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

Successful Completion of Second Clinical Trial on CP024 Intranasal Growth Hormone

Published: Wednesday, February 13, 2013
Last Updated: Tuesday, February 12, 2013
Bookmark and Share
Clinical trial results show that CP024 is safe and well tolerated with pharmacokinetics.

Critical Pharmaceuticals has announced that it has successfully completed a second clinical study on its CP024 growth hormone nasal spray.

The results of this trial in healthy subjects showed that CP024 is safe and well tolerated with pharmacokinetics that are highly reproducible ensuring accuracy and ease of dose titration.

Uniquely for a nasal formulation, CP024 strongly induces the production of insulin-like growth factor (IGF-1), which is the principal mediator of growth hormone activity.

Dr Gareth King, CEO Critical Pharmaceuticals commented “We are very excited about the latest clinical results with CP024 which provide clear proof of concept for this product, and which will support our search for a suitable development and commercialization partner to progress the product into phase 2/3 clinical studies. As well as providing an attractive alternative to injection, we believe CP024 may have clinical benefits by reducing circulating growth hormone levels which reduce insulin sensitivity seen with current treatments of growth hormone while maintaining therapeutic IGF-1 levels.”

In the clinical trial, six dose levels of CP024 (between 2-6 mg growth hormone) were administered to healthy subjects along with an infusion of octreotide to suppress the production of endogenous growth hormone.

The objectives of the study were to measure the pharmacokinetics, pharmacodynamics and dose response relationship of CP024 compared to a subcutaneous dose of 0.75 mg Omnitrope®.

Results confirmed:
• CP024 was well tolerated and the few adverse events observed were mild and transient and similar to those observed with over the counter marketed nasal products (e.g. Beconase®).
• CP024 pharmacokinetics were highly reproducible and importantly showed a linear dose response indicating that it would be possible to accurately set and titrate dose in children and adults.
• Insulin-like growth factor 1 (IGF-1) was strongly induced after dosing with CP024 and is the only reported product to induce therapeutic levels of this important biomarker after intranasal administration. IGF-1 is produced in the liver in response to systemic growth hormone and is the principal mediator of its growth promoting effects.

The need for new products to treat growth hormone deficiency
Human growth hormone (hGH) is a leading biological drug for the treatment of growth disorders in adults and children with global sales in excess of $3bn in 2011.

All marketed growth hormone products require subcutaneous injection and CP024 nasal growth hormone offers an attractive non-invasive route for delivery.

Non-adherence to hGH therapy is estimated to be as high as 66% with 70% of patients unhappy with daily injection and 30% considering stopping treatment. As well as reduced efficacy, non-adherence also leads to increased healthcare costs.

Nasal delivery provides an attractive alternative; studies show that for vaccine delivery, where there is a choice, children prefer nasal administration over injections.

CP024 is a dry powder formulation of hGH containing CriticalSorb™ absorption promoter, a best in class nasal absorption promoter, and delivered using an easy to use nasal spray device.

CriticalSorb™ is a marketed pharmaceutical excipient with an extensive toxicology package demonstrating its safety profile. Critical Pharmaceuticals has pending patents in major territories for CriticalSorb™ and its CP024 nasal growth hormone product.

CP024 has been developed with funding support from the Wellcome Trust.


Further Information
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 2,500+ scientific posters on ePosters
  • More than 3,700+ 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

Critical Pharmaceuticals Announce Interim Results of CP024 Nasal hGH Phase 1 Program
Clinical data show that CP024 is able to induce IGF-1 to the same levels as a subcutaneous injection of the marketed product.
Thursday, September 08, 2011
CriticalSorb™ Nasal Drug Delivery Technology Shows Excellent Local Tolerability in Long Term Preclinical Studies
Critical Pharmaceuticals is preparing to take the nasal drug delivery technology forward into a phase I clinical trial.
Wednesday, March 09, 2011
Scientific News
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Novel Technique for Kidney Research Developed
To better understand how the treatment leads to kidney damage, and possibly prevent it, a team of researchers at Yale School of Medicine developed a new 3D-imaging technique to peer deep into these vital organs.
Microscopic Fish are 3D-Printed to do More Than Swim
Researchers demonstrate a novel method to build microscopic robots with complex shapes and functionalities.
Promising Class of New Cancer Drugs Cause Memory Loss in Mice
New findings from The Rockefeller University suggest that the original version of BET inhibitors causes molecular changes in mouse neurons, and can lead to memory loss in mice that receive it.
A Better Way to Personalize Bladder Cancer Treatments
Researchers at UC Davis, in collaboration with colleagues at Jackson Laboratory, have developed a new way to personalize treatments for aggressive bladder cancer.
Breath of Fresh Air for Asthmatics
Researchers hope to develop a platform that will allow a range of drugs to be delivered by inhalation.
Capturing Cell Growth in 3-D
Spinout’s microfluidics device better models how cancer and other cells interact in the body.
Elastic Patch Releases Drugs in a Stretch
Researchers from have developed a drug delivery technology that consists of an elastic patch that can be applied to the skin and will release drugs whenever the patch is stretched.
New Extra ‘Sticky’ Microgel Could Revolutionise Bladder Cancer Treatment
Researchers have designed a new super-efficient way of delivering an anti-cancer drug which could extend and improve the quality of life for bladder cancer patients - and perhaps save lives.
Liposomes: A Basis for Drugs of the Future
An international group of scientists have recently presented a review of liposomes, microscopic capsules widely used all over the world in the development of new drugs.
SELECTBIO

Skyscraper Banner
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!