says. She says she was willing to try anything, and halotherapy made sense to her.

After three sessions, she didn’t feel any noticeable difference. but then she hit rock bottom. She was hospitalized and doctors put her on an oxygen tank 24/7. then, at her next salt spa session, she says something happened.

“I came in here, sat for 15 minutes and shut my oxygen off. I couldn’t believe I could sit here and not use oxygen. Something is working. Something is right,” Kacy says. “Today, I’m oxygen free.”

Nita Desai, the salt spa’s co-owner — who is a western family physician, as well as holistic medical doctor and certified Ayurvedic practitioner — says those kind of results are common.

In fact, she says, one study of halotherapy found that close to 80 percent of patients experienced reduced or no symptoms after 14 to 24 treatments. These people didn’t need any additional therapy for a six-month average.

In other words, Desai says, many people “can do 14 treatments and go six months without another asthma attack.”

How it works

The trick? The salt is slightly negatively charged, and mucus membranes are positively charged. The negative molecules stick to the positive, or the salt affixes to the mucus, drawing out the water and liquefying the mucus, so the body can expel it, according to Allen Tawa, co-owner of the salt spa.

Advocates say salt has an anti-inflammatory effect on mucus, increasing ciliary activity to help liquefy and bring up mucus in your airways. It claims to clear pollens, viruses, pollutants and toxins out of the lungs, sinuses and nasal passageways.

Advocates claim it can help people with asthma, allergies, respiratory irritations and inflammations, bronchitis, cystic fibrosis, chronic cough, sore throat, congestion or a runny nose, snoring, tonsillitis, chronic rhinitis, skin conditions (eczema, psoriasis, acne) and children with ear infections, as well as prevent illnesses, reduce stress and anxiety and regulate sleep patterns.

An added bonus, Tawa says, is the negatively charged atmosphere has a calming effect on the nerves and body (like the salty beach air, but 10 times as concentrated), and it filters out pollens and irritating particles in the air. Some air filters use this “negative ion technology.”

Plus, Tawa says, salt is antibacterial, antiviral and anti-inflammatory.

The real player is the “halogenerator” machine, which grinds salt to one tenths of a micron in size — small enough to penetrate into the lowest depths of the lungs, Tawa says. The salt on the ground and walls only plays a 5 percent role in the treatment, but it helps create that negatively charged environment, he says.

In a sense, Desai says, a salt spa is like you are sitting in a Neti Pot, which flushes out the nasal cavities with saline water.

But she says it won’t affect your blood pressure; after one hour in the salt room, you only consume as much salt as one potato chip.

The idea came from salt caves in Eastern Europe. Salt miners weren’t suffering respiratory and pulmonary problems, and people began investigating the connection between salt and health. this led to “speleotherapy,” or cave therapy. Patients descend into salt caves for several hours daily for several weeks.

Boulder’s center opened about a year and a half ago. but halotherapy has now been used in Eastern Europe and Russia for more than a decade.

In fact, most of its research comes from Eastern Europe. Desai cites more than 200 articles on the topic by the head of the Clinical Research Respiratory Center in St. Petersburg, Russia.

In 2006, the new England Journal of Medicine published an article showing how hypertonic saline (extra-salty, sterile water) had a positive impact on the lung function in cystic fibrosis patients. The patients also had fewer lung infections. The study was funded by the Cystic Fibrosis Foundation.

But still, critics say, there are no clinical studies in the United States.

And the Salt Spa Colorado doesn’t advertise as a “medical treatment.”

National Jewish Health, the nation’s top respiratory hospital, does not recommend salt spas for patients, says William Allstetter, the director of media and external relations.

He says the only published studied he’s aware of are three small ones from “obscure Russian medical journals.”

“We could not possibly ask our patients to inhale a potentially irritating substance based on such meager evidence,” Allstetter says, adding that National Jewish has no plans to study halotherapy or begin offering it in the future.

That isn’t stopping as many as 170 patients who visit the Salt Spa Colorado every week during the winter cold season. And Kacy, the asthma patient, doesn’t plan on cutting back her lengthy drives to sit in the salt chamber. Regular sessions last 45 minutes, and sometimes Kacy spends two to three sessions back-to-back.

She says she’s excited for her upcoming doctor’s visit to see how her lungs have improved and hopefully cut back on medicine.

“I think I will absolutely be able to cut it down. I don’t think I need it at all anymore. like now,” she pauses to take a deep breath and smiles. “I’ll just be sitting here and suddenly take this deep breath and think, whoa, I didn’t know I could breathe that deeply.”