Leo Pharma, a global leader in dermatology preparations, has rolled out a first-of-its-kind support programme for psoriasis patients in the region starting next month.

Leo Pharma, makers of a new once-daily gel formulation for the treatment of scalp psoriasis, said that its programme MOMENT will be run across the UAE and the Gulf in partnership with psychologists and dermatologists.

“There are a sizeable number of psoriasis patients across the UAE and the Gulf region and MOMENT will address them on an emotional scale, a very imperative need considering the psychological impact of this skin disease on a person,” said Hisham Omar, general manager, Gulf Region, Iran, Yemen & Turkey, Leo Pharma.

“We believe that MOMENT is perhaps a first-of-its-kind support programme for psoriasis patients in the Gulf since such endeavours are largely unknown and are far and few in the region, he said, adding that the support programme had been running in other countries in the world and some parts of the Mena successfully.”

“Psoriasis being a life-long disease, national support groups play a very important role in engaging the patients on a psychological plane helping them manage their life on a day-to-day basis,” said Dr Hussain Abdel Dayem, consultant dermatologist at Al Noor Hospital, Abu Dhabi.

He said currently there are no national support groups for psoriasis patients in the UAE or the Gulf region.

“It is estimated that some 2.8 per cent of the UAE’s population has psoriasis affliction and support groups are a dire necessity. Psoriasis affects all ages and mostly among middle aged people, but we have even seen it among kids,” Dr Dayem said.

I'm saying nothing: https://psoriasisclub.org/showthread.php?tid=513

Detailed Results:
In this study, treatment with brodalumab every other week resulted in mean improvements in PASI scores of 85.9 percent (140 mg), 86.3 percent (210 mg) and 45.0 percent (70 mg) versus 16.0 percent with placebo (all p<0.001). A monthly dose of brodalumab at 280 mg was associated with a mean PASI improvement of 76 percent. Approximately 30 percent of patients in the placebo group had worsening psoriasis.

The study also evaluated secondary endpoints including PASI 75, PASI 90 and PASI 100, which indicate 75 percent, 90 percent and 100 percent reductions in patient PASI scores from baseline, respectively. In patients dosed with 140 mg of brodalumab, 77 percent achieved a 75 percent reduction in their PASI score, 72 percent achieved a 90 percent reduction and 38 percent experienced total clearance (PASI 100) (all p<0.001). In patients dosed with 210 mg of brodalumab, 82 percent achieved a 75 percent reduction, 75 percent achieved a 90 percent reduction and 62 percent experienced total clearance (PASI 100) (all p<0.001). 

The most commonly reported adverse events in the combined brodalumab groups were common cold (eight percent), upper respiratory tract infection (eight percent) and injection site redness (six percent). Two cases of grade three neutropenia were reported in the 210 mg brodalumab group.

Study Design:
The study was a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging trial designed to assess the efficacy and safety of brodalumab in moderate to severe plaque psoriasis. Patients with a PASI >12 and affected body surface area >10 percent were randomized to receive brodalumab (70, 140 or 210 mg at day one and weeks 1, 2, 4, 6, 8 and 10 or 280 mg monthly) or placebo.

About Brodalumab (AMG 827)
Brodalumab (AMG 827) is a highly-selective human monoclonal antibody that binds to and blocks signaling via the IL-17 receptor. The IL-17 pathway plays an important role in inducing and promoting inflammatory disease processes.

Brodalumab is the only investigational treatment in development that blocks the IL-17 receptor, thereby blocking several of the IL-17 ligands at once from sending signals to the body. Currently, other agents in development seek to target the individual IL-17 ligands.  By stopping IL-17 ligands from binding with the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation and other ailments.

Brodalumab is currently being investigated for the treatment of psoriasis (Phase 2 and planned Phase 3), psoriatic arthritis (Phase 2) and asthma (Phase 2).

Source: amgen.com

New Phase II data, published today in the New England Journal of Medicine, showed that Eli Lilly and Company's (NYSE: LLY) ixekizumab (pronounced ix" e kiz' ue mab, previously known as LY2439821), an anti-IL-17 monoclonal antibody, met its primary endpoint in patients with moderate-to-severe plaque psoriasis, with significantly more patients achieving at least a 75 percent improvement in Psoriasis Area and Severity Index (PASI) scores from baseline (PASI 75) compared with placebo at week 12.

PASI score represents a combined assessment of overall skin lesions ranging from 0 for no psoriasis to 72 for the worst possible psoriasis in a patient and is a standard measure of skin disease severity in clinical trials in psoriasis. A PASI 75 response in a patient represents a 75 percent reduction of PASI scores from baseline. 

In the 142-subject study, significantly more patients achieved a PASI 75 response in the 150 mg (82 percent), 75 mg (83 percent) and 25 mg (77 percent) ixekizumab groups compared with placebo (8 percent, p < 0.001) at week 12. The 10 mg dose (29 percent) did not separate from placebo at week 12.

Secondary endpoints included an evaluation of the percentage of patients achieving at least 90 percent and 100 percent improvement in PASI (PASI 90 or PASI 100) at week 12. In patients treated with ixekizumab, the percentages of patients achieving a PASI 90 response were 71 percent (150 mg), 59 percent (75 mg) and 50 percent (25 mg), which were significantly higher than with placebo (0 percent). PASI 100 responses were significantly better at the 150 mg dose (39 percent) and 75 mg dose (38 percent) when compared with placebo (0 percent). PASI 100 responses at the 25 mg (17 percent) and 10 mg doses (0 percent) were not significantly greater than placebo, nor was the PASI 90 response at the 10 mg dose (18 percent).

PASI 75 response was significantly better than placebo as early as week 2 at the highest dose, and significant differences from placebo in PASI scores were seen as early as week 1 at the two highest doses and by week 4 for the remaining two doses. Differences from placebo were sustained to week 20 in both PASI 75 responses and PASI scores.

Skin disease severity also was evaluated by static Physician Global Assessments (sPGA), with patients having a score of 3-5 (moderate to severe disease) at baseline. Significantly more patients treated with ixekizumab achieved an sPGA score of 0 (clear of disease) or 1 (minimal disease), when compared with placebo at week 12. The percentage of patients achieving an sPGA 0 or 1 score were 71 percent (150 mg), 72 percent (75 mg), 70 percent (25 mg) and 25 percent (10 mg) compared with 8 percent (placebo), with the highest three doses being significantly higher than placebo. The percentage of patients achieving an sPGA score of 0 at week 12 were 46 percent (150 mg), 38 percent (75 mg), 20 percent (25 mg), 7 percent (10 mg) and 0 percent (placebo), again with the highest three ixekizumab doses being significantly higher than placebo.

Approximately 40 percent of patients in the two highest dose groups had complete clearance of psoriasis plaques on the skin, as reflected by a reduction in the PASI score by 100 percent or an sPGA score of 0 at 12 weeks.

In addition, significant reductions in mean Nail Psoriasis Severity Index (NAPSI) and Psoriasis Scalp Severity Index (PSSI), which evaluate disease in the difficult-to-treat areas of nails and scalp, respectively, were seen at the two highest ixekizumab doses compared with placebo at week 12 (NAPSI: 150 mg [-49.3 percent], 75 mg  [-57.1 percent], placebo [+6.8 percent]; PSSI: 150 mg [-84.8 percent], 75 mg [-94.8 percent], placebo [-30.5 percent]).

The frequency of adverse events in both the combined ixekizumab groups and in the placebo group was 63 percent, with the most common adverse events observed being nasopharyngitis (inflammation of the nasal passages and of the upper part of the pharynx), upper respiratory infection, injection site reactions and headache. There were no serious adverse events reported. Infections occurred in 33 percent (38 patients) of subjects receiving ixekizumab and 26 percent (seven patients) receiving placebo. No dose-related trends in infections or other adverse events were observed. Four patients (one in the placebo group, two in the 10 mg group and one in 25 mg group) discontinued the study due to adverse events.

"These data suggest ixekizumab may be an effective treatment for patients with chronic moderate-to-severe plaque psoriasis and could represent a new treatment approach for patients with this condition," said Craig Leonardi, M.D., clinical professor of dermatology at the Saint Louis University School of Medicine, and lead author of the manuscript. "Further studies are needed, but we are encouraged by the results showing improvements in skin clearance early in treatment."

Source: lilly.com

hi my name is kristine joined today, a lil about myself i have had Psoriasis since i was 2 am now 48, and it loves me that much it never leaves lol, been on most of the treatments e.g creams light treatments tablets hospital stays, and now tablets again , at the moment i am on Fumaderm, , but the side effects are quite bad ,cramps flushing and always on the toilet, but am tryin to stay with it . thnxs for readin kristine

The latest set of quality standards covering a wide range of topics, including heart failure, irritable bowel syndrome, skin cancer, and obesity in adults, has been referred to NICE "National Institute For Health And Clinical Excellence"

NICE will also, for the first time, develop public health quality standards in areas that relate to the NHS.

The topics cover standards for smoking cessation, encouraging physical activity in all people in contact with the NHS and for preventing and managing alcohol misuse.

This is in line with a recommendation by the NHS Future Forum - a group of 45 independent health experts led by Professor Steve Field -for NICE to develop quality standards setting out the evidence based action that the NHS can take in relation to the main lifestyle risk factors.

This latest referral from the Department of Health will see NICE produce its first quality standards for blood disorders, hearing loss, skin conditions including psoriasis, and a number of service delivery standards such as out-of-hours care and trauma services.

Source: nice.org.uk

Joint-Venture of Fujifilm and Kyowa Hakko Kirin for the development, manufacturing and sales of biosimilars.

FUJIFILM Corporation (President and CEO Shigetaka Komori; hereinafter "Fujifilm") and Kyowa Hakko Kirin Co., Ltd. (President and CEO Nobuo Hanai; hereinafter "Kyowa Hakko Kirin") commenced business operations of the "FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd." (President and CEO Hideaki Nomura; hereinafter "Fujifilm Kyowa Kirin Biologics"), a joint-venture for the development, manufacturing and sales of biosimilars.

Fujifilm Kyowa Kirin Biologics will merge Fujifilm's advanced production technology, quality control technology and analysis technology developed through its photographic film business over many years, with Kyowa Hakko Kirin's proprietary technologies and know-how, accumulated through its biopharmaceutical R&D and manufacturing, in order to create revolutionary production processes and to achieve cost reduction for biosimilars. The development and timely introduction of highly reliable, high-quality and cost-competitive biosimilars through this partnership will aim to obtain position as the market leader.

Fujifilm Kyowa Kirin Biologics will first focus on the development of the biosimilar of the fully human anti-TNF-α monoclonal antibody HUMIRA (adalimumab), a drug with high therapeutic effects for psoriasis. After introducing the producing cell already produced by Kyowa Hakko Kirin, Fujifilm Kyowa Kirin Biologics plans to start clinical trials in the beginning of 2013. It will then proceed with its development aiming for market introduction 4 to 5 years after the start of clinical trials. The company also plans to start clinical trials of 1 biosimilar every year after 2014.

Source: fujifilm.com

After my report about Psoriasis 360 closing it's FB site and my thread Should Drug Manufacturers run help websites for psoriasis? I'm pleased to see the following information I have found today.

Quote:After Facebook's decision on August 15 to enforce open walls on the site's pharma pages, companies had two options: close down their pages altogether, or let the public openly comment on their products.

Quote:FDA issues may deter drugmakers from engaging in social media.

Quote:The firm was the latest among several drugmakers to do so following the social network's decision to enforce rules requiring corporate-run pages to allow comments.

Quote:It's like setting up a Twitter account and shutting it down because people are sending in comments.

Quote:Industry needs to differentiate as to when a company becomes responsible for certain activities, Is providing a platform enough to convert something into advertising?  

The following findings are based on the results of the Psoriasis Uncovered survey conducted during September 2010 amongst 363 Australians with psoriasis (aged 18+). The objective of the research was to assess the impact that living with psoriasis has on people’s experiences and choices in life: emotionally, socially and sexually. The average age of diagnosis within the sample was 22.3; the average time respondents have lived with psoriasis was 23.4 years. Of the survey sample, 55% were female and 45% were male. Ninety-two percent of respondents experienced flare-ups per year.

A hidden disease
• 71% try to conceal their psoriasis break-outs (or flare-ups) from other people most of the time or all of the time.
• A greater proportion of younger sufferers (under the age of 35) hide their flare-ups compared with those of 35 or older (82% vs. 68%).
• Of those who hide their condition, 83% hide it from the general public.
• 65% hide their psoriasis from their work colleagues and 49% hide it from their boss.
• Psoriasis is hidden from work colleagues by both men (68%) and women (63%).
• 58% hide their skin affliction from their friends and 39% even hide it from their closest friends.
• 40% of both men and women hide their psoriasis from their extended family and 20% even hide it from their partner or spouse.

The case for concealment: insecurity and stigma
• Embarrassment is the leading cause sufferers conceal their condition (82%).
• 48% hide their psoriasis because of a fear of having to explain or talk about it, with those aged 25-35 particularly scared to talk about their psoriasis (67%).
• 26% hide their condition because they fear they will be judged and 19% worry they will be discriminated against.
• The fear of being judged is particularly strong for those under 35 years of age (44%).
• Nearly half (47%) of all sufferers worry that the general public think their skin condition is a contagious disease.
• More than 1 in 3 (38%) feel the general public stare at them because of their psoriasis with 26% fearing that the general public are repulsed by the sight of their symptoms. Interestingly, this worry is felt equally by both men (27%) and women (24%).

Deflated passion and romance
• Almost two thirds (61%) of sufferers don’t feel sexy or attractive because of their psoriasis and this insecurity is shared by both women (66%) and men (56%).
• Sufferers aged 25-35 are particularly vulnerable to not feeling attractive or sexy (87%).
• 30% of sufferers do not feel affectionate toward their partner or children.
• As a result of their condition 30% do not want sex and surprisingly, the ‘mojo’ of both men and women wane due to their condition (33% of females and 26% of males do not want sex).

Relationship strains and mood swings
• 79% feel that their skin condition impacts negatively on their relationships.
• 80% experience mood changes, such as frustration and anger, when their psoriasis flares up or when they are experiencing symptoms.
• 94% of those who experience mood swings feel so much frustration with their symptoms that it wrecks havoc on many parts of their life, including their:
- Relationships (41%)
- Family life (38%)
- Social life (55%) and
- General health and well-being (64%).
• For sufferers aged 25-35, disruption to social life and relationships is particularly common (70% and 54%, respectively).

Work, rest and play: sufferers lose out time and time again
• One third of sufferers (33%) have not been able to attend an important event, such as a holiday or work meeting, due to a flare-up with younger people (aged 18–25) missing out the most (66%).
• Sufferers under retirement age miss an average of 4.4 days of work per year because of their condition, almost half of their annual sick-day entitlement.
• Nearly two thirds (64%) of sufferers who were diagnosed with psoriasis before the age of 10 were bullied at school because of their condition.

Increased alcohol intake: a vicious circle for some psoriasis sufferers
• Psoriasis leads more than 1 in 10 sufferers to drink more alcohol.
• Heightened alcohol intake is particularly prevalent in men (nearly 1 in 5 men drink more since having the condition and 1 in 10 men say that it makes them drink more alcohol).

Research methodology:
Psoriasis Uncovered was a quantitative survey conducted in Australia during September 2010 in conjunction with an independent market research agency, Stollznow Research. The sample includes 363 Australians of 18 years of age or older with psoriasis. The respondents were recruited via dermatologists and online advertising – 42% responded to the survey online, 58% submitted their answers via a written questionnaire. The survey is a partnership initiative between Psoriasis Australia and Abbott Australasia and the questionnaire was developed in consultation with Dr Chris Baker, St Vincent’s Hospital, Melbourne.

If you're told you need a Psoriasis Biopsy also known as skin biopsy, don't worry it's not as bad as it sounds. I have had three Psoriasis Biopsy's and didn't feel a thing. One was given as a test and taken from the top of my leg, another I donated for research which was taken from my back, and I've had another from a scalp pustule.

It's a simple procedure:

• You will probably be asked to sign a form to give consent and to accept the local anaesthetic.
  
• Your skin at the chosen site will be cleaned with a sterilizing solution.
  
• Next you will be given a local anaesthetic by needle into the chosen site. It doesn't hurt but may give a very slight stinging sensation for a second
  
• There are different types of Psoriasis Biopsy but they all involve taking a very small piece of your skin, usually around 2-4 mm Square.
  
• Depending on the depth you may be given a stitch. this will be removed in a few days, although mine fell out by themselves.
  
• Next you get a plaster.
  
• If you have been really brave you may get a Lollipop.
  

Hello all,

Been away for 2 weeks. Hello to all the new members and the usual suspects.

Has anyone had Rheumatic fever and strep virus?

LL

Abbott today announced that AbbVie [pronounced Abb-vee] will be the name of the new, independent research-based pharmaceutical company it expects to launch by the end of 2012.

The naming of the new company is the latest milestone in the process that began in October 2011, when Abbott announced it would separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals. AbbVie, the research-based pharmaceutical company, will include Abbott’s current portfolio of leading proprietary pharmaceuticals and biologics. The diversified medical products company, which will retain the Abbott name, will consist of Abbott’s existing diversified medical products portfolio, including its branded generic pharmaceutical, devices, diagnostics and nutritional businesses. Both companies will be global leaders in their respective industries.

Miles D. White will remain chairman and CEO of Abbott. Richard A. Gonzalez, currently executive vice president, Global Pharmaceuticals, will become chairman and CEO of AbbVie.

The name is derived from a combination of Abbott and "vie," which references the Latin root "vi" meaning life.

"The beginning of the name connects the new company to Abbott and its heritage of pioneering science," said Mr. Gonzalez. "The 'vie' calls attention to the vital work the company will continue to advance to improve the lives of people around the world."

"With a powerful family of products and a continued focus on breakthrough innovations targeting some of the most critical medical needs, AbbVie will be positioned to deliver market-leading performance and better health for patients," said Mr. White.

The research-based pharmaceutical company has nearly $18 billion in annual revenue today and will have a sustainable portfolio of market-leading brands, including Humira, Lupron, Synagis, Kaletra, Creon and Synthroid.  An attractive pipeline of innovative R&D assets – in important specialty therapeutic areas such as Hepatitis C, immunology, chronic kidney disease, women's health, oncology and neuroscience – will help drive future growth.

The AbbVie logo and graphic identity will be unveiled when the new company is launched.

Source: abbott.com

Nearly 18 months after the Psoriasis 360 initiative was launched Janssen has called time on the campaign’s Facebook page.

Announcing its decision the UK pharma company said company personnel had found themselves having to remove an increasing number of posts, with the effect of “stifling worthwhile discussions”.

Janssen siad that within the last three months alone a third of all posts to the page had to be removed, the majority because they mentioned prescription-only medicines, but a “significant minority” were disallowed because they included offensive language.

When posts mentioned a specific prescription-only drug by name, or talked about the effectiveness of a particular treatment (or its side effects) Janssen either had to ask for them to be changed or the company had to disallow them.

I rest my case https://psoriasisclub.org/showthread.php?tid=513

My dermatologist has spoken to me about testing a new treatment she said it was a JAK inhibitor. I have found this

Quote:Emerging clinical research has demonstrated the integral role of Janus kinase (JAK) proteins in the pathogenesis of psoriasis. As of 2010, two new oral JAK inhibitor drugs, ruxolitinib and tofacitinib (formerly called tasocitinib), have shown rapid and promising efficacy in Phase I/II trials with patients showing significant skin clearing within one week of beginning treatment. Ruxolitimib has completed Phase II clinical trials supplied as a topical cream.

Hi Guys and Gals!!

I'm Krissie and am glad to be part of this forum. I've been following @psoriasisclub on twitter for a while now but never actually seem to be online on the PC much these days to get signed up to the forum etc.

I've had psoriasis for pretty much all of my life. I was diagnosed at age 4 and am now 35 so I can't really remember any life before/without the condition. Unlike many people mine did not ease off at all in my teenage years and I can say with 100% honesty that I have had a total of about 4 months completely free of the skin condition in the 31 years that I have lived with it (I've had 2 rounds of UVB therapy which cleared my skin up for 2 months each). At the moment my skin is fairly clear (as opposed to completely covered) and I am not using over 200g of Dovonex in a fortnight but I am suffering really badly with PSA.

I'm currently off work for the second time in 2 months (just went back to work 4 weeks ago after a bad spell) due to PSA affecting my hands, wrists and neck. I can't lift anything and have lost a lot of dexterity in my hands. I've spent the past 6 months chopping and changing medications. The meds tried have been Naproxen, diclofenac, celebrex, cocodamol (8mg), codydramol (16mg) and cocodamol (30mg) and I have just been prescribed Tramadol today for the pain... Zombie city here I come!!

I'm waiting for a rheumatology appointment at my local hospital, had to start again after the previous "specialist" informed me there was nothing wrong with me... I got very angry at that because I wasn't going through a flare at the time I saw him so had no physical symptoms and he had no interest in listening to the symptoms I had experienced. I'm 6 weeks into a 16 week wait for an appointment and dreading having to be signed off work until then.

Work wise I'm a microbiologist and up until recently I have been very much inclined to stay away from DMARDS due to their immunosuppresant actions.. To take these I'd have to give up work. Now though I am weighing up being in constant pain vs. changing my career and pain relief is winning.

I'm keen to offer support and a listening ear to anyone who needs it, having spent a lifetime with psoriasis I can relate to the problems faced by all ages (kids/teens/adults) and would be willing to chat to anyone about how psoriasis is affecting their lives/confidence.

At the same time I'm looking for advice and support from fellow sufferers and I'd love to hear the personal stories of your experiences with psoriasis and heath care providers.

Enough of my rambling... In advance, I'd like to say it's nice to meet you all.

Krissie

I have been given Duoderm hydrocolloid dressings to use on the soles of my feet when my thick PPP skin cracks, opens and bleeds. It works beautifully. With Duoderm on my feet I can walk happily - without it it would be just impossible. Thank you Duoderm.

The problem now is with how to get Duoderm off my favourite pair of socks . The dressing 'peeled' inside my socks when I was out walking yesterday and there'd a large gunky area that I just can't shift. It's bound to happen again. Suggestions very welcome ...

Thanks for all the welcomes you've all given me. Makes me feel a lot happier and not so isolated

First it was beer, then it was cigarettes. Finally, researchers have found a vice that's not tied to psoriasis: coffee.

In fact, when Dr. Abrar Qureshi and his team at Brigham and Women's Hospital in Boston first set out to study whether there was a link between the skin disease and java, they thought the anti-inflammatory properties of caffeine might actually protect against psoriasis.

That had been reported by a group of Irani researchers, who applied caffeine directly to the skin of volunteers with psoriasis and found an apparent benefit.

To see whether consumed caffeine had any influence on whether a person developed psoriasis, Qureshi and his colleagues looked at more than 82,000 participants in the Nurses' Health Study.

All of the participants had filled out questionnaires about their daily food and beverage intake in 1991 and were free of psoriasis at that point.

Over the next 14 years, nearly 1,000 people in the study developed psoriasis, the team reports in the Archives of Dermatology.

Initially, the risk did seem a bit higher among those who got a lot of caffeine in their diet, whether from coffee, tea, soft drinks or chocolate.

Earlier studies from Qureshi's team have tied psoriasis to both alcohol and tobacco, so when the researchers took the latter into account they found there was no longer any link between caffeine and skin problems.

Although the earlier research doesn't prove that either smoking or drinking causes psoriasis by itself, the findings are another good reason to cut back on unhealthy habits, Qureshi told Reuters Health.

"From a lifestyle point of view," he said, "I'd recommend exercising more, drinking less and quitting smoking."

Dr. Esther Lopez-Garcia, who was not involved in the new work but has studied the health effects of coffee, said there is good evidence that the brew -- at least when filtered -- isn't harmful for healthy people.

"There is also a growing body of evidence suggesting that coffee drinking may decrease the risk of diabetes, stroke and some types of cancer," Lopez-Garcia, of Universidad Autonoma de Madrid in Spain, told Reuters Health in an email.

But she warned that the drink can worsen problems like insomnia, anxiety and high blood pressure.

"Because of these side effects of coffee, it is prudent to recommend moderate coffee consumption," she said.

Source: reuters.com

So back in 2004 channel 4 put a programme on about a man with a skin condition where his skin fell off with an slight friction. At this time I was in one heck of a state with my psoriasis. After watching this I got a real sense of perspective of my own life and helped me through a tough time. Even now when I feel I'm up against it I still think of the amazing man in the programme.

If you have a spare hour it may be worth watching, all you need to do is go to 4 on demand and search for it and watch! 

Provectus Pharmaceuticals, Inc. 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."

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.

Source: pvct.com

A clinical study co‐led by the Montreal Heart Institute and Innovaderm Research Inc. shows that a Humira (adalimumab) could be associated with a significant decrease in vascular inflammation, a major risk factor of cardiovascular disease. The goal of this clinical study was to show that a treatment to reduce skin inflammation in psoriasis patients could be associated with a decrease in vascular inflammation.

The study had positive results, as vascular inflammation decreased significantly in patients suffering from psoriasis who were treated with adalimumab, a biological anti‐inflammatory compound. The study also showed a 51% decrease in C‐reactive protein among patients treated with adalimumab compared to a 2% decrease among patients in the control group. These results are significant, as a high level of C‐reactive protein is known to be associated with an increased risk of heart attack and stroke. In relation to the treatment of psoriasis, 70% of patients who received the compound presented with a major decrease in skin lesion severity, compared to 20% of patients in the control group.

According to Dr. Robert Bissonnette, President and Founder of Innovaderm Research Inc. and co‐principal author of the study, said "This study is a great example of the high‐level research being conducted in Montréal. "He added that this clinical research study suggests that it is possible to assess the impact of psoriasis treatments on the heart without having to resort to long‐term studies that require thousands of patients and have higher costs.

"These findings are extremely encouraging for people suffering from psoriasis, as they face a greater risk of cardiovascular disease," explained Dr. Jean‐Claude Tardif, Director of the Research Centre of the Montreal Heart Institute and co‐principal author of the study. He also emphasized the importance of regular medical follow‐up for people with psoriasis to prevent cardiovascular events and establish an optimum therapeutic approach.

Between May 2009 and June 2011, 30 patients suffering from moderate to severe psoriasis and with a history of coronary artery disease or multiple associated risk factors were followed for four months as part of a randomized clinical study. The patients were divided into two groups: the first group was treated with sub‐cutaneous injections of adalimumab while the second group received no treatment or a routine treatment (i.e., topical formulation, phototherapy). Each patient's level of vascular inflammation was measured at the start and end of the study with positron emission tomography (PET), a type of medical imaging, to scan the carotid arteries and the ascending aorta.

Source: icm-mhi.org

VBL Therapeutics, a clinical stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced that a Phase 2 sub-study of VB-201 in moderate to severe psoriasis patients with cardiovascular risk has successfully achieved its primary endpoint demonstrating a statistically significant reduction in vascular inflammation associated with atherosclerotic lesions as measured by PET-CT imaging. VB-201 is a first-in-class, oral disease-modifying agent selected from a series of proprietary oxidized phospholipid analogs pioneered by the company in the Lecinoxoid molecular class. The compound is being developed as an oral controller medicine for chronic immuno-inflammatory disease and atherosclerosis inflammation.

The findings validate the compound's novel mechanism of action for the control and attenuation of chronic immuno-inflammatory diseases via the highly selective modulation of components of the innate immune system. Central to the overall mechanism of action for VB-201 are the targeted antagonism of cell-surface Toll-Like Receptor (TLR)-2 and TLR-4 co-receptor CD-14, and the inhibition of chemokine-mediated migration of monocytes to inflamed tissue. The study data support the growing scientific evidence that these mechanisms are important in regulating inflammation in atherosclerosis. VB-201 is a first-in-class, specific, orally-available innate immunity controller drug.

"The Phase 2 data are promising and demonstrate an anti-inflammatory effect of VB-201 on psoriasis patients with atherosclerosis within a short time period," said Dr. Kimball. "VB-201 is the first drug we aware of to demonstrate a reduction in the inflammation associated with atherosclerosis through this pathway. These data are especially important given the growing evidence linking cardiovascular events and elevated mortality in patients with chronic inflammation, including patients with psoriasis. This study serves as a proof of concept for this compound's novel mechanism of action and demonstrates an anti-inflammatory effect on two systemic inflammatory conditions simultaneously—atherosclerosis of the vascular wall and psoriasis."

In the pre-defined cardiovascular sub-study, PET-CT scans were used to evaluate the effect of VB-201 on the suppression of active inflammation in atherosclerotic lesions. PET-CT has been validated as an imaging tool for measuring vascular inflammation related to atherosclerosis and has been shown to predict cardiovascular events. VB-201 produced a statistically significant, dose-responsive mean reduction of 12.7 percent of the inflammation associated with vascular endothelial lesions (80 mg dose group)

In the overall Phase 2 study, VB-201 demonstrated an excellent safety and tolerability profile. There were no treatment-related serious adverse events observed, and the overall rates of adverse events were similar across the VB-201 drug and placebo dosing arms. Statistically significant improvements in the psoriasis efficacy endpoints, Physician Global Assessment and Patient Global Assessment.

"We are excited to reveal that the favorable experimental data in the atherosclerosis models has translated into proof of concept in humans," said Yael Cohen, M.D., vice president, clinical development at VBL. "We believe that these data suggest that VB-201 is an excellent candidate for both the control of primary chronic immuno-inflammatory disease as well as the reduction of the elevated cardiovascular risk accompanying the primary disease. It's encouraging to see the psoriasis efficacy measures did not plateau at the conclusion of the 12-week trial and, as a result, an additional trial with higher dosage and longer duration is underway."

Source: news-medical.net