Wednesday, September 7th, 2011
Clinical trial of vessel dilator for congestive heart failure (CHF) patients

Madeleine Pharmaceuticals, based in Mount Barker, South Australia, has reached agreement with Medtronic Inc. to conduct a clinical trial with a Medtronic programmable infusion pump to evaluate a drug-device combination of Pro ANP 31-67, Madeleine’s lead drug candidate. The clinical trials will be conducted at the Royal Adelaide Hospital under the direction of Professors Stephen Worthley and Paul Rolan.

Patients suffering from congestive heart failure (CHF), a condition which is defined as the inability of the heart to supply sufficient blood flow to meet the needs of the body, will be given Pro ANP 31-67, also known as vessel dilator, in order to judge the pharmacokinetics of the peptide in the body and provide information on the safety of administration. These studies may provide the basis for further investigations of the drug in this major affliction.

Heart failure is a common, costly, disabling, and potentially deadly condition. In developed countries, around 2% of adults suffer from heart failure, but in those over the age of 65, this increases to 6–10%. Heart failure is the leading cause of hospitalization in people older than 65. Heart failure affects close to 5 million people in the USA alone and each year close to 500,000 new cases are diagnosed. More than 50% of patients treated and released from hospital for treatment of CHF seek re-admission within 6 months after treatment and the average duration of hospital stay is 6 days. Madeleine anticipates that vessel dilator could shorten hospitalization stay or reduce post-acute re-hospitalization of heart failure patients; two potential significant contributors to reducing health care costs.

Stephen Worthley, Helpman Chair of Cardiovascular Medicine at University of Adelaide, is currently conducting an ongoing study in patients with a most severe form of CHF, namely: acute decompensated congestive heart failure (ADCHF). “I am very pleased that we could engage Medtronic to work with Madeleine to evaluate the pharmacokinetics of a subcutaneous infusion of this peptide. Our ongoing studies are looking at intravenous infusion for an acute application. A longer term administration via the subcutaneous route using Medtronic’s infusion system can serve as a potential new therapeutic approach for the patients in the post-acute setting.”

Paul Rolan, Professor of Clinical Pharmacology at the University of Adelaide, is pleased that Madeleine has such a strong partner as Medtronic, adding: “Medtronic is an innovator and their understanding of this disease and vessel dilator is unprecedented for a device technology company. We intend to learn a great deal from each other in this study.”

Vessel dilator was identified by Professor David Vesely whilst working at the Veteran’s Hospital in the United States. His work focused on a class of novel natural peptides called cardiac hormones or natriuretic peptides. Madeleine has acquired the rights to patents filed by Professor Vesely.

Madeleine has received funds from the Bio Innovation SA, NCRIS (National Collaborative Research Infrastructure Strategy), Commercialisation Australia and Terra Rossa Capital.

Contact Profile

Madeleine Pharmaceuticals

Madeleine Pharmaceuticals is privately held and based in South Australia focussed on the clinical development and manufacture of natriuretic peptides.
Martha Merz, Madeleine Pharmaceuticals
P: 0414 69 70 71


Clinical trial of vessel dilator with Medtronic for congestive heart failure (CHF) patients



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