Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Ferrer Successfully Completes a Phase III Clinical Trial in Adult and Paediatric Patients with Impetigo

Published: Monday, June 10, 2013
Last Updated: Monday, June 10, 2013
Bookmark and Share
Ozenoxacin, a novel bactericidal non-fluorinated quinolone, in development as a topical treatment for impetigo and other infectious dermatological conditions, is now available for licensing and commercialization from Ferrer.

Ferrer has announced that it has successfully completed a phase III clinical trial in adult and paediatric patients with impetigo involving Ozenoxacin formulated as a topical treatment for dermatological infectious conditions.

The study demonstrated the superiority of Ozenoxacin 1 per cent cream, applied topically bid for five days, versus placebo on both the clinical and bacteriological endpoints by end of therapy visit (day 6-7).

In addition, Ozenoxacin 1 per cent cream demonstrated a superior bacteriological cure compared to placebo as early as visit two (day 3-4).

The trial also demonstrated that Ozenoxacin 1 per cent cream is safe and very well tolerated in the adult and paediatric population, which confirms the results of an absorption, tolerance and safety study in juveniles aged two months and above announced previously.

The trial, conducted at 27 centers in the United States, South Africa, Germany, Romania and Ukraine, involved 465 adult and paediatric patients aged two years and older with a clinical diagnosis of bullous or non-bullous impetigo.

Ozenoxacin is a novel non-fluorinated quinolone antibacterial agent. In preclinical studies, the bactericidal action of Ozenoxacin (via potent dual inhibition of DNA gyrase and Topoisomerase IV) has been shown to confer an excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria.

Importantly, given the maturity of other products in this field, these include clinical isolates of organisms with emerging resistance to quinolones and other commonly prescribed topical antibiotics.

"Impetigo due to bacterial skin infections remains a common problem worldwide, especially in infants and young children living in warm, humid climates," said Fernando Garcia Alonso, chief scientific officer at Ferrer.

Alonso continued, "The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents. The clinical studies performed by Ferrer with Ozenoxacin aim to provide infants and others with impetigo an alternative, safe and effective topical antibacterial treatment. In addition, Ozenoxacin could represent a topical treatment for a broad range of other infectious dermatological conditions, with a combined market value approaching USD 800 million per annum. This study, along with a previously announced absorption, tolerability and safety trial in adult and juvenile patients with impetigo aged two months and over, may form the basis of a first regulatory filing for Ozenoxacin in 2015."

The product is available for licensing worldwide from Ferrer, except in China, Japan, Korea and Taiwan.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Ferrer Initiates Second Phase III Clinical Study for Ozenoxacin
Ozenoxacin, a novel bactericidal non-fluorinated quinolone that successfully completed a first phase III clinical trial in adult and paediatric patients with impetigo, is available from Ferrer for licensing and commercialization.
Friday, June 13, 2014
Ferrer to Develop Lorediplon for Insomnia with Ildong and Ergomed
A Phase IIa clinical study will test the efficacy, safety and tolerability profile.
Thursday, February 06, 2014
Scientific News
New Database for Sharing MS Clinical Trial Data
A new database containing nearly 2500 patient records from the placebo arms of nine multiple sclerosis (MS) clinical trials is now available for research by qualified investigators.
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
BMS’s Opdivo Clinical Trial Shows Promise
Safety profile of the combination regimen from CheckMate -069 was consistent with previously reported studies and adverse events were managed using established safety algorithms.
Treatment of Common Prostate Cancer
Researchers at UTSW have found that the prostate cancer treatments suppress immune response and may promote relapse.
Cancer Drug Could Treat Blood Vessel Deformities
A drug currently being trialled in cancer patients could also be used to treat an often incurable condition that can cause painful blood vessel overgrowths inside the skin.
Structure of Crucial Enzyme Identified
Researchers at UTSW have determined the atomic structure of an enzyme that plays an essential role in cell division and better treatment of cancer.
New Immunotherapy Trial for Type 1 Diabetes
The search for a treatment for Type 1 diabetes (T1D) - which affects over 400,000 people in the UK – will be stepped up with the start of a new phase one clinical trial at Guy’s Hospital in London.
Recruitment of First Patient in Clinical Study
Company has announced recruitment of first patient in clinical study assessing Visco-ease with Beatson Cancer Centre for the treatment of RIX.
Fighting Prostate Cancer
Identifying the most promising compounds which can be used as medications for prostate cancer.
Chi-Med Initiates Sulfatinib Phase III Registration Study
Company has initiated SANET-p, a Phase III registration trial of sulfatinib with pancreatic neuroendocrine tumors (“NETs”).
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!