Healthcare Industry News: organ transplant
News Release - June 14, 2007
Living Cell Technologies Announces First Diabetes Patient Successfully Dosed in Phase I/IIa DiabeCell(R) TrialProprietary Pig Cell Implant Technology
MELBOURNE, AUSTRALIA--(Healthcare Sales & Marketing Network)--Jun 14, 2007 -- Living Cell Technologies Ltd. (ASX:LCT.AX ), a leading developer of live cell therapy products to treat life threatening human diseases, announced today that it has successfully dosed its first patient in a Phase I/IIa clinical trial using its proprietary DiabeCell® pig islet cell transplant to treat type I diabetes.
The DiabeCell® clinical trial is being conducted in six type 1 (insulin-dependent) diabetics. Recipients in this first trial are given the lowest clinically effective dose to demonstrate safety and then dosing is repeated for additional clinical benefit. The patients receive an initial transplant dose equivalent to 5,000 IEQ (islet equivalents/kg) administered by injection into the peritoneal cavity, followed by a second transplant six months later. Follow up monitoring will continue for 12 months.
The primary efficacy endpoint for the trial is reduction in hemoglobin A1C (HbA1C) levels over the 12-month post-transplant period compared with baseline (week-1). Secondary efficacy endpoints include glucose lability, reductions in hypoglycemia and nocturnal hypoglycemia, reductions in the average daily insulin dose of > 20%, changes in endogenous insulin secretion, and quality-of-life changes.
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 so that when the recipient diabetic is injected, it is not destroyed by the recipient's immune system. The natural cells are coated in an alginate gel that forms a tiny capsule around the cells and prevents the patient's immune system from destroying the transplant.
Professor Bob Elliott, LCT's Medical Director, commented, "DiabeCell® has the potential to provide greater independence from insulin for diabetics, as well as better control of dangerous blood glucose levels and long-term secondary complications, as well as the benefits from not requiring immunosuppressive treatment. If the trial is successful, a major stride in developing a better treatment for diabetes will have been accomplished."
The 12-month Phase I/IIa trial is being conducted at the Sklifosovsky Clinical and Research Institute in Moscow, which has extensive experience in organ transplantation and xenotransplantation. Boston-based contract research organization (CRO) GenyResearch Group is managing the project to ensure all elements of the trial adhere to international regulatory standards. LCT's Russian partner is funding the trial, including GenyResearch Group's services. LCT is supplying the cells and will retain all intellectual property and commercial rights to the product.
Once the initial Phase I/IIa trial is completed to ensure safety, a second 12-month study addressing the level of its effect in diabetics will be conducted.
The Company owns and operates a bio-certified pig herd for supply of cells, a GMP manufacturing unit to prepare the treatment and a specialized monitoring laboratory for assessing transplant recipients. The company also holds a strong patent portfolio in markets where DiabeCell® will be commercialized.
Dr Paul Tan, LCT CEO, stated, "The movement of DiabeCell® into the clinic is a significant milestone for LCT. We have a commercial strategy in place and look forward to progressing discussions with various regulatory authorities and partners."
Scientific papers relating to DiabeCell® are available for download on the LCT website at www.lctglobal.com/scientificarticles.php.
About Living Cell Technologies: www.lctglobal.com
Living Cell Technologies Ltd (ASX:LCT.AX ) develops live cell therapy products to treat life threatening human diseases. The ASX listed, vertically integrated company focuses on developing treatments where healthy living cells are injected into patients to replace or repair damaged tissue, without requiring the use of toxic drugs to prevent rejection. LCT owns a biocertified pig herd for the supply of medical-grade cells and is developing products to treat diabetes and neurological disorders.
Source: Living Cell Technologies
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