Corporate Banner
Satellite Banner
Biologics & Bioprocessing
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

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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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 and The University of Nottingham to Develop Nano-Enabled Nasal Spray for Osteoporosis
The Technology Strategy Board and the Engineering and Physical Sciences Research Council (EPSRC) provide grant funding to support the £545,000 project.
Thursday, February 16, 2012
Scientific News
Madison Researchers Begin Work on Zika Virus
Work will start with basic questions about Zika virus infection.
Envigo Rat Models Proven to be Susceptible to Intra-Vaginal HSV-2 Infection and Protectable
Scientific findings establish the effectiveness of new approach to investigate the protective effects of vaccine candidates and anti-viral microbodies and to study asymptomatic primary genital HSV-2 infection.
Drug that Activates Innate Immune System Identified
Researchers from the institute have identified a drug, which is straightforward to synthesize and to couple to antigens that induce an immune response and may prove useful in the generation of vaccines.
Valvena, GSK Sign New R&D Collaboration
Valneva to supply process development services for EB66® -based Influenza vaccines.
Counting Cancer-busting Oxygen Molecules
Researchers from the Centre for Nanoscale BioPhotonics (CNBP), an Australian Research Centre of Excellence, have shown that nanoparticles used in combination with X-rays, are a viable method for killing cancer cells deep within the living body.
Therapeutic Approach Gives Hope for Multiple Myeloma
A new therapeutic approach tested by a team from Maisonneuve-Rosemont Hospital (CIUSSS-EST, Montreal) and the University of Montreal gives promising results for the treatment of multiple myeloma, a cancer of the bone marrow currently considered incurable with conventional chemotherapy and for which the average life expectancy is about 6 or 7 years.
Protein Protects Against Flu in Mice
The engineered molecule doesn’t provoke inflammation and may hail a new class of antivirals.
Crowdfunding the Fight Against Cancer
From budding social causes to groundbreaking businesses to the next big band, crowdfunding has helped connect countless worthy projects with like-minded people willing to support their efforts, even in small ways. But could crowdfunding help fight cancer?
Natural Protein Points to New Inflammation Treatment
Findings may offer insight to effective treatments for inflammatory diseases, such as rheumatoid arthritis, psoriasis, and multiple sclerosis.
Tricked-Out Immune Cells Could Attack Cancer
New cell-engineering technique may lead to precision immunotherapies.
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!