Ausio Pharmaceuticals To Present At Bio(r) 2009

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15th May 2009, 07:21am - Views: 450

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Ausio Pharmaceuticals to Present at Bio(R) 2009

CINCINNATI, May 15 /PRNewswire-AsiaNet/ --

    Initial results from preclinical and Phase 1 safety studies, and plans for Phase 2 studies for menopausal

symptoms and benign prostatic hyperplasia (BPH) are to be presented

    Ausio Pharmaceuticals, LLC, a biotechnology development company focused on medicines for an aging

global population, will lead off the Bio(R) Business Forum in a presentation on May 19, 2009 at 9:00 AM in

Atlanta, Georgia. Ausio has developed AUS-131, a pharmaceutical formulation of the soy metabolite S-equol.

AUS-131 is expected to provide soy health benefits by consistently delivering therapeutically appropriate

levels of S-equol, validated in clinical trial programs. Ausio has successfully completed two Phase 1 clinical

trials for AUS-131, and Phase 2 studies are scheduled for treatment of menopausal symptoms and BPH.

    AUS-131 Preclinical and Phase 1 Clinical Results

    AUS-131 is pure, synthetic S-equol, a soy metabolite, and acts as a nonsteroidal, nonhormonal, selective

estrogen receptor beta (ER beta) agonist. The safety profile of AUS-131 in FDA-required preclinical studies

was excellent, and AUS-131 has demonstrated positive effects in rodent models of menopausal hot flashes

and BPH, supporting its promise for the treatment of these conditions in humans. In Phase 1 trials, AUS-131

demonstrated a favorable safety and pharmacokinetic profile, with no significant drug-related adverse events

at doses several-fold higher than the expected therapeutic range.  

    Phase 2 clinical trials to assess the efficacy of AUS-131 for relief of menopausal symptoms and BPH are on

schedule to begin September 2009. The expected completion date for the Phase 2 clinical trials is Q2 2010.  

    About AUS-131

    AUS-131 is pure, synthetic S-equol, a potent metabolite of the soy isoflavone, daidzein, which is produced

in only a subset of individuals. AUS-131 is a first-in-class, nonsteroidal, nonhormonal, selective ER beta

agonist that has the potential to provide therapeutic benefits with an excellent safety profile compared to

estrogen. AUS-131 is being evaluated for a wide range of indications, including menopausal symptoms,

benign prostatic hyperplasia, osteoporosis, and topical applications.

    Ausio Pharmaceuticals, LLC is a global biotechnology development company committed to cultivating key

partnerships with the goal of advancing medicines for an aging population. Ausio was founded in 2006 based

on technologies licensed from the Australian Health and Nutrition Association Ltd, NSW, Australia and

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio and has garnered strong patent position for its

lead compound, AUS-131. 

SOURCE: Ausio Pharmaceuticals, LLC

    CONTACT: Dr Richard Jackson of Ausio Pharmaceuticals, LLC, 




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