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Provectus Biopharmaceuticals Protocol for Phase 2 Study of Mechanism of Action of PH-10 on Immunologic Makers of …

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KNOXVILLE, Tenn.--(BUSINESS WIRE)--Headline and subhead of release should reference "Markers" instead of "Makers."

The corrected release reads:

PROVECTUS BIOPHARMACEUTICALS PROTOCOL FOR PHASE 2 STUDY OF MECHANISM OF ACTION OF PH-10 ON IMMUNOLOGIC MARKERS OF PSORIASIS NOW AVAILABLE ONLINE

Study Will Assess Effects Of PH-10 On Immunologic Markers of Psoriasis

Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company ("Provectus"), announced today that the protocol for its phase 2 study of the mechanism of action of PH-10 in psoriasis is now available on ClinicalTrials.gov, Identifier NCT02322086: https://www.clinicaltrials.gov/ct2/show/NCT02322086.

The protocol states that the multicenter study is designed to assess treated psoriatic plaque for changes in immunologic, structural and hyperproliferative state and for any evidence of cellular atypia when treated with PH-10 and to correlate observed changes in the skin with clinical response to treatment. These assessments are expected to advance the understanding of the mechanism of action of PH-10 in psoriasis and other inflammatory dermatoses, such as atopic dermatitis, and further substantiate the safety profile of the agent.

The study will enroll up to 30 subjects with mild to moderate plaque psoriasis. Subjects will apply vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their psoriatic plaques. Biopsies of one plaque will be collected at baseline and immediately after completion of vehicle application and PH-10 application. This will allow data from each subject to serve as an internal control for assessment of clinical and cellular response to PH-10. Biopsy specimens will be assessed for changes in epidermal hyperplasia (i.e., disordered condition of the skin creating thickening and scaling); infiltration with immune cells; and molecular markers of inflammation. Correlation of clinical response to these cellular and molecular changes will be performed at the plaque level using Psoriasis Severity Index (PSI) assessment data.

Safety will be assessed by monitoring the frequency, duration, severity and attribution of clinical adverse events; evaluating changes in laboratory values and vital signs; and by correlation of clinical adverse events with observed histopathologic and immunohistopathologic changes in the skin.

Eric Wachter, PhD, Chief Technology Officer of Provectus, noted, By capturing data at the clinical and cellular level, this study should allow us to establish how PH-10 affects psoriatic plaque and other similar inflammatory diseases of the skin, and to relate the safety profile from earlier studies to such effects. We believe that understanding these effects with this level of detail will allow us to properly position PH-10 within the competitive landscape and should provide crucial safety data to support extended dosing.

Dr. Wachter added, We expect this effort to provide a comparable level of understanding of the effects of PH-10 in diseased skin to the keen insight we have gained through our clinical and nonclinical mechanism studies of PV-10, Provectus novel investigational cancer drug, in melanoma and other cancers. Because there are no good model systems for psoriasis, we believe this study affords a critical opportunity to link the clinical effects we have observed to changes in well established immunologic drivers of the disease.

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Provectus Biopharmaceuticals Protocol for Phase 2 Study of Mechanism of Action of PH-10 on Immunologic Makers of ...

Homeopathic Treatment for Psoriasis | Nucleus Homeopathy | Doctors Talk – Video

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Homeopathic Treatment for Psoriasis | Nucleus Homeopathy | Doctors Talk
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Scalp Psoriasis – New Life Outlook | Psoriasis

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About 50% of psoriasis sufferers experience psoriasis of the scalp, ranging from mild, itching and scattered red spots to thick, burning patches of silvery scales that spread onto the face and neck. The severity of your scalp psoriasis will determine the best course of treatment, and although it can take some time to bring the symptoms under control, many patients are able to manage and even improve their condition in the long run.

Theres no universal treatment for scalp psoriasis, but there are several possible ways to reduce or eradicate the symptoms. Typically, its best to begin with a milder form of treatment, working up to more powerful medications as needed. Here are a few:

Severe cases of scalp psoriasis may not respond to topical treatment or light therapy. These cases will call for a more invasive approach to eradicate the plaques:

Psoriasis on the scalp is generally superficial in nature, but in some cases, the itching, flaking and dryness can lead to more serious problems:

Living with scalp psoriasis can be physically and emotionally challenging, and although its a chronic disease that will call for long-term management, you dont have to deal with constant flare-ups. Work with your doctor and a dermatologist to adapt your treatment plan according to your changing needs and youll very likely be able to keep the symptoms under control.

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Scalp Psoriasis - New Life Outlook | Psoriasis

Is This The Future Of Late-Stage Drug Development?

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On Friday, Novartis Novartisannounced that its anti-IL17A antibody secukinumab (Cosentyx) demonstrated clear superiority over its rival, Stelara ustekinumab from Johnson & Johnson Johnson & Johnson, an antibody against IL-12 and IL-23, in the treatment of psoriasis.

What marks this out as significant is not the potential commercial impact for $NVS, nor the step-change in efficacy this delivers for patients suffering from psoriasis though quite clearly both are true.

Instead, its the commitment prior to approval to test the drug head-to-head against arguably its stiffest competitor. This kind of direct comparison is exactly what the medical profession needs without it, doctors are left with two comparable sets of data from different trial designs and little hope of determining which agent is most suited to the patient in front of them. But the industry has, in the past, been very wary of providing such unequivocal comparative evidence.

Changes, though, are being forced on drug companies. Whereas once upon a time, regulatory approval alone was sufficient to secure meaningful sales, increasingly that is no longer true. Even after the stiff battle with regulators has been won, new product launches today face an arguably even stiffer test: to win over doctors and payers.

While the options for treatment for a particular disease were limited, knowing a drug was safe and effective (the hurdles for regulatory approval) is sufficient to justify use. But almost every large indication today already boasts a slew of approved therapeutics options, all of which are safe and effective. Against such a landscape, it is increasingly obvious that driving significant use requires direct comparison trials such as the CLEAR trial in psoriasis that Novartis reported last week.

Such trial designs are double-edged swords however success will surely drive sales of the new agent, but failure to demonstrate superiority would equally certainly consign the expensively-approved newcomer to the trash can. How many people want to play double or quits with their newly-approved (or, worse still, perhaps, not-yet-approved) blockbuster candidate?

In an industry renowned for its conservative decision-making, its not surprising that owners of newly-launched drugs have tended to test the water first, and only resort to comparative trials if sales are low and slow. With Crestor rosuvastatin, for example, where AstraZeneca AstraZenecawere already selling more than $5billion a year of product, head-to-head comparison with its competitor Lipitor atorvastatin were only contemplated more than five years after approval when the impending loss of patent protection for atorvastatin threatened Crestor sales. Even when those trials failed to demonstrate any material superiority, the established sales were unaffected. That hardly counts as risk-taking.

But $NVS adopted an entirely different strategy with Cosentyx. Comparitor trials were the mainstay of the late-stage development program, rather than an afterthought. First, in 2013, in the FIXTURE study, they demonstrated superiority over an anti-TNF product, Enbrel etanercept from Amgen Amgenin a head-to-head study. With that scalp under their belt, they set their sights on the then newly-approved Stelara ustekinumab. The CLEAR study is the product of that strategy, and with the demonstrated superiority completely vindicates it.

Lets be in no doubt: this brave new world is very much to the advantage of patients and payers. Better comparator data will, in itself, lead to better outcomes and saved dollars.

It may not, however, be universally such good news for the pharmaceutical industry. The biggest drag on capital efficiency in R&D is late risk that is, risk that can only be discharged at the end of the development cycle, when the vast majority of the costs have already been expended. Failure at the end of development, or worse still, in the marketplace, erodes capital returns very quickly. If the industry is forced (by the commercial landscape, rather than by regulators) to do more comparator studies of this type, then more late-stage failures will be the order of the day.

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Is This The Future Of Late-Stage Drug Development?

Novartis AG and Amgen Inc. Take Aim at Johnson & Johnson

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Source: Novartis

Novartis AG and Amgen have both recently reported data from late stage drug trials showing that each of their promising psoriasis drugs bested Johnson & Johnson 's top-selling Stelara. The positive results set the stage for potential FDA approvals that could mean a battle over market share next year.

First out of the gate Psoriasis is a big money indication affecting as many as 125 million people worldwide. In the U.S. alone, as many as 7.5 million people suffer from the condition. As a result, drugs like Stelara post sales of about $2 billion annually. Additionally, billions of dollars more are spent treating psoriasis with other autoimmune drugs every year, including the planet's top selling drug last year, AbbVie 's Humira.

Since the patient population and resulting revenue from the indication is so big, developing new therapies to treat psoriasis has been a major focus of drugmakers like Novartis.

Thanks to positive phase 3 trial results versus Amgen's Enbrel, a leading psoriasis treatment with $1 billion in quarterly sales, Novartis' Cosentyx has already been sent to the FDA for approval. Last month, the FDA's advisory committee gave Cosentyx a universal nod for approval, clearing the way for an FDA decision in January.

Since the FDA usually sides with the advisory committee recommendation, there's a good chance that Cosentyx will get the FDA's official go-ahead. If so, Novartis' recent report that Cosentyx achieved statistically better results than Stelara in clearing at least 90% of symptoms from psoriasis patients provides another powerful marketing message for Novartis' sales team to deliver to doctors.

Fast on its heels Eager to shore up its Enbrel psoriasis market share, Amgen has teamed up with AstraZeneca on brodalumab. During phase 3 trials, brodalumab reduced symptoms by 75% in 85% of patients. Those results outperformed J&J's Stelara, which reduced symptoms by a similar amount in about 69% of patients.

Those results are solid, but more compelling may be the fact that brodalumab achieved total clearance of symptoms in 44.4% of patients taking a 210 mg dose, compared to 21.7% of patients achieving total clearance while taking Stelara.

Now that Amgen has all the data on hand from its brodalumab late stage trials, Amgen will begin discussions with regulators over filing the drug for approval. If those discussions go well, then Amgen could submit the drug to the FDA next year, clearing the way for an FDA decision late next year or early in 2016.

Major shake up Celgene won approval of its autoimmune drug for use in psoriasis patients in September, so existing therapies like J&J's Stelara are already facing competitive threats. However, those threats will increase if the FDA approves Novartis' Cosentyx in January. If regulators eventually approve brodalumab, then there's likely to be significant market share shifts among all the various psoriasis treatments by the end of 2016. Regardless, since Novartis' drug could hit the market in the first quarter, investors that would like exposure to autoimmune drugs may want to focus their attention on its shares, rather than Amgen's.

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Novartis AG and Amgen Inc. Take Aim at Johnson & Johnson

How to treat Psoriasis In Homeopathy | Homeocare International | Doctors Talk – Video

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How to treat Psoriasis In Homeopathy | Homeocare International | Doctors Talk
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Novartis psoriasis drug tops Johnson & Johnson's Stelara in late-stage: Study

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Reuters Dec 12, 2014, 02.22PM IST

(Novartis said its experimental)

ZURICH: Novartis said on Friday its experimental psoriasis drug Cosentyx was better at clearing the rough skin patches associated with the disease than Johnson & Johnson's Stelara.

Results of the late-stage Phase IIIb study involving 679 patients with moderate to severe plaque psoriasis found those taking Cosentyx achieved clear or almost clear skin after 16 weeks of treatment.

On a secondary measure, patients achieved at least a 75 per cent improvement in disease severity at week four.

Plaque psoriasis is a painful and unsightly skin condition which is known to cause itching and scaling and affects approximately 125 million people.

The data follows results last year showing Cosentyx, also known as secukinumab, was superior to Amgen's Embrel in a head-to-head study.

Cosentyx is expected to be the first in a clutch of new treatments for plaque psoriasis which target the inflammation-causing protein interleukin-17 (IL-17) to gain market approval.

European regulators gave the green light to the drug last month, while an advisory panel to the US Food and Drug Administration unanimously recommended the use of the drug.

Other drugmakers working on new treatments include Eli Lilly , AstraZeneca and Amgen.

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Novartis psoriasis drug tops Johnson & Johnson's Stelara in late-stage: Study

How To Permanently Eliminate Psoriasis | Amazing Guide About How To Permanently Eliminate Psoriasis – Video

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How To Permanently Eliminate Psoriasis | Amazing Guide About How To Permanently Eliminate Psoriasis
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How To Permanently Eliminate Psoriasis | Amazing Guide About How To Permanently Eliminate Psoriasis - Video


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