|By PR Newswire||
|September 4, 2014 02:00 AM EDT||
BALLERUP, Denmark, September 4, 2014 /PRNewswire/ --
Not for US media
The digital press release with multimedia content can be accessed here: http://www.multivu.com/players/uk/7276254-WCCS-Picato-actinickeratosis/
New data from the international FIELD Study Repeat presented today at the 15th World Congress of Cancers of the Skin (WCCS) in Edinburgh, Scotland, demonstrate initial treatment with Picato® (ingenol mebutate gel) 0.015% is efficacious in treating actinic keratoses (AK) and, when followed by a repeat cycle for persistent and newly emerging AKs, this efficacy is further increased. The data also confirm two treatment cycles of Picato® are well tolerated by patients.
These findings are significant as AK is a chronic disease. The presence of underlying sub-clinical (invisible) lesions can lead to recurrence of original AKs and the development of new lesions over time, which normally require repeat treatment. The FIELD Study Repeat followed patients over a one-year-period, confirming both the short and in particular the long-term benefits when treating once or twice of Picato® - with an overall 50% complete clearance of all AK lesions after one year*.
Presenting the data at WCCS today, Professor Claus Garbe, Department of Dermatology, University Hospital Tübingen, Germany and Principal Investigator of the FIELD Repeat Study, commented: "AK is a very common precursor to non-melanoma skin cancer, which requires ongoing treatment. The new data from the FIELD Study Repeat validate Picato® as a well-tolerated field-directed therapy, suitable for the long-term treatment of actinic keratoses, showing an overall high complete clearance rate after one year."
The FIELD Study Repeat is part of the larger international FIELD Study Programme being run by LEO Pharma, designed in partnership with leading clinicians to investigate the potential broader role of Picato® in the management of AK.
Additional data from the FIELD Study Programme was recently published in the Journal of Drugs in Dermatology (JDD) with the long-term results of the FIELD Study 1, investigating the efficacy of Picato® as a field-directed therapy used sequentially following treatment with cryosurgery.
Results show that combining lesion-specific cryosurgery with Picato® field therapy significantly improves the clearance of AK lesions, with an overall 30.5% complete clearance rate, compared to 18.5% with cryosurgery plus vehicle gel over a one year period.
This elevated efficacy results from enhancing the effect of cryosurgery with Picato® on the visible baseline lesions, and from a 'field treatment effect' of Picato® on sub-clinical lesions not visible at baseline (demonstrated by fewer patients experiencing new lesions when treated with Picato® compared to vehicle gel). The data also confirm Picato® field therapy after cryosurgery is well tolerated.
Dr William Hanke, Founder and Medical Director, Dermatologic Surgery, Laser and Skin Center of Indiana, US, and FIELD Study 1 Principal investigator, added:
"The recently published 12 month data from FIELD Study 1 show sustained patient benefits of field treatment with Picato® in combination with cryosurgery. These data are now reinforced with evidence that repeat use of Picato® is efficacious and well tolerated over the same time period. Combined, these studies provide further evidence for the role of field treatment with Picato® in achieving long-term clearance of AK lesions."
Follow @LEOHealthySkin for the latest updates from #WCCS2014.
* Patients treated twice with Picato® or treated once and remained clear at 8w, 26w and 44w, 50% were still clear at 12m (44.0%-56.1%, 95% CI)
NOTES TO EDITORS
1. About Picato® (ingenol mebutate gel)
Picato® is a topical, field-directed therapy which is self-administered by the patient to the affected areas of the skin once a day for two or three consecutive days, depending on the treatment location. Picato® has demonstrated efficacy in clearing actinic keratosis lesions on the face and scalp, as well as on the trunk and extremities, in a large clinical trial programme.
Picato® was approved by the US Food and Drug Administration (FDA) in January 2012; by the Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil in July 2012; by the Therapeutic Goods Administration (TGA) in Australia and the European Commission (EC) in Europe in November 2012, by Health Canada in January 2013 and by the Swiss Agency of Therapeutic Products (Swissmedic) in June 2013.
2. About FIELD Study Repeat
The FIELD Study Repeat involved 450 patients across 5 countries globally, designed to explore the efficacy and tolerability of Picato® repeated treatment within the same area or 'field' on the face or scalp over a 12 month period. For further information please refer to the http://www.clinicaltrials.gov website (identifier: NCT01600014).
3. About the FIELD Study 1
The FIELD Study 1 involved more than 300 patients across 35 US trial sites and explored the efficacy and safety profile of sequential treatment of AK on the face or scalp with cryosurgery followed by Picato®, 0.015% treatment compared with cryosurgery followed by vehicle gel. For further information please refer to the http://www.clinicaltrials.gov website (identifier: NCT01541553).
4. About actinic keratosis (AK)
Actinic keratoses are common skin lesions which are often red and scaly. The majority of lesions are caused by cumulative sun exposure in fair-skinned people. AK is a precursor to non-melanoma skin cancer (NMSC). The number of patients with actinic keratosis is rapidly growing, especially in Europe, the US and Australia. Prevelance currently ranges from 11-25% in the Northern Hemisphere to 40-60% in the Southern Hemisphere.
5. About LEO Pharma
Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company. LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally. The company has its own sales forces in 61 countries and employs around 4,800 people worldwide. LEO Pharma is headquartered in Denmark and is wholly owned by the LEO Foundation.
For more information about LEO Pharma, visit http://www.leo-pharma.com.
Watch us on YouTube: http://www.youtube.com/leopharmaglobal.
6. Picato® Abrev. SmPC
Contact with the eyes should be avoided. Eye disorders such as eye pain, eyelid oedema and periorbital oedema should be expected to occur after accidental eye exposure of Picato®. Picato® must not be ingested. Administration of Picato® is not recommended until the skin is healed from treatment with any previous medicinal product or surgical treatment and should not be applied to open wounds or damaged skin where the skin barrier is compromised. Picato® should not be used near the eyes, on the inside of the nostrils, on the inside of the ears or on the lips. Local skin responses such as erythema, flaking/scaling, and crusting should be expected to occur after cutaneous application of Picato®. Due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised. Lesions clinically atypical for actinic keratosis or suspicious for malignancy should be biopsied to determine appropriate treatment. There are no data from the use of ingenol mebutate gel in pregnant women. Risks to humans receiving cutaneous treatment with ingenol mebutate gel are considered unlikely as Picato® is not absorbed systemically. As a precautionary measure, it is preferable to avoid the use of Picato® during pregnancy. Actinic keratosis is not a condition generally seen within the paediatric population. The safety and efficacy of Picato® for actinic keratosis in patients less than 18 years of age have not been established. Please see full prescribing information available at http://www.leo-pharma.com.
1. Garbe C. Ingenol mebutate gel 0.015% repeat use for multiple actinic keratoses on face and scalp: a 12 month pahse 3 clinical study. Presented at the World Congress on Cancers of the Skin, Edinburgh, Scotland. 4 September 2014
2. LP0041-22 Clinical Study Report EudraCT no. 2011-005018-13 01-Jul-2014 page 1,165
3. Berman B et al. Cutis. 2012; 89:241-50
4. Berman B et al. Journal of drugs in dermatology : JDD. 2014; 13:741-7
5. Lebwohl M et al. N Eng J Med. 2012; 366:1010-9
6. Goldberg L and Mamelak A. Journal of drugs in Dermatology. 2010; 9:1125-32
7. Frost C et al. The British journal of dermatology. 1994; 142:722-6
8. Sober A. Cancer. 1995; 75(2 Suppl):645-50
9. Ulrich M et al. Expert Opinion. 2010; 15:545 - 55
Global Media Contact
Global Communications Manager
LEO Pharma A/S, Denmark
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
Mar. 25, 2017 09:15 AM EDT Reads: 2,343
SYS-CON Events announced today that SD Times | BZ Media has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. BZ Media LLC is a high-tech media company that produces technical conferences and expositions, and publishes a magazine, newsletters and websites in the software development, SharePoint, mobile development and commercial UAV markets.
Mar. 25, 2017 09:15 AM EDT Reads: 4,081
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Mar. 25, 2017 08:30 AM EDT Reads: 1,923
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
Mar. 25, 2017 08:00 AM EDT Reads: 1,718
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Mar. 25, 2017 08:00 AM EDT Reads: 13,902
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
Mar. 25, 2017 08:00 AM EDT Reads: 1,146
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Mar. 25, 2017 08:00 AM EDT Reads: 3,983
Historically, some banking activities such as trading have been relying heavily on analytics and cutting edge algorithmic tools. The coming of age of powerful data analytics solutions combined with the development of intelligent algorithms have created new opportunities for financial institutions. In his session at 20th Cloud Expo, Sebastien Meunier, Head of Digital for North America at Chappuis Halder & Co., will discuss how these tools can be leveraged to develop a lasting competitive advanta...
Mar. 25, 2017 07:45 AM EDT Reads: 2,560
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
Mar. 25, 2017 06:45 AM EDT Reads: 1,036
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
Mar. 25, 2017 06:45 AM EDT Reads: 744
SYS-CON Events announced today that HTBase will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. HTBase (Gartner 2016 Cool Vendor) delivers a Composable IT infrastructure solution architected for agility and increased efficiency. It turns compute, storage, and fabric into fluid pools of resources that are easily composed and re-composed to meet each application’s needs. With HTBase, companies can quickly prov...
Mar. 25, 2017 06:45 AM EDT Reads: 2,714
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Mar. 25, 2017 06:30 AM EDT Reads: 1,522
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
Mar. 25, 2017 06:15 AM EDT Reads: 1,628
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Mar. 25, 2017 05:30 AM EDT Reads: 1,383
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership abi...
Mar. 25, 2017 05:00 AM EDT Reads: 10,854