Living Cell Technologies Announces Positive Preliminary Data From DiabeCell Phase I/IIa Trial in Type I Diabetes
Initial Safety and Efficacy Demonstrated in First Two Patients
MELBOURNE, AUSTRALIA and AUCKLAND, NEW ZEALAND - Living Cell Technologies Limited today released positive preliminary results for its Phase I/IIa clinical trial of the company's proprietary DiabeCell® porcine islet cell implant for the treatment of type 1 diabetes.
The clinical trial is being conducted in six type 1 (insulin-dependent) diabetic patients. Participants in this trial are first administered the lowest clinically effective dose and then given additional treatments to achieve additional clinical benefit. Patients receive an initial dose equivalent to 5,000 IEQ (islet equivalents/kg) administered by injection into the peritoneal cavity, followed by a second dose six months later. Follow up monitoring continues for 12 months after the conclusion of the trial.
The primary efficacy endpoint for the trial is reduction in hemoglobin A1C (HbA1C) levels during the 12-month post-transplant period compared with baseline (week-1) levels. Secondary efficacy endpoints include glucose lability, reductions in hypoglycemia and nocturnal hypoglycemia, reductions in the average daily insulin dose of > 25%, changes in endogenous insulin secretion, and quality-of-life changes.
As of the date of this announcement, two of the six patients planned for the trial have been implanted with DiabeCell®. The first patient received the first dose in June 2007, and the second patient received the first dose in September 2007 at the Sklifasovsky Institute in Moscow. The clinical trial monitor, Geny Research Group Inc., a Boston based Clinical Research Organization, has indicated that both patients appear to be well and have shown no adverse effects. Each of them achieved much greater than the 25% minimum target reduction in daily insulin requirements at the three-month and one-month follow-ups, respectively.
Dr Paul Tan, LCT CEO stated, "This early indication of success is heartening for the prospects of the trial and development of a commercially available product. Our goal is to provide type 1 diabetics with more control over their blood glucose levels and increased independence from the need for insulin injections." The Company cautioned that the data is very preliminary and should be interpreted in the context of complete data that will be accrued from the remainder of the trial.
LCT intends to conduct a second Phase I/IIa clinical trial of 12 months duration in New Zealand of its DiabeCell® product with a patient cohort composed of eight long-standing type 1 diabetics. Patients will receive higher doses of DiabeCell® than in the trial currently underway. It is anticipated that this trial will start in late 2007 and then will be followed by a larger pivotal trial.
Further information on the Company's current clinical trial is available at http://www.lctglobal.com/news/167.php or http://www.lctglobal.com/news/149.php.
About Living Cell Technologies: www.lctglobal.com
Living Cell is developing cell-based products to treat life threatening human diseases. The Company owns a biocertified pig herd that it uses as a source of cells for treating diabetes and neurological disorders. For patients with Type 1 diabetes, the Company transplants microencapsulated islet cells so that near-normal blood glucose levels may be achieved without the need for administration of insulin or at significantly reduced levels. The company entered clinical trials for its diabetes product in 2007. For the treatment of Huntington's disease and other neurological disorders, the company transplants microencapsulated choroid plexus cells that deliver beneficial proteins and neurotrophic factors to the brain. Living Cell's technology enables healthy living cells to be injected into patients to replace or repair damaged tissue without requiring the use of immunosuppressive drugs to prevent rejection. Living Cell also offers medical-grade porcine-derived products for the repair and replacement of damaged tissues, as well as for research and other purposes.
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