LCT expands NZ trial of Diabecell to gather crucial dose-related data

By David Binning
Monday, 20 December, 2010

Australian xenotransplantation pioneers Living Cell Technologies announced today that the New Zealand minister of health has approved the expansion of the company’s clinical trial of Diabecell, a porcine-based implant designed to treat Type 1 diabetes.

The company will add two more patients to the trial, bringing the total to 14.

Read more about xenotransplantation.

The development follows last week's announcement by LCT that Russia had become the first country in the world to approve the supply and sale of Diabecell for Type 1 diabetics, following a three-year trial in Moscow. The decision marked the first official approval of a xenotransplantation therapeutic anywhere in the world.

The new entrants to the New Zealand trial will be dosed at 5000 islet equivalents per kilogram of body weight, thereby broadening the dose spectrum of the trial.

To date the lowest dosage was 10,000 islet equivalents, rising in 5,000 increments to 20,000.

LCT said that the fourth treatment arm at low 5,000 dose will help build the dose ranging data set needed to define target product profile for Phase III trials.

Based on the data collected to date, LCT said that it appears that Diabecell may be more effective in lower doses, an outcome which would enhance the marketability of the product.

“As often happens in medicine, we see a threshold zenith where there appears to be little additional therapeutic response to higher doses of DIABECELL, and it is currently thought that this threshold may have been reached in this clinical trial,” said LCT chairman and medical director Professor Bob Elliott.

“We believe reducing the dose may increase the clinical benefit of this treatment and will also mean we will require fewer islet cells to treat each patient. If this is proven true, it will be a very good outcome for the commercialisation of Diabecell.”

In addition to getting the go ahead from the health minister, New Zealand’s Northern X Regional Ethics Committee and the Data Safety and Monitoring Board have also formally approved the expansion of the trial.

LCT said that the safety profile of Diabecell as well as its therapeutic benefit continues to be confirmed as it continues with its dose-ranging studies in preparation for crucial Phase III trials expected to occur sometime next year.

“The data generated from this trial is invaluable to finalizing our target product profile so we can finalise planning of our final Phase III trials next year,” said LCT CEO Dr Ross Macdonald.

“We are working quickly toward the commercialisation of DIABECELL and gathering as much data as possible to ensure DIABECELL offers the optimal level of benefit to patients.” Eleven of the 12 Type 1 diabetes patients enlisted for the trial to date have received Diabecell, leading to marked improvement in diabetes management as well as a sharp reduction – in some cases complete elimination – of episodes of life-threatening low blood glucose levels, a condition known as hypoglycaemic unawareness.

Related News

Microgravity causes changes in gene expression rhythms

Astronauts exposed to microgravity experience changes to physiology, including immune...

NSW, Qld announce RSV immunisation programs for infants

The government-funded programs have been designed to ensure infants and young children at the...

Gut bacteria appear important for overcoming milk allergy

Gut bacteria are thought to help reduce allergic reactions to some foods, but little is known...


  • All content Copyright © 2024 Westwick-Farrow Pty Ltd