Category Archives: Psoriasis

By RTT News, July 08, 2013, 06:07:00 AM EDT

(RTTNews.com) - Swiss drug maker Novartis AG ( NVS ) Monday announced that a Phase III study of psoriasis drug secukinumab or AIN457 showed that it is superior to Enbrel or etanercept and that it met all primary and secondary endpoints.

The healthcare products major noted that in a head-to-head Phase III psoriasis study, secukinumab was superior to Enbrel in clearing skin. Enbrel is an anti-tumor necrosis factor or anti-TNF therapy.

According to Novartis, Fixture, a pivotal trial for registration, was a randomized, double-blind, double-dummy, placebo controlled, multicenter global study of subcutaneous secukinumab in moderate-to-severe plaque psoriasis involving 1,307 patients.

Fixture trial is the full year investigative eXamination of secukinumab against eTanercept using 2 dosing regimens to determine efficacy in psoriasis. The study was to establish treatment measures and assess the efficacy of secukinumab, including Psoriasis Area and Severity Index 75, or PASI 75 and the Investigator's Global Assessment, a standard tool to assess the clearing of skin after treatment.

The firm noted that in the Fixture study, the observed safety profile of secukinumab was consistent with previously reported results from Phase II studies in moderate-to-severe plaque psoriasis and no new safety concerns were identified.

Tim Wright, Global Head of Development, Novartis Pharmaceuticals stated, "With 40-50% of people living with moderate-to-severe plaque psoriasis dissatisfied with their current therapies, there is clearly an unmet medical need for new therapies that act faster and longer to relieve pain, itching and other symptoms."

The company said regulatory submissions for secukinumab, a therapy targeting IL-17A, are on track for the second half of 2013. Secukinumab is a fully human monoclonal antibody that selectively binds to and neutralizes IL-17A, a key pro-inflammatory cytokine.

The full results from the secukinumab Phase III study are likely to be presented at major medical congresses later this year.

Separately, Novartis said it has signed a development and licensing agreement with Biological E Ltd. or BioE, an Indian biopharmaceutical company, for two vaccines to protect against typhoid and paratyphoid fevers.

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Novartis Says Secukinumab Is Superior To Enbrel In Psoriasis, Meets Endpoints

HAYWARD, Calif., July 8, 2013 (GLOBE NEWSWIRE) -- A natural and innovative formulation of olive polyphenols for the management of inflammation based skin ailments, including Psoriasis, Eczema and other skin disorders affecting consumers around the world, has been recognized as novel by the Australian Patent Office.

Recognizing CreAgri's early efforts in the area of skin conditions that have proven refractory to treatment with immunosuppressive and glucorticoid drugs, the Australian Government has granted the California based nutraceutical leader patent protection for the use of hydroxytyrosl and olive polyphenols in the management of a number of inflammatory skin conditions, including psoriasis, eczema, allergic dermatitis and other similar disorders.

The patent, AU #2006269843 B2, "Vegetation water composition for the treatment of inflammatory skin conditions," is CreAgri's first patent addressing specifically skin disorders that relate to the correct functioning of the immune system, and is its 5th Australian patent.

"We believe in protecting innovation by the Patent system worldwide," affirms Dr. Roberto Crea, PhD., CEO of CreAgri, and inventor of the patent. "Our research of the last several year is finally being recognized as original, innovative and useful to millions of people who are suffering with diseases for which new, natural, safe and inexpensive treatment have yet to be discovered."

Skin diseases affect more than 40 million people in the United States. Psoriasis affects 8-10 million, and 30 million have eczema. Skin conditions can range from mild symptoms to extremely uncomfortable and even life-threatening.1 To these people the only options available until today were expensive and often toxic treatments, while side effects are just a way of life.

Psoriasis, an immune-mediated disease is a life-long condition and currently is treated topically with expensive and often toxic intra-dermal recombinant DNA biologics or with steroids, moisturizers, salicylic acid, anthralin, retinoids, calcipotriene, (a form of vitamin D), and coal tar. Other solutions include oral methotrexate and cyclosporine; PUVA and UVB phototherapy and laser. Each solution has its own downturn. Phototheraphy for example may contribute to skin cancer, while steroids, methotraxate and cyclosporine need a constant monitoring due to their serious side effects2, but above all none of them provides a safe, easily accessible, and non toxic long lasting solution to the problem.

"HIDROX(R), CreAgri's proprietary formulation of olive polyphenols rich in hydroxytyrosl, is the first formulation of its kind for the management of immuno-related and inflammation-based skin disorders," declares Victor Moreno, PhD, CreAgri's Senior Advisor, "For the first time consumers worldwide have an all natural remedy at their fingertips to manage a range of skin diseases originating from chronic inflammation."

"Conditions such as eczema, and psoriasis aren't only a medical emergency but they are also a social scourge"2, declares Paolo Pontoniere, VP of Corporate Communications at CreAgri, "Withdrawn from society because of their physical appearance a generation of never-exposed is moving among us. We see them on the beaches, in our offices, and in our schools, dressed head to toe oblivious to heat or sun. The Australian patent office has now recognized that HIDROX(R), CreAgri's formulation of organic olive polyphenols, may be an innovative solution for the long term management of these problems."

About HIDROX

HIDROX(R) is CREAGRI(R)'s trademarked hydroxytyrosol formulation, a powerful polyphenol scientifically recognized for its anti-inflammatory and anti-oxidant properties and efficacy in heart, skin and joint health. GRAS certified, HIDROX(R) has been subjected to a comprehensive set of clinical, safety and efficacy tests. HIDROX(R) is also covered by the largest number of international patents for applications that include hydroxytyrosol and olive polyphenol.

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CreAgri's HIDROX(R) Receives International Patent for Psoriasis and Other Inflammatory Skin Conditions

FIXTURE trial of more than 1,300 moderate-to-severe plaque psoriasis patients showed superiority of secukinumab (AIN457) to Enbrel(etanercept) All primary and secondary endpoints were met FIXTURE is a pivotal trial for registration; Regulatory submissions for secukinumab (AIN457), a therapy targeting IL-17A, are on track for the second half of 2013

Basel, July 8, 2013 - Novartis announced today top-line results from the head-to-head Phase III psoriasis study which showed the superiority of secukinumab (AIN457) in clearing skin to Enbrel* (etanercept), an anti-tumor necrosis factor (anti-TNF) therapy. In addition, secukinumab (AIN457) met all primary and secondary endpoints.

The FIXTURE trial (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis) was a randomized, double-blind, double-dummy, placebo-controlled, multicenter global study of subcutaneous secukinumab (AIN457) in moderate-to-severe plaque psoriasis involving 1,307 patients. It was designed to demonstrate efficacy after 12 weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long-term efficacy up to 52 weeks. Established treatment measures were used to assess the efficacy of secukinumab (AIN457) including PASI 75 (Psoriasis Area and Severity Index 75) and the Investigator`s Global Assessment (IGA mod 2011), a standard tool to assess the clearing of skin after treatment.

"These results showing that secukinumab (AIN457) is superior to Enbrel, a current standard-of-care therapy, are great news for people living with moderate-to-severe plaque psoriasis," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "With 40-50% of people living with moderate-to-severe plaque psoriasis dissatisfied with their current therapies, there is clearly an unmet medical need for new therapies that act faster and longer to relieve pain, itching and other symptoms."

Full results from the secukinumab (AIN457) Phase III study program, the largest undertaken in moderate-to-severe plaque psoriasis to date, are expected to be presented at major medical congresses later this year.

Secukinumab (AIN457) is the first medicine selectively targeting IL-17A to present Phase III results. IL-17A is a central cytokine (messenger protein) in the development of psoriasis, and is found in high concentration in skin affected by the disease[1]-[3]. Research shows that IL-17A plays a role in driving the body`s autoimmune response in disorders such as moderate-to-severe plaque psoriasis and is a preferred target for investigational therapies[1]-[5].

In the FIXTURE study, the observed safety profile of secukinumab (AIN457) was consistent with previously reported results from Phase II studies in moderate-to-severe plaque psoriasis and no new safety concerns were identified[6],[7].

About plaque psoriasis Approximately 2% of the world`s population, or around 125 million people, are affected by plaque psoriasis[8],[9], with more than one third of these suffering from its moderate-to-severe form[10]. Psoriasis is a chronic disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain[8]. This common and distressing disease is not simply a cosmetic problem - even those with very mild symptoms find their condition affects their everyday lives[11]. Psoriasis is also associated with psychosocial effects and those with more severe disease are at a greater risk of death from comorbid diseases such as heart disease and diabetes[12],[13].

About the secukinumab (AIN457) clinical trial program in psoriasis The robust secukinumab (AIN457) Phase III clinical trial program involved more than 3,300 patients in over 35 countries on five continents. Primary endpoints for four studies related to PASI 75 and IGA (IGA mod 2011) and the fifth study evaluated the proportion of patients who maintained PASI 75 after having achieved PASI 75 after 12 weeks of active treatment. The studies evaluated 150 mg and 300 mg doses of secukinumab (AIN457).

About secukinumab (AIN457) Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes IL-17A, a key pro-inflammatory cytokine[1]-[3]. Proof-of-concept and Phase II studies in moderate-to-severe plaque psoriasis and arthritic conditions (psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis) have suggested that secukinumab (AIN457) may potentially provide a new mechanism of action for the successful treatment of immune-mediated diseases[6],[7],[14]-[16]. The Phase III programs for these potential indications are ongoing. Results are being released this year for moderate-to-severe plaque psoriasis, and in 2014 and beyond for arthritic conditions. Phase II studies are also ongoing in other areas, including multiple sclerosis.

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Novartis announces secukinumab (AIN457) demonstrated superiority to Enbrel® in head-to-head Phase III psoriasis study

MECHELEN, BELGIUM--(Marketwired - Jul 8, 2013) - Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today that it has been awarded a EUR2.4 million TGO (transformational medical research) grant from the Flemish agency for Innovation by Science and Technology (IWT) for psoriasis research and development. The goal of this 4-year project is to bring a novel mode of action compound into the clinic that might lead to a safe and effective treatment for patients suffering from psoriasis.

Psoriasis is a common skin disease with a high impact on well-being and for which options for patient are currently limited. Psoriasis is a chronic disease, affecting approximately 3% of the population. It has no final cure and therefore represents a high burden to quality of life.

Galapagos has discovered a compound series which presents a novel mode of action in psoriasis. This 4-year IWT funded research program will explore the potential application of this compound series in disease models for psoriasis, both in preclinical systems as well as in a clinical setting. After the discovery phase, Galapagos will initiate clinical trials with this innovative, oral compound for psoriasis by using an adaptive trial design, with the aim of achieving an efficiency gain in development costs and timelines. In the clinic, pharmacodynamic assessments will be evaluated in healthy volunteers by mimicking inflammation characteristics in a Proof-of-Mechanism study. Galapagos will collaborate in this project with Professor Dr Jo Lambert at Ghent University.

"We are very pleased with this IWT grant, which really underscores how IWT supports innovation by biotechnology companies. This grant makes it possible to work towards a novel therapy which will hopefully improve the quality of life of psoriasis patients," said Piet Wigerinck, CSO of Galapagos. "Together with GSK2586184, inlicensed by GlaxoSmithKline in 2012, we expect to have two drugs in development for psoriasis within two years."

About Psoriasis

Psoriasis is an immune-mediated disease that affects the skin. It is caused by the immune system being mistakenly triggered, resulting in overproduction of new skin cells. The cause is not fully understood, but it is believed to have a genetic component and certain medications and infections are well-known risk factors. Psoriasis affects approximately 3% of people globally and it can occur at any age, although it most commonly appears for the first time between the ages of 15 and 25 years. There are five types of psoriasis with the most common form being plaque psoriasis, characterized by red patches covered by a silvery white scale appearing on the top first layer of the skin. Psoriasis can also cause inflammation of the joints, which is known as psoriatic arthritis, affecting between 10-30% of all people with psoriasis. Psoriasis is typically a lifelong condition and there is currently no cure, but various treatments can help to control the symptoms. Treating moderate to severe psoriasis usually involves a combination of treatment strategies: topical treatments, light therapy and/or systemic medications, including biologic drugs.

About IWT

The agency for Innovation by Science and Technology (abbreviated as IWT) is the government agency founded in 1991 by the Flemish Government to support technological innovation projects in Flanders. Each year IWT distributes about EUR 300 million in subsidies for innovation projects to companies, organizations, research and educational institutions in Flanders. In addition to financial support, IWT also assists companies by, for instance helping them find the right information or the right partners at home or abroad, providing assistance with the preparation of projects for European programmes and with technology transfer throughout Europe. IWT also has an important coordination mandate aimed at promoting close cooperation among all the actors involved in technological innovation in Flanders. IWT Monitoring&Analysis, M&A for short, monitors innovation and regularly publishes studies. For more information, please visit http://www.iwt.be or call +32 2 209 09 00.

About Galapagos

Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is specialized in novel modes-of-action, with a large pipeline of five clinical, six pre-clinical, and 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.

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Galapagos receives EUR2.4 million IWT grant for psoriasis research

Mechelen, Belgium; 8 July 2013 - Galapagos NV (GLPGF) announced today that it has been awarded a 2.4 million TGO (transformational medical research) grant from the Flemish agency for Innovation by Science and Technology (IWT) for psoriasis research and development. The goal of this 4-year project is to bring a novel mode of action compound into the clinic that might lead to a safe and effective treatment for patients suffering from psoriasis.

Psoriasis is a common skin disease with a high impact on well-being and for which options for patient are currently limited. Psoriasis is a chronic disease, affecting approximately 3% of the population. It has no final cure and therefore represents a high burden to quality of life.

Galapagos has discovered a compound series which presents a novel mode of action in psoriasis. This 4-year IWT funded research program will explore the potential application of this compound series in disease models for psoriasis, both in preclinical systems as well as in a clinical setting. After the discovery phase, Galapagos will initiate clinical trials with this innovative, oral compound for psoriasis by using an adaptive trial design, with the aim of achieving an efficiency gain in development costs and timelines. In the clinic, pharmacodynamic assessments will be evaluated in healthy volunteers by mimicking inflammation characteristics in a Proof-of-Mechanism study. Galapagos will collaborate in this project with Professor Dr Jo Lambert at Ghent University.

"We are very pleased with this IWT grant, which really underscores how IWT supports innovation by biotechnology companies. This grant makes it possible to work towards a novel therapy which will hopefully improve the quality of life of psoriasis patients," said Piet Wigerinck, CSO of Galapagos. "Together with GSK2586184, inlicensed by GlaxoSmithKline in 2012, we expect to have two drugs in development for psoriasis within two years."

About Psoriasis Psoriasis is an immune-mediated disease that affects the skin. It is caused by the immune system being mistakenly triggered, resulting in overproduction of new skin cells. The cause is not fully understood, but it is believed to have a genetic component and certain medications and infections are well-known risk factors. Psoriasis affects approximately 3% of people globally and it can occur at any age, although it most commonly appears for the first time between the ages of 15 and 25 years. There are five types of psoriasis with the most common form being plaque psoriasis, characterized by red patches covered by a silvery white scale appearing on the top first layer of the skin. Psoriasis can also cause inflammation of the joints, which is known as psoriatic arthritis, affecting between 10-30% of all people with psoriasis. Psoriasis is typically a lifelong condition and there is currently no cure, but various treatments can help to control the symptoms. Treating moderate to severe psoriasis usually involves a combination of treatment strategies: topical treatments, light therapy and/or systemic medications, including biologic drugs.

About IWT The agency for Innovation by Science and Technology (abbreviated as IWT) is the government agency founded in 1991 by the Flemish Government to support technological innovation projects in Flanders. Each year IWT distributes about EUR300 million in subsidies for innovation projects to companies, organizations, research and educational institutions in Flanders. In addition to financial support, IWT also assists companies by, for instance helping them find the right information or the right partners at home or abroad, providing assistance with the preparation of projects for European programmes and with technology transfer throughout Europe. IWT also has an important coordination mandate aimed at promoting close cooperation among all the actors involved in technological innovation in Flanders. IWT Monitoring&Analysis, M&A for short, monitors innovation and regularly publishes studies. For more information, please visit http://www.iwt.be or call +32 2 209 09 00.

About Galapagos Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline of five clinical, six pre-clinical, and 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and about to enter Phase 2 studies in Crohn`s disease. AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2B. Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1B patient study in metastasis. GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof of Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and is currently in a First-in-Human Phase 1 study. The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: http://www.glpg.com

Contact

Galapagos NV Dr Piet Wigerinck, Chief Scientific Officer Tel. +32 477 627103

Elizabeth Goodwin, Director Investor Relations Tel: +31 6 2291 6240 ir@glpg.com

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Galapagos receives €2.4 million IWT grant for psoriasis research

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http://Honest-Product-Reviews.org/psoriasis-free-for-life Click The Link To The Left To Claim Your Massive 70% Discount! As many will know through their own suffering or that of a friend,...

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Psoriasis 2013 Congress - Luigi Naldi, Coordinator of the Scientific Programme, Italy
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Psoriasis 2013 Congress - Luigi Naldi, Coordinator of the Scientific Programme, Italy - Video