Diabetes Patient Successfully Transplanted in World-first DiabeCell(R) Trial
- Category: DNA RNA and Cells
- Published on Friday, 15 June 2007 04:00
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MELBOURNE, Australia and AUCKLAND, New Zealand | June 14, 2007 | Living Cell Technologies Ltd (ASX:LCT) is pleased to announce it has successfully transplanted the first of six type I (insulin dependent) diabetic patients in a world-first Phase I/IIa clinical trial under current regulatory standards, using its DiabeCell® pig islet cell transplant.
Patients in the Phase I/II trial will receive two low doses of the pig islet cells (DiabeCell®) every 6 months over a 12 month period, followed by a further 12 month study addressing the level of its therapeutic effect. In LCT’s dose ranging clinical program for DiabeCell®, recipients in this first trial are given the lowest clinically effective dose to demonstrate safety. The dosing is repeated for additional clinical benefit.
The company hopes to commercialise the product for general use by 2012.
“DiabeCell® has the potential to provide a very important new treatment for insulin-dependent diabetics, providing a better control of dangerous blood glucose levels and long-term secondary complications. If the trial is successful, a major stride in developing a better treatment for diabetes will have been accomplished,” commented Professor Bob Elliott, LCT’s Medical Director.
DiabeCell® is a pig pancreatic islet cell product that secretes insulin in response to the patient’s blood glucose levels. People with type I diabetes are not able to produce their own insulin because their pancreas cells are not functioning. DiabeCell® has been uniquely developed with a gel that forms a tiny capsule around the cells and prevents the patient’s immune system from destroying the transplant.
“This transplant launches LCT’s lead product into the clinic and moves the Company into a phase for growth in the value of our business,” said Dr Paul Tan, LCT CEO.
The trial is being held at the prestigious Sklifasovsky Institute in Moscow, which has extensive experience in organ transplantation and xenotransplantation. Boston-based GenyResearch Group acts as the project manager to ensure all elements of the trial adhere to international regulatory standards.
The company has been developing the necessary components to obtain regulatory approval for over a decade, with LCT now the only company with the current capabilities of owning a biocertified pig herd for supply of the cells, a GMP manufacturing unit to prepare the treatment and a specialised monitoring laboratory for assessing transplant recipients. The company also holds a strong patent portfolio in markets where DiabeCell® will be commercialised. Under the agreement, LCT will supply the cells and retain all IP and commercial rights to the product. The Russian partners will cover all costs of conducting the trial.
SOURCE: Living Cell Technologies Ltd