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

Initiation of a Phase IIa Clinical Study for Lynovex® in Cystic Fibrosis

Published: Thursday, June 26, 2014
Last Updated: Wednesday, June 25, 2014
Bookmark and Share
Results from the trial are expected to be announced H2 2014.

NovaBiotics Ltd has announced the initiation of an open label/single arm Phase IIa clinical study to assess the safety, tolerability, pharmacokinetics and initial evidence of efficacy of orally-dosed Lynovex®. The Phase IIa trial will be undertaken in collaboration with the University of Aberdeen and NHS Grampian.

Lynovex® is a candidate therapeutic for cystic fibrosis and has unique multi-functionality. Lynovex® has the potential to break down the mucus produced in the airways of CF patients and at the same time, has been shown to kill the bacteria responsible for the recurrent respiratory infections in cystic fibrosis.

Furthermore, Lynovex® disrupts and prevents the biofilms which these bacteria typically form in the cystic fibrosis airway.

By functioning in this way, Lynovex® could improve lung function and halt or prevent long term damage or degeneration of respiratory tissues in CF patients. Lynovex® has been designated as an Orphan Drug by the EMA.

The trial follows the generation of very promising results from a study in which the antibacterial and mucolytic impact of Lynovex® was determined against sputum samples from cystic fibrosis patients.

The Phase IIa study will determine levels of Lynovex® in the blood and sputum of cystic fibrosis patients after it has been administered in tablet form and will monitor levels of bacteria in sputum, lung function and weight as well as general health and quality of life parameters.

Results from the trial are expected to be announced H2 2014 and are part of the Company’s wider plan to develop orally administered Lynovex® as an intervention in acute exacerbations of cystic fibrosis.

Dr Deborah O’Neil, CEO of NovaBiotics, said: “There has been significant drive from the patients to run this trial and tremendous support from all the collaborators, the University of Aberdeen, Health Science Scotland, NHS Grampian and of course, the Cystic Fibrosis Trust. Each and every one of the stakeholders in this study, the patients especially, agree that cystic fibrosis is an orphan disease that remains totally underserved by current treatments. Everyone involved in Lynovex’s clinical development wants to help deliver new and effective ways to treat this disease. We believe Lynovex® could provide significant benefit to the majority of cystic fibrosis patients and we eagerly anticipate the results of this trial and to be able to progress the product further through an expedited regulatory process towards eventual clinical use.”

Professor Graham Devereux of the University of Aberdeen and Consultant for NHS Grampian, one of the specialists at Aberdeen Royal Infirmary who looks after patients with Cystic Fibrosis, said “The bacteria causing problems in Cystic Fibrosis are all too often highly resistant to current antibiotics, by reducing antibiotic resistance Lynovex® could make a real difference to all patients with Cystic Fibrosis, this is rather exciting.”

Dr Janet Allen, Director of Research and Care at the Cystic Fibrosis Trust said: “It is exciting to see how the Cystic Fibrosis Trust’s partnerships with industry are helping to deliver new and successful ways to help treat this disease and we all look forward to seeing the results of the Phase 2IIa trial in due course. By engaging with partners in research and industry the Trust believes it can help speed up the development of new therapies and treatments such as Lynovex® to further the quality and length of life of all people who have cystic fibrosis.”


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 3,300+ scientific posters on ePosters
  • More than 4,900+ 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.


Scientific News
Oxygen Can Impair Cancer Immunotherapy
Researchers have identified a mechanism within the lungs where anticancer immune resposnse is inhibited.
Symmetry is Key to Collagen
Researchers describe how symmetry may be the key to growing collagen fibres outside the body.
Biological Barcodes Using CRISPR
Using genome editing tools, researchers are getting closer to understand differentiation of various cell types during development.
Decades Old Chemicals Linked to Current Increased Autism Risk
The chemcials - organochlorines - were banned in the US in 1977 but their side effects are still being seen.
Gene Therapy Via Ultrasound
Research into a gene therapy approach called sonoporation could help combat heart disease and cancer.
The Fight Against Fungal Infections
A pioneering university research team has recently employed such a system within their laboratory to obtain a greater understanding of the dynamics and progression of C. albicans in vivo using a mouse model.
Fly Study into Therapies for HVP-Induced Cancer
Fruit flies may help scientists understand the mechanism by which HPV can cause cancer as well as identify potential drug treatments.
Exploring Ebola-Malaria Link
Data shows people infected with Ebola were more likely to survive if co-infected with malarial parasite.
Precision Nanobots Target Cancerous Tumours
Researchers achieve breakthrough toward redefining anti-cancer drug administration using nanorobotics.
Characterizing the Mouse Gut Microbiome
Study establishes the first public collection of bacteria from the intestine of mice.
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!