DiabeCell – for insulin dependent diabetes

A porcine pancreatic cell product for the treatment of insulin-dependent diabetes.

The islet cell efficiently secretes insulin, which is defective or absent in patients with type 1 diabetes. The cells are introduced into the abdomen of the patient in a simple procedure under local anaesthesia.
The encapsulated DiabeCells do not require the use of
immunosuppressant drugs.

Market

• Injections of insulin is an imperfect treatment.
• There are significant lifestyle and management issues related to the treatment.
• The World Health Organisation states that by 2030 there will be 370 million people with diabetes.
• In the US in 2002, diabetes cost $US132 Billion to treat.
• It is estimated that one in every ten health dollars spent in the US is on someone with diabetes. Diabetes is Australia’s fastest growing chronic disease.
• 520,000 Australians are diagnosed with diabetes. For every one who knows they have it, another has it but doesn’t know it – yet.
• Type 1 diabetes represents 10 to 15% of all cases.

Product Development

• Approved for a Phase I/IIA clinical trial in Russia designed according to FDA guidelines and monitored by a Boston-based Contract Research Organisation.
• NZ regulatory and ethics recommendation received to commence phase I/IIa clinical trial following Ministerial approval.
• Successful safety / efficacy of DiabeCell in preclinical primate diabetes trial.
• The company has completed the world's largest controlled diabetic primate pre-clinical study of its kind. The DiabeCell treatment was well tolerated with no adverse reaction in the treated monkeys and their insulin requirements were reduced.
• Long-term safety of islet cells [patient with implanted cells producing insulin at 9 years].

Scientific References

• Elliott RB, Escobar L, Tan PL, Garkavenko O, Calafiore R, Basta P, Vasconcellos AV, Emerich DF, Thanos C, Bambra C. Intraperitoneal alginate-encapsulated neonatal porcine islets in a placebo-controlled study with 16 diabetic cynomolgus primates. Transplantation Proceedings. 2005 Oct; 37(8):3505-8
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• Halberstadt CR, Williams D, Emerich D, Goddard M, Vasconcellos AV, Curry W, Bhatia A, Gores PF. Subcutaneous transplantation of islets into streptozocin-induced diabetic rats. Cell Transplant. 2005;14(8):595-605.
• Elliott RB, Escobar L, Garkavenko O, Bambra C. Safety and
  Efficacy of Encapsulated Islet Xenotransplantation. Congress of the Transplantation society, 5 - 10 September 2004, Vienna, Austria. (poster)
• Elliott RB, Escobar L, Calafiore R, Basta G, Garkavenko O, Vasconcellos A, Bambra C. Transplantation of micro and macro encapsulated piglet islets into mice and monkeys. Transplantation Proceedings. Jan 2005, 37(1): 466-469, 2005
• Wang DZ, Skinner S, Elliott R, Escobar L, Salto-Tellez M, Garkavenko O, Khoo A, Lee KO, Calne R, Isaac JR Xenotransplantation of neonatal porcine islets and Sertoli cells into nonimmunosuppressed streptozotocin-induced diabetic rats. Transplantation Proceedings. Jan-Feb 2005 37 (1): 470-1
• Isaac JR, Skinner S, Elliott RB, Salto-Tellez M, Garkavenko O,
  Khoo A, Lee KO, Calne R, Wang DZ Transplantation of Neonatal Porcine Islets and Sertoli Cells into nonimmunosuppressed nonhuman Primates Transplantation Proceedings. 2005
  Jan/Feb; 37(1): 487-80

Clinical Trials

• LCT will conduct two type I diabetes clinical trials in 2007. To be kept informed of developments, please send your contact details to lct@lctglobal.com The trials will be conducted in Auckland, New Zealand and Moscow, Russia, under strict regulatory guidelines and monitoring protocols.