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Category Archives: Psoriasis

Celgene's Psoriasis Drug Eases Symptoms in One Third of Patients

Posted: March 2, 2013 at 3:57 pm

By Dow Jones Business News, March 02, 2013, 11:34:00 AM EDT

By Joseph Walker

Celgene Corp. ( CELG ) said its experimental anti-inflammatory drug Apremilast relieved symptoms in about a third of psoriasis patients during a late-stage study, a data point the firm will use to seek regulatory approval for what it expects could be a drug with annual sales reaching $2 billion.

However, a smaller proportion of patients saw a significant improvement from Apremilast in the late-stage trial than in a previous study, which could dampen hopes for the drug's market potential. Even before the data were announced Saturday, some analysts had expressed skepticism about Celgene's ambitious revenue estimates for the drug, which will compete against generic topical creams and branded drugs from AbbVie Inc. (ABBV) and Amgen Inc. (AMGN).

Celgene is counting on Apremilast to become one of three new blockbusters as it expands its portfolio beyond its core blood-cancer therapies. If approved, the drug would become a new treatment for millions of patients with mild-to-severe psoriasis, an autoimmune skin disease that reddens the skin and causes patches of dead cells and silvery scales to develop on the body.

In data presented at a meeting of the American Academy of Dermatology in Miami, Celgene said 33.1% of patients in the late-stage study had a 75% reduction in their psoriasis, compared to 5.3% of patients who received a placebo. The earlier mid-stage trial showed improvement among 41% of patients, according to the ISI Group, though that study had far fewer patients. Celgene said 58.7% of patients saw their psoriasis symptoms reduced by 50%, compared to 17% of placebo patients.

The late-stage trial showed positive safety data, with about 3.6% of patients experiencing severe adverse events, compared to 3.2% in the placebo group. There were no cases of tuberculosis or lymphoma after 16 weeks of treatment. Celgene said the drug's safety profile could position it well against competing therapies such as Amgen's Enbrel and AbbVie's Humira, which have labels warning of the risk of lymphoma and TB.

"Dermatologists want safety--they don't want long term monitoring of serious side effects for their patients," said Brian Gill, Celgene's vice president of communications.

Despite their safety risks, however, existing drugs such as Enbrel and Humira are generally thought to be more effective than Apremilast, and in 2011 each generated more than $1 billion in world-wide psoriasis sales, according to the ISI Group.

Celgene, which said in January that the late-stage trial had achieved its primary endpoint, will seek regulatory approval from the U.S. Food and Drug Administration in the first half of this year. The new drug application will include data from an additional late-stage Apremilast trial, which will be released before the company files a new drug application with the FDA.

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Celgene drug shown to be effective, safe in psoriasis trial

Posted: at 3:57 pm

(Reuters) - Celgene Corp's experimental drug apremilast proved to be more effective than a dummy pill for psoriasis patients in a late-stage study, clearing the way for the company to file for U.S. regulatory approval in the second half of 2013.

Celgene said 59 percent of patients in the 844-patient trial achieved a 50 percent improvement in symptoms at 16 weeks, using a standard score of the severity and extent of psoriasis, compared with 17 percent of placebo patients. A 75 percent improvement in symptoms was seen in 33 percent of the treatment group and 5 percent of the placebo group.

The Phase 3 trial is the first of two pivotal studies of the drug in patients with psoriasis, a disease in which itchy, painful skin plaques are thought to be caused by an inflammatory response initiated by the body's immune system.

Apremilast is a pill that inhibits an enzyme known as phosphodiesterase 4, or PDE4, and acts to damp down inflammation.

Celgene said previously it planned to file for Food and Drug Administration approval of the drug as a treatment for psoriatic arthritis in the first quarter of this year.

Side effects were consistent with those seen in earlier trials of the drug, with the most common being diarrhea and nausea.

Celgene said no cases of tuberculosis or lymphoma were observed through Week 16, and there was no increase in risk of cardiovascular events or serious opportunistic infection.

"From a physician's perspective, this can definitely be a first-line therapy because of the excellent risk/benefit profile," said Dr. Richard Langley, director of dermatology research at Dalhousie University in Halifax, and one of the study's lead investigators. "I think the patient acceptance of this drug and the physician acceptance is going to be extremely high."

He noted that most psoriasis patients are currently treated with methotrexate, which can cause serious side effects.

Newer biologic drugs used to treat psoriasis, which include Amgen Inc's Enbrel and AbbVie Inc's Humira, can make patients more susceptible to infection, Dr. Langley said.

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Celgene Psoriasis Drug Helped Third of Patients in Study

Posted: at 3:57 pm

Celgene Corp. (CELG), the maker of the cancer drug Revlimid, said its experimental psoriasis medicine helped quell the redness and inflammation associated with the skin disorder in a study.

The drug, apremilast, helped one-third of patients achieve a 75 reduction of symptoms, based on a standard Psoriasis Area and Severity Index measurement. That compared with 5.3 percent of those on placebo with the same score, called PASI-75, Celgene said in a statement as it presents the data at the American Academy of Dermatology meeting in Miami Beach, Florida, today.

Psoriasis is an autoimmune disease that causes red, scaly patches on the skin and affects as many as 7.5 million in the U.S., according to the National Psoriasis Foundation. The market for treatments may approach $10 billion worldwide, according to Mark Schoenebaum, an analyst with ISI Group Inc. in New York. He said investors may have been looking for at least 40 percent of patients reaching the PASI-75 metric.

This would place apremilast slightly less effective than the biologic therapies (e.g., Enbrel, Humira, Stelara) but with a best-in-class safety profile, Schoenebaum wrote in a Feb. 28 research note.

The data presented today were from a study called ESTEEM 1, one of two clinical trials in the third and final phase generally required for regulatory approval. Summit, New Jersey- based Celgene said in January that both ESTEEM 1 and ESTEEM 2, which together included about 1,250 patients, had met their study goals and that it plans to seek regulatory approval for apremilast in psoriasis in the second half of this year.

Celgene also has tested the drug in psoriatic arthritis, another autoimmune condition, and has plans to apply for approval in that indication in the first half of this year. Its also running trials in ankylosing spondylitis, Behcets disease and rheumatoid arthritis. Apremilast may bring in $1.14 billion in revenue in 2017, according to the average of 12 analysts estimates compiled by Bloomberg.

Celgene today also reported that 59 percent of patients achieved a 50 percent reduction in symptoms, compared with 17 percent of those taking a placebo. The drug was generally well tolerated, with a 3.6 percent of patients on apremilast and 3.2 percent on placebo reporting severe side effects, Celgene said.

Apremilast is an oral drug that inhibits an enzyme called PDE4 thats associated with inflammation, according to Celgene. Other drugs such as Amgen Inc. (AMGN) and Pfizer Inc. (PFE)s Enbrel and AbbVie Inc. (ABBV)s Humira, which target the inflammatory protein TNF, and Johnson & Johnson (JNJ)s Stelara, which suppresses IL-12 and IL-23, are given by injection.

To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Celgene Psoriasis Drug Helped Third of Patients in Study

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Research and Markets: Plaque Psoriasis (Psoriasis Vulgaris) – Pipeline Review, H2 2012

Posted: at 3:57 pm

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/24x56x/plaque_psoriasis) has announced the addition of Global Markets Direct's new report "Plaque Psoriasis (Psoriasis Vulgaris) - Pipeline Review, H2 2012" to their offering.

Global Markets Direct's, 'Plaque Psoriasis (Psoriasis Vulgaris) - Pipeline Review, H2 2012', provides an overview of the Plaque Psoriasis (Psoriasis Vulgaris) therapeutic pipeline. This report provides information on the therapeutic development for Plaque Psoriasis (Psoriasis Vulgaris), complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Plaque Psoriasis (Psoriasis Vulgaris).

Scope

- A snapshot of the global therapeutic scenario for Plaque Psoriasis (Psoriasis Vulgaris).

- A review of the Plaque Psoriasis (Psoriasis Vulgaris) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.

- Coverage of products based on various stages of development ranging from discovery till registration stages.

- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.

- Coverage of the Plaque Psoriasis (Psoriasis Vulgaris) pipeline on the basis of route of administration and molecule type.

- Profiles of late-stage pipeline products featuring sections on product description, mechanism of action and research & development progress.

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Dr Priya Punjabi:- Psoriasis 2010 – Video

Posted: February 26, 2013 at 10:47 pm


Dr Priya Punjabi:- Psoriasis 2010
I created this video with the YouTube Video Editor (www.youtube.com

By: Priya Punjabi

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Dr Priya Punjabi:- Psoriasis 2010 - Video

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www.xtracnow.com | Treat Psoriasis with Xtrac | It’s Your Health Radio with CEO, Dr. Dolev Rafaeli – Video

Posted: February 25, 2013 at 6:54 pm


http://www.xtracnow.com | Treat Psoriasis with Xtrac | It #39;s Your Health Radio with CEO, Dr. Dolev Rafaeli
Photomedex is a global skin health company in 55 countries with 50% of our Operations in the US. Our focus is on two things: First and biggest, Photomedex is a company that treats psoriasis in physician #39;s clinics with our Xtrac laser treatment. Second is Photomedex #39;s consumer lines (including the no!no! hair remover and Neova skincare). Most people don #39;t realize that psoriasis is an auto-immune disease. Photomedex ran a consumer-driven survey to understand the needs of those suffering psoriasis roughly two years ago. About 2 1/2% of the population suffer from Psoriasis. People are able to treat the itchiness, but were not able to find an overall solution. There is a treatment to live clear with Psoriasis: the Xtrac Laser by Photomedex. Photomedex was the first to come out with a device-based solution, the Xtrac Laser, that was the first cleared by the FDA to provide the service and solution to the patient. Exposure to UVB rays slows down or delays the growth of the skin cells that causes Psoriasis, however, an over-exposure to the sun may cause skin damage or skin cancer. The Science behind Xtrac takes the healthy aspects of UVB and focuses it ONLY on the diseased tissue. The Xtrac Laser is not painful and has no side effects. Simply visit a service-providing clinic and walk out 10 minutes later. When someone suffering with Psoriasis finishes the sessions they are able to live clear without pain, discomfort, or other side effects. The Xtrac does not CURE Psoriasis, but ...

By: xtracpsoriasis

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Harry Styles' ex Cara Delevingne models on catwalk with scabby red patches on legs and Tweets about psoriasis problems

Posted: at 6:54 pm

Stunning Cara Delevingne has shocked onlookers by taking to the catwalk with nasty-looking red patches on her legs at Milan Fashion Week.

Cara displayed the marks while modelling for Versace on Friday and it's thought that the 'wounds' are due to skin condition psoriasis, which causes red scaly blotches on the skin.

'Be gone psoriasis, you're no fun!' Cara, 20, Tweeted on Saturday.

She soon had her fans' support though, with one follower re-Tweeting Cara's message and jokingly adding: "As fun as cystitis!"

Psoriasis can be made worse by stress, drinking and smoking.

Model-of-the-moment Cara has fitted a lot of partying into her schedule recently.

Harry Styles' ex, who put in a number of appearances at London Fashion Week last week, was spotted taking a tumble down some stairs on Tuesday following a partying marathon with BFF Rita Ora.

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Harry Styles' ex Cara Delevingne models on catwalk with scabby red patches on legs and Tweets about psoriasis problems

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Cara Delevingne Suffering From Psoriasis As Red Blotches Make Appearance At Milan Fashion Week

Posted: at 6:54 pm

WENN

Cara Delevingne is the model of the moment, having made an impressive run at London Fashion Week with her non-stop partying antics and her super-glamorous appearance on the catwalks for Burberry, Matthew Williamson, Topshop and Mulberry but it's not all as glam as we once thought, as she suffers quite badly from psoriasis.

The young beauty, who has been in Milan for fashion week this weekend, has tweeted about her frustrations, as she wrote: "Be gone psoriasis, you're no fun!", before retweeting a fan's come which said it was "about as much fun as cystitis".

Cara Delevingne Suffering From Psoriasis As Red Blotches Make Appearance At Milan Fashion Week

Cara makes a stunning appearance for Matthew Williamson (Wenn)

Our backstage insider from Burberry has told us that Cara was quite happy to stand there "stark naked" at London Fashion Week, while she was "caked in foundation", all over her body to hide the red blotches.

Over the weekend, the Mail Online published pictures of Cara modelling for Versace in a stunning red gown but were surprised to see the "angry, red blemishes", on the 20-year-old's legs.

Like a trooper, it seems that the psoriasis was left uncovered for her appearance on the catwalk. The skin condition, which has no known cure, causes red scaly patches and can be inflammed by stress, smoking, drinking and other triggers.

Other celebrity suffers include Kim Kardashian, Kris Jenner, LeAnn Rimes, as well as fellow model CariDee English.

Check out the beautiful Cara at work

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Coronado Biosciences Announces Initiation of Investigator-Initiated Study Evaluating TSO in Psoriasis

Posted: at 6:54 pm

BURLINGTON, Mass., Feb. 25, 2013 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc. (CNDO), a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, announced today the initiation of an Investigator-Initiated Study (IIS) evaluating TSO (Trichuris suis ova or CNDO-201) for the treatment of psoriasis. The first site initiated in the multicenter study is the Icahn School of Medicine at Mount Sinai (ISMMS). Dr. Mark G. Lebwohl, Sol and Clara Kest Professor and Chairman of the Department of Dermatology, is the Principal Investigator of the trial at ISMMS.

"We are excited to be working with Mount Sinai and Professor Lebwohl, a renowned thought leader, in our pursuit of potential treatments of diseases for our lead program, TSO, where the hygiene hypothesis and immunology are important for their basic epidemiology," said Dr. Karin Hehenberger, Executive Vice President & Chief Medical Officer of Coronado. "Psoriasis is one of these diseases with critical medical need and we believe the objective nature of the assessment of progression or worsening of this disease lends itself well to this type of pilot trial."

This trial is an open-label study designed to enroll 20 patients with moderate to severe plaque psoriasis. ISMMS is the first of three sites which the company anticipates being involved in this study. Participants will receive eight doses of either TSO 2500 or TSO 7500 orally every other week over a 16-week treatment period. The trial will evaluate the effect of TSO on clinical response of psoriasis. The primary endpoint will be the average improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 16. The goal of the pilot study is to test for early safety and efficacy of TSO at two different doses.

About Psoriasis

Psoriasis (psoriasis vulgaris) is a chronic inflammatory skin disease characterized by red, scaly, raised plaques. The disease process is driven by T-cell infiltration and associated elevation in cytokine levels leading to increased cell division and aberrant differentiation, resulting in the psoriatic phenotype. Plaque psoriasis has a worldwide prevalence of 2-3%, and is a chronic, recurrent skin condition with varying degrees of severity. It is the most common autoimmune disease in the U.S. As many as 7.5 million Americans have psoriasis.

Psoriasis can profoundly impact a patient's quality of life, causing disability of physical and mental functioning comparable to other major medical diseases such as type 2 diabetes, hypertension, myocardial infarction, depression, and arthritis. It is also associated with serious co-morbidities, including psoriatic arthritis, depression, malignancy, metabolic syndrome, cardiovascular morbidity and mortality. While many patients with mild disease are able to control psoriasis symptoms with topical medications alone, patients with moderate to severe disease usually require treatment with systemic agents to achieve good clearance. These systemic agents are usually well tolerated, but can have potentially significant side effects including organ toxicity, infection, malignancy, and teratogenicity that limit their usefulness in the long-term management of psoriasis.

Biologic agents have been a significant advancement in the treatment of moderate to severe psoriasis, but can have limited and/or diminishing efficacy and require administration by subcutaneous injection or intravenous infusion. These agents are still relatively new and long term safety issues (e.g., infection including tuberculosis, malignancies including lymphoma, and demyelinating neurologic events) are not fully understood. Despite all the available treatments, there is still a need for therapies that will provide high continuous efficacy, improved safety, and a more convenient route of administration to maximize compliance and satisfaction with treatment, leading to decreased burden of the disease.

About TSO

TSO (Trichuris suis ova or CNDO-201), the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and pro-inflammatory cytokines. The use of TSO as a therapeutic is based on the "hygiene hypothesis" and numerous animal and human studies. TSO was chosen as the biological agent of choice because it is not a human pathogen, and is spontaneously eliminated from the body within several weeks after dosing.

In February 2012, the company reported positive results from a phase 1 clinical study of TSO in patients with Crohn's disease, where TSO was shown to be safe and well tolerated. The phase 1 trial was a multi-center, sequential dose, dose-escalation, double-blind, placebo-controlled study of 36 patients with Crohn's disease. In August 2012, Coronado initiated TRUST- I (TRichUris Suis ova Trial), a phase 2 clinical trial of TSO in patients with Crohn's disease in the United States, which is expected to be completed in the second half of 2013.

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1home remedies for psoriasis treatment – Video

Posted: February 24, 2013 at 5:44 pm


1home remedies for psoriasis treatment

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