Tampa dermatologist seeing positive results in plaque psoriasis clinical trial

Tampa dermatologist Dr. Seth Forman is overlooking a clinical trial, in hopes of finding an effective treatment for those who suffer from plaque psoriasis.

The new medication, which is currently unnamed, has produced promising results thus far. Patients have been treated with a topical steroid that is applied to the surface of the skin, with the ability to help alleviate largely affected areas on the body.

Battling plaque psoriasis can be challenging, said the Tampa dermatologist. Our hope is that this medication will help take control of the scaling, thickness and redness of the skin.

According to the National Psoriasis Foundation, plaque psoriasis appears as raised, red patches covered with a silvery white buildup of dead skin cells or scale that is most common on the scalp, knees, elbows and lower back.

The clinical trial being conducted by the Tampa dermatologist began in August and will continue for the next several months until enough research is accrued.

We are very happy with the results weve seen so far, said Dr. Forman. Only through extensive, ongoing research can we give people the option of getting the best medication that is proven to effectively relieve symptoms.

In addition to plaque psoriasis, Dr. Formans office is conducting clinical trials for nail psoriasis and eczema.

Dr. Forman is the founder of Forman Dermatology and Skin institute, located in Tampa, Fla. and has appeared on TV shows across the country, including the nationally syndicated show The Doctors, to provide sun-protection tips and to demonstrate his breakthrough skin cancer treatments.

If interested in being a part of the clinical trial for plaque psoriasis, or for more on Dr. Seth Forman, Tampa dermatology or Forman Dermatology and Skin Cancer Institute, please visit http://www.FormanDerm.com.

About Dr. Seth Forman: Dr. Forman is a board-certified dermatologist practicing in Tampa, Florida. He was voted the Best Dermatologist in Carrollwood the past three years by the Carrollwood News and Tribune. In December 2011, he opened his new Tampa dermatology office, Forman Dermatology and Skin Cancer Institute, where he gives psoriasis sufferers access to the latest treatment options, including topical and oral medications, as well as biological and phototherapy. Dr. Forman is one of the few Tampa dermatologists to offer narrowband light therapy, which uses pharmaceutical grade light to suppress psoriasis. Hes also one of the few board-certified dermatologists in the U.S. to use the SRT-100 radiotherapy to treat basal cell carcinoma, the most common form of skin cancer.

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Tampa dermatologist seeing positive results in plaque psoriasis clinical trial

BUSINESS WIRE: Celgene to Present Long-Term Efficacy and Safety Data on Oral OTEZLA (apremilast) in Plaque Psoriasis …

MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS BERICHTENDE UNTERNEHMEN VERANTWORTLICH.

New analyses of ESTEEM trials evaluate safety, efficacy and tolerability of OTEZLA in patients with moderate to severe plaque psoriasis

Analysis of PALACE 52-week data assesses impact of OTEZLA on signs and symptoms of psoriatic arthritis

11 featured abstracts underscore growing body of evidence and depth of the OTEZLA clinical development program in plaque psoriasis and psoriatic arthritis

OTEZLA recently approved by the U.S. Food and Drug Administration for moderate to severe plaque psoriasis patients who are candidates for phototherapy or systemic therapy

BOUDRY, Switzerland --(BUSINESS WIRE)-- 07.10.2014 --

Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced that the latest research findings on OTEZLA (apremilast), the Companys oral, selective inhibitor of phosphodiesterase 4 (PDE4), in plaque psoriasis and psoriatic arthritis will be presented at the 23rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, October 8 12, 2014. In total, 11 abstracts (two oral presentations and nine e-Posters) will be presented at the meeting.

OTEZLA data to be presented include long-term (52-week) results from Celgenes pivotal trial, ESTEEM 2 and pooled analyses of safety and tolerability results from the ESTEEM 1 and 2 studies in patients with moderate to severe plaque psoriasis. Additional analyses will evaluate the effect of OTEZLA on pruritus (itching), difficult-to-treat areas such as nail and scalp, and palmoplantar (hand and feet) psoriasis, work productivity and improvements in health-related quality of life.

An analysis of long-term results from the PALACE clinical trial program evaluating OTEZLA in patients with active psoriatic arthritis will also be presented at the meeting. The analysis assesses the effect of OTEZLA treatment through 52 weeks on the signs and symptoms of psoriatic arthritis, including enthesitis (inflammation at sites where tendons or ligaments insert into bone) and dactylitis (inflammation of an entire finger or toe) in patients with pre-existing enthesitis or dactylitis.

During the Congress, Celgene will host a variety of programs focusing on the unmet needs for people living with psoriasis and psoriatic arthritis, including a symposium for healthcare professionals and programs for patient/professional advocacy organizations and media.

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BUSINESS WIRE: Celgene to Present Long-Term Efficacy and Safety Data on Oral OTEZLA (apremilast) in Plaque Psoriasis ...

Psoriasis Revolution Review Reveals Dan Crawford's New Psoriasis Cure System

Denver,Colorado (PRWEB) November 29, 2014

The Psoriasis Revolution review published by Daily Gossip reveals that psoriasis actually is a commonly diagnosed disease, in people from all around the globe.

Psoriasis is described as a horrible skin disease, characterized by relapsing immune mediated redness and irritation. Patients dealing with this condition experience pain, as well as skin blotches.

To help all sufferers, Dan Crawford has released the Psoriasis Revolution program. This new program is available in a 250 page guide, revealing an effective psoriasis natural cure.

In fact, Dan had actually been a psoriasis patient himself, dealing with this condition for years. He managed to cure his disease with the use of his natural program, so Dan shared it with sufferers from all over the world.

Read the full complete review here: http://www.dailygossip.org/psoriasis-revolution-review-does-it-work-8865

The Psoriasis Revolution guide presents a holistic system that promises to help patients eliminate psoriasis in 30 to 60 days, while regaining natural internal balance. The author of this program reveals a 7 step method to stop psoriasis forever.

The method also promises to help sufferers achieve relief from all the common symptoms of psoriasis. This includes red and inflamed itchy skin, but also burning or bleeding, which will be gone in just 7 days.

Daily Gossip reveals in its Psoriasis Revolution review that the program developed by Dan is unique, as it actually focuses on fixing the root cause of psoriasis, to make sure that the disease will be overcome for good.

Learn more about this new system by using the following link: http://www.dailygossip.org/psoriasis-revolution-full-review-8864

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Psoriasis Revolution Review Reveals Dan Crawford's New Psoriasis Cure System

AstraZeneca/Amgen's Brodalumab Excels in Psoriasis Study – Analyst Blog

AstraZeneca ( AZN ) and partner Amgen ( AMGN ) announced encouraging results from the pivotal, multi-arm phase III AMAGINE-2 study (n>1800) on their psoriasis candidate, brodalumab. The study compared brodalumab with both Johnson & Johnson's ( JNJ ) Stelara and placebo in treating patients suffering from moderate-to-severe plaque psoriasis.

Results showed that a greater proportion of patients treated with brodalumab 210 mg (44.4%), brodalumab weight based group (33.6%) and brodalumab 140 mg (25.7%) achieved total clearance of skin disease as measured by the Psoriasis Area Severity Index (PASI 100). In comparison, patients under Stelara achieved 21.7% and under placebo a mere 0.6%.

Moreover, according to the PASI 75 score (at least a 75% improvement in disease severity), results showed that a higher number of patients on brodalumab 210 mg (86.3%) and the brodalumab weight based group (77%) achieved the same as compared to those on brodalumab 140 mg (66.6%), Stelara (70%) and placebo (8.1%). The other key secondary endpoints of the study were also met.

We note that the companies' AMAGINE program consists of three phase III studies - AMAGINE-1, AMAGINE-2 and AMAGINE-3. While results from the AMAGINE-1 study were out in May this year, AstraZeneca and Amgen announced encouraging results from the AMAGINE-3 study earlier in the month (read more: AstraZeneca/Amgen's Brodalumab Positive in Psoriasis Trial ).

With results from all the three studies out, the companies are now planning to discuss with regulatory authorities the global filing plan for the candidate which is expected next year.

Our Take

We are encouraged by the positive results from the AMAGINE program on brodalumab. Brodalumab is an important candidate for both AstraZeneca and Amgen. However, the psoriasis market currently looks extremely crowded with the presence of products like Stelara, Enbrel and Otezla.

Brodalumab is also being developed for the treatment of asthma. According to AstraZeneca, analyst estimates for brodalumab range between $0.5 billion and $1.5 billion.

Amgen and AstraZeneca are both Zacks Rank #3 (Hold) stocks. A better-ranked stock in the health care sector is Allergan Inc. ( AGN ) carrying a Zacks Rank #1 (Strong Buy).

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AstraZeneca/Amgen's Brodalumab Excels in Psoriasis Study - Analyst Blog

Psoriasis Drug Trial Meets Goals, Reimbursement Rate For Cologuard Finalized

Amgen Inc. (AMGN: Quote) and AstraZeneca plc's (AZN: Quote) phase III trial of psoriasis drug candidate Brodalumab has met its primary endpoint of achieving total clearance of skin disease when compared with placebo as well as Janssen Biotech Inc.'s approved drug Stelara.

The trial, dubbed AMAGINE-2, is the third and final pivotal study in the companies' phase III psoriasis program. Brodalumab is being co-developed by Amgen and AstraZeneca.

Top-line results from AMAGINE-1, comparing Brodalumab with placebo, were released in May 2014 while top-line results from AMAGINE-3, comparing Brodalumab with Stelara and placebo, were announced as recently as November 11, 2014.

The trials AMAGINE-2 and AMAGINE-3 are identical in design.

AMGN closed Tuesday's trading at $162.24, down 1.18%.

Exact Sciences Corp.'s (EXAS: Quote) Cologuard will be reimbursed at $502 per test, according to the final payment decision issued by the Centers for Medicare & Medicaid Services.

Cologuard is the first and only FDA-approved noninvasive stool DNA colorectal cancer screening test.

EXAS closed Tuesday's trading at $24.90, up 2.55%.

Intra-Cellular Therapies Inc. (ITCI: Quote) has enrolled the first patient in its phase III trial of ITI-007 for the treatment of schizophrenia.

The trial, dubbed ITI-007-301, is designed to enroll over 400 patients with an acutely exacerbated episode of schizophrenia who will be randomized to receive one of three treatments namely, 60 mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio. Top-line results from this trial could be available as early as the fourth quarter of 2015.

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Psoriasis Drug Trial Meets Goals, Reimbursement Rate For Cologuard Finalized

Celgene gets positive CHMP opinion for OTEZLA to treat psoriasis and psoriatic arthritis

Published 25 November 2014

Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA (apremilast), the Company's oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:

Psoriasis is an immune mediated skin condition characterised by raised scaly lesions on the skin. It affects approximately 14 million people across Europe and about 125 million people worldwide.

Plaque psoriasis, also called psoriasis vulgaris, is the most common form of the disease, representing about 80 percent of cases. Up to 30 percent of people with psoriasis may develop psoriatic arthritis, which involves pain and swelling in jointsand other manifestations and may lead to significant disability.

"This CHMP positive opinion is an important step forward for people with psoriasis and psoriatic arthritis in Europe. These immune mediated diseases are frequently debilitating and cause severe physical and emotional pain to the individual," stated Tuomo Ptsi, President, Celgene Europe, the Middle East and Africa (EMEA).

"We are proud to have moved one step closer to offering patients OTEZLA, a new, oral treatment approach that could significantly help control their symptoms and make a considerable difference to their quality of life."

In the ESTEEM studies, which form the basis of CHMP's positive opinion for apremilast in psoriasis, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 (a 75 percent improvement in the Psoriasis Area Severity Index) scores at week 16, the primary endpoint.

Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch, known to have a marked impact on patients' quality of life and perception of disease severity.

In the PALACE program, which forms the basis for CHMP's positive opinion for apremilast in psoriatic arthritis, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20 percent improvement in the American College of Rheumatology disease activity criteria) response at 16 weeks, the primary endpoint.

Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, as well as dactylitis, enthesitis and overall physical function.

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Celgene gets positive CHMP opinion for OTEZLA to treat psoriasis and psoriatic arthritis

Novartis' Psoriasis Drug Cosentyx Backed for EU Approval – Analyst Blog

Novartis AG ( NVS ) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion on the approval of Cosentyx (secukinumab, formerly known as AIN457). Cosentyx is the first IL-17A inhibitor to be recommended as a first-line treatment option for psoriasis patients who require systemic therapy in Europe.

Cosentyx works by inhibiting IL-17A, a protein that is found in high concentrations in skin affected by the disease.

The CHMP's favorable opinion comes shortly after Cosentyx received a unanimous recommendation from the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) last month -- a final decision from the FDA should be out in early 2015. The favorable opinion of the CHMP will now be reviewed by the European Commission with a final decision expected in the next couple of months.

With the CHMP in favor of approving Cosentyx, we believe chances of approval are high. Once approved, Cosentyx will be entering an extremely crowded psoriasis market given the presence of products like Stelara, Enbrel and Otezla.

Moreover, new treatments are currently in development including Amgen ( AMGN )/AstraZeneca's ( AZN ) brodalumab.

However, with Cosentyx consistently demonstrating very high skin clearance, including superiority to Enbrel in the head-to-head FIXTURE study, and given the high rate of dissatisfaction among patients regarding existing treatment options, Cosentyx could rapidly gain share once approved.

Meanwhile, Novartis is evaluating Cosentyx for several other indications including ankylosing spondylitis and psoriatic arthritis among others.

Novartis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Allergan Inc. ( AGN ) carrying a Zacks Rank #1 (Strong Buy).

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Novartis' Psoriasis Drug Cosentyx Backed for EU Approval - Analyst Blog

Homeopathic Treatment for Psoriasis Types, Symptoms, Medicines | Doctors Talk – Video


Homeopathic Treatment for Psoriasis Types, Symptoms, Medicines | Doctors Talk
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Ayurvedic Treatment for Psoriasis and Fungal Infections | Auyshman Bhava – Video


Ayurvedic Treatment for Psoriasis and Fungal Infections | Auyshman Bhava
Ayushman Bhava is an exclusive Program by CVR Health TV in which Ayurvedic Specialists and Doctors give solutions to the health problems. Watch CVR Health, the 24/7 health channel with doctors...

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Living with Psoriasis is more than skin deep

Living with Psoriasis is more than skin deep

New online psoriasis resource launched following research findings

29 October 2014 - Living with psoriasis can affect many aspects of your daily life including your overall physiological and emotional health1. To coincide with World Psoriasis Day (29 October) and help people understand and manage their condition more effectively, a new educational website, mypsoriais.co.nz has been launched by AbbVie.

In New Zealand there has been a real need for information specifically for Kiwis, as a survey* by AbbVie revealed many New Zealanders (57% of survey participants) have never accessed any type of online psoriasis support.2 mypsoriasis.co.nz specifically addresses this need by providing a range of support materials including a useful My Journey tab to help patients map their psoriasis journey and learn some of what they can expect as part of living with psoriasis in New Zealand.

Psoriasis is a relatively common autoimmune disease that affects one in 50 New Zealand adults. It is caused by over-activity of the immune system in the skin. It most frequently develops in young adults and continues throughout their life. The most common form of psoriasis causes raised, inflamed, scaly, red skin lesions, known as plaques.1

Dermatologist Dr Steven Lamb says World Psoriasis Day is a really important event in helping raise awareness of an often overlooked condition.

World Psoriasis Day provides a good opportunity to educate the public about psoriasis and highlights what its like living with the condition. It also helps those living with psoriasis realise that there are effective treatments and that they don't have to put up with the symptoms and psychological effects that come with having psoriasis.

The online quantitative survey completed by 492 New Zealanders also found there was a lack of available information on the likely prognosis and implications of psoriasis at diagnosis, with nearly half of survey respondents (49%) indicating that they did not feel they were given sufficient information about the condition and what their diagnosis meant for them.2

Feedback such as this from patients and a lack of awareness in the community about psoriasis were the driving forces behind creating the educational website.

We have a greater understanding now of the psychological and social effects of psoriasis on the individual patients who live with the condition having significant impaired quality of life. Patients have social isolation issues, difficulty maintaining relationships, avoidance of social situations and higher rates of stress and anxiety.

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Living with Psoriasis is more than skin deep

Novartis Wins European Backing for Psoriasis Drug Cosentyx

Novartis AG (NOVN) won European backing for a treatment against psoriasis that will compete with Amgen Inc.s Enbrel and may garner more than $1 billion in annual sales.

Novartiss secukinumab, which the company plans to sell under the brand name Cosentyx, was recommended by the European Medicine Agencys Committee for Medicinal Products for Human Use, for the treatment of moderate-to-severe plaque psoriasis in adult patients, the Basel, Switzerland-based drugmaker said in a statement today. The European Commission, the EUs executive arm, usually follows the panels advice.

The drug is the first in a class of therapies called interleukin-17A inhibitors to be recommended as a first-line treatment for the skin disease, a malady that afflicts more than 125 million people globally. Cosentyx may earn Novartis $1.1 billion in sales in 2020, according to the average of six analyst estimates compiled by Bloomberg.

In a study, the drug cleared the skin of patients better than Amgens Enbrel, the $4.6 billion-a-year drug that is considered the standard of care. Novartis is also awaiting approval for the drug in the U.S. after a panel of advisers to the Food and Drug Administration voted unanimously last month that secukinumab should be approved by the agency.

To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Robert Valpuesta, David Risser

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Novartis Wins European Backing for Psoriasis Drug Cosentyx

10 Tips to Manage Psoriasis and Eczema this Winter

Roslyn Heights, NY (PRWEB) November 19, 2014

A shocking number of Americans have psoriasis and eczema39 million adults and childrenwhich is more than four times the population of New York City, the largest city in the US. According to dermatology specialists Dr. Joshua Fox and Dr. Robert Levine with Advanced Dermatology, PC, the seasonal change to cold, dry air creates difficulties for people dealing with these chronic skin disorders.

It is important to manage symptoms, says Dr. Fox, who has served on the board of the National Psoriasis Foundation. Psoriasis and eczema can be painful. They can make everyday actions uncomfortable for adults and children, men and women, and they carry a stigma that can lead to a loss of self-esteem, depression, and other health complications.

Symptoms Psoriasis appears on the skin as red or white, scaly patches that often itch and bleed. The patches can also look scaly or silvery in color. Nails can become yellow, ridged and separate from the nail bed. Up to 30 percent of people with the disease develop psoriatic arthritis, and recent studies indicate that patients with moderate to severe disease are also at increased risk for other associated health conditions, including heart disease, heart attack, diabetes, high blood pressure, obesity, depression and hypertension.

Eczema, a hypersensitivity disease, inflames the skin, causing pain, itching, dryness, swelling, cracking, weeping and scaling. Eczema lesions can bubble, ooze, and crust over if scratched. Skin infections can occur if bacteria invade the skin lesions.

Diagnosis Once patients understand their psoriasis or eczema is not contagious, they seem to be relieved, says Dr. Fox. They are comforted to know there is help for their symptoms.

Psoraisis is an autoimmune disease apparently cause by an overactive immune system that overproduces skin cells. Eczema, on the other hand, is caused by a deficient immune system in which an imbalance of skin proteins creates skin sensitivities. This is a significant distinction because it informs treatment, explains Dr. Fox. A dermatologist will diagnose the condition and provide the most effective care for individual patients.

Psoriasis treatments:

Eczema treatments:

Dr. Foxs and Dr. Levines tips for managing psoriasis and eczema throughout the winter

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10 Tips to Manage Psoriasis and Eczema this Winter

Amgen, AstraZeneca Report Phase 3 Brodalumab Meets Endpoints In Psoriasis

By Cyndi Root

Amgen and AstraZeneca report that a Phase 3 trial of brodalumab has met its primary endpoint and all secondary endpoints in the treatment of moderate-to-severe plaque psoriasis. The two companies announced the results in a press release, stating that the AMAGINE-3 study compared brodalumab to Stelara (ustekinumab) and placebo. Amgen and AstraZeneca are conducting studies of five of Amgens monoclonal antibodies, including brodalumab, under a collaboration agreement initiated in April 2012.

Sean E. Harper, M.D., executive VP of Research and Development at Amgen, said, These results are of particular importance as they are the first to demonstrate superiority to Stelara in achieving total skin clearance, and the second positive pivotal Phase 3 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis."

Brodalumab

Brodalumab (AMG 827) is a human monoclonal antibody that dampens inflammatory signals by blocking IL-17 ligand binding to the receptor. Influencing the IL-17 pathway and stopping IL-17 ligand binding reduces inflammatory signals, thereby reducing psoriasis. Amgen is also investigating brodalumab for psoriatic arthritis in Phase 3 trials and in Phase 2 asthma trials.

Brodalumab Study

The AMAGINE-3 study compared two doses of brodalumab to Stelara and a placebo in 1,800 patients with moderate-to-severe plaque psoriasis. The study showed that brodalumab was superior to Stelara in achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index, thereby meeting the trials primary endpoint. Compared to the placebo, brodalumab patients achieved at least a 75 percent improvement from baseline in disease severity at week 12 and clear or almost clear skin. The 210 mg brodalumab group fared better than the 140 mg group, as 36.7 percent achieved skin clearance compared to 27 percent. Both the 210 and 140 mg brodalumab doses proved superior to Stelara patients, as only 18.5 percent achieved skin clearance.

Dr. Harper said, "Despite a variety of treatment options available for psoriasis, many patients still do not meet skin clearance goals. Amgen and AstraZeneca state that they will share results later in the year on the AMAGINE-2 trial evaluating brodalumab versus Stelara.

Stelara

Stelara is a Johnson & Johnson Drug, manufactured by J & Js subsidiary Centocor Ortho Biotech of Horsham, PA. The Food and Drug Administration (FDA) approved Stelara (ustekinumab) in 2009 for moderate to severe psoriasis. Stelara is a monoclonal antibody, a biological treatment that mimics the bodys antibodies and blocks two proteins that cause inflammation.

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Amgen, AstraZeneca Report Phase 3 Brodalumab Meets Endpoints In Psoriasis