BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Ardana Plc Announces Positive Phase 1 Results


3/18/2008 12:07:01 PM

Edinburgh, UK, 18 March 2008 - Ardana plc (LSE:ARA) the pharmaceutical company specialising in improving human reproductive health, today announces positive results of its Testosterone Cream in a Phase I study to evaluate the absorption of testosterone in women from their unique cream formulation . This Phase I dose-finding study provided clear evidence of the effectiveness of Ardana’s cream in the transdermal delivery of testosterone in females.

Among other potential uses, Testosterone Cream could be developed as an androgen supplementation in the management of Female Sexual Dysfunction (FSD) and specifically Hypoactive Sexual Desire Disorder (HSDD). FSD is believed to be a relatively common condition, with an estimated prevalence within the general population of between 19% and 43%1.

The double-blind, randomised, placebo-controlled study was conducted by Dr Shalendar Bhasin at Boston University in the USA and involved 9 surgically menopausal women between 18 and 55 years of age. These subjects received in random order a single application of Testosterone Cream at a dose of 0.2g, 0.4g and 0.6g, or a placebo cream. Both placebo and active cream were applied to one upper arm only.

Preliminary analysis of the data show that the three doses, 0.2g, 0.4g, 0.6g, resulted in an increase in the average concentrations of testosterone over 24 hours of 10.6, 16.2 and 20.0 ng/dL respectively. The maximal concentrations were 36.6, 47.2 and 48.9 ng/dL respectively.

Ardana’s Testosterone Cream, which is also in Phase III clinical development for hypogonadal men in the USA, is a novel, patented method of delivering testosterone. Because of its reduced surface area requirement, Ardana’s Testosterone Cream appears to deliver testosterone more efficiently than existing gel-based testosterone products. The cosmetic-like cream consistency and low alcohol content contribute to a potentially user-friendly preparation. The Company recently announced positive results of a differentiation study which showed that the dermal tolerability of Testosterone Cream was comparable to normal saline.

Commenting on today’s announcement, Dr. Huw Jones, Ardana’s CEO, said: “We are very encouraged by these preliminary data for our novel Testosterone Cream as a potentially beneficial product for women. Testosterone is naturally present in women and restoration of testosterone deficiency has the potential to treat associated conditions such as Hypoactive Sexual Desire Disorder.”

1.JAMA. 1999 Feb 10;281(6):537-44.

For more information contact: Ardana plc Dr. Huw Jones. Chief Executive Officer Tel: + 44 (0) 131 226 8550

Financial Dynamics Julia Phillips Emma Thompson Tel: +44 (0)20 7831 3113



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES