Navigation Links
LEO Pharma's PEP005 Meets Primary Endpoint in Phase III Trial for Pre-Cancerous Skin Condition
Date:2/1/2010

BALLERUP, Denmark, Feb. 1 /PRNewswire-USNewswire/ -- LEO Pharma today announced that in a Phase III study, PEP005 (ingenol mebutate) Gel, the company's lead candidate for the topical treatment of actinic (solar) keratosis (AK) or pre-cancerous lesions, met its primary clinical endpoint of complete clearance of AK lesions in non-head locations.  Findings from the REGION Ib study in body AK support results from the earlier REGION-I trial, a study evaluating PEP005 for the treatment of AK on the head reported in December 2009.

AK is a pre-cancerous skin condition that if left untreated, can lead to the development of skin cancer.

"PEP005 is a recent addition to LEO Pharma's robust dermatology pipeline.  We could not be happier with the preliminary findings that suggest PEP005 may be a promising new treatment option for patients with this type condition, a pre-cursor to skin cancer," said Lars Olsen, Executive Vice President for Research & Development, LEO Pharma.  

Cryotherapy, a procedure in which the surface skin lesions are frozen, is currently the most common treatment alternative for AK. It is used as the sole approach in approximately 75% of treatments for AK lesions, and in combination with topical drugs in approximately 9% of treatments. The American Academy of Dermatology reports that 40 percent of cases of squamous cell carcinoma begin as AKs.

Approximately 250 patients were enrolled in the REGION Ib study, which evaluated the use of a 0.05% concentration of PEP005 Gel applied daily as monotherapy for two consecutive days to AK lesions on non-head locations.  

PEP005 Gel demonstrated a favorable safety profile and was well tolerated; side effects were consistent with those seen in Phase II studies. There were no drug-related serious adverse events reported. The trials were initiated and run by Peplin, Inc., acquired by LEO Pharma in September 2009.  

Results from REGION I and Ib will be presented at an upcoming meeting of the American Academy of Dermatology.

LEO Pharma expects to file for regulatory approval of the treatment in the U.S. and Europe in 2011.

About Actinic Keratosis

Actinic keratosis (AK) is a common pre-cancerous skin condition caused by sun exposure, which can develop into skin cancers if left untreated. The number of AK patients is both large and rapidly growing, and AK is a serious health problem.

About LEO Pharma

Founded more than 100 years ago, LEO Pharma is an independent, research-based specialty pharmaceutical company committed to the discovery and development of novel drugs for patients within the areas of Dermatology and Critical Care Medicine. Wholly owned by The LEO Foundation, the company is headquartered in Ballerup, Denmark, outside of Copenhagen, and is represented in more than 90 countries worldwide.  Employees number more than 3,000, with 550 scientists and specialists working to develop new chemical entities.

With a strong portfolio of approved products and a robust pipeline of treatments in development for conditions including psoriasis, eczema and actinic (solar) keratosis, LEO Pharma is one of the leading dermatology companies in the U.S. and the world.  

For more information about LEO Pharma, visit www.leopharma.com.

SOURCE LEO Pharma

RELATED LINKS
http://www.leopharma.com

'/>"/>

SOURCE LEO Pharma
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
2. Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers
3. Pharmasset Commences Dosing in Phase 3 Registration Studies of Clevudine for HBV
4. Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C
5. Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART
6. Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
7. Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
8. Pharmasset Reports First Fiscal Quarter 2008 Financial Results
9. Pharmasset Presents Results of 4-Week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
10. Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
11. Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... -- Bracket , a leading clinical trial technology and ... platform, Bracket eCOA (SM) 6.0, at the 52 nd ... 2016 in Philadelphia , Pennsylvania.  A demonstration ... of its kind to fully integrate with RTSM, will be ... is a flexible platform for electronic clinical outcomes assessments that ...
(Date:6/23/2016)... 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in ... America . ... ... ... ...
Breaking Medicine Technology:
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... ... ... BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a ... an hour by 2020 and then adjusting it yearly to increase at the same rate ... assure the wage floor does not erode again, and make future increases more predictable. , ...
Breaking Medicine News(10 mins):