Acrux Limited (ASX: ACR), the Australian pharmaceuticalcompany which specialises in administering drugs through the skin,today announced positive results from two more clinical studies of itsTestosterone MD-Lotion® treatment for testosterone deficiency in men,which is associated with a number of symptoms including lethargy,depression and reduced libido. Both studies were conducted at theCentre for Clinical Studies, Melbourne, with Professor Susan Davissupervising as Principal Investigator.
The studies compared bloodlevels of testosterone in healthy volunteers. The aim of the firststudy was to compare two different formulations of Testosterone MDLotion®, and the aim of the second study was to compare two differentapplication sites.
The results of the first study showed thatboth formulations provided similar blood levels, providing options forcontinued development of either formulation. In the second study, therewas a significant difference in absorption between the two differentapplication sites, providing important information for the design ofthe remaining clinical studies in men.
In both studies, thelotion was well tolerated, with no application site reactions noted,and no serious adverse events recorded. Full details of the studies arepresented in Appendix 1.
Acrux's development of Testosterone MDLotion® is continuing, with further studies to commence shortly toconfirm the doses required to maintain testosterone blood levels in thetarget range for effective treatment.
Acrux CEO and ManagingDirector, Dr Igor Gonda said: "We believe our fast drying, no-touchmetered dose lotion has significant competitive advantage over theexisting products in this growing market. The remaining trials suit ourexpertise and require moderate investment, so in line with ourfinancial plans we intend to complete them ourselves before choosingthe best option for sales and marketing".
The remaining development programme:
Thethree remaining clinical studies will involve measuring the amount ofdrug delivered to the bloodstream ("pharmacokinetics"), followingadvice from the US Food and Drug Administration (FDA). This means thatthe programme is more straightforward and has lower risk and lower costthan a traditional clinical study programme. Acrux plans to completeall remaining development, using its own expertise and experience inpharmacokinetic studies. A New Drug Application is targeted formid-2008 to obtain FDA approval to market the product in the USA. Thenext clinical study will commence later this year. This study willassess testosterone blood levels in male volunteers after multipledoses of Testosterone MD-Lotion®, with completion of the study plannedfor early 2006.
The target market:
It is estimated that fourto five million men suffer from low testosterone (hypogonadism) in theUSA alone, with this figure predicted to increase in future years.Global sales in the year to January 2005 of products to treathypogonadism were US $415 million, representing an increase of 12% overthe previous year (IMS Health, IMS Midas, MAT, Jan 2005).
www.acrux.com.auAcrux is a specialty pharmaceutical company, developing andcommercialising a range of patented, patient-preferred healthcareproducts for global markets, using its innovative technology toadminister drugs through the skin.
Acrux's product pipeline includes treatments of hormonaldeficiencies, pain and central nervous system disorders, as well as acontraceptive.
19 human clinical trials have been completed with 7 different drug products and the lead product, EvamistTM (Estradiol MDTS®), is currently in a phase 3 clinical trial in the USA.Acrux has licensed USA rights for EvamistTM(Estradiol MDTS®) and Testosterone MDTS® to VIVUS and AUS/NZdistribution rights for Testosterone MDTS® and Fentanyl MDTS® to CSLLimited. Acrux has also licensed its technology to Eli Lilly forveterinary healthcare products, to Napa Biosciences for certaindermatology products and to Connetics for anti-psoriatics and localanaesthetics.
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