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New - Oral Treprostinil Research.
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PHSANZ ASM 2014

With only 43 days to go for the 4th PHSANZ ASM at Novotel Twin Waters, it's time to get on and register - Registering early is important to help us ensure correct numbers for catering and other requirements at the venue.

Also, please give some consideration to your travel arrangements – our previous newsletter has all the details of the options available and can be viewed by clicking here.
 

IMPORTANT REMINDER

Abstracts submissions for the for PHSANZ ASM are due 5pm September 8th (6 days to go!)

 

RESEARCH in Australia

 

New PHT Research


Phase 3 Clinical Research Study of Oral Treprostinil for the Treatment of Pulmonary Arterial Hypertension.

Six (6) Australian hospital centres (see details below) are participating in a Phase III clinical trial of patients with pulmonary arterial hypertension (PAH) involving a sustained release oral formulation of treprostinil (a prostacyclin analogue). This randomized, double-blind, placebo-controlled study is evaluating the study drug administered in combination with background oral monotherapy; either a phosphodiesterase (PDE)-5 inhibitor (sildenafil or tadalafil), an endothelin receptor antagonist (ERA; ambrisentan, bosentan or macitentan) or a soluble guanylate cyclase stimulator (sGC; riociguat).

Treprostinil is currently approved in the United States and other territories for the treatment of PAH when administered by subcutaneous or intravenous infusion (Remodulin), by inhalation (Tyvaso), and most recently by the oral formulation  (Orenitram). The sponsor is continuing  to develop  this oral formulation administered three times daily, which offers a potentially easier mode of administration for patients. Over 1,000 PAH patients have received oral treprostinil with the longest exposure at almost 7 years in an ongoing open-label study. A previous randomized, double blind, placebo controlled study of oral treprostinil administered as monotherapy demonstrated a statistically significant improvement in exercise capacity in PAH patients after 12 weeks of therapy. This pivotal study supported the recent approval by the US FDA of oral treprostinil (Orenitram®) for the treatment of WHO Group I PAH.

Approximately 858 subjects and 150 research sites across 24 countries will participate in this study. The patients that complete this double-blind placebo-controlled study per protocol may also be eligible for long term therapy with oral treprostinil via the open-label extension study.

For further information, or if you think that any of your PAH patients may be suitable for referral to participate in this clinical trial, please contact your local trial centre.
 
Principal Investigator Hospital / location Contact number(s)
Dr Fiona Kermeen Prince Charles Hospital, Chermside 07 3139 4511, 3139 5696 (fax), 07 3139
5159 (study coordinator)
Prof Anne Keogh St. Vincent’s Hospital, Darlinghurst 02 8382 2641, 02 8382 3723
Prof Trevor Williams Alfred Hospital, Melbourne 03 9076 2405, 03 9076 2743 (Nurses:
Trudi Miller/Christianne Manterfield)
Dr Benjamin Ng Nepean Hospital, Kingswood 02 4734 4209
Prof Peter Youssef Royal Prince Alfred Hospital,
Camperdown
02 9515 9337
Dr Nathan Dwyer Royal Hobart Hospital, Hobart 03 6222 7881, 03 6222 8034
 
Register Today - With Less than 7 weeks to go until the 2014 PHSANZ ASM it's time to register and make your travel arrangements!

Registration is fast and easy via our online portal at www.phsanz.com.au and best of all it's free for all clinical members.
 
ABSTRACT SUBMISSIONS CLOSE MONDAY SEPTEMBER 1 at 5pm.

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