LCT wins approval to initiate Phase I/IIa diabetes trial in New Zealand

The minister’s approval is the culmination of a thorough regulatory process under the Medicines Act 1981, involving detailed consideration of clinical and ethical issues by a wide range of expert bodies over a two-year period, and public consultation. Approval is subject to extensive conditions designed to safeguard the health and safety of the trial’s participants and the wider public, and will be monitored on an ongoing basis by the Ministry of Health.

Living Cell Technologies (LCT) commenced a Phase I/IIa clinical trial of DiabeCell in Russia in June 2007 and continues to enroll patients into the program. The Russian component of Phase I/IIa development was designed to include only the lowest dose, 5,000 islet equivalents (IEQ/kg) of the DiabeCell product; however, as a result of positive preliminary results, it was expanded to include a higher dose, 10,000 IEQ/kg, which is now being studied.

The minister’s approval allows LCT to extend its Phase I/IIa clinical data. The New Zealand trial will enroll eight patients, four of whom are to receive the dose of 10,000 IEQ/kg followed by four patients to receive the high dose of 15,000 IEQ/kg.

Robert Caspari, CEO of LCT, said: “Obtaining approval to begin our clinical trial is a major milestone for the company and also makes it easier for LCT to obtain approvals in other countries.

“Porcine insulin has been used therapeutically for 80 years to treat type 1 diabetes. Early data shows that utilizing our proprietary encapsulation technology with islet cells may significantly reduce daily insulin requirements in type 1 diabetics.”