Baker Institute spin-off enters agreement

V-Kardia, the first spin-off company from the Baker Heart Research Institute in Melbourne, has entered into an agreement with Californian-based molecular cardiology company, Celladon, to develop and supply its V-Focus device for percutaneous delivery of gene therapy for congestive heart failure.

Announced today at the Bio 2005 conference in Philadelphia, the V-Focus device is a closed loop catheter system that allows cardiac circulation to be isolated for the delivery of gene therapies and drugs directly to the heart.

The procedure takes about 15 minutes and involves the delivery of the therapy directly into the heart's muscle cells. It is carried out in conscious patients and is similar to the delivery of coronary angioplasty, and therefore easily adapted by interventional cardiologists.

"The agreement involves V-Kardia developing the delivery system in conjunction with Celladon through to FDA approval," said Erica Hughes, chief operating officer with V-Kardia. "V-Kardia has also entered into a supply agreement with Celladon and will receive contract development payments, payments for devices and license fees including milestones and royalties on product sales."

Congestive heart failure is a life-threatening condition where the heart loses its ability to pump blood efficiently. It results in a severely diminished quality of life for sufferers, and has a mortality rate higher than most cancers -- 70 per cent of people with heart failure die of the disease within 10 years.

Celladon's treatment, which targets the SERCA2a pathway, increases calcium cycling in the heart muscle cells -- with the aim of increasing the ability of the cells to function.

"The device can be used for any gene or drug that you want to target directly to the heart," said Hughes. "The problem at the moment is that treatments for heart disease are in the form of a pill that circulates throughout the body and affect other organs, such as the kidney.

"This system isolates the heart's circulation, reducing any detrimental affects on the kidney as well as enabling the use of lower doses of a treatment."

Hughes said the V-Focus system also has applications for other organs. Celladon will receive options to use the V-Kardia system with five additional therapeutic targets for cardiovascular and other indications.

"At the moment our focus is to develop the device through to FDA approval," said Hughes. "Then we will start to look at applying it to other organs such as the kidney and the liver."

Incorporated in January 2005, V-Kardia is 100% owned by the Baker Institute. Hughes said the Melbourne-based team, which has an R&D focus, is currently expanding and they are recruiting a team to set up a US subsidiary in Minneapolis, where the manufacturing will be based.

V-Kardia will supply devices for Celladon's clinical trials in heart failure patients scheduled to commence in 2006.