ambro morgans article

Picked this up off another poster, hope they don,t mind.

Ventracor loving its new trial designs

Kayt Davies
Thursday, 15 February 2007

HEART company Ventracor had a busy Valentine's Day, announcing its half-year results and new ideas for its upcoming clinical trial designs that could solve problems with slow enrolments and shave as much as 18 months off its estimated time to market. The new trial designs are so innovative that Ventracor has lodged patent applications for them.

Chief executive Peter Crosby said: "Ventracor's overall objective is to reach the end point of FDA approval to market the VentrAssist heart device in the US as soon as possible."

In order to achieve this Ventracor is progressing the VentrAssist through clinical trials in patients ineligible for heart transplant (destination therapy) and to support patients while they wait for transplant hearts to become available (bridge to transplant).

The major hindrance has been the need for trials to have a randomly assigned control arm, which has meant that patients going into the trial had to be prepared to receive either the Ventracor device or Nasdaq-listed Thoratec's HeartmateXVE, which Crosby described as "big, cumbersome and associated with a number of problems."

The upshot, in his words, is that it's been hard to get people willing to take that risk.

Under the current FDA requirement that VentrAssist be tested against another FDA-approved left ventricular assist device, and with the HeartmateXVE being the only one, it has been, until now, a necessary component of the VentrAssist's path to market.

Crosby was saying yesterday though that Ventracor had proposed an alternative study design for its two concurrent upcoming trials that would deal with both this issue and the need for destination therapy data from an end point that is two years after the implantation of the last patient.

While he wasn't yet disclosing the solutions Ventracor is proposing, he said: "We have discussed the trial designs with the FDA and if the results of the trials meet the statistical end points we are pretty confident that we will get approval."

He confirmed that the US Food and Drug Administration had approved both trial protocols.

Crosby said the trials would be run concurrently at up to 40 centres in the US and that the implants used in the trials would be sold on normal commercial terms, and would contribute to future revenue growth.

Simple maths on the figures below indicate that the trials alone will involve 240 VentrAssist devices sold at approximately $100,000 each (total around $24 million) during the period of patient recruitment.

Releasing its half-year figures the company announced that total revenue received during the six months was $2.6 million (up from $1.3 million for the same period last year), including revenues of $1.2 million (up from $500,000) from the sale of its VentrAssist in Australasia, Europe and the US.

Crosby noted that while the company's loss for the half year was $17.9 million (more than the 2005 half-year loss of $14.8 million) the figure reflected an increase in spending on regulatory, clinical affairs and marketing. The company's cash position as at December 31, 2006 was $35.1 million.

ABN Amro Morgans analyst Scott Power noted the announcements and recommended buying Ventracor scrip up to $1.25.

Background Notes

The details Ventracor did release about the new trials are as follows:

The Destination Therapy Protocol is a prospective, randomised, controlled trial with two modules. Both modules have event driven end points.

Module A (primary) consists of 180 patients with 2:1 randomisation of the VentrAssist to the control arm, which does not require implantation of an LVAD approved by the FDA for DT.

Module B (secondary) consists of up to 45 patients, with randomisation of the VentrAssist to an LVAD approved by the FDA for DT.

The BTT Protocol is a single arm prospective trial to an objective performance criterion, defined as heart transplantation or listed for heart transplantation at 180 days. There will be an interim analysis at 98 outcomes. Data from patients in the feasibility trial may be pooled with data from patients in the pivotal trial.

Enrolment in both trials will commence following FDA approval after review of data from patients in the currently running feasibility trial.