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Release issued 12th May 2003Acrux Limited announced today the commencement of Phase 2 clinical trials of its investigational product for treating women with low libido. Acrux subsidiary FemPharm Proprietary Limited will conduct the trial of Testosterone Metered-Dose Transdermal Spray (MDTS®), for which an Investigational New Drug (IND) application has already been cleared by the United States Food and Drug Administration (FDA). "There is increasing recognition that a cluster of symptoms, including low libido, fatigue and reduced sense of well-being, is associated with low serum testosterone levels in some women," said Dr Andrew Humberstone, Director of Pharmaceutical Research and Development at FemPharm. "Several studies have shown that these symptoms can be improved by the administration of testosterone. However, there are currently no products approved for these indications and the establishment of the minimum effective and safe dose has been limited by lack of availability of low dose testosterone formulations suitable for women. Our aim is to develop a safe and effective treatment of low libido in these women." The clinical study will compare the effect of testosterone with placebo on the frequency of satisfactory sexual events in women who have low serum testosterone levels and low libido. "We are fortunate to be able to work with leading researchers in Australia. Ethics Committee approval has been obtained in Melbourne and Perth already. Clinical centres in Adelaide and Brisbane will also be involved in this Phase 2 study in 200 premenopausal women." Acrux Limited's group of companies is engaged in the development of proprietary transdermal and cosmeceutic products using technology licensed from Monash University, Melbourne, Australia. The company has completed eleven human clinical trials with 6 different drugs using the proprietary ACROSS® enhancers and Metered Dose Transdermal System (MDTS®) for transdermal administration. Acrux portfolio includes treatments of hormonal deficiencies, pain, anxiety, Alzheimer's and Parkinson's disease, nausea and urinary incontinence. In addition to the projects funded internally, Acrux has a research and development collaboration with Pharmacia (recently acquired by Pfizer Inc.) and it has also sub-licensed its technology for anti-psoriatics and local anesthetics to Connetics Australia Pty. Ltd., a subsidiary of the US company Connetics. Further information about Acrux can be found at www.Acrux.com.au. Acrux Limited is located at 103- 113 Stanley Street, West Melbourne, VIC 3001, Australia, tel +61 3 8379 0100, fax +61 3 8379 0101.
If you want to find out more about the company visit Acrux profile.
(23rd September 2003) Acrux licenses Technology to Eli Lilly and Company for Animal Health Products
(3rd February 2003) Prominent Australian Businessman Nuno D'Aquino named as Acrux Ltd Chairman
(22nd October 2002) Acrux reports on progress with the treatment of female sexual dysfunction
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