28 June 2010: Sydney, Australia & Auckland, New Zealand. Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY), a global company pioneering the development of cell implants to treat diabetes, today announced that its DIABECELLR Phase I/IIa clinical data was presented at the 70th Scientific Session of the American Diabetes Association (ADA) on June 27 in Orlando, Florida by Professor Boris Draznin, Director, Adult Diabetes Program, University of Colorado Denver, School of Medicine. The ADA annual conference is the world's largest and most prestigious diabetes meeting, attended by over 20,000 members of the professional diabetes community including physicians, scientists, and other clinicians and health care professionals.
LCT's lead product, DIABECELL®, comprises encapsulated neonatal pancreatic islets that are implanted into the abdomen of patients using a simple laparoscopic procedure. Professor Draznin's presentation on the use of DIABECELLR to treat Type 1 diabetes concluded that it is possible to achieve therapeutic success without immunosuppression. The results of the first trial established proof of concept in humans and safety objectives have been met. DIABECELLR is presently in a dose escalating Phase II clinical trial in New Zealand. "There is growing acknowledgment by the diabetes medical community globally that DIABECELLR holds great promise in providing an improved treatment for Type 1 diabetes," said Professor Bob Elliott, LCT Medical Director. The full presentation is appended.
Transplantation of Microencapsulated Neonatal Porcine Islets in Patients with Type 1 Diabetes: Safety and Efficacy
Robert B. Elliott, Olga Garkavenko, Paul Tan, Nikolai N. Skaletsky, Andrei Guliev, Boris Draznin Auckland, New Zealand, Moscow, Russia, Aurora, CO
We examined the safety and efficacy of xenotransplantation without immunosuppression in 7 patients with Type 1 diabetes (T1D). Patients aged 23 to 63 and with duration of T1D between 5 and 15 years volunteered for this study. Intraperitoneal transplants were performed by laparoscopic surgery under general anesthesia at the Sklifosovsky Institute, Moscow, Russia.
Neonatal islets were isolated from the pathogen-free herd of Auckland Island pigs and encapsulated using alginate/polyornithine/alginate proprietary technology. Doses of microencapsulated neonatal islets have varied from 5,000 to10, 000 islet equivalents per Kg of body weight given on 1-3 occasions. No immune suppressants were used. Patients were treated with insulin pump or by multiple daily injections. They were monitored either continuously or intermittently with a continuous glucose monitoring device, using standard best clinical practice protocols. Two of seven patients became insulin independent. One of these two patients has been normoglycemic and insulin independent ten months after the third implant. Maximal insulin dose was reduced by a mean of 47.3% and HbA1C was reduced from 8.5% pre-transplantation to 7.0% at various times post-transplantation. Viable islets as adjudged by live/dead stains in intact capsules were recovered from the five patients who have had more than one implant. Porcine insulin was detected by high performance liquid chromatography in post implant sera in three patients who were so tested: one in a random sample taken from a patient at the time of insulin independence and in two other patients still treated with insulin at the time of oral glucose stimulation. No serious adverse reactions were noted, including hypoglycaemia, in any of the patients studied. There has been no evidence of xenosis. We conclude that intra-peritoneal transplantation of neonatal microencapsulated pig islets appears to be safe, including multiple implants. Clear evidence of benefit has been seen in the majority of patients so far, with promising duration of effect. A formal Phase1/2a trial using a similar protocol has been initiated in New Zealand.
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| At the company: Dr. Paul Tan Chief Executive Officer Mob: 021 608 784 (NZ) Tel:+64 9 276 2690 ptan@lctglobal.com Prof. Bob Elliott Medical Director Mob: +64 27 292 4177 Tel:+64 9 276 2690 belliott@lctglobal.com Ms Susanne Clay Chief Business Officer Tel: +64 9 270 7954 Mobile: +64 21 418 833 sclay@lctglobal.com |
Media and investor enquiries: NZ and Australia: Buchan Consulting Rebecca Wilson Tel: +61 3 9866 4722 Mobile: +61 417 382 391 rwilson@bcg.com.au Paul Dekkers Tel: +612 9237 2800 pdekkers@bcg.com.au |
About Living Cell Technologies - www.lctglobal.com
Living Cell Technologies (LCT) 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 Parkinson・s disease and other neurological disorders, the company transplants microencapsulated choroid plexus cells that deliver beneficial proteins and neurotrophic factors to the brain. LCT・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. LCT 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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